SKYRIZI™▼(risankizumab) Receives NICE Positive Technology Appraisal Guidance for the Treatment of Plaque Psoriasis in Adults

Press releases   •   Aug 21, 2019 09:19 BST

MAIDENHEAD, UK, 21 August 2019 - AbbVie (NYSE: ABBV), a research-based biopharmaceutical company, announces that eligible patients in England and Wales with plaque psoriasis who have failed conventional systemic therapies will have access to SKYRIZI™▼(risankizumab) following the issuing by the National Institute for Health and Care Excellence (NICE) of the Technology Appraisal Guidance (TAG) recommending the treatment1.

The TAG represents the completion of the final step of NICE assessment and follows a positive recommendation by NICE through its Fast Track Appraisal process, which has an accelerated timeframe of 30 days for implementation rather than the usual 90 days associated with a Single Technology Appraisal.

Plaque psoriasis is a chronic condition affecting an estimated 820,000 people in the UK and many patients still do not reach treatment goals or lose treatment response over time2-4. In clinical studies risankizumab demonstrated high rates of skin clearance at 16 weeks and this clearance was also maintained through to one year (52 weeks).5

This announcement means that risankizumab will be made available to eligible patients almost two months earlier than would have been the case via other NICE assessment routes.

Skyrizi is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.

About risankizumab in the UK

Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information6

Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. It is also contraindicated in patients with clinically important active infections (e.g. tuberculosis). Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie on UK_PVVendor@abbvie.com. With biological medicines, healthcare professionals should report adverse reactions by brand name and batch number.

This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) at https://www.medicines.org.uk/emc . Globally, prescribing information varies; refer to the individual country product label for complete information.

-Ends-

UK Media:

Sarah Beck

+44 (0)7818 428111

Sarah.beck@abbvie.com

References:

1 The Technology Appraisal Guidance (TAG) can be accessed via the NICE website

2 International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/wp-content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf. Accessed March 22, 2019

3 Mroweitz, U., et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan; 303(1): 1–10

4 National Institute for Health and Care Excellence. Resource impact template: Brodalumab for treating moderate to severe plaque psoriasis (TA511). March 2018, available at: www.nice.org.uk/guidance/ta511/resources/resource-impact-template-excel-4786962589 (accessed August 2019)

5 Blauvelt, A. et al. Risankizumab Efficacy/Safety in Moderate-to-Severe Plaque Psoriasis: 16-Week Results From IMMhance [abstract P066]. Acta Derm Venereol. 2018; 98(suppl 219): 30

6 SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.medicines.org.uk/emc

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

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New chemotherapy-free combination treatment VENCLYXTO®▼(venetoclax) plus rituximab accepted for use on the NHS in Scotland for people with previously treated Chronic Lymphocytic Leukaemia

Press releases   •   Aug 12, 2019 14:31 BST

  • For the first time, people in Scotland with Chronic Lymphocytic Leukaemia (CLL), who have received at least one prior therapy, now have access to a new chemotherapy-free option with a fixed treatment duration of 24 months.1
  • SMC acceptance is based on the MURANO phase 3 clinical trial, in which venetoclax plus rituximab (VenR) reduced the risk of disease progression or death by eighty-three percent compared to a standard of care chemoimmunotherapy regimen of bendamustine plus rituximab (BR).1
  • CLL is the most common form of adult leukaemia with over 3,500 people diagnosed every year in the UK.2,3

MAIDENHEAD, UK, 12th August 2019 – AbbVie (NYSE: ABBV) announced today that NHS patients in Scotland with relapsed/refractory chronic lymphocytic leukaemia (R/R CLL) who have received at least one prior therapy will now have access to venetoclax plus rituximab, a new chemotherapy-free option with a fixed treatment duration of 24 months. The Scottish Medicines Consortium’s (SMC’s) acceptance follows The National Institute for Health and Care Excellence (NICE) recommendation for the combination therapy to be made available on the NHS in England and Wales on 18th January 2019.4

CLL is the most common form of adult leukaemia, or blood cancer, in which too many immature lymphocytes (a type of white blood cell) are found predominantly in the blood and bone marrow.3,5 Over 3,500 people are diagnosed with CLL in the UK each year.2 For those patients living with CLL requiring treatment, the majority will eventually have their disease recur.6

Zack Pemberton-Whiteley, Patient Advocacy Director at Leukaemia Care said: “We’re delighted the SMC has decided to make the venetoclax plus rituximab combination treatment available in Scotland on the NHS to people living with relapsed or refractory CLL. This decision has the potential to change outcomes in an area where we have seen few clinical advances until recently. Hearing your disease has relapsed or become refractory can be overwhelming for patients and their families, so the SMC’s decision to make available an effective chemotherapy-free option with a fixed treatment duration is very much welcomed by the patient community.”

The SMC’s positive Final Advice is based on results from the pivotal phase 3 MURANO clinical trial, which evaluated the efficacy and safety of venetoclax in combination with rituximab compared to a standard of care chemoimmunotherapy regimen of bendamustine in combination with rituximab. At the time of the primary analysis, the trial demonstrated an eighty-three percent reduction in the risk of disease progression or death (hazard ratio [HR]:0.17; 95% confidence interval [CI]: 0.11-0.25; P<0.0001) and prolonged overall survival (OS) compared to the standard of care chemoimmunotherapy (HR: 0.48; 95% CI: 0.25-0.90; overall survival data are not yet mature).1

Dr Mike Leach, Consultant Haematologist at the Beatson West of Scotland Cancer Centre in Glasgow, said: “The SMC’s approval of venetoclax plus rituximab for the second line treatment of CLL is a significant step forward for patients in Scotland. The MURANO study data has highlighted that venetoclax plus rituximab achieves superior progression-free survival compared to a commonly used chemotherapy-based combination. It is capable of achieving deep levels of response with a fixed duration of therapy and allows treatment free periods for our CLL patients.”

In the MURANO clinical trial, undetectable minimal residual disease (uMRD), also known as minimal residual disease negativity (MRD-), was a secondary endpoint. Undetectable minimal residual disease, is defined as the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment.7 At the nine-month time point, sixty-two percent (n=121/194) of patients in the trial who received venetoclax plus rituximab achieved uMRD in the peripheral blood versus thirteen percent (n=26/195) who received bendamustine plus rituximab.1

Recent post treatment follow-up data has provided evidence on long-term outcomes for venetoclax in combination with rituximab. Of the 130 patients who completed rituximab plus the 24-month fixed duration of venetoclax, the estimated Progression Free Survival (PFS) rate at six and 12 months were 92 percent and 87 percent, respectively.8

Alice Butler, Medical Director at AbbVie commented, “AbbVie is committed to developing and delivering breakthrough therapeutic options in CLL, an area where there is high unmet need and where there are few treatments available. We have worked closely with the SMC to bring venetoclax plus rituximab to patients in Scotland as quickly as possible. This is a very positive outcome for Scottish patients and today’s decision will motivate us further in our ongoing drive to improve patient outcomes in blood cancer.”

Venetoclax is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.

- Ends -

The final SMC guidance can be accessed via the SMC website.

For venetoclax’s Summary of Product Characteristics, please visit: https://www.medicines.org.uk/emc/medicine/32650.

Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie UK Ltd. Please contact uk_pvvendor@abbvie.com

For further information:

AbbVie UK Media:

Joanna Jones 

07795590344

Joanna.jones@abbvie.co

Francesca Morley

07795360167

Francesca.Morley@virgohealth.com

Notes to editors

About venetoclax

Venetoclax is an oral B-cell lymphoma-2 (BCL-2) inhibitor. The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be overexpressed in CLL cells.9 Venetoclax, which is an oral once-daily treatment, is designed to selectively inhibit the function of the BCL-2 protein restoring the death instinct in the cancerous cells.9

In the MURANO phase 3 clinical trial, the most common adverse event of any grade in both the treatment and control groups was neutropenia (60.8% of the patients in the venetoclax–rituximab group and 44.1% of the patients in the bendamustine–rituximab group). The incidence of serious adverse events was similar in the two groups.1

About AbbVie in Oncology

At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie's oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumour types.

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvieuk on Twitter.

References

1 Seymour JF, Kipps TJ, Eichhorst B, et al. Venetoclax-rituximab in relapsed or refractory chronic lymphocytic leukemia. N Engl J Med. 2018;378(12):1107-1120.

2 Cancer Research UK. Chronic lymphocytic leukaemia (CLL) incidence statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/leukaemia-cll/incidence. Accessed: July 2019

3 Cancer Research UK. Chronic lymphocytic leukaemia (CLL): Risks and causes. Available at: https://www.cancerresearchuk.org/about-cancer/chronic-lymphocytic-leukaemia-cll/risks-causes Accessed: July 2019

NICE. Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia. Available at: https://www.nice.org.uk/Guidance/TA561. Accessed: July 2019

5 National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ®)–Patient Version. Available at: https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq. Accessed: July 2019

National Cancer Institute. Living as a Chronic Lymphocytic Leukemia Survivor. Available at: https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/after-treatment/follow-up.html. Accessed: July 2019.

7 Hallek M, Cheson BD, Catovsky D, et al. Guidelines for diagnosis, indications for treatment, response assessment and supportive management of chronic lymphocytic leukemia. Blood. 2018; 131(25):2745-2760

8 Seymour J, et al. MURANO trial establishes feasibility of time-limited venetoclax-rituximab (VenR) combination therapy in relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL). Presented at the 2018 American Society of Hematology Annual Meeting & Exposition: December 1, 2018; San Diego.

9 Venclyxto Summary of Product Characteristics. Available at: https://www.medicines.org.uk/emc/medicine/32650. Accessed: July 2019

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Results From SKYRIZI™ ▼ (risankizumab) Phase 3 Study in Moderate to Severe Plaque Psoriasis Published in The Lancet

Press releases   •   Jul 24, 2019 14:33 BST

  • In the IMMvent study, 72 percent and 84 percent of patients treated with SKYRIZI™ (risankizumab) achieved PASI 90 and sPGA 0/1, respectively, at week 16 [i]

Maidenhead, UK, 24 July 2019 — AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the publication of positive results from the pivotal Phase 3 IMMvent clinical study in The Lancet. The study evaluates the safety and efficacy of SKYRIZI™ (risankizumab) up to 44 weeks compared to adalimumab in adult patients with moderate to severe chronic plaque psoriasis.1 Risankizumab met the co-primary endpoints of at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (0/1) versus adalimumab at weeks 16 and 44 (p<0.0001).1

“By achieving high levels of skin clearance through to week 44, risankizumab demonstrated the ability to make a positive, lasting impact on all the signs and symptoms of psoriasis,” said Dr Anthony Bewley, Consultant Dermatologist, Barts Health NHS Trust, London. “I am really pleased to see that my patients stand to benefit from the positive IMMvent study results about risankizumab that appeared recently in The Lancet.”

At week 16, 72 percent of patients receiving risankizumab (n=301) at the label dose achieved PASI 90 compared to 47 percent of patients treated with adalimumab (n=304) at the label dose.1 84 percent of risankizumab-treated patients achieved a sPGA score of clear or almost clear (0/1) compared to 60 percent of patients receiving adalimumab.1 Additionally, 40 percent and 41 percent of patients treated with risankizumab achieved complete skin clearance (defined as PASI 100 and sPGA 0, respectively) at week 16 compared to 23 percent of patients treated with adalimumab (for both measures of skin clearance).1

In the second phase (week 16 to week 44) of IMMvent, patients receiving adalimumab who achieved a response of at least PASI 50 but less than PASI 90 at week 16 (intermediate responders*) were re-randomised to either switch to risankizumab (n=53) or continue adalimumab (n=56).1 Of these patients, those re-randomised to risankizumab saw significantly greater response rates.1 66 percent achieved PASI 90 at week 44 when switched to risankizumab, compared to 21 percent of patients who continued on adalimumab (p<0.001).1 Additionally, 40 percent of patients who switched to risankizumab achieved complete skin clearance (PASI 100 or sPGA 0) at week 44 compared to 7 percent of patients who continued treatment with adalimumab (for both measures of skin clearance). All the patients who switched to risankizumab at week 16 started at the initial label dose schedule.1

Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.

“Publication of these positive results in The Lancet marks another important milestone demonstrating the potential of risankizumab to be an important treatment option that is now available in our dermatology portfolio,” said Dr Alice Butler, UK Medical Director, AbbVie.

IMMvent Efficacy Results1**
Week 16 (all patients) Week 44 (intermediate responders group)*
Risankizumab (n=301) Adalimumab (n=304) Adalimumab/ risankizumab (n=53) Adalimumab/ adalimumab (n=56)
PASI 90 72% 47% 66% 21%
sPGA 0/1 84% 60% 74% 34%
PASI 100 40% 23% 40% 7%
sPGA 0 41% 23% 40% 7%
*Intermediate responders are defined as patients who achieved at least PASI 50 but less than PASI 90 at week 16.**All primary and ranked secondary endpoints achieved p-values of <0.0001.

The study also showed patients treated with risankizumab self-reported an improved quality of life. At week 16, significantly more patients treated with risankizumab achieved a Dermatology Life Quality Index (DLQI) score of 0 or 1, indicating psoriasis no longer had an impact on their health-related life quality, compared to adalimumab.[ii] Risankizumab-treated patients maintained reported outcomes at week 44.2

In the study, no new safety findings were observed in patients receiving continuous risankizumab or in those switched from adalimumab to risankizumab.1 There was no increase in adverse events in patients re-randomised from adalimumab to risankizumab.1 Serious adverse events occurred in 3 percent of patients treated with both risankizumab and adalimumab.1 The most frequently reported adverse events for both risankizumab and adalimumab were viral upper respiratory tract infection, upper respiratory tract infection and headache.1

About the Phase 3 IMMvent study1

The IMMvent study is a Phase 3 randomised, double-blind, active-controlled study designed to evaluate the safety and efficacy of risankizumab compared to adalimumab in adult patients with moderate to severe chronic plaque psoriasis. Risankizumab is a humanised immunoglobulin G1 (IgG1) monoclonal antibody designed to selectively inhibit IL-23 by binding to its p19 subunit and is approved in the EU for adults living with moderate to severe psoriasis who are candidates for systemic treatment.3

In the first phase, patients were randomised 1:1 to either risankizumab (150 mg) or adalimumab (80 mg initial dose followed by 40 mg one week later and every other week thereafter) as a subcutaneous injection. Patients originally randomised to risankizumab received it throughout the study given at baseline, week 4, week 16, week 28 and week 40. Those originally randomised to adalimumab followed a treatment course based on week 16 response: those with less than PASI 50 at week 16 switched to risankizumab; those with PASI 90 continued adalimumab; and those with a PASI 50 but less than PASI 90 response were re-randomised to switch to risankizumab or continue adalimumab. Any patient re-randomised from adalimumab to risankizumab at week 16 received it at week 16, week 20, week 32 and week 44. Results from the study showed risankizumab achieved all primary and ranked secondary endpoints.More information on this trial can be found at www.clinicaltrials.gov (NCT02694523).

About risankizumab in the European Union3

Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information[iii]

Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

About adalimumab in the European Union[iv]

Adalimumab is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.

Important EU Safety Information4

Adalimumab is contraindicated in patients with active tuberculosis or other severe infections such as sepsis, and opportunistic infections and in patients with moderate to severe heart failure (NYHA class III/IV). It is also contraindicated in patients hypersensitive to the active substance or to any of the excipients; serious allergic reactions including anaphylaxis have been reported. The use of adalimumab increases the risk of developing serious infections, including hepatitis B reactivation, which may, in rare cases, be life-threatening. Rare cases of lymphoma and leukaemia have been reported in patients treated with adalimumab. On rare occasions, a severe type of cancer called hepatosplenic T-cell lymphoma has been observed and often results in death. A risk for the development of malignancies in patients treated with TNF-antagonists cannot be excluded. Rare cases of pancytopenia, aplastic anaemia, demyelinating disease, lupus, lupus-related conditions and Stevens-Johnson syndrome have been reported in patients treated with adalimumab. The most frequently reported adverse events across all indications included respiratory infections, injection site reactions, headache and musculoskeletal pain.

This is not a complete summary of all safety information. See SKYRIZI (risankizumab) and HUMIRA (adalimumab) full summary of product characteristics (SmPC) at https://www.medicines.org.uk/emc. Globally, prescribing information varies; refer to the individual country product label for complete information.


[i]
Reich, K., Efficacy and Safety of Risankizumab Compared with Adalimumab in Patients with Moderate-to-Severe Plaque Psoriasis: Results from a Randomized, Double-blind, Active-comparator, Controlled Phase 3 Trial (IMMvent). The Lancet. 2019.

[ii] Crowley, J., et al. ePoster #P1947. 27th European Academy of Dermatology and Venereology (EADV) Congress. September 2018.

[iii] SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu.

[iv] HUMIRA [Summary of Product Characteristics]. AbbVie Ltd.; Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000481/WC500050870.pdf. Last updated October 5, 2017. Accessed June, 2019.

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

Read more »

AbbVie Appoints New General Manager in U.K.

Press releases   •   Jul 19, 2019 13:03 BST

Maidenhead, UK, 19th July 2019 – AbbVie, a global biopharmaceutical company, today announced that Todd Manning has been named General Manager, AbbVie U.K. This change will be effective 1st September 2019.

Todd moves to the UK from his current position within the company as General Manager, AbbVie Ireland. Elected to the Irish Pharmaceutical Healthcare Association (IPHA) strategy board in 2016 and to the Board of Directors in 2018, he has held the positions of Deputy Vice President and Chair of the Finance Committee. He also served on several working groups including Market Access and Biotherapeutics.

Since joining Abbott in 2004 he has held roles of increasing responsibility; Director, Immunology, Ireland; Director, Immunology, Canada; HCV Senior Commercial Director, Western Europe & Canada. Prior to joining the organisation, Todd was with TAP Pharmaceuticals, Inc. where he held a variety of commercial sales and marketing positions.

Todd earned a Bachelor’s degree in Chemistry from the College of Holy Cross in Massachusetts.

Todd will succeed Jérôme Bouyer, UK General Manager since July 2017, who is appointed Vice President, AbbVie Eastern Europe Middle East and Africa (EEMEA).

###

Media:

Gwenan White, Communications Director AbbVie U.K.

+44 787 6391 429

gwenan.white@abbvie.com 

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

Todd Manning has been named General Manager, AbbVie U.K. This change will be effective 1st September 2019. Todd moves to the UK from his current position within the company as General Manager, AbbVie Ireland.

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NICE Issues Positive Final Appraisal Document for SKYRIZI™▼(risankizumab) for the Treatment of Plaque Psoriasis in Adults

Press releases   •   Jul 12, 2019 10:16 BST

– Positive NICE Final Appraisal Document (FAD) for SKYRIZI™ (risankizumab), a humanised immunoglobulin G1 (IgG1) monoclonal antibody, means that adult patients in England and Wales with plaque psoriasis, who have failed conventional systemic therapies, will have NHS access to treatment with high rate of skin clearance at 16 weeks that is maintained through to one year (52 weeks)1

- Risankizumab has been reviewed by NICE through its Fast Track Appraisal process, meaning that NHS England/commissioners have committed to providing funding for risankizumab within 30 days of final guidance publication (expected 21 August 2019)

NICE FAD based on results from four pivotal Phase 3 studies, UltIMMa-1, UltIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis1-4

– Plaque psoriasis is a chronic condition affecting an estimated 820,000 people in the UK and many patients still do not reach treatment goals or lose treatment response over time5-6,7

MAIDENHEAD, UK, 12 July, 2019 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that the National Institute for Health and Care Excellence (NICE) has published a positive Final Appraisal Document (FAD), confirming that SKYRIZI™▼(risankizumab) is recommended for the treatment of severe psoriasis in adult patientswho have failed conventional systemic therapies.8

Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.

In clinical studies, risankizumab demonstrated high rates of skin clearance at 16 weeks and this clearance was also maintained through to one year (52 weeks).1

Helen McAteer, Chief Executive of The Psoriasis Association, said: “The positive guidance from NICE is a welcome step change for people in England and Wales with severe psoriasis as it means they will be able to access a treatment option on the NHS that offers maintenance dosing of 12-week injections over those dosed more frequently, and good PASI90 and PASI100 clearance data. We know that these things are important to patients.”

Psoriasis is a chronic skin condition that causes red, flaky, crusty patches of skin covered with silvery scales. These patches normally appear on the elbows, knees, scalp and lower back, but can appear anywhere on the body9. Psoriasis affects around 1.75 percent of people in the UK7.

Professor Richard Warren, Consultant Dermatologist, Salford Royal NHS Foundation Trust, said: “NICE’s recommendation to offer routine NHS access to risankizumab gives clinicians a new treatment option in the management of severe psoriasis. The mode of action of risankizumab, which inhibits the p19 subunit of IL-23 cytokine, thought to drive psoriasis pathogenesis, addresses significant remaining unmet need and enhances our ability to achieve high levels of skin clearance for people with severe psoriasis.”

The NICE FAD is based on results from four pivotal Phase 3 studies, UltIMMa-1, UltIMMa-2, IMMvent and IMMhance evaluating more than 2,000 patients with moderate to severe plaque psoriasis.1-4 Across all four studies, the co-primary endpoints were at least a 90 percent improvement in the Psoriasis Area and Severity Index (PASI 90) and a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) at week 16.1-4

The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients.4 Common adverse reactions (frequency defined as greater than or equal to 1/100 events to less than 1/10) included tinea infections, headache, pruritus, fatigue and injection site reactions.4

"AbbVie is committed to developing life-changing medicines. Ensuring rapid access to such medicines is a critical part of that commitment and we have worked closely with NICE for risankizumab to be considered through the Fast Track Appraisal process. Risankizumab’s availability on the NHS will represent the fastest time between marketing authorisation and reimbursement of any biologic treatment for psoriasis,” said Dr Alice Butler, UK Medical Director, AbbVie.

The European Commission granted Marketing Authorisation for risankizumab on 26 April 2019.

About risankizumab in the UK

Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information4

Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. It is also contraindicated in patients with clinically important active infections (e.g. tuberculosis). Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunizations should be considered according to current immunization guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie on UK_PVVendor@abbvie.com. With biological medicines, healthcare professionals should report adverse reactions by brand name and batch number.

This is not a complete summary of all safety information. See SKYRIZI full summary of product characteristics (SmPC) at https://www.medicines.org.uk/emc . Globally, prescribing information varies; refer to the individual country product label for complete information.

-ENDS-

UK Media:

Sarah Beck

+44 (0)7818 428111

Sarah.beck@abbvie.com

References:

  • 1.Blauvelt, A. et al. Risankizumab Efficacy/Safety in Moderate-to-Severe Plaque Psoriasis: 16-Week Results From IMMhance [abstract P066]. Acta Derm Venereol. 2018; 98(suppl 219): 30.
  • 2.Gordon K, et al. Efficacy and safety of risankizumab in moderate-to-severe plaque psoriasis (UltIMMa-1 and UltIMMa-2): results from two double-blind, randomised, placebo-controlled and ustekinumab-controlled phase 3 trials. The Lancet. 2018 Aug 25;392(10148):650-661.
  • 3.Reich, K., et al. Efficacy and Safety of Risankizumab Compared with Adalimumab in Patients with Moderate-to-Severe Plaque Psoriasis: Results from the Phase 3 IMMvent Trial. ePoster #P1813. European Academy of Dermatology and Venereology Congress. 2018.
  • 4.SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.medicines.org.uk/emc
  • 5.International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/wp-content/uploads/2017/01/Brochure-Psoriasis-is-a-serious-disease-deserving-global-attention.pdf. Accessed March 22, 2019.
  • 6.Mroweitz, U., et al. Definition of treatment goals for moderate to severe psoriasis: a European consensus. Arch Dermatol Res. 2011 Jan; 303(1): 1–10.
  • 7.National Institute for Health and Care Excellence. Resource impact template: Brodalumab for treating moderate to severe plaque psoriasis (TA511). March 2018, available at: www.nice.org.uk/guidance/ta511/resources/resource-impact-template-excel-4786962589 (accessed July 2019)
  • 8.National Institute for Health and Care Excellence, Fast Track Appraisal: Risankizumab for treating moderate to severe plaque psoriasis (ID1398), available at https://www.nice.org.uk/guidance/indevelopment/gid-ta10349 (accessed July 2019)
  • 9.NHS, psoriasis overview, available at https://www.nhs.uk/conditions/psoriasis/ (accessed July 2019)

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

Read more »

Results from Upadacitinib Phase 3 SELECT-COMPARE Study Published in Arthritis and Rheumatology

Press releases   •   Jul 11, 2019 16:26 BST

  • SELECT-COMPARE, the largest of the six studies in the robust SELECT programme, evaluates upadacitinib in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate (MTX), and remain on a stable background of MTX1
  • Both primary endpoints of the study were met, including the proportion of patients achieving ACR20 response and clinical remission (DAS28-CRP<2.6) at week 12 for upadacitinib versus placebo1
  • No new safety signals were reported compared to previously reported Phase 3 studies1-5
  • Upadacitinib, an oral agent engineered by AbbVie to selectively inhibit JAK1, is being studied as a once-daily therapy in rheumatoid arthritis

MAIDENHEAD, 11 July 2019 AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the publication of positive results from the pivotal Phase 3 SELECT-COMPARE clinical trial in Arthritis and Rheumatology. The study evaluates upadacitinib compared to placebo and adalimumab in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate (MTX), and remain on a stable background of MTX. Data show that at 12 weeks, patients receiving a once-daily dose of upadacitinib (15mg, n=651 met the primary endpoints with significantly higher rates of ACR20 response (71%) and clinical remission* (29%) versus patients receiving placebo (36% and 6% respectively, n=651, p≤0.001 for both endpoints).1

All key secondary endpoints were also achieved, including significantly higher rates of ACR50 response, in patients receiving upadacitinib versus placebo or adalimumab [n=327] in combination with methotrexate at week 12 [p≤0.001].1 Upadacitinib-treated patients showed significant improvements from baseline compared to patients receiving adalimumab in reduction of pain [-32.1 versus -25.6, p=≤0.001], as measured by the Visual Analog Scale (VAS), and improvements in physical function [0.60 versus -0.49, p≤0.01] , as measured by the Health Assessment Questionnaire-Disability Index (HAQ-DI), at week 12.1

Primary and secondary endpoints met at week 12 were maintained through 26 weeks, including significantly higher rates of low disease activity** and clinical remission* achieved in patients receiving upadacitinib plus MTX than those receiving adalimumab plus MTX and placebo plus MTX, respectively.1

At week 12, an additional efficacy endpoint also demonstrated a significantly higher proportion of patients receiving upadacitinib plus MTX achieved low disease activity (45%) and remission (29%) versus adalimumab plus MTX (29% and 18% respectively, p≤0.001 for both endpoints)***.1 This was maintained through week 26 when upadacitinib was also shown to significantly inhibit radiographic progression, as measured by a mean change from baseline in modified Sharp score (mTSS), versus placebo [p≤0.001].1

The overall safety profile of upadacitinib was similar to adalimumab, except for higher rates of herpes zoster and CPK elevations with upadacitinib.1 No new safety signals were reported compared to previously reported Phase 3 studies.1-5 Upadacitinib is an investigational oral agent and has not been approved by any regulatory authorities.

“Over the past two decades important advances in the treatment of rheumatoid arthritis have been made, making clinical remission a possibility for more people living with rheumatoid arthritis,” said Alice Butler, UK Medical Director, AbbVie. “We are encouraged by the positive results of SELECT-COMPARE showing a significant impact on both signs and symptoms and radiographic progression compared to placebo, as well as improvements in important measures such as ACR response, remission and low disease activity compared to adalimumab."

Rheumatoid arthritis is a chronic and debilitating disease that affects an estimated 400,000 people in the UK.6 Despite current treatment recommendations underscoring the importance of clinical remission and low disease activity as treatment targets in the treatment of rheumatoid arthritis, many patients living with the disease do not achieve these results.7-8 Achieving clinical remission can allow patients to return to living a more normal life and decreases the likelihood of severe joint damage.9

* Remission is defined as [DAS28-CRP]<2.6

** LDA is defined as Disease Activity Score 28 C-Reactive Protein [DAS28-CRP]≤3.2.

*** Multiplicity control was applied to comparisons for upadacitinib + MTX versus placebo + MTX, but not for upadacitinib + MTX versus adalimumab + MTX.


About SELECT-COMPARE1

SELECT-COMPARE is a Phase 3, multicenter, randomized, double-blind, study designed to evaluate the safety and efficacy of upadacitinib compared to placebo and adalimumab in adult patients with moderately to severely active rheumatoid arthritis who are on a stable background of methotrexate and who have an inadequate response to methotrexate. Patients received background methotrexate and were randomized 2:2:1 to receive upadacitinib (15 mg once-daily), placebo or adalimumab (given as a subcutaneous injection of 40 mg every other week).

The primary endpoints included the percentage of subjects achieving ACR20 response and clinical remission (based on DAS28-CRP) after 12 weeks of treatment compared to placebo. Ranked secondary endpoints included change in the mTSS compared to placebo at week 26 and a comparison versus adalimumab in percentage of subjects achieving ACR50 response, low disease activity, change from baseline in pain as measured by VAS and change from baseline in physical function, as measured by the HAQ-DI at week 12. The trial is ongoing and includes a 48 week randomized, double-blind treatment period followed by a long-term extension study of up to five years. More information on this trial can be found at www.clinicaltrials.gov (NCT02629159).

About the SELECT Study Programme1-5

The robust SELECT Phase 3 rheumatoid arthritis programme evaluates more than 4,900 patients with moderately to severely active rheumatoid arthritis in six studies. The studies include assessments of efficacy, safety and tolerability across a broad range of rheumatoid arthritis patients. Key measures of efficacy evaluated include ACR responses, Disease Activity Score (DAS28-CRP) and inhibition of radiographic progression. More information on these trials can be found at www.clinicaltrials.gov (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951, NCT02675426).

About Upadacitinib

Discovered and developed by AbbVie, upadacitinib is an investigational, oral, small molecule JAK1-selective inhibitor being studied for moderately to severely active rheumatoid arthritis. Upadacitinib is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk . Follow @abbvieuk on Twitter

###

UK Media:

Natalie Bennett
AbbVie

T: 07818 428074
E: natalie.bennett@abbvie.com

Becky Wright
Four Health Communications
T:020 3761 4495
E:Becky.Wright@fourhealthcommunications.com

References

  1. Fleischmann, R, et al. Upadacitinib versus Placebo or Adalimumab in Rheumatoid Arthritis: Results of a Phase 3, Double-Blind, Randomized Controlled Trial. Arthritis and Rheumatology. 2019.
  2. Smolen, J.S., et al. A Phase 3 Randomised, Placebo-controlled, Double-Blind Study of Upadacitinib as Monotherapy in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: SELECT-MONOTHERAPY. The Lancet. 2019.
  3. Burmester GR, et al; Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
  4. Genovese MC, et al; Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
  5. van Vollenhoven, et al. A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naïve Patients with Active Rheumatoid Arthritis. 2018 ACR/ARHP Annual Meeting; 891
  6. NICE. Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (TA375). January 2016.
  7. Nagy G, van Vollenhoven RF. Sustained biologic-free and drug-free remission in rheumatoid arthritis, where are we now? Arthritis Res Ther 2015; 17:181
  8. Smolen JS, Landewé R, Bijlsma J, et al. EULAR recommendations for the management of rheumatoid arthritis with synthetic and biological disease-modifying antirheumatic drugs: 2016 update. Ann Rheum Dis 2017.Jun;76(6):960-97
  9. Ajeganova S. and Huizinga T. Sustained remission in rheumatoid arthritis: latest evidence and clinical considerations. Ther Adv Musculoskelet Dis. 2017 Oct;9(10):249-262. doi: 10.1177/1759720X17720366

July 2019

UK-UPAD-190042


About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

Read more »

AbbVie UK publishes 2018 transparency data; supporting collaboration of medical opinion towards advancing patient care and the development of new medicines

Press releases   •   Jun 28, 2019 13:00 BST

Maidenhead, UK, 28th June 2019 – For the fourth year, AbbVie is pleased to see a rise in the number of doctors willing to consent to their transfers of value being made public.

Each year AbbVie discloses transfers of value to healthcare professionals and healthcare organisations to the Association of the British Pharmaceutical Industry (ABPI).

79 per cent (Nearly 4 in 5) of doctors who received sponsorship, fees or ‘in-kind’ support from AbbVie in 2018 opted-in for their individual data to be made public in the scheme.

AbbVie is encouraged that this marks increased confidence in AbbVie transparency from the medical profession. The collaboration of medical opinion is essential to advance patient care, gain insights into unmet medical needs and progress the development of new medicines. We believe interactions with healthcare professionals, healthcare organisations and patient organisations bring value to patient care.

AbbVie is proud of its collaboration with HCPs and HCOs which has contributed to delivering innovative medicines and has changed the way many diseases impact on patients’ lives. Open communication about these interactions increases understanding of this important collaboration.

Overall the total sum that AbbVie invests in working with and supporting UK healthcare organisations and doctors increased from 2018 compared to the year before with a rise of 31% per cent to £17.1m. Of this figure nearly 58 per cent is on the administration of clinical trials – demonstrating the enduring importance of the UK as a centre of excellence in the development of new medicines.

The full set of AbbVie data is available from the ABPI disclosure UK web portal at: http://www.disclosureuk.org.uk/

Please send data on file requests to UKMediaRelations@abbvie.com.

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

Read more »

New Two-Year Data at the 24th World Congress of Dermatology Shows SKYRIZI™ ▼(risankizumab) Maintains Complete Skin Clearance in a Significant Number of Patients

Press releases   •   Jun 12, 2019 13:15 BST

  • The co-primary and secondary endpoints for the IMMhance study were met
  • Longer-term results from IMMhance in additional analyses showed 73 percent and 72 percent of patients treated with continuous risankizumab experienced complete skin clearance (defined as sPGA 0 and PASI 100, respectively) at week 94, among patients who achieved sPGA 0/1 at week 281
  • No new safety findings observed at two years (104 weeks)1
  • Risankizumab, a humanised immunoglobulin G1 (IgG1) monoclonal antibody designed to selectively inhibit IL-23 by binding to its p19 subunit, is approved by the European Medicines Agency to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy 2,3

MAIDENHEAD, June 11, 2019– AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced new results showing a significant number of patients treated with SKYRIZI™ (risankizumab) experienced complete skin clearance at week 94.1 In the study, at week 28 patients who achieved a static Physician Global Assessment (sPGA) score of clear or almost clear (sPGA 0/1) were re-randomised to continue treatment with risankizumab or withdrawal.1 After 94 weeks of continuous treatment with risankizumab, 73 percent and 72 percent of these patients achieved a sPGA score of clear (sPGA 0) and a 100 percent improvement in the Psoriasis Area and Severity Index (PASI 100), respectively, compared to 2 percent of patients re-randomised to withdrawal (p<0.001).1 These two-year results (up to 104 weeks) from the Phase 3 IMMhance study, evaluating the efficacy and safety of risankizumab in adult patients with moderate to severe psoriasis, will be presented today at the 24th World Congress of Dermatology (WCD) in Milan.

"Results show that risankizumab has the potential to provide long-term relief from the signs and symptoms of psoriasis” said Marek Honczarenko, M.D., Ph. D., vice president, immunology development, AbbVie. “Our studies demonstrated that risankizumab can not only offer complete skin clearance at two years of treatment for the majority of patients, but re-treatment with risankizumab following a relapse can help patients regain skin clearance in just 16 weeks. We are pleased to add positive long-term data to the growing body of evidence supporting the efficacy and safety profile of risankizumab for adult patients with moderate to severe psoriasis.”

Risankizumab is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation globally.

There were two phases in the IMMhance study.1 Results from the first phase showed that after 16 weeks of treatment, risankizumab (n=407) met the co-primary endpoints of PASI 90 and sPGA 0/1 versus placebo (n=100)(p<0.001).1 The second phase (week 28 through week 104) evaluated the efficacy and safety of continuous therapy with risankizumab versus randomised withdrawal, as well as retreatment.1 Patients who achieved sPGA 0/1 at week 28 with risankizumab were re-randomised to continue risankizumab (n=111) every 12 weeks or to withdrawal (n=225).1 The primary endpoint from the second phase of the study, sPGA 0/1, was also met at one year (52 weeks)(p<0.001).1

For those re-randomised to continue risankizumab, the last dose was given at week 88.1 Between one year (week 52) and week 94, the proportion of these patients who achieved complete skin clearance continued to increase.1 sPGA 0 and PASI 100 responses increased from 65 percent and 64 percent at week 52 to 73 percent and 72 percent at week 94, respectively (p<0.001).1 At two years, 81 percent and 78 percent of patients treated with continuous risankizumab maintained clear or almost clear skin (sPGA 0/1 or PASI 90) compared to 7percent and 4 percent re-randomised to withdrawal, respectively (p<0.001).1

Among patients re-randomised to withdrawal who experienced a loss of response (defined as a sPGA score of moderate to severe [≥3]) on or after week 32 (n=153), 84 percent regained clear or almost clear skin (sPGA 0/1) after 16 weeks of re-treatment with risankizumab.1

“In the IMMhance study, risankizumab provided an increasing number of patients with complete skin clearance up to 94 weeks,” said Melinda Gooderham, M.D., dermatologist and medical director at the SKiN Centre for Dermatology in Peterborough, Ontario and a study investigator. “Risankizumab not only offers relief from the signs and symptoms of psoriasis following a withdrawal from medication, but the study further demonstrates the significant rates of complete skin clearance that can be achieved with continuous treatment at the recommended dose. These data underscore the lasting impact this new treatment option could provide for people living with psoriasis.”

No new safety findings were observed in patients who continued with risankizumab for two years compared with those who withdrew to placebo at week 28.1

About the Phase 3 IMMhance Study1

The IMMhance study is an ongoing Phase 3, multicentre, randomised, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of risankizumab compared to placebo in adult patients with moderate to severe plaque psoriasis. In the first phase, patients were randomised 4:1 to risankizumab (n=407) (150 mg), given as a subcutaneous injection at baseline, 4 weeks later and every 12 weeks thereafter, or placebo (n=100). In the second phase of this study (week 28 through week 104), patients originally randomised to risankizumab who achieved sPGA 0/1 at week 28 were re-randomised to risankizumab (maintenance, n=111) or placebo (withdrawal, n=225). Safety was assessed in all patients. Patients received their last dose of risankizumab at week 88 and follow up was conducted until week 104.

This Phase 3 study was conducted in cooperation between AbbVie and Boehringer Ingelheim. More information on this trial can be found at www.clinicaltrials.gov (NCT02672852).

About (risankizumab) in the European Union3

Risankizumab is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.

Important EU Safety Information3

Risankizumab is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Risankizumab may increase the risk of infection. In patients with a chronic infection, a history of recurrent infection, or known risk factors for infection, risankizumab should be used with caution. Treatment with risankizumab should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.

Prior to initiating treatment with risankizumab, patients should be evaluated for tuberculosis (TB) infection. Patients receiving risankizumab should be monitored for signs and symptoms of active TB. Anti-TB therapy should be considered prior to initiating risankizumab in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed.

Prior to initiating therapy with risankizumab, completion of all appropriate immunisations should be considered according to current immunisation guidelines. If a patient has received live vaccination (viral or bacterial), it is recommended to wait at least 4 weeks prior to starting treatment with risankizumab. Patients treated with risankizumab should not receive live vaccines during treatment and for at least 21 weeks after treatment.

The most frequently reported adverse reactions were upper respiratory infections, which occurred in 13 percent of patients. Commonly (greater than or equal to 1/100 to less than 1/10) reported adverse reactions included tinea infections, headache, pruritus, fatigue and injection site reactions.

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie at UK_PVVendor@abbvie.com. With biological medicines, healthcare professionals should report adverse reactions by brand name and batch number.

This is not a complete summary of all safety information. See risankizumab full summary of product characteristics (SmPC) at www.medicines.org.uk/emc.

References:

1.Blauvelt, A., et al. Efficacy and Safety of Continuous Q12W Risankizumab Versus Treatment Withdrawal: 2-Year Double-Blinded Results from the Phase 3 IMMhance Trial. 24th World Congress of Dermatology. 2019.

2.Papp K.A., et al. Risankizumab versus Ustekinumab for Moderate-to-Severe Plaque Psoriasis. N Engl J Med. 2017 Apr 20; 376:1551-1560.

3.SKYRIZI [Summary of Product Characteristics]. AbbVie Ltd. Available at: https://www.ema.europa.eu. 

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

Read more »

AbbVie Presents Data from VENCLYXTO®▼(venetoclax) Chemotherapy-Free Combination Regimen for Patients with Previously Untreated Chronic Lymphocytic

Press releases   •   Jun 04, 2019 16:43 BST

  • Phase 3 CLL14 data were highlighted in an oral presentation (abstract #7502) today at ASCO and published in the New England Journal of Medicine
  • Patients treated with venetoclax plus obinutuzumab lived significantly longer without their disease progressing, and sustained that benefit after stopping treatment, compared to those treated with obinutuzumab plus chlorambucil
  • Rates of undetectable minimal residual disease* in peripheral blood were higher in patients treated with venetoclax plus obinutuzumab three months after treatment completion1

MAIDENHEAD, UK, 4 June, 2019 – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today presented data from the CLL14 trial, the first randomised clinical trial to examine stopping an oral-based, chemotherapy-free combination after 12 months in previously untreated patients with CLL and coexisting medical conditions. The results demonstrate that venetoclax plus obinutuzumab prolonged progression-free survival (PFS) and achieved higher rates of complete response and undetectable minimal residual disease (uMRD) compared to a commonly used chemoimmunotherapy obinutuzumab plus chlorambucil.1

These data were presented today in an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (abstract #7502) and were simultaneously published in the New England Journal of Medicine (NEJM). *Undetectable minimal residual disease (uMRD), is defined as the presence of less than one CLL cell in 10,000 white blood cells remaining in the blood or bone marrow following treatment.2

Dr Angus Broom, Consultant Haematologist at the Western General Hospital in Edinburgh and CLL14 Study Investigator, said: “The results of the Phase 3 CLL14 clinical trial, presented today at the annual American Society of Clinical Oncology and published in the prestigious New England Journal of Medicine (NEJM), highlight that a one year fixed treatment duration of venetoclax plus obinutuzumab induces a longer time without disease progression compared to a commonly used chemoimmunotherapy, in previously untreated, unfit CLL patients. Improved progression-free survival with this chemotherapy-free regimen was also demonstrated after stopping treatment, as well as higher rates of uMRD, compared to obinutuzumab plus chlorambucil.”

CLL is the most common form of adult leukaemia, or blood cancer, in which too many immature lymphocytes (a type of white blood cell) are found predominantly in the blood and bone marrow.3,4. Over 3,500 people are diagnosed with CLL in the UK each year.5 The average age of CLL diagnosis is 72 years and almost 90% of CLL patients have one or more co-morbidities.3,6 Although many patients diagnosed with CLL will be put on a ‘Watch and Wait’ management strategy, around two thirds will eventually require treatment.7

In the CLL14 trial, investigator-assessed results demonstrated that patients with CLL who were treated with venetoclax plus obinutuzumab achieved superior PFS compared to patients treated with obinutuzumab plus chlorambucil. Twenty-four-month PFS estimates were 88.2 percent and 64.1 percent, respectively (hazard ratio [HR]: 0.35, 95% confidence interval [CI]: 0.23, 0.53; P<0.0001). Higher rates of uMRD were observed with venetoclax plus obinutuzumab compared to obinutuzumab plus chlorambucil in both peripheral blood (75.5 percent versus 35.2 percent, P<0.0001) and bone marrow (56.9 percent versus 17.1 percent [P<0.0001]) three months after treatment completion.1 uMRD in the blood or bone marrow is an important therapeutic goal in patients with CLL as it can be associated with prolonged PFS and overall survival (OS).Complete response rates were also significantly higher with venetoclax plus obinutuzumab than with chlorambucil plus obinutuzumab (49.5 percent versus 23.1 percent [P<0.0001]).1

"Conducting CLL14 was another collaborative and bold attempt to continue pushing the boundaries of treatment in CLL,” said Mohamed Zaki, M.D., Ph.D., vice president, global head of hematology development, AbbVie. “The combination of venetoclax plus obinutuzumab significantly prolonged progression-free survival and patients maintained that benefit after stopping treatment. After the recent approval in the U.S., we look forward to continue working with health authorities worldwide as we aim to bring venetoclax plus obinutuzumab to patients with previously untreated CLL.”

In the CLL14 trial, the safety profile of both treatment groups showed no new safety signals or increase in known toxicities.1

Venetoclax is being developed by AbbVie and Roche. It is commercialised by AbbVie outside of the U.S. and jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the U.S.

- Ends -

For venetoclax’s Summary of Product Characteristics, please visit: https://www.medicines.org.uk/emc/medicine/32650.

Adverse events should be reported. This medicinal product is subject to additional monitoring and it is therefore important to report any suspected adverse events related to this medicinal product.Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to AbbVie UK Ltd. Please contact uk_pvvendor@abbvie.com

AbbVie UK Media:

Joanna Jones

07795590344

Joanna.jones@abbvie.com

Francesca Morley

07795360167

Francesca.Morley@virgohealth.com

Notes to editors

About the Phase 3 CLL14 Trial

The prospective, multicenter, open-label, randomized Phase 3 CLL14 trial evaluated the efficacy and safety of a combined investigational regimen of venetoclax plus obinutuzumab (n=216) versus obinutuzumab plus chlorambucil (n=216) in previously untreated patients with CLL and coexisting medical conditions. The trial was conducted in close collaboration with the German CLL Study Group (DCLLSG). The therapies were administered for a fixed duration of 12 months for venetoclax in combination with six cycles of obinutuzumab. The trial enrolled 432 patients, all of whom were previously untreated according to the International Workshop on Chronic Lymphocytic Leukemia (iwCLL) criteria. The primary endpoint was PFS based on investigator assessment, using iwCLL criteria.1

Key secondary endpoints were PFS as assessed by an independent review committee, MRD-negativity in peripheral blood and bone marrow, overall and complete response rates, MRD-negativity in complete response in peripheral blood and bone marrow, and overall survival (OS).1

In the CLL14 trial, the safety profile of both treatment groups showed no new safety signals or increase in known toxicities. At least one AE of any grade occurred in 94.3 percent of patients in the venetoclax plus obinutuzumab arm. The most common Grade 3/4 AEs in patients receiving venetoclax plus obinutuzumab were febrile neutropaenia (5.2 percent) and infections (17.5 percent). Tumor lysis syndrome (TLS) was reported in three patients in the venetoclax plus obinutuzumab group (all during treatment with obinutuzumab and before venetoclax).1 None of these events met the Howard criteria for clinical TLS.9

About venetoclax

Venetoclax is an oral B-cell lymphoma-2 (BCL-2) inhibitor. The BCL-2 protein prevents apoptosis (programmed cell death) of some cells, including lymphocytes, and can be overexpressed in CLL cells.10 Venetoclax, which is an oral once-daily treatment, is designed to selectively inhibit the function of the BCL-2 protein restoring the death instinct in the cancerous cells.10

In January 2019, venetoclax in combination with rituximab was recommended by NICE (The National Institute for Health and Care Excellence) for the treatment of relapsed/refractory CLL on the NHS, based on the pivotal results from the Phase 3 MURANO clinical trial. It is the first 24-month fixed treatment duration, chemotherapy-free combination approved for use in this patient population.11

In May 2019, the U.S. Food and Drug Administration approved venetoclax in combination with obinutuzumab for previously untreated patients with chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL)12. The efficacy and safety of venetoclax in patients with newly diagnosed CLL has not been evaluated by the European Medicines Agency.

About AbbVie in Oncology

At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. With the acquisitions of Pharmacyclics in 2015 and Stemcentrx in 2016, our research and development efforts, and through collaborations, AbbVie's oncology portfolio now consists of marketed medicines and a pipeline containing multiple new molecules being evaluated worldwide in more than 200 clinical trials and more than 20 different tumour types. For more information, please visit www.abbvie.co.uk/our-science/therapeutic-focus-areas/Oncology.html

About AbbVie

AbbVie is a global, research and development-based biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow @abbvieuk on Twitter.

REFERENCES

Fischer K, Al-Sawaf, Bahlo J, et al. Venetoclax and Obinutuzumab in Patients with CLL and Coexisting Conditions. New England Journal of Medicine. 2019. Available at: https://www.nejm.org/doi/full/10.1056/NEJMoa1815281?query=main_nav_lg. Accessed: June 2019. 

2 Hallek M, Cheson BD, Catovsky D, et al. Guidelines for diagnosis, indications for treatment, response assessment and supportive management of chronic lymphocytic leukemia. Blood. 2018; 131(25):2745-2760

3 London Cancer. Chronic Lymphocytic Leukaemia. Available at: http://www.londoncancer.org/media/123091/Chronic-Lymphocytic-Leukaemia_London-Cancer-Guidelines.pdf. Available at: April 2019

4 National Cancer Institute. Chronic Lymphocytic Leukemia Treatment (PDQ®)–Patient Version. Available at: https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq. Accessed: April 2019

5 Cancer Research UK. Chronic lymphocytic leukaemia (CLL) incidence statistics. Available at: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/leukaemia-cll/incidence. Accessed: April 2019

6 Schuh A H, Parry-Jones N, Appleby N et al. Guidelines for the treatment of Chronic Lymphocytic Leukaemia. British Journal of Haematology. 2018

7 Leukaemia Care. Watch Wait Worry. Available at: https://www.leukaemiacare.org.uk/get-involved/our-campaigns/watch-wait-worry/. Accessed: April 2019

Bottcher S, Ritgen M, Fischer K, et al. Minimal residual disease quantification is an independent predictor of progression-free and overall survival in chronic lymphocytic leukemia: a multivariate analysis from the randomized GCLLSG CLL8 trial. J Clin Oncol. 2012;30(9):980-988.

9 Howard SC, Jones DP, Pui CH. The tumor lysis syndrome. N Engl J M 2011;364:1844-1854

10 Venclyxto Summary of Product Characteristics. Available from: https://www.medicines.org.uk/emc/medicine/32650. Accessed: April 2019

11 National Institute for Health and Care Excellence. Venetoclax with rituximab for previously treated chronic lymphocytic leukaemia. Available at: https://www.nice.org.uk/guidance/ta561/chapter/1-Recommendations

12 U.S. Food & Drug Administration. FDA approves Venetoclax for CLL and SLL. Available at: https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-venetoclax-cll-and-sll. Accessed: May 2019

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Results from Upadacitinib Phase 3 SELECT-MONOTHERAPY Study Published in The Lancet

Press releases   •   May 28, 2019 08:00 BST

      • SELECT-MONOTHERAPY evaluates the safety and efficacy of upadacitinib monotherapy in adult patients with moderately to severely active rheumatoid arthritis and inadequate response to a stable dose of methotrexate1
      • Upadacitinib (15 mg and 30 mg), once daily, achieved both primary endpoints with significantly higher rates of ACR20 response and low disease activity (defined as DAS28[CRP]≤3.2) at week 14 versus continued treatment with methotrexate1
      • Patients receiving either dose of upadacitinib monotherapy also achieved significantly higher rates of clinical remission (defined as DAS28[CRP]<2.6) at week 14 than those continuing methotrexate 1
      • The safety profile of upadacitinib was consistent with previously reported Phase 3 studies1

      Maidenhead, 28 May, 2019 — AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced the publication of positive results from the pivotal Phase 3 SELECT-MONOTHERAPY clinical trial in The Lancet. The study, in 648 patients evaluates upadacitinib as a monotherapy treatment versus continuing methotrexate in patients with moderately to severely active rheumatoid arthritisand an inadequate response to methotrexate.1 After 14 weeks of treatment, both once-daily doses of upadacitinib (15 mg n=217 and 30 mg n=215) met the study's primary endpoints with significantly higher rates of ACR20** and low disease activity (LDA)*** versus continuing stable methotrexate therapy (n=216).1 Both doses also achieved all key secondary endpoints, including the proportion of patients achieving remission**** and improvements in physical function (defined as change in HAQ-DI from baseline).1 Upadacitinib, an oral investigational JAK1-selective inhibitor is not approved by regulatory authorities and its safety and efficacy have not been established.

      "These results show that upadacitinib as a monotherapy can provide clinically meaningful responses, including low disease activity, remission and significant improvements in physical function,” said Josef S. Smolen, M.D., Department of Medicine, Division of Rheumatology, Medical University of Vienna, Austria, and first author on the publication. "Data from this study support the potential for upadacitinib as an important treatment option for patients with rheumatoid arthritis."

      Rheumatoid arthritis, which affects an estimated 400,000 people in the UK, is a chronic and debilitating disease. 2 Methotrexate is commonly used as a first-line therapy in rheumatoid arthritis, but many patients do not respond to or cannot tolerate methotrexate, which puts them at risk for disease progression.3-5 After inadequate response to methotrexate alone, methotrexate is commonly used as a background therapy with biologic DMARDs to optimise their efficacy.4,6

      “We are encouraged by the positive results published in The Lancet," said Alice Butler, UK Medical Director, AbbVie. "Data from this study, the third of six in the SELECT clinical trial programme evaluating the potential for upadacitinib in rheumatoid arthritis, helps to deepen our understanding of JAK1-selective inhibition and the potential for monotherapy in this complex disease”

      Results showed that after 14 weeks, 68 percent and 71 percent of patients who switched to upadacitinib monotherapy 15 mg and 30 mg at baseline, respectively, achieved ACR20 versus 41 percent of patients who continued to receive methotrexate therapy (p≤0.0001 for both doses). 1 Low disease activity***was achieved by 45 percent of patients receiving upadacitinib 15 mg and 53 percent receiving upadacitinib 30 mg versus 19 percent receiving methotrexate (p<0.0001 for both doses) at week 14.1

      The study also showed a significantly higher proportion of upadacitinib patients in both dose groups achieved clinical remission****, ACR50 and ACR70 at week 14 compared to patients continuing on methotrexate. 1 28 and 41 percent of upadacitinib-treated patients in the 15 mg and 30 mg groups, respectively, achieved clinical remission**** compared to 8 percent of those who continued methotrexate (p≤0.0001 for both doses).1 ACR50 and ACR70 were achieved by 42 and 23 percent, 52 and 33 percent for patients in the 15 mg and 30 mg upadacitinib groups, respectively, versus 15 and 3 percent of patients continuing on methotrexate.1

      SELECT-MONOTHERAPY Efficacy Results at Week 14*1

      Methotrexate  

      (n=216)

      Upadacitinib 15mg

      (n=217)

      Upadacitinib 30mg

      (n=215)

      ACR20** 41% 68% 71%
      ACR50** 15% 42% 53%
      ACR70** 3% 23% 33%
      LDA*** 19% 45% 53%
      Clinical Remission**** 8% 28% 41%

      *All week 14 endpoints shown in the table achieved p-values of <0.001 versus methotrexate for both doses. Not all key secondary endpoints shown. Methotrexate patients shown are patients who continued on their baseline methotrexate dose in a blinded manner.

      **ACR20/50/70 is defined as American College of Rheumatology 20 percent/50 percent/70 percent improvements in both tender and swollen joint counts, plus 3 of the following: patient assessments of pain, global disease activity and physical function, physician global assessment of disease activity and acute phase reactant.

      *** LDA was defined by a clinical response Disease Activity Score with 28 joint counts (C-reactive protein) (DAS28 [CRP]) less than or equal to 3.2.

      **** Clinical remission was based on DAS28 (CRP) less than 2.6.

      In the study, the safety profile of upadacitinib was consistent with previously reported Phase 3 SELECT clinical trials. 1,7-11 Serious adverse events occurred in 5 percent/3 percent of patients in the 15 mg/30 mg upadacitinib groups, respectively, compared to 3 percent in the methotrexate group.1 Three major adverse cardiovascular events (MACE) occurred in patients with known cardiovascular (CV) risk factors (one in the 15 mg group and two in the 30 mg group).1 One MACE in the 15 mg arm was a fatal hemorrhagic stroke due to a ruptured aneurysm.1 No other deaths were reported.1 There was one adjudicated pulmonary embolism (PE) reported in the 15 mg group in a patient with multiple known risk factors.1 Three malignancies were reported in the study, one in the methotrexate group and two in the 15 mg group.1 One patient in the upadacitinib 15 mg group and one in the methotrexate group experienced a serious infection.1 Herpes zoster was reported by one (1 percent) patient in the methotrexate group, three (1 percent) in the 15 mg group, and six (3 percent) in the 30 mg group.1

      About SELECT-MONOTHERAPY1

      SELECT-MONOTHERAPY is a Phase 3, multicentered, randomised, double-blind, double-dummy study designed to evaluate the safety and efficacy of upadacitinib monotherapy in adult patients with moderately to severely active rheumatoid arthritis and an inadequate response to a stable dose of methotrexate. Patients were randomised to switch from methotrexate to upadacitinib monotherapy (15 mg (n=217) or 30 mg (n=215)) once-daily or continue on their prior stable dose of methotrexate (n=216) in a blinded manner.

      The two independent primary endpoints comparing upadacitinib 15 mg and 30 mg with continued methotrexate included the percentage of subjects achieving an ACR20 response and low disease activity (LDA)*** after 14 weeks of treatment. Key secondary endpoints included the proportion of patients achieving ACR50, ACR70 and clinical remission**** at week 14. The trial is ongoing and the second phase is a blinded long-term extension period, of up to five years, to evaluate the long-term safety, tolerability, and efficacy of the two once-daily doses (15 mg and 30 mg) of upadacitinib monotherapy in patients who have completed the first phase. More information on this trial can be found at www.clinicaltrials.gov (NCT02706951).

      About the SELECT Study Programme1,7-11

      The robust SELECT Phase 3 rheumatoid arthritis programme evaluates more than 4,900 patients with moderately to severely active rheumatoid arthritis in six studies. The studies include assessments of efficacy, safety and tolerability across a broad range of rheumatoid arthritis patients. Key measures of efficacy evaluated include ACR responses, Disease Activity Score (DAS28-CRP) and inhibition of radiographic progression. More information on these trials can be found at www.clinicaltrials.gov (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951, NCT02675426).

      About Upadacitinib

      Discovered and developed by AbbVie, upadacitinib is an investigational, oral, small molecule JAK1-selective inhibitor being studied for moderately to severely active rheumatoid arthritis and other immune-mediated diseases. 12,13 Upadacitinib is not approved and its safety and efficacy have not been evaluated by regulatory authorities.

      -ENDS-

      UK Media:

      Natalie Bennett

      AbbVie

      T: 07818 428074
      E: natalie.bennett@abbvie.com

      References  

    1. Smolen, J.S., et al. A Phase 3 Randomised, Placebo-controlled, Double-Blind Study of Upadacitinib as Monotherapy in Patients with Active Rheumatoid Arthritis and Inadequate Response to Methotrexate: SELECT-MONOTHERAPY. The Lancet. 2019.
    2. NICE. Adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, tocilizumab and abatacept for rheumatoid arthritis not previously treated with DMARDs or after conventional DMARDs only have failed (TA375). January 2016.
    3. Shinde, CG, et al. Methotrexate: a gold standard for treatment of rheumatoid arthritis.J Pain Palliat Care Pharmacother. 2014 Dec;28(4):351-8. doi: 10.3109/15360288.2014.959238. Epub 2014 Oct 16.
    4. Swierkot J and Szechinski J. Methotrexate in rheumatoid arthritis. Pharmacol Rep. 20116 Jul-Aug;58(4)473-92
    5. Fautrel B, Nab HW, et al. Identifying patients with rheumatoid arthritis with moderate disease activity at risk of significant radiographic progression despite methotrexate treatment. RMD Open. 2015; 1(1). DOI: 10.1136/rmdopen-2014-000018
    6. Singh, JA, et al. 2015 American College of Rheumatology Guideline for the Treatment of Rheumatoid Arthritis. Arthritis Care & Research. 2015 Jan;68(1):1-26. doi: 10.1002/art.39480. Epub 2015 Nov 6. https://doi.org/10.1002/acr.22783.
    7. Fleischmann R, et al. A Phase 3, Randomized, Double-Blind Study Comparing Upadacitinib to Placebo and to Adalimumab, in Patients with Active Rheumatoid Arthritis with Inadequate Response to Methotrexate. 2018 ACR/ARHP Annual Meeting; 890
    8. Burmester GR, et al; Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying anti-rheumatic drugs (SELECT-NEXT): a randomised, double-blind, placebo-controlled phase 3 trial. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
    9. Genovese MC, et al; Safety and efficacy of upadacitinib in patients with active rheumatoid arthritis refractory to biologic disease-modifying anti-rheumatic drugs (SELECT-BEYOND): a double-blind, randomised controlled phase 3. Lancet. 2018 Jun 23;391(10139):2503-2512. doi: 10.1016/S0140-6736(18)31115-2. Epub 2018 Jun 18.
    10. van Vollenhoven, et al. A Phase 3, Randomized, Controlled Trial Comparing Upadacitinib Monotherapy to MTX Monotherapy in MTX-Naïve Patients with Active Rheumatoid Arthritis. 2018 ACR/ARHP Annual Meeting; 891
    11. A Phase 3 Study to Compare ABT-494 to Abatacept in Subjects With Rheumatoid Arthritis on Stable Dose of Conventional Synthetic Disease-Modifying Antirheumatic Drugs (csDMARDs) Who Have an Inadequate Response or Intolerance to Biologic DMARDs (SELECT-CHOICE). Clinicaltrials.gov. 2019. Available at: https://clinicaltrials.gov/ct2/show/NCT03086343. Accessed on March 4, 2019.
    12. Parmentier et al. In Vitro and In Vivo Characterization of the JAK1 Selectivity of Upadacitinib (ABT-494). BMC Rheumatology.2018 2:23; https://doi.org/10.1186/s41927-018-0031-x
    13. Pipeline – Our Science | AbbVie. AbbVie. 2018. Available at: https://www.abbvie.com/our-science/pipeline.html. Accessed on February 22, 2019.

  


May 2019

UK-IMMR-190012


About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

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Contacts 6 contacts

For general press enquiries please contact the AbbVie Corporate Communications team at UKMediaRelations@abbvie.com or call us on 01628 925200

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About AbbVie UK

We're a company that takes on the toughest health challenges.

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on twitter: @abbvieuk.

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