SMC Accepts AbbVie’s RINVOQ [® ]▼ (upadacitinib) For Use in Adults with Active Psoriatic Arthritis
- This decision means that upadacitinib will be available in Scotland for eligible patients with previously treated active psoriatic arthritis (PsA) 1
- Across pivotal clinical trial programmes, upadacitinib (15 mg, once daily) demonstrated efficacy across multiple measures of disease activity in psoriatic arthritis (PsA) with a safety profile consistent with that seen in rheumatoid arthritis (RA)2,3,4
- Upadacitinib is now the first-ever, once-daily oral JAK approved for the treatment of PsA, ankylosing spondyloarthritis, and rheumatoid arthritis
MAIDENHEAD, UK, May 10, 2021 – AbbVie (NYSE: ABBV) today announced that the Scottish Medicines Consortium (SMC) has issued a positive decision recommending RINVOQ® ▼ (upadacitinib, 15 mg), within NHS Scotland for the treatment of adults with active psoriatic arthritis (PsA). 1 Upadacitinib is an oral, once daily selective and reversible janus kinase inhibitor (JAKi).5
In its guidance, the SMC recommends upadacitinib for adults with active PsA, who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Upadacitinib may be used as monotherapy or in combination with methotrexate (MTX).5 The publication of this guidance means that eligible patients will now be able to access upadacitinib via NHS Scotland.
In both the Phase 3 SELECT-PsA 1 and SELECT-PsA 2 clinical trials, upadacitinib met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis who had an inadequate response to non-biologic disease-modifying antirheumatic drugs (DMARDs) or biologic DMARDs, respectively.2,6,7
PsA is a systemic inflammatory disease with hallmark manifestations across multiple domains including joints and skin. In psoriatic arthritis, the immune system creates inflammation that can lead to skin lesions associated with psoriasis, pain, fatigue and stiffness in the joints.8,9
Iain McInnes, Vice Principal and Versus Arthritis Professor of Rheumatology at University of Glasgow, UK said, “This is a welcome decision from the SMC which offers us another treatment option when treating people with active psoriatic arthritis in Scotland. Clinical studies have shown that upadacitinib can improve musculoskeletal symptoms, psoriasis, pain and fatigue in people living with psoriatic arthritis. This milestone is a meaningful advance in the therapeutic area, allowing patients in Scotland access to a broader choice of treatment options for their individual needs.”
Helen McAteer, Chief Executive of the Psoriasis Association said, “The Psoriasis Association welcomes the news of a new treatment option being accepted for the treatment of adults with active psoriatic arthritis in NHS Scotland. There remains a high unmet need for people living with this complex auto-immune condition. PsA can make every day challenging, with patients experiencing not only pain, joint stiffness and fatigue, but also significant emotional impacts such as anxiety, low mood and trouble sleeping, particularly if the PsA is poorly controlled.”
Commenting on today’s publication of the decision by the SMC, AbbVie UK medical director, Belinda Byrne said, “We are delighted with the SMC’s decision to accept upadacitinib for adults living with active psoriatic arthritis in Scotland. This approval is another important milestone in our commitment to develop a portfolio of solutions that advance standards of care for people living with rheumatic diseases.”
About upadacitinib 1
Upadacitinib is a once-daily, oral, selective, and reversible janus kinase (JAK) inhibitor. It received marketing authorisation in December 2019 for the treatment of adult patients with moderate to severe active RA, who have had an inadequate response or are intolerant to one or more DMARDs and it may be used as monotherapy or in combination with the DMARD methotrexate. Upadacitinib prescribing information can be found at: https://www.medicines.org.uk/emc/product/10972/smpc
Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to AbbVie UK Ltd. Please contact GBPV@abbvie.com
About SELECT-PsA 1 2
SELECT-PsA 1 is a Phase 3, multicentre, randomised, double-blind, parallel-group, active and placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib compared to placebo and adalimumab in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one non-biologic DMARD. Patients were randomised to upadacitinib 15 mg, upadacitinib 30 mg, adalimumab 40 mg EOW or placebo at baseline. At week 24, placebo patients were switched to either upadacitinib 15 mg or upadacitinib 30 mg.
The primary endpoint was the percentage of subjects receiving upadacitinib 15 mg or upadacitinib 30 mg who achieved an ACR20 response at 12 weeks of treatment versus placebo. Key secondary endpoints included change from baseline in HAQ-DI, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16 and proportion of patients achieving minimal disease activity (MDA) at week 24. These are not all of the secondary endpoints. The trial is ongoing, and the long-term extension will provide data on the long-term safety, tolerability and efficacy of upadacitinib in patients who have completed the placebo-controlled period.
Top-line results from SELECT-PsA 1 were previously announced in February 2020. More information on this trial can be found at www.clinicaltrials.gov (NCT03104400).
About SELECT-PsA 2 6,7
SELECT-PsA 2 is a Phase 3, multicentre, randomised, double-blind, parallel-group, placebo-controlled study designed to evaluate the safety and efficacy of upadacitinib in adult patients with active psoriatic arthritis who have a history of inadequate response to at least one biologic (bDMARD). Patients were randomised to upadacitinib 15 mg, upadacitinib 30 mg or placebo followed by either upadacitinib 15 mg or upadacitinib 30 mg at week 24.
The primary endpoint was the percentage of subjects achieving an ACR20 response after 12 weeks of treatment. Key secondary endpoints included change from baseline in HAQ-DI, proportion of patients achieving ACR50 and ACR70 at week 12, proportion of patients achieving PASI 75 at week 16, as well as proportion of patients achieving MDA at week 24. These are not all of the secondary endpoints. The trial is ongoing, and the long-term extension will provide data on the long-term safety, tolerability and efficacy of upadacitinib in patients who have completed the placebo-controlled period.
Top-line results from SELECT-PsA 2 were previously announced in October 2019. More information on this trial can be found at www.clinicaltrials.gov (NCT03104374).
About AbbVie in Rheumatology
For more than 20 years, AbbVie has been dedicated to improving care for people living with rheumatic diseases. Our longstanding commitment to discovering and delivering transformative therapies is underscored by our pursuit of cutting-edge science that improves our understanding of promising new pathways and targets in order to help more people living with rheumatic diseases reach their treatment goals.
About AbbVie UK
AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. The company strive to have a remarkable impact on people's lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.co.uk. Follow us on Twitter, YouTube.
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1. Scottish Medicine’s Consortium. Medicines advice for upadacitinib (Rinvoq). Available at https://www.scottishmedicines.org.uk/medicines-advice/upadacitinb-rinvoq-abb-smc2361/. Accessed April 2021.
2. McInnes I, et al. Efficacy and Safety of Upadacitinib Versus Placebo and Adalimumab in Patients With Active Psoriatic Arthritis and Inadequate Response to Non-Biologic Disease-Modifying Anti-Rheumatic Drugs (SELECT-PsA-1): a Double-Blind, Randomized Controlled Phase 3 Trial. Annals of the Rheumatic Diseases 2020;79:16-17.
3. Mease PJ, et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. Annals of the Rheumatic Diseases. 2020 Dec 3;annrheumdis-2020-218870. doi: 10.1136/annrheumdis-2020-218870
4. Cohen S., et al. Safety profile of upadacitinib in Rheumatoid Arthritis: Integrated analysis from the SELECT Phase 3 Clinical Program. Annals of the Rheumatic Diseases 2021. 80:304-311 doi:10.1136/annrheumdiss-2020-218510
5. RINVOQ 15 mg prolonged-release tablets SMPC. Available at: https://www.medicines.org.uk/emc/product/10972/smpc. Accessed April 2021.
6. Mease, PJ, et al. Upadacitinib for psoriatic arthritits refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2020;80:312-320.
7. Mease, PJ, et al. Upadacitinib for psoriatic arthritits refractory to biologics: SELECT-PsA 2. Ann Rheum Dis. 2020;80(suppl. 2):35.
8. Duarte GV, et al. Psoriatic arthritis. Best Pract Res Clin Rheumatol. 2012 Feb;26(1):147-56. doi: 10.1016/j.berh.2012.01.003.
9. Diseases & Conditions: Psoriatic Arthritis. 2019. American College of Rheumatology. Available at: https://www.rheumatology.org/I-Am-A/Patient-Caregiver/Diseases-Conditions/Psoriatic-Arthritis. Accessed April 2021.