NICE recommends AbbVie’s RINVOQ[® ▼ (upadacitinib) ]For Use in Adults with Active Psoriatic Arthritis
- This decision means that upadacitinib will be available in England and Wales 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 now MHRA-approved across four indications (atopic dermatitis, rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis)
MAIDENHEAD, UK, 11th January 2022 – AbbVie (NYSE: ABBV) today announced that the National Institute for Health and Care Excellence (NICE) has issued a Final Appraisal Determination (FAD) recommending RINVOQ® ▼ (upadacitinib), 15 mg as a new option for treating adults with active PsA, alone or with methotrexate, for those whose disease has not responded well enough to disease-modifying antirheumatic drugs (DMARDs) or who cannot tolerate them. It is recommended only if they have peripheral arthritis with 3 or more tender joints and 3 or more swollen ligaments, and they have had two conventional DMARDs and at least 1 biological DMARD, or TNF-alpha inhibitors are contraindicated but would otherwise be considered.1
Upadacitinib is an oral, once daily selective and reversible janus kinase inhibitor (JAKi).5 Upadacitinib may be used as monotherapy or in combination with methotrexate (MTX).5 The publication of the NICE FAD means that eligible patients will now be able to access upadacitinib via the NHS in England and Wales. Upadacitinib has been recommended in Scotland since May 2021.6
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.2,3
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, swelling and stiffness in the joints.7,8
Dr Arvind Kaul, Consultant Rheumatologist and Honorary Senior Lecturer at St. George’s University Hospitals NHS Foundation Trust, said, “The NICE recommendation of upadacitinib provides another effective treatment option for those living with active psoriatic arthritis in England and Wales. Clinical studies have demonstrated that upadacitinib shows improvements in musculoskeletal symptoms, psoriasis, pain and fatigue in people and living with psoriatic arthritis. This milestone is a meaningful advance in the therapeutic area, allowing patients across England and Wales access to a broader choice of treatment options for their individual needs.”
Helen McAteer, Chief Executive of the Psoriasis Association said, “The Psoriasis Association is encouraged to see a new treatment option available on the NHS in England and Wales for the treatment of adults with active psoriatic arthritis. PsA can make every day challenging, with patients experiencing agonising pain, joint stiffness and fatigue, in addition to anxiety and low mood, particularly if the PsA is poorly controlled.”
Commenting on today’s publication of the decision by NICE, AbbVie UK medical director, Belinda Byrne said, “We are delighted that NICE has recommended upadacitinib for use in adults living with active psoriatic arthritis in England and Wales. At AbbVie, we understand how rheumatic diseases can impact the daily lives of patients and we strive to provide a variety of treatment options for those affected.”
Upadacitinib is a once-daily, oral, selective, and reversible janus kinase (JAK) inhibitor. It received marketing authorisation in January 2021 for the treatment of adult patients with active PsA, 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 12
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 23
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.
- National Institute for Health and Care Excellence. Upadacitinib for treating active plaque psoriasis Available at: https://www.nice.org.uk/guidance/gid-ta10666/documents/final-appraisal-determination-document Accessed January 2022.
- 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.
- 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
- 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
- RINVOQ 15 mg prolonged-release tablets SMPC. Available at: https://www.medicines.org.uk/emc/product/10972/smpc. Accessed January 2022.
- Scottish Medicine’s Consortium. Medicines advice for upadacitinib (Rinvoq). Available at https://www.scottishmedicines.org.uk/medicines-advice/upadacitinib-rinvoq-abb-smc2361/ . Accessed January 2022.
- 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.
- 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 January 2022.
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