AbbVie’s RINVOQ® ▼ (upadacitinib) Accepted for Use

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).  Upadacitinib is an oral, once daily selective and reversible janus kinase inhibitor (JAKi).

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). 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.

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.

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.”