AbbVie's JAK Inhibitor Rinvoq Receives EU Approval for Psoriatic Arthritis and Ankylosing Spondylitis
AbbVie
Innovative Drug Developer
European Commission
The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.
Today, AbbVie announced that the European Commission (EC) has approved an expanded indication for its JAK inhibitor Rinvoq (upadacitinib) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to one or more disease-modifying antirheumatic drugs (DMARDs). Rinvoq may be used as monotherapy or in combination with methotrexate. Rinvoq has also been approved for the treatment of adult patients with active ankylosing spondylitis (AS) who have had an inadequate response to conventional therapy. This marks the first approval of this JAK inhibitor for these two patient populations.
Psoriatic arthritis is a systemic inflammatory disease with manifestations in multiple body regions. In patients with psoriatic arthritis, immune-mediated inflammation can lead to psoriasis-associated skin lesions, joint pain, fatigue, and stiffness. Ankylosing spondylitis is a chronic, inflammatory musculoskeletal disease primarily affecting the spine, characterized by debilitating symptoms such as pain, limited mobility, and structural damage. Despite advances in therapies for these conditions, many patients still do not achieve adequate symptom relief.
Rinvoq is a once-daily oral selective JAK1 small-molecule inhibitor. Previously, the FDA approved it for marketing to treat adult patients with moderately to severely active rheumatoid arthritis. Additionally, it is undergoing clinical studies for several other inflammatory indications, including Crohn’s disease, ulcerative colitis, and atopic dermatitis.
These two approvals are supported by the results of three clinical trials. In the two Phase 3 clinical trials, SELECT-PsA1 and SELECT-PsA2, Rinvoq met the primary endpoints in adult patients with active psoriatic arthritis who had an inadequate response to DMARDs. Specifically, it demonstrated a significant improvement in ACR20 response at Week 12 compared with placebo. Compared with adalimumab, a common therapy, Rinvoq also met the non-inferiority criteria. Patients treated with Rinvoq showed greater improvements in physical function and skin symptoms compared with those in the placebo group.
In the Phase 2/3 SELECT-AXIS1 clinical trial, Rinvoq was evaluated for the treatment of adult patients with ankylosing spondylitis who were naïve to biologic DMARDs. The trial results demonstrated that Rinvoq met its primary endpoint, showing a statistically significant improvement in the Assessment of SpondyloArthritis international Society (ASAS) 40 response rate compared with placebo.
“Psoriatic arthritis and ankylosing spondylitis have a significant impact on many aspects of patients’ lives,” said Dr. Tom Hudson, Chief Scientific Officer and Senior Vice President of Research and Development at AbbVie. “We are proud to provide a new treatment option for patients with psoriatic arthritis, as well as a ‘first-in-class’ treatment option for patients with ankylosing spondylitis.”
Note: This article is intended to introduce medical and health research and does not constitute a recommendation for treatment plans. For guidance on treatment options, please consult a licensed healthcare provider at a reputable hospital.
References:
[1] European Commission Approves AbbVie's RINVOQ™ (Upadacitinib) for the Treatment of Psoriatic Arthritis and Ankylosing Spondylitis. Retrieved January 25, 2021, from https://news.abbvie.com/news/press-releases/european-commission-approves-abbvies-rinvoq-upadacitinib-for-treatment-psoriatic-arthritis-and-ankylosing-spondylitis.htm
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