AbbVie Announces Phase 3 Success of JAK1 Inhibitor Rinvoq in Adults with Active Psoriatic Arthritis

Today, AbbVie announced that its JAK1-selective inhibitor Rinvoq (upadacitinib) met the primary and key secondary endpoints in the Phase 3 SELECT-PsA 2 trial evaluating adult patients with active psoriatic arthritis.

Psoriatic arthritis is a chronic inflammatory disease that can lead to irreversible joint deformity and disability. It is estimated that there are more than 50 million patients with psoriatic arthritis worldwide. Psoriatic arthritis typically affects the joints of the fingers and toes first, causing joint swelling, pain, and impaired mobility, accompanied by nail and toenail lesions. In severe cases, other joints are also affected, significantly hindering motor function.

Rinvoq is a once-daily, oral small-molecule selective JAK1 inhibitor. The FDA has previously approved it for the treatment of adult patients with moderate to severe active rheumatoid arthritis (RA). Furthermore, it is undergoing clinical studies for multiple inflammatory indications, including psoriatic arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, and atopic dermatitis.

In the SELECT-PsA 2, a randomized, double-blind, placebo-controlled Phase 3 trial, patients had previously received treatment with one or more biologic disease-modifying antirheumatic drugs (bDMARDs) but had an inadequate response. The trial results showed that after 12 weeks of treatment, the proportion of patients achieving ACR20 (one of the American College of Rheumatology response criteria) was 57% and 64% among those receiving two different doses of Rinvoq (15 mg or 30 mg), respectively, compared to 24% in the placebo group, thereby meeting the primary efficacy endpoint of the trial.

▲Selected Efficacy Results from the SELECT-PsA 2 Trial (Image source: Reference [1])

After 12 weeks of treatment, the proportions of patients achieving ACR50 in the treatment groups were 32% and 38%, respectively, compared with 5% in the placebo group. The proportions of patients achieving ACR70 in the treatment groups were 9% and 17%, respectively, compared with 0.5% in the placebo group. In addition, Rinvoq met multiple other secondary endpoints.

“Many patients with psoriatic arthritis are still unable to achieve their treatment goals, indicating a high unmet medical need for this disease,” said Michael Severino, M.D., President of AbbVie. “This trial demonstrates the potential of Rinvoq to improve disease symptoms in patients with psoriatic arthritis, and the data from this trial will support our regulatory submissions for Rinvoq in the treatment of psoriatic arthritis.”

References:

[1] RINVOQ™ (upadacitinib) Meets Primary and All Ranked Secondary Endpoints in Phase 3 Study in Psoriatic Arthritis, Retrieved October 31, 2019, from https://www.prnewswire.com/news-releases/rinvoq-upadacitinib-meets-primary-and-all-ranked-secondary-endpoints-in-phase-3-study-in-psoriatic-arthritis-300948804.html

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