AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis

Compiled by S.Li

On June 1 local time, AbbVie announced that it had submitted applications for a new indication of the selective, reversible JAK inhibitor Rinvoq (upadacitinib) to the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), seeking approval for the treatment of adult patients with active psoriatic arthritis.

This application is based on the results of two Phase 3 clinical trials, SELECT-PsA 1 and SELECT-PsA 2. Both trials were randomized, double-blind, controlled studies involving 2,000 patients with active psoriatic arthritis. In both studies, Rinvoq met the primary endpoint of achieving an ACR20 response (one of the American College of Rheumatology criteria for evaluating treatment efficacy) at Week 12, compared with placebo.

In the SELECT-PsA 1 trial, the proportions of patients achieving an ACR20 response were 71% and 79% in the groups receiving 15 mg and 30 mg of Rinvoq, respectively, compared with 36% in the placebo group. In the SELECT-PsA 2 trial, after 12 weeks of treatment, the proportions of patients achieving an ACR20 response were 57% and 64% in the groups receiving the two different doses of Rinvoq, respectively, compared with 24% in the placebo group.

The SELECT-PsA 1 trial also evaluated efficacy compared with adalimumab: at Week 12, Rinvoq 15 mg demonstrated non-inferiority to adalimumab in terms of the ACR20 response. Patients treated with Rinvoq also showed greater improvements in physical function (HAQ-DI) and skin symptoms (PASI 75), and a higher proportion of patients achieved minimal disease activity. In terms of overall safety, Rinvoq’s profile in the psoriatic arthritis trials was consistent with that observed in previous Phase 3 clinical trials in rheumatoid arthritis, with no new major safety risks identified.

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 selective, reversible JAK inhibitor discovered and developed by AbbVie. In August 2019, it received approval from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to methotrexate. In December 2019, it was approved in the European Union for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have responded inadequately to or are intolerant of one or more disease-modifying antirheumatic drugs (DMARDs). Currently, studies evaluating Rinvoq for the treatment of multiple immune-mediated inflammatory diseases are ongoing, including psoriatic arthritis, rheumatoid arthritis, axial spondyloarthritis, Crohn’s disease, atopic dermatitis, ulcerative colitis, and giant cell arteritis.

Reference Source: AbbVie Submits Regulatory Applications to FDA and EMA for RINVOQ™ (upadacitinib) for the Treatment of Adults with Active Psoriatic Arthritis