1/26/2022
A new medication has been approved by the U.S. FDA for the treatment of psoriatic arthritis (PsA) – upadacitinib (Rinvoq).
Upadacitinib is the latest Janus kinase (JAK) inhibitor to receive FDA approval to treat a form of spondyloarthritis (SpA). Tofacitinib, also known as Xeljanz or Xeljanz XR, is already approved for PsA, and was also recently approved for ankylosing spondylitis (AS).
As detailed in a recent Spondylitis Plus article, JAK inhibitors are the latest class of synthetic (non-biologic) drugs, taken orally, that have been proven effective in clinical trials for treating multiple forms of arthritis, including AS and PsA.1
Upadacitinib is approved for the treatment of adults with active PsA who have had an inadequate response or intolerance to one or more TNF inhibitors.2
Support for the approval comes from two phase III clinical trials. In the SELECT-PsA 1 trial, 1,704 adults with PsA were given upadacitinib (15mg or 30mg once daily), a placebo, or the TNF inhibitor adalimumab (Humira).3 This study, importantly, not only compared upadacitinib to a placebo, but also compared the drug to adalimumab (both medications are made by AbbVie).
At week 12, 70.6% of those who received 15mg upadacitinib achieved an ACR20 response (at least a 20% improvement in disease activity), compared with 65% who received adalimumab, and 36.2% who received a placebo. In addition, those treated with upadacitinib saw improvements in dactylitis (the swelling of an entire finger or toe) and enthesitis (inflammation of tendons and/or ligaments) related to PsA, along with fatigue, psoriasis, and physical function.2
Published in the New England Journal of Medicine, the study showed consequential results for those with PsA, according to Atul Deodhar, MD, rheumatologist and member of SAA’s Medical and Scientific Advisory Board. “The study showed that Rinvoq [upadacitinib] was as effective as Humira. For a pill to be as effective as an injectable medication is significant,” said Dr. Deodhar.
In the SELECT-PsA 2 trial, 57% of patients taking 15mg upadacitinib achieved ACR20 responses at week 12, compared to 24% who received a placebo.
In both studies, the safety profile of upadacitinib in patients with PsA was consistent with that previously observed in patients with rheumatoid arthritis. Adverse effects included infections, liver disorders, cardiovascular events, and increased incidence of shingles.
In September, the FDA issued a new drug safety report for JAK inhibitors, after a review of a large, randomized safety trial of the JAK inhibitor tofacitinib that included RA patients aged 50 or older who had one or more preexisting cardiovascular risk factors. Based on data from that trial, the FDA has required new label updates for the JAK inhibitors upadacitinib, tofacitinib, and baricitinib warning of increased risks of heart attack, stroke, certain cancers, and other serious side-effects.4
Those who are prescribed a JAK inhibitor should speak to their doctor about these potential side-effects.
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