The European Commission also approved Rinvoq to treat active psoriatic arthritis (PsA) in adults who have not responded to, or are intolerant of, standard therapies.
These approvals, which follow a positive recommendation from the Committee for Medicinal Products for Human Use (part of the European Medicines Agency), cover all member states of the European Union, as well as Iceland, Liechtenstein, and Norway.
“We are proud to provide RINVOQ as a new treatment option to patients with PsA and a first-in-class treatment option to those living with AS,” Tom Hudson, MD, senior vice president of research and development, and chief scientific officer at AbbVie, said in a press release. “These approvals are important milestones in our commitment to develop a portfolio of solutions that advance standards of care for people living with rheumatic diseases.”
Rinvoq is an oral medication that works by blocking the activity of an enzyme called Janus kinase (JAK). This lowers the activity of the immune system, thereby lessening the inflammation that drives symptoms in AS and PsA. The medication had been approved in the EU and the U.S. to treat certain individuals with rheumatoid arthritis. The approved dose is 15 mg.
The commission’s latest approval was based in part on data from the Phase 2/3 clinical trial SELECT-AXIS 1 (NCT03178487),which tested Rinvoq in individuals with active AS who had never taken biologic disease-modifying anti-rheumatic drugs (DMARDs) and had an inadequate response or were intolerant to nonsteroidal anti-inflammatory drugs (e.g., ibuprofen).
SELECT-AXIS 1 met its primary goal with significantly more patients on Rinvoq than on a placebo (52% vs. 26%) achieving at least a 40% clinical improvement at week 14, as measured with the Assessment of Spondyloarthritis International Society, which evaluates four domains: pain, function, inflammation, and a patient global assessment.
Lessened disease activity, as well as a higher proportion of participants in partial remission, also were observed with Rinvoq as compared to the placebo.
The new approval is also supported by two Phase 3 clinical trials that tested the medication in individuals with PsA. Both trials, SELECT-PsA 1 (NCT03104400) and SELECT-PsA 2 (NCT03104374), met their primary goal; compared to a placebo, more participants on Rinvoq had a decrease in disease activity of at least 20%, as assessed with the American College of Rheumatology criteria, at week 12.
Safety results from all three of these AbbVie-sponsored trials were overall consistent with each other and with previous data from rheumatoid arthritis patients. No new significant safety risks were identified.
In SELECT-AXIS 1, serious adverse events were reported in 1% of the patients in both the Rinvoq and placebo groups. The most frequent adverse events associated with the medication included diarrhea, nasopharyngitis (the common cold), headache, nausea, and increased levels of creatine phosphokinase (a marker of muscle damage) in the blood.
“In clinical trials, RINVOQ demonstrated improvements across multiple manifestations of these diseases,” said Iain McInnes, MD, PhD, professor at the University of Glasgow who served as a clinical trial investigator of Rinvoq. “The approvals of RINVOQ for the treatment of PsA and AS offer physicians in the European Union an important new therapeutic option and for their patients a new opportunity to find meaningful relief from their debilitating symptoms.”
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