AbbVie has reported that the Phase III SELECT-PsA 1 study of Rinvoq (upadacitinib) has met its primary endpoint in adults with active psoriatic arthritis.
Rinvoq is a selective and reversible Janus kinase (JAK) developed to treat immune-mediated inflammatory diseases, including psoriatic arthritis. The drug holds approval in the US and EU to treat moderately to severely active rheumatoid arthritis in adults.
The multi-centre, randomised, double-blind, parallel-group, active, placebo-controlled Phase III trial assessed the safety and efficacy of a 15mg and 30mg dose of the drug in psoriatic arthritis patients.
It enrolled patients who did not have an adequate response to or are intolerant to non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
The trial met the primary goal of ACR20 response at week 12, with 71% and 79% of participants on the 15mg and 30mg dose of the drug showing at least a 20% improvement, compared to 36% on placebo.
Adalimumab was another comparator in the trial, where both Rinvoq doses demonstrated non-inferiority and the 30mg dose exhibited superiority.
In addition, 38% and 52% of subjects treated with the 15mg and 30mg dose, respectively, achieved ACR50 at week 12 versus 13% with placebo. ACR70 at week 12 was experienced by 16% and 25% of patients, respectively, versus 2%.
Greater physical function improvements were achieved at week 12 with Rinvoq. The drug also inhibited radiographic progression after 24 weeks of therapy.
Data also revealed that the safety profile of the drug was consistent with its prior data, with no new safety risks.
AbbVie vice-chairman and president Michael Severino said: “The results of this large Phase III study further support the potential of RINVOQ to help these patients.
“We look forward to sharing these data with regulatory bodies around the world to support our application for label expansion for Rinvoq to include adult patients with active psoriatic arthritis.”
The Phase III trial is ongoing and the long-term extension will monitor the safety, tolerability and efficacy of the drug over the long-term in participants who completed the placebo-controlled period.