AbbVie has reported positive data from the ongoing Phase III SELECT-PsA 2 clinical trial of Rinvoq (upadacitinib) to treat active psoriatic arthritis.
The trial assessed a 15mg and 30mg once-daily dose of Rinvoq in patients who had not experienced adequate response to one or more biologic disease-modifying anti-rheumatic drugs (bDMARDs).
The drug is a selective and reversible inhibitor of JAK that is being developed by AbbVie for the treatment of various immune-mediated diseases.
The multi-centre, randomised, double-blind, parallel-group, placebo-controlled Phase III trial assessed the safety and efficacy of the drug in adult patients.
Participants received a 15mg or 30mg dose of Rinvoq or placebo followed by the drug dose at week 24.
The trial’s primary endpoint was the proportion of patients with an ACR20 response after 12 weeks of treatment.
SELECT-PsA 2 also tracked secondary endpoints, including the change from baseline in HAQ-DI, the proportion of patients who had ACR50 and ACR70 at week 12, those with PASI 75 at week 16, and the proportion of participants achieving MDA at week 24.
The trial met the primary endpoint and patients treated with either of the AbbVie drug doses showed significantly greater responses across all key secondary endpoints compared to placebo.
According to the data, 57% and 64% of patients treated with a 15mg and 30mg dose, respectively, had ACR20 response at week 12 versus 24% on placebo.
Additionally, 32% and 38% of subjects achieved ACR50, respectively, compared to 5% in the placebo arm.
At week 12, 9% and 17% of participants treated with a 15mg and 30mg dose, respectively, experienced ACR70, while 0.5% patients on placebo showed the response.
Rinvoq also led to improvements in physical function at week 12, skin symptoms at week 16, and minimal disease activity (MDA) at week 24.
AbbVie vice-chairman and president Michael Severino said: “Too many people living with psoriatic arthritis still fail to achieve their treatment goals, underscoring a clear medical need for additional therapeutic options.
“We are pleased with these data, which show the potential of Rinvoq to improve outcomes for people with psoriatic arthritis across a variety of symptoms. Data from this Phase III study will support regulatory submissions for RINVOQ in psoriatic arthritis.”
The trial’s long-term extension is still blinded in order to investigate the long-term safety, tolerability and efficacy of the once-daily 15mg and 30mg doses of the drug in subjects who have completed the placebo-controlled period.