Rinvoq meets primary and all secondary endpoints in phase III study in psoriatic arthritis.-AbbVie

AbbVie announced positive top-line data from the SELECT-PsA 2 Phase III study . In this study, both doses of Rinvoq (upadacitinib; 15 mg and 30 mg, once daily) met the primary endpoint of ACR20 response at week 12 versus placebo in adult patients with active psoriatic arthritis who have responded inadequately to one or more biologic disease modifying anti-rheumatic drugs (bDMARDs). In addition, patients on both doses of Rinvoq achieved significantly greater responses compared to placebo for all ranked secondary endpoints. SELECT-PsA 2 is the first study evaluating the efficacy and safety of Rinvoq in adult patients with active psoriatic arthritis. Rinvoq, a selective and reversible JAK inhibitor discovered and developed by AbbVie, is being studied as a once-daily therapy in psoriatic arthritis and multiple immune-mediated diseases.

Results show that at week 12, 57/64 percent of patients receiving 15/30 mg of Rinvoq achieved ACR20, respectively, compared to 24 percent in the placebo group (p<0.0001). additionally, acr50 was achieved by 32 38 percent of patients receiving 15 30 mg of rinvoq, respectively, compared to 5 percent on placebo at week 12 (p><0.0001). 9 17 percent of patients achieved acr70 in the 15 30 mg rinvoq groups, respectively, compared to 0.5 percent in the placebo group at week 12 (p><0.0001). patients receiving rinvoq also had greater improvements in physical function at week 12, as measured by the health assessment questionnaire disability index (haq-di).>

Rinvoq showed improvement in skin symptoms at week 16, with 52/57 percent of patients receiving 15/30 mg of Rinvoq achieving a 75 percent improvement in the Psoriasis Area Severity Index (PASI 75), respectively, compared to 16 percent on placebo (p<0.0001). 25 29 percent of 15 30 mg rinvoq-treated patients achieved minimal disease activity (mda) at week 24 (p><0.0001), respectively, compared to 3 percent in the placebo group.>

In this study, the safety profile of Rinvoq was consistent with that observed in previously reported studies in patients with rheumatoid arthritis, with no new safety risks detected. Through week 24, serious infections occurred in 0.5/2.8 percent of patients in the 15/30 mg Rinvoq groups, respectively, compared to 0.5 percent in the placebo group. There was one pulmonary embolism reported in the 15 mg Rinvoq group and none in the 30 mg and placebo groups. There was one non-fatal adjudicated major adverse cardiovascular event (MACE) in the 15 mg Rinvoq group (acute myocardial infarction) and no MACE in the 30 mg and placebo groups. One death was reported in a patient receiving placebo (motor vehicle accident).