Health Canada Approves Upadacitinib to Treat Adults with PsA

Health Canada has approved upadacitinib (Rinvoq) in a 15 mg dose to treat adults with active psoriatic arthritis (PsA) who have had an inadequate response to, or are intolerant of, methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs). The treatment is an oral, once daily, selective and reversible Janus kinase inhibitor (jakinib) that can be used as monotherapy or combined with methotrexate.¹

This Canadian approval was supported by data from the SELECT-PsA 1 (NCT03104400) and SELECT-PsA 2 (NCT03104374) clinical trials. Both studies were phase 3, randomized, multicenter, double-blind, parallel-group, placebo-controlled trials examining the efficacy and safety of upadacitinib in adults with PsA. SELECT-PsA 1 compared upadacitinib with placebo and adalimumab in adults for whom at least one non-biologic DMARD had proved inadequate. SELECT-PsA 2 was a placebo-controlled trial that evaluated adults for whom at least one biologic DMARD had proved inadequate.^2,3

The Research

At week 12 of SELECTPsA 1, upadacitinib met the study’s primary endpoint of an ACR20 response (i.e., improvement of 20% in the number of tender and number of swollen joints, and a 20% improvement in three of the following five criteria: patient global assessment, physician global assessment, functional ability measure, visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein [CRP]). The treatment was given once daily at a dose of 15 or 30 mg, and 71% and 79% of patients treated with upadacitinib, respectively, achieved an ACR20 response compared with 36% of patients treated with placebo (P<0.0001).

Also at week 12, the 30 mg dose of upadacitinib achieved an ACR20 response superior to adalimumab in patients. Both the 15 and 30 mg doses of upadacitinib proved non-inferior to adalimumab.

An ACR50 response at week 12 was achieved in 38% of patients treated with 15 mg of upadacitinib and 52% of patients treated with 30 mg of upadacitinib, compared with 13% in patients treated with placebo (P<0.0001). Additionally, at week 12, an ACR70 response was achieved in 16% of patients treated with 15 mg of upadacitinib and 25% of patients treated with 30 mg of upadacitinib, compared with 2% of patients treated with placebo (nominal P<0.0001).

At week 24, both upadacitinib doses significantly inhibited radiographic progression compared with placebo (P<0.01). This result was measured by the change from baseline in the modified van der Heijde-Sharp score for PsA.

In SELECT-PsA 2, 57% of patients who received 15 mg of upadacitinib and 64% of patients who received 30 mg of upadacitinib achieved an ACR20 response by week 12, compared with 24% of placebo-treated patients (P<0.0001).