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
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).