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In patients with psoriatic arthritis refractory or intolerant to biologic disease-modifying antirheumatic drugs (DMARDs), upadacitinib (Abbvie; Rinvoq) 15 mg and 30 mg once per day was more effective than placebo over 24 weeks in improving signs and symptoms of psoriatic arthritis.
In patients with psoriatic arthritis refractory or intolerant to biologic disease-modifying antirheumatic drugs (DMARDs), upadacitinib (Abbvie; Rinvoq) 15 mg and 30 mg once per day was more effective than placebo over 24 weeks in improving signs and symptoms of psoriatic arthritis, according to a study published in Annals of the Rheumatic Diseases.1
“Greater efficacy was demonstrated for once per day upadacitinib 15 mg and 30 mg versus placebo for clinical manifestations of psoriatic arthritis including musculoskeletal symptoms (peripheral arthritis, enthesitis, dactylitis, and spondylitis), psoriasis, physical function, pain, fatigue, and quality of life,” wrote Philip Mease, MD, of the Swedish Medical Center in Seattle, Washington, and colleagues.
Despite the availability of biologic DMARDs in psoriatic arthritis, under one-third of patients achieve minimal disease activity (MDA), highlighting the need for additional treatment options. Upadacitinib, an oral, reversible Janus kinase inhibitor, is approved for the treatment of rheumatoid arthritis. Upadacitinib has shown improvements in multiple composite measures and patient-reported outcomes in patients with rheumatoid arthritis refractory to biologic DMARDs.
In this phase 3 trial, dubbed SELECT-PsA 2, Mease and colleagues evaluated upadacitinib in patients with psoriatic arthritis and prior inadequate response or intolerance to at least one biologic DMARD.
The 24-week trial included 642 patients who were randomized in a 2:2:1:1 ratio to receive once per day upadacitinib 15 mg or 30 mg, or placebo switched to either upadacitinib 15 mg or 30 mg once per day at week 24. The primary outcome was the proportion of patients achieving American College of Rheumatology (ACR) 20 response at week 12. Achievement of MDA was assessed at week 24.
At week 12, 56.9% of patients receiving upadacitinib 15 mg and 63.8% of patients receiving upadacitinib 30 mg achieved ACR20, versus 24.1% of those receiving placebo (p<0.001 for both comparisons). At week 24, MDA was achieved by 25.1% of upadacitinib 15 mg-treated patients and 28.9% of upadacitinib 30 mg-treated patients, versus 2.8% of the patients receiving placebo (p<0.001 for both comparisons).
“Notably, efficacy was achieved with both upadacitinib doses as monotherapy and in combination with non-biologic DMARDs,” investigators wrote. “Both upadacitinib doses also provided rapid efficacy on arthritis signs/symptoms, as evidenced by greater improvement of ACR20 compared with placebo at week 2.”
For treatment-emergent adverse events, the rates were generally similar with placebo and upadacitinib 15 mg and higher with upadacitinib 30 mg at week 24. For serious infections, the rates were 0.5% for both placebo and upadacitinib 15 mg, and 2.8% for upadacitinib 30 mg.
Investigators noted that the safety findings of upadacitinib are consistent with those reported in rheumatoid arthritis, with no new safety risks identified.
Mease PJ, Lertratanakul A, Anderson JK, Hellgren K, et al. Upadacitinib for psoriatic arthritis refractory to biologics: SELECT-PsA 2. [published online ahead of print, 2020 Dec 3].Annals of the Rheumatic Diseases.2021;80:312-320. doi: 10.1136/annrheumdis-2020-218870.