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SAN DIEGO – Tofacitinib significantly improved patient-reported outcomes among patients with active psoriatic arthritis, according to the results from phase 3 trials OPAL Broaden (12 months; ClinicalTrials.gov identifier: NCT01877668) and OPAL Beyond (6 months; ClinicalTrials.gov identifier: NCT01882439) presented at the 2017 ACR/ARHP Annual Meeting, November 3 to 8.
Patients with active psoriatic arthritis who were refractory to at least 1 conventional synthetic disease-modifying antirheumatic drug were randomly assigned to receive tofacitinib 5 mg, tofacitinib 10 mg, or placebo. At 3 months, patients were advanced to either tofacitinib 5 mg, tofacitinib 10 mg, or subcutaneous adalimumab 40 mg every 2 weeks (OPAL Broaden only). Patient-reported outcomes were assessed with surveys at baseline and throughout the study.
At month 3, both tofacitinib groups had significantly improved scores on the Patient Global Assessment of Disease Activity Visual Analog Scale and the Pain Visual Analog Scale compared with placebo (P ≤.05). Similarly, scores on the Short Form-36 Health Survey Version 2 (physical component summary, physical functioning, bodily pain, and vitality domains) and Functional Assessment of Chronic Illness Therapy-Fatigue were improved compared with placebo for both tofacitinib doses at 3 months (P ≤.05).
Minimum clinically important differences were noted in a statistically significant proportion of patients for both doses of tofacitinib in the physical component summary, physical functioning, and bodily pain domains of the Short Form-36 Health Survey Version 2. For the general health and mental health domains, a statistically significant proportion of patients receiving 10 mg tofacitinib improved. In OPAL Broaden, a significant proportion of patients receiving tofacitinib reported improvements in Functional Assessment of Chronic Illness Therapy Fatigue.
In OPAL Broaden, improvements in patient-reported outcomes were similar between tofacitinib and adalimumab groups.
Improvements from baseline were noted as early as the second week for patients receiving tofacitinib.
The study authors concluded that “patients with active [psoriatic arthritis] receiving tofacitinib reported statistically greater and clinically meaningful improvements in [patient-reported outcomes] compared with [placebo] at Month 3 in both [randomized controlled trials].”
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Strand V, de Vlam K, Covarrubias-Cobos JA, et al. Effect of tofacitinib on patient-reported outcomes in patients with active psoriatic arthritis: results from 2 phase 3 studies. Presented at: 2017 ACR/ARHP Annual Meeting; November 3-8, 2017; San Diego, California. Poster 596.