Refractory PsA: tofacitinib improves PROs in OPAL Beyond

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Takeaway

  • Tofacitinib (Xeljanz)-treated patients with active psoriatic arthritis (PsA) reported improvement (in excess of placebo-treated patients) on numerous patient-reported outcomes (PROs), including symptoms, disease activity, function, pain, and QoL vs placebo.
  • All patients (tofacitinib and placebo) had previously displayed inadequate responses to tumor necrosis factor inhibitors (TNFi-IR) in the phase 3 OPAL Beyond trial.

Why this matters

  • Tofacitinib should be considered in TNFi-IR patients with active PsA.

Study design

  • Post hoc analysis of TNFi-IR patients (n=394) in the phase 3 multicenter OPAL Beyond trial.
  • Patients received tofacitinib 5 or 10 mg twice daily or placebo; placebo patients were switched to tofacitinib at month 3.
  • Funding: Pfizer Inc.

Key results

  • At 3 months, tofacitinib (at both doses) exceeded placebo (P≤.05) on 12 PROs, including Patient Global Assessment of disease activity (PtGA), Pain (visual analog scale [VAS]), 5 of 8 domains on the Short-Form 36 version 2 (SF-36v2), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue), EuroQol 5-Dimensions-3-level (EQ-5D-3L), EQ-VAS, and Ankylosing Spondylitis Quality of Life (ASQoL).
  • At 3 months, tofacitinib-treated patients (at both doses) reported improvements in at least minimum clinically important differences (MCID; %) in PtGA, Patient Global Joint and Skin Assessment, Pain, ASQoL, and 5 domains of the SF-36v2 vs placebo (P≤.05).

Limitations

  • Placebo-controlled period restricted to first 3 months.
  • Post hoc analysis.