Article
Ixekizumab provides improvements through 52 weeks in physical function, quality of life, and work productivity in biologic disease-modifying antirheumatic drug-naive patients with active psoriatic arthritis
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Published: | September 4, 2017 |
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Background: Results from the phase 3 trial, SPIRIT-P1, showed that ixekizumab significantly improved patient reported outcome (PRO) measures at week 24 (Wk24).
Methods: We evaluated the effect of ixekizumab on PROs at Wk52. Patients with active psoriatic arthritis (N=417) were randomized to ixekizumab 80mg every 4 (IXEQ4W) or 2 (IXEQ2W) weeks (after 160mg starting dose); adalimumab 40mg; or placebo, in the double-blind treatment period (Wk0–24). 381 patients entered the extension period (Wk24–52). Placebo- and adalimumab treated patients were randomly re-assigned to IXEQ4W or IXEQ2W at Wk16 (inadequate responders) or Wk24; adalimumab-treated patients started ixekizumab at Wk24 (inadequate responders) or Wk32, after 8-wk wash-out. Physical function and quality-of-life were impaired at baseline.
Results: 69% of patients treated with ixekizumab achieved ACR20 response at Wk52. In these patients, improvements in presenteeism, work productivity and activity impairment at Wk52 were consistent with those seen at Wk24, and the percentage achieving minimally clinically important difference from baseline HAQ DI score (≥0.35) was sustained at Wk52.
Conclusion: Patients receiving adalimumab→ixekizumab showed improvements in ACR20 response and most PRO measures, consistent with those treated with ixekizumab for up to Wk52. Ixekizumab provided improvements in physical function, quality-of-life, and work productivity through 52 weeks.