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Efficacy and safety of tildrakizumab in patients with active psoriatic arthritis: Results of a randomised, double-blind, placebo-controlled, multiple-dose, 52-week phase IIb study

Annals of Rheumatic Diseases Aug 18, 2021

Mease PJ, Chohan S, Fructuoso FJG, et al. - In this randomised, double-blind, placebo-controlled, phase IIb study, other than dactylitis and enthesitis, tildrakizumab [a high-affinity anti-IL-23p19 monoclonal antibody] treatment significantly reduced psoriatic arthritis (PsA) joint and skin symptoms. Through W52, the treatment was generally well tolerated.

  • A total of 391 of the 500 patients who were screened were randomly assigned and treated.

  • At W24, 71.4%–79.5% of tildrakizumab-treated patients achieved ACR20 (≥ 20% improvement by American College of Rheumatology criteria), compared with 50.6% of placebo-treated patients. Patients who received tildrakizumab vs placebo had higher rates of ACR50, Disease Activity Score in 28 joints with C reactive protein < 3.2, minimal disease activity, and 75%/90%/100% improvement from baseline Psoriasis Area and Severity Index responses at W24 and through W52.

  • Dactylitis and enthesitis did not improve, while the findings for other outcomes were inconsistent.

  • Patients who were shifted to tildrakizumab 200 mg at W24 had responses that were consistent with baseline therapy.

  • Through W52, TEAEs and significant TEAEs occurred in 64.5% and 3.3% of all participants, respectively, and were equivalent across treatment groups.

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