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.
-
Exclusive Write-ups & Webinars by KOLs
-
Daily Quiz by specialty
-
Paid Market Research Surveys
-
Case discussions, News & Journals' summaries