Long-term efficacy and safety of tildrakizumab for moderate-to-severe psoriasis: Pooled analyses of two randomized phase III clinical trials (reSURFACE 1 and reSURFACE 2) through 148 weeks
British Journal of Dermatology Jul 24, 2019
Reich K, et al. - For patients with moderate-to-severe psoriasis, researchers assessed the long-term effectiveness and safety of tildrakizumab [specific anti-interleukin-23p19 monoclonal antibody approved for plaque psoriasis treatment], therapy for up to 148 weeks. In this pooled analysis from two double-blind, randomized controlled trials (reSURFACE 1 and reSURFACE 2), effectiveness was evaluated for responders (≥ 75% improvement in Psoriasis Area and Severity Index; PASI 75) and partial responders (PASI 50–75) to tildrakizumab 100 mg and 200 mg at week 28 who were maintained on the same dose (administered every 12 weeks), and for partial responders or nonresponders (PASI < 50) to etanercept 50 mg at week 28 who, after a 4-week washout, were switched to tildrakizumab 200 mg (administered at weeks 32 and 36, and every 12 weeks thereafter). Safety has been evaluated in the all-patients-as-treated population. In patients who initially responded to either 100 mg or 200 mg of tildrakizumab, efficacy was maintained up to 148 weeks with continued treatment. Tildrakizumab showed high efficacy levels after a few doses among partial or nonresponders to etanercept, and efficacy was also maintained over time. Finally, tildrakizumab's safety profile was beneficial over 3 years, with low rates of severe infections, malignancies, and major adverse cardiovascular events.
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