Tildrakizumab efficacy, drug survival, and safety are comparable in patients with psoriasis with and without metabolic syndrome: Long-term results from two phase 3 randomized controlled studies (reSURFACE 1 and reSURFACE 2).

Abstract Background Data for the effect of metabolic syndrome (MetS) on efficacy and safety of biologic agents for psoriasis treatment are limited. Objective To evaluate long-term tildrakizumab efficacy, drug survival, and safety in patients with psoriasis by baseline MetS status. Methods Post hoc analyses of up to 3 years of efficacy data and 5 years of safety data from the phase 3, double-blind, randomized controlled reSURFACE 1 and 2 trial (NCT01722331; NCT01729754) base and extension studies were conducted for patients receiving continuous tildrakizumab 100 or 200 mg. Results Of 338 (n = 124/214) and 307 (n = 147/160) patients continuously receiving tildrakizumab 100 and 200 mg, respectively, throughout the studies, 26/44 (21%/21%) and 34/30 (23%/19%) met MetS criteria. Proportions of Psoriasis Area and Severity Index (PASI) 75 responders in reSURFACE 1/2 were generally comparable in patients with vs without MetS at week 52 (tildrakizumab 100 mg, 85%/86% vs 86%/94%; tildrakizumab 200 mg, 76%/87% vs 76%/87%) and through week 148. Results were similar for PASI 90/100 responders. Tildrakizumab’s safety profile did not vary by MetS status. Limitations Small sample size and post hoc analysis limit interpretation. Conclusion Long-term tildrakizumab efficacy and safety were comparable between patients with and without MetS.