Efficacy and Safety of Tildrakizumab in Older Patients: Pooled Analyses of Two Randomized Phase III Clinical Trials (reSURFACE 1 and reSURFACE 2) Through 244 Weeks

Abstract

The evidence on treating older patients with psoriasis with modern biologics is scarce. This study compared the efficacy and safety of tildrakizumab among younger and older patients with psoriasis (< 65/≥ 65 years) in a post hoc analysis of 2 phase III trials (reSURFACE1/2, n = 1,862). Tildrakizumab 100 mg/200 mg was administered at weeks 0/4/every 12 weeks thereafter. At week 28, patients with ≥ 75% improvement in baseline Psoriasis Area and Severity Index (PASI75) in reSURFACE1 were re-randomized to the same tildrakizumab dose or placebo; in reSURFACE2, PASI75 responders to 200 mg were re-randomized to tildrakizumab 100 mg or 200 mg; PASI75 responders to 100 mg maintained their dose. At weeks 64/52 (reSURFACE1/2), PASI50 responders entered an extension period (weeks 256/244). Outcomes were proportion of patients with PASI < 3, Dermatology Life Quality Index (DLQI) 0/1, comorbidities, comedication, and side-effects. The proportion of patients with a PASI < 3 was similar and maintained (tildrakizumab 100 mg and 200 mg, week 244: 83.3% and 84.1%/92.3% and 100.0%); DLQI 0/1 proportions at week 52 were 66.8% and 72.0%/68.3% and 81.3%. Comorbidity and comedication were more common in older patients. The safety profile of tildrakizumab appeared favourable in both groups. Tildrakizumab in patients ≥ 65 years appears effective and safe in long-term psoriasis management. These findings might assist treatment selection and overcome treatment reluctance.

Keywords

• adverse drug events
• clinical efficacy
• clinical trials, Phase III as topic
• older adults, frail
• tildrakizumab