Tildrakizumab efficacy and safety are unaffected by metabolic syndrome status in patients with moderate to severe chronic psoriasis, according to study results published in the Journal of the American Academy of Dermatology.
A post hoc analysis was performed of pooled data from the phase 3, double-blind, randomized, placebo-controlled reSURFACE 1 and reSURFACE 2 studies (ClinicalTrials.gov identifier: NCT01722331 and NCT01729754, respectively), which explored the safety and efficacy of tildrakizumab in patients with moderate to severe chronic plaque psoriasis. A total of 146 patients (30.1% women) with metabolic syndrome and 553 patients (31.6% women) without metabolic syndrome were included.
The percentage of patients with ≥75% improvement in Psoriasis Area and Severity Index (PASI) scores at both 12 weeks and 52 weeks was comparable between patients with and without metabolic syndrome at both 100-mg and 200-mg doses of tildrakizumab. The percentage of patients with ≥90% and 100% improvement in PASI score at 52 weeks was also similar, regardless of metabolic syndrome status. Overall reductions in mean PASI score from baseline were similar as well.
The percentage of patients with more than one serious adverse event or infection was similar regardless of metabolic syndrome status. Infection was the most commonly reported treatment-emergent adverse event, with similar incidence rates seen in patients with and without metabolic syndrome at the 100-mg dose. There were numerically higher rates of infection seen in patients with metabolic syndrome receiving 200 mg tildrakizumab compared with in patients without metabolic syndrome.
The authors noted that the relatively small sample size of patients with metabolic syndrome limited the power of the post hoc analyses for statistical analysis.
“Despite limitations, these results suggest efficacy, safety, and drug survival of tildrakizumab are comparable in patients with psoriasis regardless of [metabolic syndrome] status,” the researchers concluded.
Disclosure: Funding for the studies were provided by Merck Sharp & Dohme Corp. and Sun Pharmaceuticals, Inc. Several study authors declared affiliations with the pharmaceutical industry. Please see the original reference for a full list of disclosures.
Lebwohl MG, Leonardi CL, Mehta NN, et al. Tildrakizumab efficacy and safety are not altered by metabolic syndrome status in patients with psoriasis: post hoc analysis of 2 phase 3 randomized controlled studies (reSURFACE 1 and reSURFACE 2) [published online September 26, 2019]. J Am Acad Dermatol. doi:10.1016/j.jaad.2019.09.042