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Introduction <p>Psoriasis may increase risk for comorbid diabetes and obesity. Tildrakizumab, an anti-interleukin-23 monoclonal antibody approved for the treatment of adults with moderate-to-severe plaque psoriasis, was evaluated in the pivotal phase&#xa0;3 trials reSURFACE&#xa0;1 and reSURFACE&#xa0;2. This analysis evaluates the effects of comorbid diabetes with and without obesity on the efficacy and safety of tildrakizumab in patients with moderate-to-severe plaque psoriasis.</p> Methods <p>This is a post hoc, pooled subgroup analysis of patients in reSURFACE&#xa0;1 and reSURFACE&#xa0;2 grouped by diabetes and obesity status. Patients randomized to tildrakizumab 100&#xa0;mg at week&#xa0;0, week&#xa0;4, and every 12&#xa0;weeks thereafter, or placebo, were included. The original coprimary endpoints were the proportions of patients achieving a ≥ 75% improvement in Psoriasis Area and Severity Index score (PASI&#xa0;75 response) and Physician Global Assessment score of 0/1 with ≥ 2-grade improvement (PGA&#xa0;0/1 response) from baseline at week&#xa0;12. Safety was assessed from treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).</p> Results <p>Of 926 patients, 93&#xa0;had diabetes mellitus. At week&#xa0;12, regardless of diabetes status, significantly more patients receiving tildrakizumab vs placebo achieved a PASI&#xa0;75 response (diabetes, 61.4% vs 5.6%; without diabetes, 62.6% vs 5.8%) and PGA&#xa0;0/1 response (with diabetes, 54.4% vs 2.8%; without diabetes, 56.5% vs 6.2%; all <i>P</i> &lt; 0.0001). Diabetes status did not significantly affect tildrakizumab efficacy at week&#xa0;28. Patients with diabetes and comorbid obesity had generally similar responses. Although subgroup sizes were small, patients with diabetes and comorbid obesity had numerically higher frequencies of TEAEs and SAEs than those without diabetes.</p> Conclusions <p>Short-term efficacy of tildrakizumab was maintained in patients with and without diabetes mellitus. A higher frequency of AEs in patients with diabetes and obesity may be attributable to underlying disease and associated higher inflammation.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT01722331 (reSURFACE&#xa0;1), NCT01729754 (reSURFACE&#xa0;2).</p>

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Efficacy and Safety of Tildrakizumab for Moderate-to-Severe Plaque Psoriasis with Diabetes: Pooled Subgroup Analysis of reSURFACE 1 and reSURFACE 2

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月16日

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  • Jerry Bagel,
  • Ranga Gogineni,
  • Asif Shaikh,
  • Mark G. Lebwohl

摘要

Introduction

Psoriasis may increase risk for comorbid diabetes and obesity. Tildrakizumab, an anti-interleukin-23 monoclonal antibody approved for the treatment of adults with moderate-to-severe plaque psoriasis, was evaluated in the pivotal phase 3 trials reSURFACE 1 and reSURFACE 2. This analysis evaluates the effects of comorbid diabetes with and without obesity on the efficacy and safety of tildrakizumab in patients with moderate-to-severe plaque psoriasis.

Methods

This is a post hoc, pooled subgroup analysis of patients in reSURFACE 1 and reSURFACE 2 grouped by diabetes and obesity status. Patients randomized to tildrakizumab 100 mg at week 0, week 4, and every 12 weeks thereafter, or placebo, were included. The original coprimary endpoints were the proportions of patients achieving a ≥ 75% improvement in Psoriasis Area and Severity Index score (PASI 75 response) and Physician Global Assessment score of 0/1 with ≥ 2-grade improvement (PGA 0/1 response) from baseline at week 12. Safety was assessed from treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

Results

Of 926 patients, 93 had diabetes mellitus. At week 12, regardless of diabetes status, significantly more patients receiving tildrakizumab vs placebo achieved a PASI 75 response (diabetes, 61.4% vs 5.6%; without diabetes, 62.6% vs 5.8%) and PGA 0/1 response (with diabetes, 54.4% vs 2.8%; without diabetes, 56.5% vs 6.2%; all P < 0.0001). Diabetes status did not significantly affect tildrakizumab efficacy at week 28. Patients with diabetes and comorbid obesity had generally similar responses. Although subgroup sizes were small, patients with diabetes and comorbid obesity had numerically higher frequencies of TEAEs and SAEs than those without diabetes.

Conclusions

Short-term efficacy of tildrakizumab was maintained in patients with and without diabetes mellitus. A higher frequency of AEs in patients with diabetes and obesity may be attributable to underlying disease and associated higher inflammation.

Trial Registration

ClinicalTrials.gov identifier, NCT01722331 (reSURFACE 1), NCT01729754 (reSURFACE 2).