Efficacy of Tildrakizumab Across Different Body Weights in Moderate-to-Severe Psoriasis Over 5 Years: Pooled Analyses from the reSURFACE Pivotal Studies

Diamant Thaçi; Sascha Gerdes; Kristian Gaarn Du Jardin; Jean-Luc Perrot; Lluís Puig

doi:10.1007/s13555-022-00793-z

Efficacy of Tildrakizumab Across Different Body Weights in Moderate-to-Severe Psoriasis Over 5 Years: Pooled Analyses from the reSURFACE Pivotal Studies

Dermatol Ther (Heidelb). 2022 Oct;12(10):2325-2341. doi: 10.1007/s13555-022-00793-z. Epub 2022 Sep 13.

Authors

Diamant Thaçi¹, Sascha Gerdes², Kristian Gaarn Du Jardin³, Jean-Luc Perrot⁴, Lluís Puig⁵

Affiliations

¹ Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Ratzeburger Allee 160, 23562, Lübeck, Germany. Diamant.Thaci@uksh.de.
² Department of Dermatology, Venereology and Allergology, Center for Inflammatory Skin Diseases, University Medical Center Schleswig-Holstein, Campus Kiel, Kiel, Germany.
³ Almirall R&D, Barcelona, Spain.
⁴ Department of Dermatology, University Hospital of St-Etienne, St-Etienne, France.
⁵ Department of Dermatology, Hospital de La Santa Creu I Sant Pau, Universitat Autònoma de Barcelona, Barcelona, Spain.

Abstract

Introduction: Tildrakizumab (TIL), a monoclonal antibody that selectively targets interleukin-23p19, has been approved for the treatment of moderate-to-severe plaque psoriasis. According to the European Medicines Agency Summary of Product Characteristics, the recommended dose is 100 mg, but a 200 mg dose can be used in patients with certain characteristics, such as a high disease burden or body weight (BW) ≥ 90 kg. Fixed one-dose biological therapies tend to become less effective in patients with high BW. This post-hoc study describes the long-term efficacy of TIL across different BWs in pivotal clinical trials.

Methods: A 5-year pooled analysis of two double-blind, randomised, controlled phase III trials-reSURFACE 1 and 2-was performed. Efficacy measures were the proportions of the patients with an absolute Psoriasis Area and Severity Index (PASI) of < 3 and < 1 and a Dermatology Life Quality Index (DLQI) of 0/1. The study population included patients randomised to TIL 100 mg or TIL 200 mg who received ≥ 1 TIL dose up to week 12 (part 1 of the trial) or up to week 28 (part 2) and patients who were responders (≥ 75% improvement in PASI) to TIL 100 or TIL 200 mg at week 28 and who were maintained on the same dose up to week 244. Efficacy was evaluated by analysing BW subgroups at weeks 28, 52 and 244. Missing data were analysed using multiple imputation. Safety was assessed in the all-patients-as-treated population.

Results: The proportions of TIL-treated patients with PASI < 3 and < 1 (up to week 244) and DLQI 0/1 (up to week 52) were similar for patients with BW < 90 or ≥ 90 kg, regardless of dose. Patients ≥ 120 kg had greater efficacy outcomes at the 200 mg dose. Safety outcomes were similar regardless of treatment dose and weight (< 120/≥ 120 kg).

Conclusion: In patients with BW ≥ 120 kg, TIL 200 mg is more efficacious than TIL 100 mg, with similar favourable safety profiles obtained regardless of dose and BW group.

Trial registration: ClinicalTrials.gov NCT01722331 (reSURFACE 1) and NCT01729754 (reSURFACE 2).

Keywords: Body weight; DLQI; PASI; Psoriasis; Tildrakizumab.

Associated data

ClinicalTrials.gov/NCT01722331
ClinicalTrials.gov/NCT01729754