학술논문
Differences in treatment response between female and male psoriatic arthritis patients during IL-12/23 therapy with or without methotrexate: post hoc analysis of results from the randomised MUST trial
Document Type
article
Author
Frank Behrens; Jürgen Rech; Jürgen Braun; Denis Poddubnyy; Gerd R Burmester; Uta Kiltz; Stephanie Finzel; Diamant Thaçi; Herbert Kellner; Karolina Benesova; Reinhard E Voll; Jan Brandt; Andrea Rubbert-Roth; David M Kofler; Klaus Krüger; Siegfried Wassenberg; Winfried Demary; Regina Max; Peter Kastner; Michaela Koehm; Ulrich von Hinüber; Raoul Bergner; Jan Brandt-Jürgens; Ann C Foldenauer; Tanja Rossmanith; Maren Sieburg; Rieke HE Alten; Arnd Kleye; David Kofler; Gabriele Lorenz; Holger Schwenke; Astrid Thiele; Jochen Walter
Source
RMD Open, Vol 9, Iss 4 (2023)
Subject
Language
English
ISSN
2056-5933
Abstract
Background The influence of sex on treatment outcomes during interleukin-12/23 therapy in patients with psoriatic arthritis (PsA) has not been explored.Objective To conduct exploratory post hoc analyses of sex-stratified data from the MUST trial, an investigator-initiated, multicentre, phase 3b study in which patients with active PsA initiating treatment with open-label ustekinumab were randomised to treatment with placebo or methotrexate (MTX).Methods We evaluated baseline characteristics, key treatment outcomes and adverse events stratified by sex, with a focus on outcomes that did not include erythrocyte sedimentation rate (ESR) as a component due to the known elevation of ESR in females.Results A total of 166 patients were treated with ustekinumab+MTX (37 female, 50 male) or ustekinumab+placebo (32 female, 47 male). At baseline, females had a significantly longer time since PsA diagnosis and greater impairment in physical function, but similar joint counts. At week 24, both females and males showed marked improvements to ustekinumab with or without MTX. Females generally had numerically reduced treatment responses compared with males, although differences did not achieve statistical significance. MTX did not show an overall effect on treatment outcomes, but was associated with faster enthesitis responses in males only. Adverse events were generally comparable, but females in the ustekinumab+MTX group had higher levels of gastrointestinal disorders.Conclusion Females and males with PsA had differences in baseline characteristics, treatment responses and adverse events during therapy. A better understanding of sex-based differences in PsA may help optimise treatment.