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. 2023 Dec 19;9(4):e003538.
doi: 10.1136/rmdopen-2023-003538.

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

Michaela Koehm  1   2   3 , Ann C Foldenauer  2   3 , Tanja Rossmanith  2   3 , Herbert Kellner  4 , Uta Kiltz  5   6 , Gerd R Burmester  7 , David M Kofler  8 , Jan Brandt  9 , Stephanie Finzel  10 , Raoul Bergner  11 , Maren Sieburg  12 , Frank Behrens  13   2   3 ; MUST Investigator Group
Collaborators, Affiliations

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

Michaela Koehm et al. RMD Open. .

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.

Keywords: arthritis, psoriatic; biological therapy; epidemiology; methotrexate; treatment.

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Conflict of interest statement

Competing interests: MK received consulting fees or honoraria from Amgen, Janssen-Cilag, Lilly, Novartis and UCB and received travel support from UCB. UK received grant and research support and consultancy fees from AbbVie, Amgen, Biocad, Biogen, BMS, Chugai, Eli Lilly, Fresenius, Gilead, Grünenthal, GSK, Hexal, Janssen, MSD, Novartis, onkowissen.de, Pfizer, Roche, UCB and Viatris and participated on a data safety monitoring or advisory board for the COPAGO trial, conducted by the German Ministry of Health. GRB received fees or honoraria for serving as a speaker and/or consultant from Abbvie, Galapagos, Janssen, Lilly, Novartis and UCB, meeting or travel support from Abbvie and Lilly and is the editor-in-chief of RMD Open. DMK received honoraria for serving as a speaker for Sanofi-Aventis. SF received scientific grants from Novartis, honoraria or fees for serving as a speaker and/or consultant from Abbvie, AstraZeneca, Chugai, Galapagos, Novartis, NovoNordisc and UCB, and travel or meeting support from Abbvie, Galapagos, Janssen Cilag, Novartis, SOBI and UCB. RB received honoraria or fees for serving as a speaker and/or consultant from Abbvie, BMS, Chugai, GSK, Galapagos, Novartis, Roche and Vifor and meeting or travel support from Chugai and Galapagos. MS received research support from Charité. FB received research support for this study from Janssen Cilag, consulting fees or honoraria from Abbvie, Acelyrin, Amgen, Janssen Cilag, Lily, Novartis, Pfizer and UCB, and meeting or travel support from Abbvie and UCB. ACF, TR, HK and JB have no competing interests to declare.

Figures

Figure 1
Figure 1
Efficacy outcomes by sex for (A) median HAQ-DI and joint counts at week 24; (B) change from baseline to week 24 in HAQ-DI and joint counts; (C) change from baseline to week 24 in DAPSA, PASI, PhGA, PtGA and pain; (D) proportion of patients with enthesitis. The ustekinumab+MTX subgroup included 37 females and 50 males. The ustekinumab+placebo subgroup included 32 females and 47 males. The exact numbers of patients for outcomes with missing values are shown in online supplemental tables S1 and S2. Bars indicate SD (for mean values) or IQR (for median values). P values within treatment groups were determined by the Wilcoxon test. DAPSA, Disease Activity in Psoriatic Arthritis; HAQ-DI, Health Assessment Questionnaire-Disability Index; LEI, Leeds Enthesitis Index; MDA, minimal disease activity; MTX, methotrexate; PASI, Psoriasis Area and Severity Index; PhGA, physician global assessment of disease activity; PtGA, patient global assessment of disease activity; SJC, swollen joint count; TJC, tender joint count.
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