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
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
Affiliations
Frank Behrens
Clinical Research, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Frankfurt am Main, Germany
Jürgen Rech
5 University of Erlangen-Nuremberg, Erlangen, Germany
Jürgen Braun
Rheumazentrum Ruhrgebiet, Herne, and Department of Biochemistry, Ruhr Universität, Bochum, Germany
Denis Poddubnyy
Department of Gastroenterology, Infectiology and Rheumatology (including Nutrition Medicine), Charite Universitatsmedizin Berlin, Berlin, Germany
Gerd R Burmester
Department of Rheumatology and Clinical Immunology, Charité Universitätsmedizin Berlin, Berlin, Germany
Uta Kiltz
Ruhr-Universität Bochum, Bochum, Germany
Stephanie Finzel
19Department of Rheumatology and Clinical Immunology, University Medical Center Freiburg, Freiburg, Germany
Diamant Thaçi
7 Comprehensive Center of Inflammation Medicine, University Hospital Schleswig-Holstein Campus, Luebeck, Germany
Herbert Kellner
Specialist Practice in Rheumatology and Gastroenterology, Munich, Germany
Karolina Benesova
1 Department of Internal Medicine V Hematology Oncology Rheumatology, Heidelberg University Hospital, Heidelberg, Germany
Reinhard E Voll
Department of Rheumatology and Clinical Immunology, Medical Center – University of Freiburg, Faculty of Medicine, Freiburg, Germany
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.
