Gender-specific differences in patients with psoriatic arthritis receiving ustekinumab or tumour necrosis factor inhibitor: real-world data

Author:

Van Kuijk Arno W R1,Nurmohamed Mike T1,Siebert Stefan2ORCID,Bergmans Paul3,de Vlam Kurt4,Gremese Elisa5,Joven-Ibáñez Beatriz6,Korotaeva T V7,Lavie Frederic8,Sharaf Mohamed9,Noël Wim10,Theander Elke11,Smolen Josef S12,Gossec Laure1314ORCID,van der Horst-Bruinsma Irene E15ORCID

Affiliation:

1. Department of Rheumatology, Amsterdam Rheumatology and Immunology Center | Reade , Amsterdam, Netherlands

2. School of Infection and Immunity, University of Glasgow , Glasgow, UK

3. Biostatistics, Janssen-Cilag BV , Breda, Netherlands

4. Department of Rheumatology, University Hospitals Leuven , Leuven, Belgium

5. Department of Medical and Surgical Sciences, Catholic University of the Sacred Heart, Fondazione Policlinico A Gemelli IRCCS , Rome, Italy

6. Department of Rheumatology, University Hospital , Madrid, Spain

7. Department of Spondyloarthritis and Psoriatic Arthritis, VA Nasonova Research Institute of Rheumatology , Moscow, Russian Federation

8. Medical Affairs, Janssen-Cilag , Issy-les-Moulineaux, Paris, France

9. Department of Rheumatology, Janssen , Dubai, UAE

10. Medical Affairs, Janssen Pharmaceutica NV , Beerse, Belgium

11. Medical Affairs, Janssen-Cilag AB , Solna, Sweden

12. Department of Internal Medicine III, Medical University of Vienna , Vienna, Austria

13. Faculty of Medicine, Sorbonne Université, INSERM, IPLESP , Paris, France

14. Department of Rheumatology, Pitié-Salpêtrière Hospital, AP-HP , Paris, France

15. Department of Rheumatology, Radboud University Medical Center , Nijmegen, Netherlands

Abstract

Abstract Objective Investigate effects of gender on disease characteristics and treatment impact in patients with PsA. Methods PsABio is a non-interventional European study in patients with PsA starting a biological DMARD [bDMARD; ustekinumab or TNF inhibitor (TNFi)]. This post-hoc analysis compared persistence, disease activity, patient-reported outcomes and safety between male and female patients at baseline and 6 and 12 months of treatment. Results At baseline, disease duration was 6.7 and 6.9 years for 512 females and 417 males respectively. Mean (95% CI) scores for females vs males were: clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA), 32.3 (30.3, 34.2) vs 26.8 (24.8, 28.9); HAQ-Disability Index (HAQ-DI), 1.3 (1.2, 1.4) vs 0.93 (0.86, 0.99); total PsA Impact of Disease-12 (PsAID-12) score, 6.0 (5.8, 6.2) vs 5.1 (4.9, 5.3), respectively. Improvements in scores were smaller in female than male patients. At 12 months, 175/303 (57.8%) female and 212/264 (80.3%) male patients achieved cDAPSA low disease activity, 96/285 (33.7%) and 137/247 (55.5%), achieved minimal disease activity (MDA), respectively. HAQ-DI scores were 0.85 (0.77, 0.92) vs 0.50 (0.43, 0.56), PsAID-12 scores 3.5 (3.3, 3.8) vs 2.4 (2.2, 2.6), respectively. Treatment persistence was lower in females than males (P ≤ 0.001). Lack of effectiveness was the predominant reason to stop, irrespective of gender and bDMARD. Conclusions Before starting bDMARDs, females had more severe disease than males and a lower percentage reached favourable disease states, with lower persistence of treatment after 12 months. A better understanding of the mechanisms underlying these differences may improve therapeutic management in females with PsA. Trial registration ClinicalTrials.gov, https://clinicaltrials.gov, NCT02627768

Funder

Olga Ucar and Ella Palmer of inScience Communications, Springer Healthcare Ltd

AstraZeneca

Publisher

Oxford University Press (OUP)

Subject

Pharmacology (medical),Rheumatology

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