OP0232 FEMALE VERSUS MALE BURDEN OF PSORIATIC ARTHRITIS IS HIGHER AND TREATMENT PERSISTENCE SHORTER AFTER USTEKINUMAB OR TUMOUR NECROSIS FACTOR INHIBITOR TREATMENT: 1-YEAR DATA FROM THE PSABIO STUDY
Authors: I. van der Horst-Bruinsma, M. Nurmohamed, A. Van Kuijk, S. Siebert, P. Bergmans, K. De Vlam, E. Gremese, B. Joven-Ibáñez, T. Korotaeva, W. Noel, P. Sfikakis, E. Theander, J. S. Smolen, L. Gossec
Journal: Annals of the Rheumatic Diseases (2021)

Background: Sex-related differences in biologic treatment of psoriatic arthritis (PsA) have been insufficiently studied in a real-world setting. Objectives: To evaluate impact of sex on PsA, treatment effectiveness and persistence after 1 year of biologic treatment. Methods: PsABio ( NCT02627768 ) is a multinational, prospective real-world study in PsA with ustekinumab (UST) or TNF inhibitor (TNFi) as 1st/2nd/3rd-line biologic. Males and females were compared for disease activity and patient-reported outcomes. Descriptive statistics including 95% CI at baseline (BL) and 12 (±3) months (LOCF) follow-up are presented. Intra-sex comparisons between UST and TNFi cohorts were done by logistic regression analysis, with propensity score adjustment for imbalanced BL covariates and non-response imputation for stopping/switching biologic drugs. Results: Among 494 females and 399 males, age and disease duration were similar. However, differences in disease characteristics at BL were considerable: females had worse scores than males for cDAPSA, HAQ-DI, EQ5D VAS, PsAID-12, pain and comorbidities. At 1 year, similar improvements from BL were observed between sexes, but females remained in a worse health state than males (Table). Achievement of composite endpoints MDA (including VLDA) and cDAPSA LDA (including remission) was high overall (38.6% and 61.5%, respectively), but reached by &gt;2-fold and 3-fold more males than females, respectively. HAQ-DI scores remained worse for females at 1 year (0.95) than for males at BL (0.93). Enthesitis resolution was achieved in 46% of females and 75% of males. No significant differences in effectiveness of UST vs TNFi were detected between sexes (Figure). Kaplan–Meier estimated drug persistence was significantly better in males than females (log-rank p=0.0007). There was no intra-sex difference between UST or TNFi in risk of stopping/switching in males or females. Table 1. Patient and disease characteristics at BL and 1-year by sex BL female BL male 1-year LOCF female 1-year LOCF male Biologic line, % 1 st 46 55 N/A N/A 2 nd 34 33 3 rd 20 13 Co-treatment, % MTX 37.4 34.3 N/A N/A Corticosteroids 34.6 32.1 NSAIDs 59.9 64.4 Antidepressant 7.9 2.5 Comorbidities, % N/A N/A Cardiovascular 69.0 59.4 metabolic syndrome 40.1 31.7 Obesity 35.2 23.7 Anxiety/depression 12.6 7.5 Smoking status, % N/A N/A Never 54.9 41.9 Past 16.8 26.6 Current 22.7 24.3 Unknown 5.7 7.3 Joint counts, n Swollen 66 6.1 (5.4; 6.9) 5.6 (4.7; 6.4) 2.2 (1.7; 2.6 ) 1.3 (1.0; 1.6 ) Tender 68 13.2 (12.0; 14.4 ) 10.0 (8.9; 11.1 ) 6.0 (5.2; 6.7 ) 3.6 (2.9; 4.3 ) cDAPSA score, mean (95% CI) cDAPSA, % 32.5 (30.5; 34.4 ) 26.9 (24.9; 29.0 ) 15.9 (14.5; 17.2 ) 10.3 (9.0; 11.6 ) Remission 1.0 (0.3; 2.6) 4.0 (2.1; 6.7) 17.8 (14.1; 22.0 ) 37.7 (32.4; 43.2 ) Low 6.7 (4.4; 9.7 ) 15.0 (11.3; 19.4 ) 33.0 (28.3; 37.9) 36.5 (31.3; 42.0) Moderate 38.9 (34.0; 44.0) 42.6 (37.2; 48.2) 34.3 (29.6; 39.2 ) 16.9 (13.0; 21.4 ) High 53.4 (48.2; 58.4 ) 38.3 (33.0; 43.9 ) 14.9 (11.6; 18.9) 8.9 (6.0; 12.5) MDA 2.3 (1.0; 4.3 ) 7.7 (5.1; 11.2 ) 27.5 (23.1; 32.1 ) 52.2 (46.6; 57.7 ) VLDA 0.0 0.9 (0.2; 2.6) 6.2 (4.1; 9.0 ) 19.7 (15.6; 24.3 ) HAQ-DI score 1.31 (1.25; 1.37 ) 0.93 (0.86; 1.00 ) 0.95 (0.89; 1.02 ) 0.53 (0.47; 0.59 ) PsAID-12 score 6.1 (5.9; 6.3 ) 5.1 (4.9; 5.3 ) 4.0 (3.8; 4.3 ) 2.7 (2.4; 2.9 ) EQ5D VAS score 48.6 (46.6; 50.5 ) 53.8 (51.6; 55.9 ) 59.2 (56.9; 61.4 ) 68.0 (65.5; 70.4 ) Enthesitis 50.7 (45.9; 55.5) 48.1 (42.8; 53.3) 32.6 (28.3; 37.3 ) 18.0 (14.1; 22.3 ) Dactylitis 15.6 (12.4; 19.3 ) 24.7 (20.4; 29.3 ) 5.7 (3.8; 8.3) 4.8 (2.9; 7.4) Data are % (95% CI) unless indicated otherwise. Bold data are significantly different (non-overlapping 95% CI). Conclusion: These real-world data from PsABio on sex differences with biologic treatment suggest that females generally start biologics in a worse PsA state than males. Although treatment improvements were similar between sexes, females remained in worse health at 1 year, and stopped/switched biologic earlier. More comprehensive treatment before severe disease manifestations evolve may improve management in females. Acknowledgements: This study was funded by Janssen Disclosure of Interests: Irene van der Horst-Bruinsma Consultant of: AbbVie, Lilly, MSD, Novartis, UCB, Grant/research support from: AbbVie, MSD, Pfizer, UCB, Michael Nurmohamed Speakers bureau: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi, UCB, Consultant of: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi, UCB, Grant/research support from: AbbVie, Bristol-Myers Squibb, Celgene, Eli Lilly, Galapagos, Gilead, Janssen, Menarini, MSD, Mundipharma, Pfizer, Roche, Sanofi, UCB, Arno Van Kuijk Consultant of: AbbVie, Janssen, LEO Pharma, Novartis, Grant/research support from: Janssen, Stefan Siebert Speakers bureau: AbbVie, Amgen (previously Celgene), Biogen, Janssen, Novartis, UCB, Consultant of: AbbVie, Janssen, UCB, Grant/research support from: Amgen (previously Celgene), Boehringer Ingelheim, Bristol-Myers Squibb, GSK, Janssen, Novartis, Pfizer, UCB, Paul Bergmans Shareholder of: Johnson &amp; Johnson, Employee of: Janssen, Kurt de Vlam Speakers bureau: AbbVie, Amgen, Eli Lilly, Novartis, UCB, Paid instructor for: Amgen, Galapagos, UCB, Consultant of: Eli Lilly, Johnson &amp;Johnson, Novartis Galapagos, UCB, Grant/research support from: Celgene, Elisa Gremese: None declared, Beatriz Joven-Ibáñez Speakers bureau: AbbVie, Celgene, Janssen, MSD, Novartis, Pfizer, Tatiana Korotaeva Speakers bureau: AbbVie, Amgen, Biocad, Janssen, Lilly, MSD, Novartis, Novartis-Sandoz, Pfizer, UCB, Consultant of: AbbVie, Amgen, Biocad, Janssen, Lilly, MSD, Novartis, Novartis-Sandoz, Pfizer, UCB, Grant/research support from: Pfizer, Wim Noel Employee of: Janssen, Petros Sfikakis Consultant of: AbbVie, Actelion, Boehringer Ingelheim, Enorasis, Farmaserv-Lilly, Genesis, Gilead, MSD, Novartis, Pfizer, UCB, Grant/research support from: AbbVie, Amgen, Boehringer Ingelheim, Faran, Janssen, Pfizer, Roche, Elke Theander Employee of: Janssen, Josef S. Smolen Speakers bureau: AbbVie, Amgen, AstraZeneca, Astro, Bristol-Myers Squibb, Celgene, Celltrion, Chugai, Gilead, ILTOO, Janssen, Lilly, MSD, Novartis-Sandoz, Pfizer, Roche, Samsung, Sanofi, UCB, Consultant of: AbbVie, AstraZeneca, Lilly, Novartis, Roche, Laure Gossec Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Biogen, Celgene, Galapagos, Gilead, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis, UCB, Grant/research support from: Amgen, Galapagos, Janssen, Lilly, Pfizer, Sandoz, Sanofi