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FRI0274 (2020)
HISTORY OF BIOLOGICS AND FEMALE GENDER ARE LINKED TO GOLIMUMAB DISCONTINUATION IN AXIAL SPONDYLOARTHRITIS: A SUB-ANALYSIS OF THE GO-PRACTICE STUDY
P. Bertin1, P. Goupille2, F. Tubach3, E. Lespessailles4, N. Harid5, S. Sequeira6, J. M. Fayette7, B. Fautrel8, R. M. Flipo9
1Limoges University Hospital, Rheumatology Department, Limoges Cedex, France
2Tours University Hospital, Rheumatology Department, Chambray-les-Tours, France
3Pitié Salpêtrière Hospital, Sorbonne Université – Assistance Publique-Hôpitaux de Paris, Department of Biostatistics, Public Health and Medical Information, Centre of Pharmacoepidemiology, Paris, France
4Orléans Regional Hospital Center, Rheumatology Department, Orléans, France
5MSD France, Puteaux, France
6ClinSearch, Medical Device and Drug Development, Malakoff, France
7ClinSearch, Biostatistics Department, Malakoff, France
8University Hospitals Pitié Salpêtrière, Rheumatology Department, Paris, France
9Lille University-Hospital, Rheumatology Department, Lille, France

Background: Golimumab ( GLM ) is the latest anti-TNFα to be indicated for treating rheumatoid arthritis ( RA ), psoriatic arthritis ( PsA ) and axial spondyloarthritis ( axSpA ). The GO-PRACTICE study was performed in France at the request of the French Health Authorities, for the reevaluation of GLM in real-life.


Objectives: The primary objective was to estimate GLM persistence at 2 years from initial prescription. This abstract focuses on a post-hoc analysis of the factors linked to GLM discontinuation in axSpA patients.


Methods: Observational, prospective, multicenter study, that consecutively recruited adult patients with RA, PsA and axSpA who were newly prescribed GLM. Patients were followed-up for 2 years and outcomes data were collected at baseline ( BL ), 1 and 2 years. Patients’ sociodemographic characteristics, disease history, comorbidities and treatment history were also collected at BL. Persistence was estimated with the Kaplan-Meier method. Cox proportional hazard models were used to assess factors associated with persistence. Selected BL characteristics were studied in univariate models, where those associated with p -value <0.20 were included in multivariate analysis. Significance level was set at p <0.05.


Results: 478 patients with axSpA were included from Jan 2015 to Mar 2016. Mean age was 43 years and 55% were female; 61% of patients were biologic-naïve (BN, n=291) and 39% (n=187) were biologic-pretreated (BP). Median time-elapsed in years since axSpA diagnosis was 1.7 (range 0–45.1) and 6.9 (range 0.2–51.8) in BN and BP patients, respectively ( P <0.001); 97% patients were prescribed 50 mg GLM monthly and co-treatments included DMARD (34%), corticosteroids (17%) and NSAIDs/analgesics (90%).

Cumulative persistence probability of GLM at 2-years was 52.6% ( Fig 1 ). Table 1 details the binary variables associated with GLM discontinuation at p <0.20. Among continuous variables, BL CRP level was associated with p <0.20. A multivariate analysis of these factors revealed that being female (HR 1.92, 95%CI 1.43–2.56, P <0.001) and being BP (HR 1.45, 95%CI (1.11–1.90), P =0.007) were risk factors for GLM discontinuation ( Table 1 ).

Logistic model results for variables of interest and their link to GLM discontinuation in axSpA

Factor Modalities χ 2 (p) Hazard ratio (HR) 95% CI
HR following univariate analysis (p>0.20)
Age Continuous variable 0.520 1.00 0.99–1.02
Disease duration 0.401 1.01 0.99–1.03
Inflammatory bowel disease Yes vs. No 0.277 0.74 0.43–1.28
Gastrointestinal disease 0.344 1.27 0.78–2.06
Uveitis 0.237 0.80 0.55–1.16
Psoriasis 0.238 0.92 0.64–1.31
     HR following multivariate analysis (variables with p<0.20 at univariate analysis)
Gender Female vs. Male < 0.001 1.92 1.43–2.56
Biologics history Pretreated vs. naïve 0.007 1.45 1.11–1.90
Serum CRP Continuous variable 0.177 0.99 0.98–1.00
DMARD history Yes vs. No 0.062 1.37 0.99–1.90
Ongoing corticosteroids 0.693 1.08 0.73–1.61
Anemia 0.170 1.82 0.78–4.24
Kidney Disease 0.508 1.50 0.45–4.97
Other physical illness 0.435 1.28 0.69–2.34

Conclusion: 2-year GLM persistence in axSpA patients was 52.6%. Females and those who were biologics-pretreated were at greater risk for discontinuing GLM before 2 years.


Disclosure of Interests: Philippe Bertin Consultant of: MSD France, Philippe Goupille Grant/research support from: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Consultant of: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Speakers bureau: AbbVie, Amgen, Biogen, BMS, Celgene, Chugai, Lilly, Janssen, Medac, MSD France, Nordic Pharma, Novartis, Pfizer, Sanofi and UCB, Florence Tubach Grant/research support from: Florence TUBACH is head of the Centre de Pharmacoépidémiologie (Cephepi) of the Assistance Publique – Hôpitaux de Paris and of the Clinical Research Unit of Pitié-Salpêtrière hospital, both these structures have received research funding, grants and fees for consultant activities from a large number of pharmaceutical companies, that have contributed indiscriminately to the salaries of its employees. Florence Tubach didn’t receive any personal remuneration from these companies., Eric Lespessailles Consultant of: Amgen, Celgene, Lilly, MSD France, Novartis, UCB, Speakers bureau: Amgen, Celgene, Lilly, MSD France, Novartis, UCB, Naoual HARID Employee of: MSD France, Saannya Sequeira Consultant of: MSD France, Jean-Marie Fayette Consultant of: MSD France, Bruno Fautrel Grant/research support from: AbbVie, Lilly, MSD, Pfizer, Consultant of: AbbVie, Biogen, BMS, Boehringer Ingelheim, Celgene, Lilly, Janssen, Medac MSD France, Nordic Pharma, Novartis, Pfizer, Roche, Sanofi Aventis, SOBI and UCB, René-Marc Flipo Consultant of: Johnson and Johnson, MSD France, Novartis, Sanofi, Speakers bureau: Johnson and Johnson, MSD France, Novartis, Sanofi

Citation: Ann Rheum Dis, volume 79, supplement 1, year 2020, page 719
Session: Spondyloarthritis - treatment (Poster Presentations)