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Incidence and risk factors for adalimumab and infliximab anti-drug antibodies in rheumatoid arthritis: A European retrospective multicohort analysis

Jocelyn Quistrebert 1, 2 Signe Hässler 1, 2 Delphine Bachelet 1, 2 Cyprien Mbogning 1, 2 Anne Musters Paul Peter Tak 3, 4, 5 Carla Ann Wijbrandts Marieke Herenius Sytske Anne Bergstra 6 Gülşah Akdemir 6 Martina Johannesson 7, 8 Bernard Combe 9, 10, 11, 12 Bruno Fautrel 13, 14, 15 Sylvie Chollet-Martin 2 Aude Gleizes 2, 16 Naoimh Donnellan Florian Deisenhammer 17 Julie Davidson 3 Agnès Hincelin-Mery 18 Pierre Dönnes Anna Fogdell-Hahn 7 Niek de Vries Tom Huizinga 6 Imad Abugessaisa 7 Saedis Saevarsdottir 7 Salima Hacein-Bey-Abina 16, 19, 20 Marc Pallardy 2 Philippe Broët 1, 2, 21, 22, 23 Xavier Mariette 24, 2, 16, *
Abstract : OBJECTIVES: To evaluate the incidence of anti-drug antibody (ADA) occurrences and ADA-related risk factors under adalimumab and infliximab treatment in rheumatoid arthritis (RA) patients. METHODS: The study combined retrospective cohorts from the ABIRISK project totaling 366 RA patients treated with adalimumab (n = 240) or infliximab (n = 126), 92.4% of them anti-TNF naive (n = 328/355) and 96.6% of them co-treated with methotrexate (n = 341/353) with up to 18 months follow-up. ADA positivity was measured by enzyme-linked immunosorbent assay. The cumulative incidence of ADA was estimated, and potential bio-clinical factors were investigated using a Cox regression model on interval-censored data. RESULTS: ADAs were detected within 18 months in 19.2% (n = 46) of the adalimumab-treated patients and 29.4% (n = 37) of the infliximab-treated patients. The cumulative incidence of ADA increased over time. In the adalimumab and infliximab groups, respectively, the incidence was 15.4% (5.2-20.2) and 0% (0-5.9) at 3 months, 17.6% (11.4-26.4) and 0% (0-25.9) at 6 months, 17.7% (12.6-37.5) and 34.1% (11.4-46.3) at 12 months, 50.0% (25.9-87.5) and 37.5% (25.9-77.4) at 15 months and 50.0% (25.9-87.5) and 66.7% (37.7-100) at 18 months. Factors associated with a higher risk of ADA development were: longer disease duration (1-3 vs. < 1 year; adalimumab: HR 3.0, 95% CI 1.0-8.7; infliximab: HR 2.7, 95% CI 1.1-6.8), moderate disease activity (DAS28 3.2-5.1 vs. < 3.2; adalimumab: HR 6.6, 95% CI 1.3-33.7) and lifetime smoking (infliximab: HR 2.7, 95% CI 1.2-6.3). CONCLUSIONS: The current study focusing on patients co-treated with methotrexate for more than 95% of them found a late occurrence of ADAs not previously observed, whereby the risk continued to increase over 18 months. Disease duration, DAS28 and lifetime smoking are clinical predictors of ADA development.
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https://hal.umontpellier.fr/hal-02566700
Contributeur : Amandine Michel-Avella <>
Soumis le : jeudi 7 mai 2020 - 11:38:31
Dernière modification le : vendredi 15 mai 2020 - 12:22:09

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Jocelyn Quistrebert, Signe Hässler, Delphine Bachelet, Cyprien Mbogning, Anne Musters, et al.. Incidence and risk factors for adalimumab and infliximab anti-drug antibodies in rheumatoid arthritis: A European retrospective multicohort analysis. Seminars in Arthritis and Rheumatism, WB Saunders, 2019, 48 (6), pp.967-975. ⟨10.1016/j.semarthrit.2018.10.006⟩. ⟨hal-02566700⟩

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