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

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Quistrebert, Jocelyn | Hässler, Signe | Bachelet, Delphine | Mbogning, Cyprien | Musters, Anne | Tak, Paul Peter | Wijbrandts, Carla Ann | Herenius, Marieke | Bergstra, Sytske Anne | Akdemir, Gülşah | Johannesson, Martina | Combe, Bernard | Fautrel, Bruno | Chollet-Martin, Sylvie | Gleizes, Aude | Donnellan, Naoimh | Deisenhammer, Florian | Davidson, Julie, E | Hincelin-Mery, Agnès | Dönnes, Pierre | Fogdell-Hahn, Anna | de Vries, Niek | Huizinga, Tom | Abugessaisa, Imad | Saevarsdottir, Saedis | Hacein-Bey-Abina, Salima | Pallardy, Marc | Broët, Philippe | Mariette, Xavier

Edité par CCSD ; WB Saunders -

International audience. 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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