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

ABIRISK Consortium

Rannsóknarafurð: Framlag til fræðitímaritsGreinritrýni

22 Tilvitnanir (Scopus)

Útdráttur

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.

Upprunalegt tungumálEnska
FræðitímaritSeminars in Arthritis and Rheumatism
DOI
ÚtgáfustaðaSamþykkt/í birtingu - 2018

Athugasemd

Funding Information:
Funding statement: The research leading to these results has received support from the Innovative Medicines Initiative Joint Undertaking under grant agreement no [115303], resources of that are composed of financial contribution from the European Union Seventh Framework Program (FP7/2007–2013) and of kind contribution from EFPIA companies.

Funding Information:
All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: J Quistrebert, S Hässler, D Bachelet, C Mbogning, A Musters, PP Tak, CA Wijbrandts, M Herenius, SA Bergstra, G Akdemir, M Johannesson, B Combe, B Fautrel, S Chollet-Martin, A Gleizes, N Donnellan, F Deisenhammer, A Hincelin-Mery, A Fogdell-Hahn, N De Vries, T Huizinga, I Abugessaisa, S Saevarsdottir, S Hacein-Bey-Abina, M Pallardy, P Broët: have nothing to disclose. X Mariette received honorarium (less than and declare: J Quistrebert, S Hässler, D Bachelet, C Mbogning, A Musters, PP Tak, CA Wijbrandts, M Herenius, SA Bergstra, G Akdemir, M Johannesson, B Combe, B Fautrel, S Chollet-Martin, A Gleizes, N Donnellan, F Deisenhammer, A Hincelin-Mery, A Fogdell-Hahn, N De Vries, T Huizinga, I Abugessaisa, S Saevarsdottir, S Hacein-Bey-Abina, M Pallardy, P Broët: have nothing to disclose. X Mariette received honorarium (less than $10,000) from BMS, GSK, Pfizer, UCB. J Davidson reports being salaried and holding shares from GlaxoSmithKline R&D, outside the submitted work. P Dönnes reports grants from Innovative Medicines Initiative Joint Undertaking during the conduct of the study.0,000) from BMS, GSK, Pfizer, UCB. J Davidson reports being salaried and holding shares from GlaxoSmithKline R&D, outside the submitted work. P Dönnes reports grants from Innovative Medicines Initiative Joint Undertaking during the conduct of the study.

Funding Information:
The first year of the IMPROVED study was sponsored by AbbVie. Study design, data collection, trial management, data analysis and preparation of the manuscript were performed by the authors.

Publisher Copyright:
© 2018

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