TY - JOUR T1 - Methotrexate effect on immunogenicity and long-term maintenance of adalimumab in axial spondyloarthritis: a multicentric randomised trial JF - RMD Open JO - RMD Open DO - 10.1136/rmdopen-2019-001047 VL - 6 IS - 1 SP - e001047 AU - Emilie Ducourau AU - Theo Rispens AU - Marine Samain AU - Emmanuelle Dernis AU - Fabienne Le Guilchard AU - Lucia Andras AU - Aleth Perdriger AU - Eric Lespessailles AU - Antoine Martin AU - Grégoire Cormier AU - Thomas Armingeat AU - Valérie Devauchelle-Pensec AU - Elisabeth Gervais AU - Benoit Le Goff AU - Annick de Vries AU - Eric Piver AU - Gilles Paintaud AU - Céline Desvignes AU - David Ternant AU - Hervé Watier AU - Philippe Goupille AU - Denis Mulleman Y1 - 2020/01/01 UR - http://rmdopen.bmj.com/content/6/1/e001047.abstract N2 - Objectives Anti-drug antibodies (ADA) are responsible for decreased adalimumab efficacy in axial spondyloarthritis (SpA). We aimed to evaluate the ability of methotrexate (MTX) to decrease adalimumab immunisation.Methods A total of 110 patients eligible to receive adalimumab 40 mg subcutaneously (s.c.) every other week were randomised (1:1 ratio) to receive, 2 weeks before adalimumab (W-2) and weekly, MTX 10 mg s.c. (MTX+) or not (MTX−). ADA detection and adalimumab serum concentration were assessed at weeks 4 (W4), 8 (W8), 12 (W12) and 26 (W26) after starting adalimumab (W0). The primary outcome was the proportion of patients with ADA at W26. Four years after the study completion, we retrospectively analysed adalimumab maintenance in relation with MTX co-treatment duration.Results We analysed data for 107 patients (MTX+; n=52; MTX-; n=55). ADA were detected at W26 in 39/107 (36.4%) patients: 13/52 (25%) in the MTX+ group and 26/55 (47.3%) in the MTX− group (p=0.03). Adalimumab concentration was significantly higher in the MTX+ than MTX− group at W4, W8, W12 and W26. The two groups did not differ in adverse events or efficacy. In the follow-up study, MTX co-treatment >W26 versus no MTX or ≤W26 was significantly associated with adalimumab long-term maintenance (p=0.04).Conclusion MTX reduces the immunogenicity and ameliorate the pharmacokinetics of adalimumab in axial SpA. A prolonged co-treatment of MTX>W26 seems to increase adalimumab long-term maintenance. ER -