RT Journal Article
SR Electronic
T1 Methotrexate effect on immunogenicity and long-term maintenance of adalimumab in axial spondyloarthritis: a multicentric randomised trial
JF RMD Open
JO RMD Open
FD EULAR
SP e001047
DO 10.1136/rmdopen-2019-001047
VO 6
IS 1
A1 Emilie Ducourau
A1 Theo Rispens
A1 Marine Samain
A1 Emmanuelle Dernis
A1 Fabienne Le Guilchard
A1 Lucia Andras
A1 Aleth Perdriger
A1 Eric Lespessailles
A1 Antoine Martin
A1 Grégoire Cormier
A1 Thomas Armingeat
A1 Valérie Devauchelle-Pensec
A1 Elisabeth Gervais
A1 Benoit Le Goff
A1 Annick de Vries
A1 Eric Piver
A1 Gilles Paintaud
A1 Céline Desvignes
A1 David Ternant
A1 Hervé Watier
A1 Philippe Goupille
A1 Denis Mulleman
YR 2020
UL http://rmdopen.bmj.com/content/6/1/e001047.abstract
AB 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.