1. A RANDOMIZED CLINICAL TRIAL OF 2-WEEK METHOTREXATE DISCONTINUATION IN RHEUMATOID ARTHRITIS PATIENTS VACCINATED WITH INACTIVATED SARS-COV-2 VACCINE
- Author
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Diogo Souza Domiciano, Sandra Gofinet Pasoto, Carlo Scognamiglio Renner Araujo, Clovis A. Silva, Ana Cristina Medeiros-Ribeiro, Andrea Yukie Shimabuco, Karina Bonfiglioli, Carla G. S. Saad, Eloisa Bonfa, Matheus Santos Rodrigues Silva, Tatiana do Nascimento Pedrosa, Emily Figueiredo Neves Yuki, Nadia E. Aikawa, Rosa Maria Rodrigues Pereira, Léonard de Vinci Kanda Kupa, and Gioanna Zou
- Subjects
medicine.medical_specialty ,Coronavirus disease 2019 (COVID-19) ,business.industry ,Immunogenicity ,Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) ,medicine.disease ,Gastroenterology ,law.invention ,Discontinuation ,Dose schedule ,Randomized controlled trial ,law ,Rheumatoid arthritis ,Internal medicine ,medicine ,Methotrexate ,business ,medicine.drug - Abstract
ObjectivesTo evaluate the effect on immunogenicity and safety of 2-week methotrexate(MTX) discontinuation after each dose of the Sinovac-CoronaVac vaccine versus MTX maintenance in rheumatoid arthritis(RA) patients.MethodsThis was a single-center, prospective, randomized, investigator-blinded, intervention study (#NCT04754698, CoronavRheum), including adult RA patients(stable CDAI10 at D28).ResultsRandomization included 138 patients with 9 exclusions(5 COVID-19, 4 protocol violations). Safety evaluation included 60(MTX-hold) and 69(MTX-maintain) patients. Further exclusions consisted of 27 patients[13(21.7%) vs. 14(20.3%),p=0.848] with positive baseline IgG/NAb and 10 patients(21.3%) in MTX-hold with CDAI>10 at D28. At D69, a higher increase in SC[29(78.4%) vs 30(54.5%),p=0.019] was observed in MTX-hold(n=37) in comparison to MTX-maintain(n=55), with parallel augmentation in GMT[34.2(25.2-46.4) vs 16.8(11.9-23.6),p=0.006]. No differences were observed for NAb positivity[23(62.2%) vs 27(49.1%),p=0.217]. Longitudinal variations in disease activity scores were alike in both groups(CDAI,p=0.144; DAS28-CRP,p=0.718).ConclusionWe provided novel data that 2-week MTX withdrawal after each vaccine dose improves anti-SARS-CoV-2 immunogenicity. The comparable longitudinal variations of disease activity in both groups suggest that discontinuation is a feasible and efficient strategy in well-controlled RA patients, and may be even safer for vaccines with longer interval between doses or single dose schedules.FundingFAPESP/CNPq/B3-Bolsa de Valores-Brasil.
- Published
- 2021
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