A RANDOMIZED CLINICAL TRIAL of 2-WEEK METHOTREXATE DISCONTINUATION in RHEUMATOID ARTHRITIS PATIENTS VACCINATED with INACTIVATED SARS-COV-2 VACCINE
Annals of the Rheumatic Diseases
; 81:371, 2022.
Artigo
em Inglês
| EMBASE | ID: covidwho-2009157
ABSTRACT
Background:
Patients with rheumatoid arthritis (RA) on methotrexate have reduced vaccine responses. Temporary discontinuation has improved immuno-genicity of anti-infuenza vaccine, but this strategy has not been evaluated in anti-SARS-CoV-2 vaccines.Objectives:
To 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.Methods:
This was a single-center, prospective, randomized, investigator-blinded, intervention study (#NCT04754698, CoronavRheum), including adult RA patients (stable CDAI≤10, prednisone ≤7.5mg/day), randomized (11) to withdraw MTX (MTX-hold) for 2 weeks after each vaccine dose or maintain MTX (MTX-maintain), evaluated at D0, D28 and D69. Co-primary outcomes were anti-SARS-CoV-2 S1/S2 IgG seroconversion(SC) and neutralizing antibody (NAb) positivity at D69. Secondary outcomes were geometric mean titers (GMT) and fare rates. For immunogenicity analyses, we excluded patients with baseline positive IgG/NAb, and, for safety reasons, those who fared at D28 (CDAI>10) and did not withdraw MTX twice.Results:
Randomization 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 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, MTX-hold (n=37) had a higher rate of seroconversion than MTX-maintain (n=55) group [29 (78.4%) vs 30 (54.5%), p=0.019], 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]. At D28 fare, rates were comparable in both groups (CDAI, p=0.122;DAS28-CRP, p=0.576), whereas CDAI>10 was more frequent in MTX-hold at D69 (p=0.024).Conclusion:
We provide novel data that 2-week MTX withdrawal after each Sinovac-CoronaVac vaccine dose improves anti-SARS-CoV-2 IgG response. The increased fare rates after second MTX withdrawal may be attributed to the short-term interval between vaccine doses. This strategy requires close surveillance and shared decision making due to the possibility of fares.
coronavac; endogenous compound; immunoglobulin G; methotrexate; neutralizing antibody; prednisone; SARS-CoV-2 antibody; adult; clinical trial; conference abstract; controlled study; coronavirus disease 2019; DAS28; drug safety; drug therapy; drug withdrawal; female; human; immunogenicity; intervention study; major clinical study; male; nonhuman; outcome assessment; prospective study; randomization; randomized controlled trial; rheumatoid arthritis; seroconversion; Severe acute respiratory syndrome coronavirus 2; shared decision making; single blind procedure
Texto completo:
Disponível
Coleções:
Bases de dados de organismos internacionais
Base de dados:
EMBASE
Tipo de estudo:
Estudo experimental
/
Estudo prognóstico
/
Ensaios controlados aleatorizados
Tópicos:
Vacinas
Idioma:
Inglês
Revista:
Annals of the Rheumatic Diseases
Ano de publicação:
2022
Tipo de documento:
Artigo
Similares
MEDLINE
...
LILACS
LIS