Open AccessThe impact of rituximab infusion protocol on the long‐term outcome in anti‐MuSK myasthenia gravis
Author(s) -
CortésVicente Elena,
RojasGarcia Ricard,
DíazManera Jordi,
Querol Luis,
Casasnovas Carlos,
GuerreroSola Antonio,
MuñozBlanco José Luis,
BárcenaLlona José Eulalio,
MárquezInfante Celedonio,
Pardo Julio,
MartínezFernández Eva María,
Usón Mercedes,
OlivaNacarino Pedro,
Sevilla Teresa,
Illa Isabel
Publication year - 2018
Publication title -
annals of clinical and translational neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.824
H-Index - 42
ISSN - 2328-9503
DOI - 10.1002/acn3.564
Subject(s) - medicine , myasthenia gravis , rituximab , protocol (science) , term (time) , immunology , antibody , pathology , alternative medicine , physics , quantum mechanics
Objective To evaluate whether the clinical benefit and relapse rates in anti‐muscle‐specific kinase (Mu SK ) myasthenia gravis ( MG ) differ depending on the protocol of rituximab followed. Methods This retrospective multicentre study in patients with Mu SK MG compared three rituximab protocols in terms of clinical status, relapse, changes in treatment, and adverse side effects. The primary effectiveness endpoint was clinical relapse requiring a further infusion of rituximab. Survival curves were estimated using Kaplan–Meier methods and survival analyses were undertaken using Cox proportional‐hazards models. Results Twenty‐five patients were included: 11 treated with protocol 4 + 2 (375 mg/m 2 /4 weeks, then monthly for 2 months), five treated with protocol 1 + 1 (two 1 g doses 2 weeks apart), and nine treated with protocol 4 (375 mg/m 2 /4 weeks). Mean follow‐up was 5.0 years ( SD 3.3). Relapse occurred in 18.2%, 80%, and 33.3%, and mean time to relapse was 3.5 ( SD 1.5), 1.1 ( SD 0.4), and 2.5 ( SD 1.4) years, respectively. Based on Kaplan–Meier estimates, patients treated with protocol 4 + 2 had fewer and later relapses than patients treated with the other two protocols (log‐rank test P = 0.0001). Patients treated with protocol 1 + 1 had a higher risk of relapse than patients treated with protocol 4 + 2 ( HR 112.8, 95% CI , 5.7–2250.4, P = 0.002). Patients treated with protocol 4 showed a trend to a higher risk of relapse than those treated with protocol 4 + 2 ( HR 9.2, 95% CI 0.9–91.8, P = 0.059). Interpretation This study provides class IV evidence that the 4 + 2 rituximab protocol has a lower clinical relapse rate and produces a more durable response than the 1 + 1 and 4 protocols in patients with Mu SK MG .