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The impact of rituximab infusion protocol on the long‐term outcome in anti‐MuSK myasthenia gravis

Authors: Cortés-Vicente, Elena; Rojas-Garcia, Ricard; Diaz-Manera, Jordi; Querol, Luis; Casasnovas, Carlos; Guerrero-Sola, Antonio; Muñoz-Blanco, José Luis; +9 Authors

The impact of rituximab infusion protocol on the long‐term outcome in anti‐MuSK myasthenia gravis

Abstract

ObjectiveTo evaluate whether the clinical benefit and relapse rates in anti-muscle-specific kinase (MuSK) myasthenia gravis (MG) differ depending on the protocol of rituximab followed. MethodsThis retrospective multicentre study in patients with MuSK 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. ResultsTwenty-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). InterpretationThis 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 MuSK MG.

I. Illa received research support from the Fondo de Investigacion en Salud, Instituto de Salud Carlos III, Ministry of Health (Spain), FIS PI16/01440 (Fondos FEDER). E. Cortes-Vicente was supported by a FIS grant (CM16/00096) from Fondo de Investigacion en Salud, Instituto de Salud Carlos III, Ministry of Health (Spain) and Fondo Social Europeo.

Country
Spain
Subjects by Vocabulary

Microsoft Academic Graph classification: medicine.medical_specialty Time to relapse Relapse rate Gastroenterology Internal medicine medicine In patient Relapse risk Adverse effect Survival analysis business.industry medicine.disease Myasthenia gravis Rituximab business medicine.drug

Medical Subject Headings: immune system diseases

Keywords

Assaigs clínics de medicaments, Malalties del sistema nerviós, General Neuroscience, Drug testing, Nervous system diseases, Neurology (clinical)

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citations
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
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This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
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