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Cochrane Database of Systematic Reviews

Rituximab para la esclerosis múltiple recurrente‐remitente

Información

DOI:
https://doi.org/10.1002/14651858.CD009130.pub3Copiar DOI
Base de datos:
  1. Cochrane Database of Systematic Reviews
Versión publicada:
  1. 06 diciembre 2013see what's new
Tipo:
  1. Intervention
Etapa:
  1. Review
Grupo Editorial Cochrane:

  1. Grupo Cochrane de Esclerosis múltiple y enfermedades raras del sistema nervioso central

Copyright:
  1. Copyright © 2013 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd.

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Autores

  • Dian He

    Department of Neurology, Affiliated Hospital of Guiyang Medical College, Guiyang, China

  • Rui Guo

    Department of Neurology, Jinan No. 6 People's Hospital, Jinan, China

  • Fubo Zhang

    Department of Neurology, Cangzhou City Cemtral Hospital, Cangzhou, China

  • Chao Zhang

    Department of Internal Medicine, Jinan No. 6 People's Hospital, Jinan, China

  • Shuai Dong

    Department of Neurology, Jinan No. 6 People's Hospital, Jinan, China

  • Hongyu Zhou

    Correspondencia a: Department of Neurology, West China Hospital, Sichuan University, Chengdu, China

    [email protected]

Contributions of authors

All correspondence: Dian He and Hongyu Zhou
Drafting of review versions: Dian He and Hongyu Zhou
Search for trials: Rui Guo and Chao Zhang
Obtaining copies of trial reports: Rui Guo and Fubo Zhang
Selection of trials for inclusion/exclusion: Dian He, Hongyu Zhou
Extraction of data: Dian He, Shuai Dong
Entry of data: Dian He, Shuai Dong
Interpretation of data analyses: Dian He, Hongyu Zhou

Declarations of interest

None known

Acknowledgements

We wish to thank Andrea Fittipaldo, Trials Search Coordinator, and Liliana Coco, Managing Editor of the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group for their help and support in developing this review. We thank all peer reviewers, and Loredana La Mantia, the quality advisor of the Cochrane Multiple Sclerosis and Rare Diseases of the Central Nervous System Group, for their constructive comments and suggestions for this review. We also thank Dr Han Wenjie and Dr Zhang Shihong for what they did previously for the first version of this review.

Version history

Published

Title

Stage

Authors

Version

2013 Dec 06

Rituximab for relapsing‐remitting multiple sclerosis

Review

Dian He, Rui Guo, Fubo Zhang, Chao Zhang, Shuai Dong, Hongyu Zhou

https://doi.org/10.1002/14651858.CD009130.pub3

2011 Dec 07

Rituximab for relapsing‐remitting multiple sclerosis

Review

Dian He, Hongyu Zhou, Wenjie Han, Shihong Zhang

https://doi.org/10.1002/14651858.CD009130.pub2

2011 May 11

Rituximab for relapsing‐remitting multiple sclerosis

Protocol

Dian He, Hongyu Zhou, Wenjie Han, Shihong Zhang

https://doi.org/10.1002/14651858.CD009130

Differences between protocol and review

In the current review, types of participants were expanded by adding the new McDonald criteria (Polman 2011). Other treatments in the 'Objectives' and 'Types of interventions' were defined as approved DMDs. Two secondary outcomes (increased disability measured with EDSS or MSFC) were removed because of a lack of such endpoints in clinical trials for MS. Two outcomes on safety (the number of patients with SAEs and the number of patients who withdrew or dropped out from the study because of AEs) were added. Three outcomes (the sum of the number of gadolinium‐enhancing T1‐weighted lesions, the number of patients with disability progression, and the time to confirmed disease progression) were rephrased because they are more formal. One subgroup analysis (different therapies, monotherapy or combination therapy) was added. All these changes in the methods from the protocol to the review have no effect on the review conclusions.

Keywords

MeSH

Medical Subject Headings (MeSH) Keywords

Medical Subject Headings Check Words

Adult; Humans;

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Study flow diagram.
Figuras y tablas -
Figure 1

Study flow diagram.

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Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
Figuras y tablas -
Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
Figuras y tablas -
Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Summary of findings for the main comparison. Rituximab for relapsing‐remitting multiple sclerosis

Rituximab for relapsing‐remitting multiple sclerosis

Patient or population: patients with relapsing‐remitting multiple sclerosis
Settings: this trial was performed in the United States and Canada
Intervention: rituximab

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Control

Rituximab

The annualised rate of relapse
Scale from: 0 to infinity.
Follow‐up: mean 48 weeks

The mean the annualised rate of relapse in the control groups was
0.72

The mean the annualised rate of relapse in the intervention groups was 0.35 lower
(0.75 to 0.05 lower)

104
(1 study)

⊕⊕⊝⊝
low1,2

The sum of the number of gadolinium‐enhancing T1‐weighted lesions
Scale from: 0 to infinity.
Follow‐up: mean 24 weeks

The mean the sum of the number of gadolinium‐enhancing t1‐weighted lesions in the control groups was
5.5

The mean the sum of the number of gadolinium‐enhancing t1‐weighted lesions in the intervention groups was
5 lower
(0.75 to 0.01 lower)

104
(1 study)

⊕⊕⊝⊝
low1,2

The number of patients with adverse effects
Follow‐up: mean 48 weeks

High

RR 0.99
(0.94 to 1.05)

104
(1 study)

⊕⊕⊝⊝
low1,2

100 per 100

99 per 100
(94 to 100)

The number of patients with serious adverse events
Follow‐up: mean 48 weeks

Low

RR 0.91
(0.33 to 2.52)

104
(1 study)

⊕⊕⊝⊝
low1,2

143 per 1000

130 per 1000
(47 to 360)

The number of patients who withdrew or dropped out from the study because of AEs
Follow‐up: mean 48 weeks

Low

RR 0.76
(0.13 to 4.35)

104
(1 study)

⊕⊕⊝⊝
low1,2

57 per 1000

43 per 1000
(7 to 248)

The number of patients with disability progression

Study population

Not estimable

0
(0)

See comment

This outcome was not included as an endpoint in the trial.

See comment

See comment

The time to confirmed disease progression

Study population

Not estimable

0
(0)

See comment

This outcome was not included as an endpoint in the trial.

See comment

See comment

*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio

GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

1 This study had a high rate of dropouts (24.0%), and the methodology for random sequence generation and allocation concealment was unclear.
2 This study had a small sample size and would only have 70% power for the primary endpoint.

Figuras y tablas -
Summary of findings for the main comparison. Rituximab for relapsing‐remitting multiple sclerosis
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