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Study flow diagram.
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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.
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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.
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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.

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