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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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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 1 The proportion of patients with at least one relapse at two years.
Figuras y tablas -
Analysis 1.1

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 1 The proportion of patients with at least one relapse at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 2 The proportion of patients with at least one relapse at two years (the likely‐case scenario).
Figuras y tablas -
Analysis 1.2

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 2 The proportion of patients with at least one relapse at two years (the likely‐case scenario).

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 3 The annualised relapse rate at two years.
Figuras y tablas -
Analysis 1.3

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 3 The annualised relapse rate at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 4 The proportion of patients with disability worsening at two years.
Figuras y tablas -
Analysis 1.4

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 4 The proportion of patients with disability worsening at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 5 The proportion of patients with disability worsening at two years (the likely‐case scenario).
Figuras y tablas -
Analysis 1.5

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 5 The proportion of patients with disability worsening at two years (the likely‐case scenario).

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 6 The mean change in SF‐36 Physical Component Summary scores from baseline to two years.
Figuras y tablas -
Analysis 1.6

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 6 The mean change in SF‐36 Physical Component Summary scores from baseline to two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 7 The mean change in SF‐36 Mental Component Summary scores from baseline to two years.
Figuras y tablas -
Analysis 1.7

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 7 The mean change in SF‐36 Mental Component Summary scores from baseline to two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 8 The number of patients with adverse events excluding relapses at two years.
Figuras y tablas -
Analysis 1.8

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 8 The number of patients with adverse events excluding relapses at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 9 The number of patients with serious adverse events excluding relapses at two years.
Figuras y tablas -
Analysis 1.9

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 9 The number of patients with serious adverse events excluding relapses at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 10 The number of patients who discontinued study drug because of adverse events excluding relapses at two years.
Figuras y tablas -
Analysis 1.10

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 10 The number of patients who discontinued study drug because of adverse events excluding relapses at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 11 The number of patients with flushing at two years.
Figuras y tablas -
Analysis 1.11

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 11 The number of patients with flushing at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 12 The number of patients with upper abdominal pain at two years.
Figuras y tablas -
Analysis 1.12

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 12 The number of patients with upper abdominal pain at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 13 The number of patients with nausea at two years.
Figuras y tablas -
Analysis 1.13

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 13 The number of patients with nausea at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 14 The number of patients with diarrhoea at two years.
Figuras y tablas -
Analysis 1.14

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 14 The number of patients with diarrhoea at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 15 The number of patients with proteinuria at two years.
Figuras y tablas -
Analysis 1.15

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 15 The number of patients with proteinuria at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 16 The number of patients with a decreased lymphocyte count of less than 0.5×109 per litre at two years.
Figuras y tablas -
Analysis 1.16

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 16 The number of patients with a decreased lymphocyte count of less than 0.5×109 per litre at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 17 The number of patients with a decreased white‐cell count of less than 3.0×109 per litre at two years.
Figuras y tablas -
Analysis 1.17

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 17 The number of patients with a decreased white‐cell count of less than 3.0×109 per litre at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 18 The number of patients with an increased alanine aminotransferase level at least three times the upper limit of the normal range at two years.
Figuras y tablas -
Analysis 1.18

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 18 The number of patients with an increased alanine aminotransferase level at least three times the upper limit of the normal range at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 19 The number of patients with gastrointestinal events at two years.
Figuras y tablas -
Analysis 1.19

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 19 The number of patients with gastrointestinal events at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 20 The number of patients with infections at two years.
Figuras y tablas -
Analysis 1.20

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 20 The number of patients with infections at two years.

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Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 21 The number of patients with serious infections at two years.
Figuras y tablas -
Analysis 1.21

Comparison 1 High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo, Outcome 21 The number of patients with serious infections at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 1 The proportion of patients with at least one relapse at two years.
Figuras y tablas -
Analysis 2.1

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 1 The proportion of patients with at least one relapse at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 2 The proportion of patients with at least one relapse at two years (the likely‐case scenario).
Figuras y tablas -
Analysis 2.2

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 2 The proportion of patients with at least one relapse at two years (the likely‐case scenario).

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 3 The annualised relapse rate at two years.
Figuras y tablas -
Analysis 2.3

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 3 The annualised relapse rate at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 4 The proportion of patients with disability worsening at two years.
Figuras y tablas -
Analysis 2.4

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 4 The proportion of patients with disability worsening at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 5 The proportion of patients with disability worsening at two years (the likely‐case scenario).
Figuras y tablas -
Analysis 2.5

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 5 The proportion of patients with disability worsening at two years (the likely‐case scenario).

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 6 The mean change in SF‐36 Physical Component Summary scores from baseline to two years.
Figuras y tablas -
Analysis 2.6

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 6 The mean change in SF‐36 Physical Component Summary scores from baseline to two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 7 The mean change in SF‐36 Mental Component Summary scores from baseline to two years.
Figuras y tablas -
Analysis 2.7

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 7 The mean change in SF‐36 Mental Component Summary scores from baseline to two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 8 The number of patients with adverse events excluding relapses at two years.
Figuras y tablas -
Analysis 2.8

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 8 The number of patients with adverse events excluding relapses at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 9 The number of patients with serious adverse events excluding relapses at two years.
Figuras y tablas -
Analysis 2.9

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 9 The number of patients with serious adverse events excluding relapses at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 10 The number of patients who discontinued study drug because of adverse events excluding relapses at two years.
Figuras y tablas -
Analysis 2.10

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 10 The number of patients who discontinued study drug because of adverse events excluding relapses at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 11 The number of patients with flushing at two years.
Figuras y tablas -
Analysis 2.11

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 11 The number of patients with flushing at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 12 The number of patients with upper abdominal pain at two years.
Figuras y tablas -
Analysis 2.12

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 12 The number of patients with upper abdominal pain at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 13 The number of patients with nausea at two years.
Figuras y tablas -
Analysis 2.13

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 13 The number of patients with nausea at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 14 The number of patients with diarrhoea at two years.
Figuras y tablas -
Analysis 2.14

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 14 The number of patients with diarrhoea at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 15 The number of patients with proteinuria at two years.
Figuras y tablas -
Analysis 2.15

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 15 The number of patients with proteinuria at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 16 The number of patients with a decreased lymphocyte count of less than 0.5×109 per litre at two years.
Figuras y tablas -
Analysis 2.16

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 16 The number of patients with a decreased lymphocyte count of less than 0.5×109 per litre at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 17 The number of patients with a decreased white‐cell count of less than 3.0×109 per litre at two years.
Figuras y tablas -
Analysis 2.17

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 17 The number of patients with a decreased white‐cell count of less than 3.0×109 per litre at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 18 The number of patients with an increased alanine aminotransferase level at least three times the upper limit of the normal range at two years.
Figuras y tablas -
Analysis 2.18

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 18 The number of patients with an increased alanine aminotransferase level at least three times the upper limit of the normal range at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 19 The number of patients with gastrointestinal events at two years.
Figuras y tablas -
Analysis 2.19

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 19 The number of patients with gastrointestinal events at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 20 The number of patients with infections at two years.
Figuras y tablas -
Analysis 2.20

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 20 The number of patients with infections at two years.

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Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 21 The number of patients with serious infections at two years.
Figuras y tablas -
Analysis 2.21

Comparison 2 Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo, Outcome 21 The number of patients with serious infections at two years.

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Summary of findings for the main comparison. Dimethyl fumarate for multiple sclerosis

Dimethyl fumarate for multiple sclerosis

Patient or population: Patients with relapsing‐remitting multiple sclerosis
Settings: United States, Germany, Poland, India, Canada, France, etc
Intervention: Dimethyl fumarate at a dose of 240 mg orally twice daily

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of Participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Placebo

Dimethyl fumarate

The proportion of patients with at least one relapse at two years
Follow‐up: 2 years

Study population

RR 0.64
(0.54 to 0.77)

1540
(2 studies)

⊕⊕⊕⊝
moderate1

437 per 1000

280 per 1000
(236 to 337)

The proportion of patients with disability worsening at two years
Follow‐up: 2 years

Study population

RR 0.65
(0.53 to 0.81)

1539
(2 studies)

⊕⊕⊝⊝
low1,2

223 per 1000

145 per 1000
(118 to 181)

The proportion of patients who discontinued study drug because of adverse events excluding relapses at two years
Follow‐up: 2 years

Study population

RR 2.18
(1.56 to 3.06)

1540
(2 studies)

⊕⊕⊕⊝
moderate1

58 per 1000

127 per 1000
(91 to 179)

The proportion of patients with lymphopenia at two years

Follow‐up: 2 years

Study population

RR 5.69
(2.40 to 13.46)

1540
(2 studies)

⊕⊕⊕⊝
moderate1

8 per 1000

44 per 1000
(19 to 105)

*The basis for the assumed risk (e.g. the median placebo 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 A high rate of dropouts existed and reasons of dropouts were unbalanced between arms
2 Disability worsening was confirmed at 3 months of follow‐up

Figuras y tablas -
Summary of findings for the main comparison. Dimethyl fumarate for multiple sclerosis
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Comparison 1. High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 The proportion of patients with at least one relapse at two years Show forest plot

2

1532

Risk Ratio (M‐H, Fixed, 95% CI)

0.57 [0.50, 0.66]

2 The proportion of patients with at least one relapse at two years (the likely‐case scenario) Show forest plot

2

1534

Risk Ratio (M‐H, Fixed, 95% CI)

0.75 [0.68, 0.83]

3 The annualised relapse rate at two years Show forest plot

2

1532

Rate Ratio (Fixed, 95% CI)

0.51 [0.45, 0.59]

4 The proportion of patients with disability worsening at two years Show forest plot

2

1532

Risk Ratio (M‐H, Fixed, 95% CI)

0.70 [0.57, 0.87]

5 The proportion of patients with disability worsening at two years (the likely‐case scenario) Show forest plot

2

1534

Risk Ratio (M‐H, Fixed, 95% CI)

0.85 [0.75, 0.97]

6 The mean change in SF‐36 Physical Component Summary scores from baseline to two years Show forest plot

2

1461

Mean Difference (IV, Fixed, 95% CI)

1.51 [0.76, 2.26]

7 The mean change in SF‐36 Mental Component Summary scores from baseline to two years Show forest plot

2

1461

Mean Difference (IV, Random, 95% CI)

1.19 [‐0.70, 3.08]

8 The number of patients with adverse events excluding relapses at two years Show forest plot

2

1531

Risk Ratio (M‐H, Fixed, 95% CI)

1.38 [1.27, 1.51]

9 The number of patients with serious adverse events excluding relapses at two years Show forest plot

2

1531

Risk Ratio (M‐H, Fixed, 95% CI)

1.07 [0.75, 1.53]

10 The number of patients who discontinued study drug because of adverse events excluding relapses at two years Show forest plot

2

1531

Risk Ratio (M‐H, Fixed, 95% CI)

2.16 [1.54, 3.03]

11 The number of patients with flushing at two years Show forest plot

2

1531

Risk Ratio (M‐H, Fixed, 95% CI)

6.57 [4.62, 9.35]

12 The number of patients with upper abdominal pain at two years Show forest plot

2

1531

Risk Ratio (M‐H, Fixed, 95% CI)

1.91 [1.35, 2.69]

13 The number of patients with nausea at two years Show forest plot

2

1531

Risk Ratio (M‐H, Fixed, 95% CI)

1.59 [1.19, 2.12]

14 The number of patients with diarrhoea at two years Show forest plot

2

1531

Risk Ratio (M‐H, Fixed, 95% CI)

1.55 [1.20, 2.01]

15 The number of patients with proteinuria at two years Show forest plot

2

1531

Risk Ratio (M‐H, Fixed, 95% CI)

1.46 [1.06, 2.00]

16 The number of patients with a decreased lymphocyte count of less than 0.5×109 per litre at two years Show forest plot

2

1531

Risk Ratio (M‐H, Fixed, 95% CI)

5.25 [2.20, 12.51]

17 The number of patients with a decreased white‐cell count of less than 3.0×109 per litre at two years Show forest plot

2

1531

Risk Ratio (M‐H, Fixed, 95% CI)

5.23 [2.47, 11.07]

18 The number of patients with an increased alanine aminotransferase level at least three times the upper limit of the normal range at two years Show forest plot

2

1531

Risk Ratio (M‐H, Random, 95% CI)

1.34 [0.61, 2.94]

19 The number of patients with gastrointestinal events at two years Show forest plot

2

1531

Risk Ratio (M‐H, Random, 95% CI)

1.67 [1.31, 2.12]

20 The number of patients with infections at two years Show forest plot

2

1531

Risk Ratio (M‐H, Fixed, 95% CI)

1.08 [0.99, 1.17]

21 The number of patients with serious infections at two years Show forest plot

2

1531

Risk Ratio (M‐H, Fixed, 95% CI)

1.38 [0.64, 2.98]
Figuras y tablas -
Comparison 1. High‐dose (240 mg orally three times daily) dimethyl fumarate versus placebo
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Comparison 2. Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 The proportion of patients with at least one relapse at two years Show forest plot

2

1540

Risk Ratio (M‐H, Random, 95% CI)

0.64 [0.54, 0.77]

2 The proportion of patients with at least one relapse at two years (the likely‐case scenario) Show forest plot

2

1546

Risk Ratio (M‐H, Fixed, 95% CI)

0.81 [0.74, 0.89]

3 The annualised relapse rate at two years Show forest plot

2

1540

Rate Ratio (Fixed, 95% CI)

0.51 [0.44, 0.59]

4 The proportion of patients with disability worsening at two years Show forest plot

2

1539

Risk Ratio (M‐H, Fixed, 95% CI)

0.65 [0.53, 0.81]

5 The proportion of patients with disability worsening at two years (the likely‐case scenario) Show forest plot

2

1546

Risk Ratio (M‐H, Fixed, 95% CI)

0.83 [0.73, 0.94]

6 The mean change in SF‐36 Physical Component Summary scores from baseline to two years Show forest plot

2

1474

Mean Difference (IV, Fixed, 95% CI)

1.54 [0.79, 2.30]

7 The mean change in SF‐36 Mental Component Summary scores from baseline to two years Show forest plot

2

1474

Mean Difference (IV, Fixed, 95% CI)

0.93 [‐0.06, 1.93]

8 The number of patients with adverse events excluding relapses at two years Show forest plot

2

1540

Risk Ratio (M‐H, Fixed, 95% CI)

1.37 [1.25, 1.49]

9 The number of patients with serious adverse events excluding relapses at two years Show forest plot

2

1540

Risk Ratio (M‐H, Random, 95% CI)

1.05 [0.63, 1.74]

10 The number of patients who discontinued study drug because of adverse events excluding relapses at two years Show forest plot

2

1540

Risk Ratio (M‐H, Fixed, 95% CI)

2.18 [1.56, 3.06]

11 The number of patients with flushing at two years Show forest plot

2

1540

Risk Ratio (M‐H, Fixed, 95% CI)

8.01 [5.66, 11.34]

12 The number of patients with upper abdominal pain at two years Show forest plot

2

1540

Risk Ratio (M‐H, Fixed, 95% CI)

1.69 [1.19, 2.41]

13 The number of patients with nausea at two years Show forest plot

2

1540

Risk Ratio (M‐H, Fixed, 95% CI)

1.39 [1.03, 1.87]

14 The number of patients with diarrhoea at two years Show forest plot

2

1540

Risk Ratio (M‐H, Random, 95% CI)

1.31 [0.91, 1.87]

15 The number of patients with proteinuria at two years Show forest plot

2

1540

Risk Ratio (M‐H, Fixed, 95% CI)

1.14 [0.81, 1.59]

16 The number of patients with a decreased lymphocyte count of less than 0.5×109 per litre at two years Show forest plot

2

1540

Risk Ratio (M‐H, Fixed, 95% CI)

5.69 [2.40, 13.46]

17 The number of patients with a decreased white‐cell count of less than 3.0×109 per litre at two years Show forest plot

2

1540

Risk Ratio (M‐H, Fixed, 95% CI)

6.53 [3.13, 13.64]

18 The number of patients with an increased alanine aminotransferase level at least three times the upper limit of the normal range at two years Show forest plot

2

1540

Risk Ratio (M‐H, Random, 95% CI)

1.33 [0.57, 3.07]

19 The number of patients with gastrointestinal events at two years Show forest plot

2

1540

Risk Ratio (M‐H, Random, 95% CI)

1.43 [1.11, 1.85]

20 The number of patients with infections at two years Show forest plot

2

1540

Risk Ratio (M‐H, Random, 95% CI)

1.04 [0.92, 1.18]

21 The number of patients with serious infections at two years Show forest plot

2

1540

Risk Ratio (M‐H, Fixed, 95% CI)

1.55 [0.73, 3.28]
Figuras y tablas -
Comparison 2. Low‐dose (240 mg orally twice daily) dimethyl fumarate versus placebo
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