Scolaris Content Display Scolaris Content Display

Study flow diagram.
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Figure 1

Study flow diagram.

'Risk of bias' summary: review authors' judgements about each risk of bias item for each included study.
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Figure 2

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

'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 3

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

Forest plot of comparison: 1 Alemtuzumab 12 mg versus interferon beta‐1a, outcome: 1.1 Relapse‐free survival.
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Figure 4

Forest plot of comparison: 1 Alemtuzumab 12 mg versus interferon beta‐1a, outcome: 1.1 Relapse‐free survival.

Forest plot of comparison: 1 Alemtuzumab 12 mg versus interferon beta‐1a, outcome: 1.2 Sustained disease progression‐free survival.
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Figure 5

Forest plot of comparison: 1 Alemtuzumab 12 mg versus interferon beta‐1a, outcome: 1.2 Sustained disease progression‐free survival.

Forest plot of comparison: 1 Alemtuzumab 12 mg versus interferon beta‐1a, outcome: 1.2 Rate of participants with at least one adverse event.
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Figure 6

Forest plot of comparison: 1 Alemtuzumab 12 mg versus interferon beta‐1a, outcome: 1.2 Rate of participants with at least one adverse event.

Comparison 1 Alemtuzumab 12 mg versus interferon beta‐1a, Outcome 1 Relapse‐free survival.
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Analysis 1.1

Comparison 1 Alemtuzumab 12 mg versus interferon beta‐1a, Outcome 1 Relapse‐free survival.

Comparison 1 Alemtuzumab 12 mg versus interferon beta‐1a, Outcome 2 Sustained disease progression‐free survival.
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Analysis 1.2

Comparison 1 Alemtuzumab 12 mg versus interferon beta‐1a, Outcome 2 Sustained disease progression‐free survival.

Comparison 1 Alemtuzumab 12 mg versus interferon beta‐1a, Outcome 3 Number of participants with at least one adverse event.
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Analysis 1.3

Comparison 1 Alemtuzumab 12 mg versus interferon beta‐1a, Outcome 3 Number of participants with at least one adverse event.

Comparison 1 Alemtuzumab 12 mg versus interferon beta‐1a, Outcome 4 Change in EDSS score.
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Analysis 1.4

Comparison 1 Alemtuzumab 12 mg versus interferon beta‐1a, Outcome 4 Change in EDSS score.

Comparison 1 Alemtuzumab 12 mg versus interferon beta‐1a, Outcome 5 Number of participants with new or enlarging T2‐hyperintense lesions.
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Analysis 1.5

Comparison 1 Alemtuzumab 12 mg versus interferon beta‐1a, Outcome 5 Number of participants with new or enlarging T2‐hyperintense lesions.

Comparison 1 Alemtuzumab 12 mg versus interferon beta‐1a, Outcome 6 Number of dropouts.
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Analysis 1.6

Comparison 1 Alemtuzumab 12 mg versus interferon beta‐1a, Outcome 6 Number of dropouts.

Summary of findings for the main comparison. Alemtuzumab 12 mg compared to interferon beta‐1a for multiple sclerosis

Alemtuzumab 12 mg compared to interferon beta‐1a for multiple sclerosis

Patient or population: patients with multiple sclerosis
Settings: outpatients
Intervention: alemtuzumab 12 mg
Comparison: interferon beta‐1a

Outcomes

Illustrative comparative risks* (95% CI)

Relative effect
(95% CI)

No of participants
(studies)

Quality of the evidence
(GRADE)

Comments

Assumed risk

Corresponding risk

Interferon beta‐1a

Alemtuzumab 12 mg

Relapse‐free survival
Follow‐up: 24 months

Not estimated

Not estimated

HR 0.50

(0.41 to 0.60)

1248
(2 studies)

⊕⊕⊕⊝
moderate5

Sustained disease progression‐free survival
Follow‐up: 24 months

Not estimated

Not estimated

HR 0.62

(0.44 to 0.87)

1191
(2 studies)

⊕⊕⊕⊝
moderate2

Number of participants with at least one adverse event

Study population

RR 1.04
(1.01 to 1.06)

1248
(2 studies)

⊕⊕⊕⊝
moderate1

94 per 100

98 per 100
(95 to 100)

Moderate

94 per 100

98 per 100
(95 to 99)

Change in EDSS score
Follow‐up: 24 months

The mean change in EDSS score in the intervention groups was
0.2 lower
(0.6 lower to 0.2 higher)

1199
(2 studies)

⊕⊝⊝⊝
very low2,3

Number of participants with new or enlarging T2‐hyperintense lesions
Follow‐up: 24 months

69 per 100

51 per 100
(41 to 63)

RR 0.74
(0.59 to 0.91)

1238
(2 studies)

⊕⊕⊕⊝
moderate4

Dropouts
Follow‐up: 24 months

Study population

RR 0.31
(0.23 to 0.41)

1248
(2 studies)

⊕⊕⊝⊝
low1,5

24 per 100

8 per 100
(6 to 10)

Moderate

24 per 100

7 per 100
(5 to 10)

*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; HR: hazard 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.

1Participants and personnel were not blinded and this outcome could be affected by this fact.
2Participants, personnel and outcome assessors were not blinded and this outcome could be affected by this fact.
3High heterogeneity; I2 = 88%.
4High heterogeneity; I2 = 80%.
5Low number of events (fewer than 300).

Figures and Tables -
Summary of findings for the main comparison. Alemtuzumab 12 mg compared to interferon beta‐1a for multiple sclerosis
Comparison 1. Alemtuzumab 12 mg versus interferon beta‐1a

Outcome or subgroup title

No. of studies

No. of participants

Statistical method

Effect size

1 Relapse‐free survival Show forest plot

2

Hazard Ratio (Fixed, 95% CI)

Subtotals only

1.1 24‐month analysis

2

Hazard Ratio (Fixed, 95% CI)

0.50 [0.41, 0.60]

2 Sustained disease progression‐free survival Show forest plot

3

Hazard Ratio (Fixed, 95% CI)

Subtotals only

2.1 24‐month analysis

2

Hazard Ratio (Fixed, 95% CI)

0.62 [0.44, 0.87]

2.2 36‐month analysis

1

Hazard Ratio (Fixed, 95% CI)

0.25 [0.11, 0.57]

3 Number of participants with at least one adverse event Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

3.1 24‐month analysis

2

1248

Risk Ratio (M‐H, Fixed, 95% CI)

1.04 [1.01, 1.06]

3.2 36‐month analysis

1

224

Risk Ratio (M‐H, Fixed, 95% CI)

1.0 [0.98, 1.02]

4 Change in EDSS score Show forest plot

3

Mean Difference (IV, Random, 95% CI)

Subtotals only

4.1 24‐month analysis

2

1199

Mean Difference (IV, Random, 95% CI)

‐0.20 [‐0.60, 0.20]

4.2 36‐month analysis

1

223

Mean Difference (IV, Random, 95% CI)

‐0.7 [‐1.04, ‐0.36]

5 Number of participants with new or enlarging T2‐hyperintense lesions Show forest plot

2

1238

Risk Ratio (M‐H, Random, 95% CI)

0.74 [0.59, 0.91]

6 Number of dropouts Show forest plot

3

Risk Ratio (M‐H, Fixed, 95% CI)

Subtotals only

6.1 24‐months analysis

2

1248

Risk Ratio (M‐H, Fixed, 95% CI)

0.31 [0.23, 0.41]

6.2 36‐months analysis

1

224

Risk Ratio (M‐H, Fixed, 95% CI)

0.81 [0.57, 1.14]

Figures and Tables -
Comparison 1. Alemtuzumab 12 mg versus interferon beta‐1a