Alemtuzumab for multiple sclerosis

Rachel Riera; Gustavo JM Porfírio; Maria R Torloni

doi:10.1002/14651858.CD011203.pub2

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Figure 1

Study flow diagram.

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Figure 2

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

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Figure 4

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

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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.

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Analysis 1.1

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

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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.

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Analysis 1.4

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

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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.

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Analysis 1.6

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

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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 low^2,3	—
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)	⊕⊕⊝⊝ low^1,5	—
	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).

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

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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]

Comparison 1. Alemtuzumab 12 mg versus interferon beta‐1a

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