Alemtuzumab for the treatment of multiple sclerosis

Figures & data

Table 1 Clinical outcomes and adverse events of alemtuzumab treated patients in Phase II (CAMMS223) and Phase III (CARE-MSI and II) clinical trials

	CAMMS223^Citation10	CARE-MSI (treatment-naïve)^Citation20	CARE-MSII (previous treatment)^Citation19
	All patients		12-mg group only
Number of alemtuzumab treated patients	222	376	426
Follow-up (years)	3	2	2
Relapse rate reduction (alemtuzumab vs interferon beta-1a), %	74 (P<0.001)	55 (P<0.0001)	49 (P<0.0001)
Annualized relapse rate (alemtuzumab vs interferon beta-1a)	0.10 vs 0.36	0.18 vs 0.39	0.26 vs 0.52
% patients with 6-month SAD	9 vs 26 (P<0.01)	8 vs 11 (not significant)	13 vs 21 (P<0.01)
Change in mean EDSS from baseline	Improvement of 0.39 compared with deterioration of 0.38 on Interferon beta-1a (P<0.01)	No significant change	Improvement of 0.17 compared with deterioration of 0.24 on interferon beta-1a (P<0.0001)
Deaths	1 (ITP), 1 (myocardial infarction)	1 (RTA)	1 (RTA), 1 (aspiration pneumonia)
Autoimmunity
Thyroid	26%	18%	17%
ITP	0.9%	0.8%	1%
Goodpasture’s syndrome	0	1	0
Neoplasia (alemtuzumab vs interferon beta-1a), %	2.8 vs 0.9	0.5 vs 0	0.6 vs 1.5

Note: Copyright © 2013. Adapted from Thieme. Coles AJ. Alemtuzumab treatment of multiple sclerosis. Semin Neurol. 2013;33(1):66–73. © Georg Thieme Verlag KG.²⁹

Abbreviations: SAD, sustained accumulation of disability; RTA, road traffic accident; EDSS, expanded disability status score; ITP, idiopathic thrombocytopenia purpura.

Table 2 Clinical outcomes and adverse events of alemtuzumab treated patients in two open-label cohorts

	Cambridge open-label long-term follow-up cohort^Citation54	Cardiff regional cohort^Citation55
Patient number	87	96
Follow-up (years)	7 (median)	5 (mean)
Relapse rate reduction from baseline	91%	81%
% patients with 6-month SAD	32	Not analyzed
Change in mean EDSS from baseline	−0.2	+0.44
Deaths	0	1 (cerebrovascular disease)
Autoimmunity
Thyroid	41%	31%
ITP	3.5%	3%
Goodpasture’s syndrome	1	0
Neoplasia	0 (1 Castleman’s disease)	2 (basal cell carcinoma, meningioma)

Abbreviations: SAD, sustained accumulation of disability; EDSS, expanded disability status score; ITP, idiopathic thrombocytopenia purpura.

Table 3 Monitoring guidelines

Monitoring test	Monitoring interval	Duration
Complete blood count	Prior to treatment initiation and at monthly intervals thereafter	For 48 months following last treatment course
Serum creatinine	Prior to treatment initiation and at monthly intervals thereafter	For 48 months following last treatment course
Urinalysis with microscopy	Prior to treatment initiation and at monthly intervals thereafter	For 48 months following last treatment course
Thyroid function tests	Prior to treatment initiation and every 3 months thereafter	For 48 months following last treatment course
Skin examination	Prior to treatment and yearly thereafter	No guidance on duration

Table 4 Worldwide licensing agreements for alemtuzumab

Country	Licensing agency	Date licensed	Indication
Argentina^Citation70	National Administration of Drugs, Food and Medical Technology (ANMAT)	June 2014	Relapsing MS Active disease defined by clinical or imaging features
Australia^Citation13	Therapeutic Goods Administration (TGA)	December 2013	Relapsing MS Active disease defined by clinical or imaging features
Brazil^Citation14	National Health Surveillance Agency (ANVISA)	March 2014	Relapsing MS
Canada^Citation12	Health Canada	December 2013	Relapsing-remitting MS Active disease defined by clinical and imaging features plus an inadequate response to interferon beta or DMTs
England and Wales^Citation16	National Institute for Health and Care Excellence (NICE)	April 2014	Active relapsing-remitting MS
Europe^Citation11	European Medicines Agency (EMA)	September 2013	Relapsing-remitting MS Active disease defined by clinical or imaging features
Mexico^Citation15	Federal Commission for Protection against Sanitary Risks (COFEPRIS)	February 2014	Relapsing-remitting MS
Scotland^Citation71	Scottish Medicines Consortium (SMC)	July 2014	Relapsing-remitting MS Active disease defined by clinical or imaging features
USA^Citation17	US Food and Drug Administration (FDA)	November 2014	Relapsing MS plus an inadequate response to two or more DMTs

Abbreviations: MS, multiple sclerosis; DMTs, disease modifying therapies.

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