Table 1.

Alemtuzumab clinical trial program

CAMMS223a [2, 9, 14]		CARE-MS I [2, 11, 14]		CARE-MS IIa [2, 12, 14]
Patients with active RRMS who were treatment naïve				Patients with active RRMS who relapsed on prior DMT
Study duration: 3 years		Study duration: 2 years		Study duration: 2 years
SC IFNβ-1a (44 µg TIW) N = 111	Alemtuzumab (12 mg/day) N = 112	SC IFNβ-1a (44 µg TIW) N = 187	Alemtuzumab (12 mg/day) N = 376	SC IFNβ-1a (44 µg TIW) N = 202	Alemtuzumab (12 mg/day) N = 426
MRI criteria: diagnosis per McDonald 2001 criteria, including brain MRI; ≥1 Gd+ lesion on any of ≤4 brain scans during ≤3-month run-in period (including baseline scan)		MRI criteria: diagnosis per McDonald 2005 criteria; brain MRI scan demonstrating white matter lesions attributable to MS (within 5 years of screening)		MRI criteria: diagnosis per McDonald 2005 criteria; white matter lesions attributable to MS and at least one of the following: ≥9 T2 lesions ≥3 mm, any axis; a Gd+ lesion ≥3 mm, any axis, with ≥1 brain T2 lesion; spinal cord lesion with ≥1 brain T2 lesion
Active MS: ≥2 relapses in the prior 2 years and ≥1 Gd+ MRI lesion at screening		Active MS: ≥2 relapses in the prior 2 years, with ≥1 relapse occurring in the year prior to study entry		Active MS: ≥2 relapses in the prior 2 years, with ≥1 relapse occurring in the year prior to study entry and ≥1 relapse occurring during prior treatmentb
Mean age: 32 years		Mean age: 33 years		Mean age: 35 years
EDSS range: 0.0–3.0 (mean 2.0)c		EDSS range: 0.0–3.0 (mean 2.0)d		EDSS range: 0.0–5.0 (mean 2.7)d
Mean/median time since first MS episode: 1.4/1.3 years		Mean/median time since first MS episode: 2.0/1.6 years		Mean/median time since first MS episode: 4.5/3.8 years

Retreatment criteria for CAMMS223 (Sanofi Genzyme, data on file) and CARE-MS extensions [15]: ≥1 relapse or ≥2 new or enlarging T₂ and/or Gd⁺ brain or spinal lesions, ≥12 months since the second alemtuzumab course

DMT disease-modifying therapy, EDSS Expanded Disability Status Scale, Gd ⁺ gadolinium-enhancing, IFN interferon, MRI magnetic resonance imaging, MS multiple sclerosis, RRMS relapsing-remitting multiple sclerosis, SC subcutaneous, TIW three times per week

^aA 24-mg/day treatment arm was included in these studies

^bTreatment with IFNβ or glatiramer acetate for ≥6 months

^cAt screening and baseline visits

^dAt screening