Potential short-term use of oral cladribine in treatment of relapsing-remitting multiple sclerosis

Figures & data

Table 1 Secondary endpoints (intention-to-treat population)

Endpoint		Cladribine		Cladribine
	Placebo	3.5 mg/kg	P value	5.25 mg/kg	P value
	(n = 437)	(n = 433)		(n = 456)
Patients relapse-free	266	345	<0.001	360	<0.001
Time to sustained progression of disability (months)	10.8	13.6	0.02	13.6	0.03
Time to first relapse (months)	4.6	13.4	<0.001	13.3	<0.001
Patients requiring rescue therapy [n (%)]	27 (6.2%)	11 (2.5%)	0.01	9 (2.0%)	0.003
Magnetic resonance imaging endpoints
Gadolinium-enhancing T1 weighted lesions (mean)	0.91	0.12	<0.001	0.11	<0.001
Active T2 weighted lesions (mean)	1.43	0.38	<0.001	0.33	<0.001
Combined unique lesions (mean)	1.72	0.43	<0.001	0.38	<0.001

Table 2 Treatment-emergent adverse events

Adverse event		Cladribine (%)
	Placebo (%)	3.5 mg/kg	5.25 mg/kg	Combined doses
	(n = 435)	(n = 430)	(n = 454)	(n = 884)
Most common
Headache	75 (17.2)	104 (24.2)	94 (20.7)	198 (22.4)
Lymphocytopenia	8 (1.8)	93 (21.6)	143 (31.5)	236 (26.7)
Nasopharyngitis	56 (12.9)	62 (14.4)	58 (12.8)	120 (13.6)
Upper respiratory tract infection	42 (9.7)	54 (12.6)	52 (11.5)	106 (12)
Nausea	39 (9)	43 (10)	50 (11)	93 (10.5)
Any serious adverse event	28 (6.4)	36 (8.4)	41 (9)	77 (8.7)
Infections and infestations	7 (1.6)	10 (2.3)	13 (2.9)	23 (2.6)
Neoplasms	0	6 (1.4)	4 (0.9)	10 (1.1)
Death	2 (0.5)	2 (0.5)	2 (0.4)	4 (0.5)