Table 3.

CLARITY Extension efficacy [66]

	PC 3.5 mg/kg [n = 244]	Cladribine tablets 3.5 mg/kg		Cladribine tablets 5.25 mg/kg
		CP 3.5 mg/kg [n = 98]	CC 7.0 mg/kg [n = 186]	CP 5.25 mg/kg [n = 92]	CC 8.75 mg/kg [n = 186]
ARR (97.5% CI)	0.10 (0.07–0.13)	0.15 (0.09–0.21)	0.10 (0.06–0.13)	0.13 (0.08–0.19)	0.12 (0.08–0.16)
Proportion of patients qualifying relapse-free [n (%)]	180 (79.6)	68 (75.6)	134 (81.2)	61 (75.3)	132 (76.7)
Proportion of patients who remained free from 3-month CDP [n (%)]	185 (75.8)	71 (72.4)	144 (77.4)	72 (78.3)	142 (76.3)

Qualified relapses were defined as a ≥ 2-point increase in at least one functional system or a ≥ 1-point increase in at least two functional systems of the EDSS, excluding bladder/bowel or cognition changes, lasting ≥ 24 h, in the absence of fever, and preceded by ≥ 30 days of clinical stability or improvement. ARR adjusted for time on study only. Data are mean (SD), unless otherwise stated. The CLARITY Extension data in this table covers the 96-week double-blind period and the 24-week supplemental follow-up (including the bridge between periods)

ARR annualized relapse rate, CC 7 mg/kg cladribine tablets 3.5 mg/kg in CLARITY followed by cladribine tablets 3.5 mg/kg in CLARITY Extension, CC 8.75 mg/kg cladribine tablets 5.25 mg/kg in CLARITY followed by cladribine tablets 3.5 mg/kg in CLARITY Extension, CP 3.5 mg/kg cladribine tablets 3.5 mg/kg in CLARITY followed by placebo in CLARITY Extension, CP 5.25 mg/kg cladribine tablets 5.25 mg/kg in CLARITY followed by placebo in CLARITY Extension, CDP confirmed disability progression, CI confidence interval, EDSS Expanded Disability Status Scale, PC 3.5 mg/kg placebo in CLARITY followed by cladribine tablets 3.5 mg/kg in CLARITY Extension, SD standard deviation