Table 1.
Key efficacy results from the CLARITY and CLARITY Extension trials (licensed dose only)
| Key efficacy parameters | CLARITYa | CLARITY Extensiona | ||
|---|---|---|---|---|
| Cladribine tablets 3.5 mg/kg | Placebo | CP 3.5 mg/kg | PC 3.5 mg/kg | |
| Annualized relapse rate (CI)b,c | 0.14 (0.12–0.17) | 0.33 (0.29–0.38) | 0.15 (0.09–0.21) | 0.10 (0.07–0.13) |
| Patients relapse free, n (%) | 345 (79.7) | 266 (60.9) | 68 (75.6) | 180 (79.6) |
| Lesion activity on brain MRI, mean number | ||||
| T1 Gd+ lesions | 0.12 | 0.91 | 0.28 | 0.07 |
| Active T2 lesions | 0.38 | 1.43 | 1.42 | 1.07 |
| Combined unique lesions | 0.43 | 1.72 | NR | NR |
CI Confidence interval, CP cladribine tablets 3.5 mg/kg in CLARITY followed by placebo in CLARITY Extension, Gd+ gadolinium-enhancing, MRI magnetic resonance imaging, NR not reported, PC placebo in CLARITY followed by cladribine tablets 3.5 mg/kg in CLARITY Extension
aNon-approved cladribine tablets doses and regimens from CLARITY and CLARITY Extension are not shown
bA relapse was defined as an increase of 2 points in at least one functional system of the Expanded Disability Status Scale (EDSS) or an increase of 1 point in at least two functional systems (excluding changes in bowel or bladder function or cognition) in the absence of fever, to have lasted for at least 24 h and to have been preceded by at least 30 days of clinical stability or improvement
c95% confidence interval for CLARITY and 97.5% confidence interval in CLARITY Extension