Table 2.
ARR and relative risk of severe a relapses at Month 6, Year 1 and Year 2 in patients treated with cladribine tablets 3.5 mg/kg versus placebo in CLARITY.
| Time | Relapses requiring: | |||
|---|---|---|---|---|
| Steroid treatment | Hospitalisation | |||
| Placebo | Cladribine tablets 3.5 mg/kg | Placebo | Cladribine tablets 3.5 mg/kg | |
| Qualifying relapses | ||||
| Month 6 | ||||
| ARR (95% CI) | 0.38 (0.30; 0.48) | 0.15 (0.11; 0.22) | 0.23 (0.17; 0.31) | 0.10 (0.06; 0.16) |
| RR (95% CI) | – | 0.40 (0.26; 0.61) | – | 0.43 (0.25; 0.74) |
| p-value | – | <0.0001 | – | 0.0024 |
| Year 1 | ||||
| ARR (95% CI) | 0.32 (0.27; 0.39) | 0.15 (0.11; 0.19) | 0.18 (0.14; 0.22) | 0.08 (0.06; 0.12) |
| RR (95% CI) | – | 0.45 (0.33; 0.62) | – | 0.46 (0.30; 0.70) |
| p-value | – | <0.0001 | – | 0.0004 |
| Year 2 | ||||
| ARR (95% CI) | 0.28 (0.25; 0.32) | 0.12 (0.09; 0.14) | 0.16 (0.13; 0.19) | 0.06 (0.05; 0.09) |
| RR (95% CI) | – | 0.41 (0.32; 0.53) | – | 0.41 (0.29; 0.57) |
| p-value | – | <0.0001 | – | <0.0001 |
| All relapses | ||||
| Month 6 | ||||
| ARR (95% CI) | 0.61 (0.51; 0.73) | 0.26 (0.20; 0.35) | 0.35 (0.27; 0.44) | 0.15 (0.11; 0.22) |
| RR (95% CI) | – | 0.43 (0.31; 0.60) | – | 0.44 (0.29; 0.68) |
| p-value | – | <0.0001 | – | 0.0002 |
| Year 1 | ||||
| ARR (95% CI) | 0.55 (0.48; 0.63) | 0.23 (0.19; 0.28) | 0.30 (0.25; 0.36) | 0.13 (0.09; 0.17) |
| RR (95% CI) | – | 0.41 (0.32; 0.53) | – | 0.42 (0.30; 0.59) |
| p-value | – | <0.0001 | – | <0.0001 |
| Year 2 | ||||
| ARR (95% CI) | 0.50 (0.45; 0.55) | 0.19 (0.16; 0.22) | 0.27 (0.24; 0.31) | 0.10 (0.08; 0.13) |
| RR (95% CI) | – | 0.38 (0.31; 0.46) | – | 0.37 (0.29; 0.48) |
| p-value | – | <0.0001 | – | <0.0001 |
ARR: annualised relapse rate; CI: confidence interval; RR: relative risk.
The p-values indicate statistical differences between the cladribine tablets 3.5 mg/kg and placebo groups.
a
Resulting in need for steroid treatment or hospitalisation.