Table 4.
Neuroradiological efficacy of daclizumab 150 mg given subcutaneously every 4 weeks in multicenter, randomized, double-blind, comparative studies of patients with RMS41,42
| Parameter | SELECT (week 52 data) | DECIDE (week 96 data) | ||
|---|---|---|---|---|
|
| ||||
| Placebo n=196 | Daclizumab 150 mg n=201 | IM IFN beta-1a n=922 | Daclizumab 150 mg n=919 | |
| New Gd+ lesions | ||||
| n | 195 | 199 | — | — |
| Mean (SD) | 1.4 (2.3) | 0.3 (0.9) | — | — |
| Odds ratio (95% CI); P-value | — | 0.15 (0.09–0.25); P<0.0001 | — | — |
| Gd+ lesions | ||||
| n | — | — | 909 | 900 |
| Mean (SD) | — | — | 1.0 (2.8) | 0.4 (1.4) |
| Odds ratio (95% CI); P-value | — | — | — | 0.25 (0.20–0.32); P<0.001 |
| New or newly enlarging T2 hyperintense lesions | ||||
| n | 195 | 199 | 841 | 864 |
| Mean (95% CI) | 8.1 (6.7–9.9) | 2.4 (2.0–3.0) | 9.4 (8.5–10.5) | 4.3 (3.9–4.8) |
| Reduction, %; P-value | — | 70 (59.4–77.9); P <0.0001 | — | 54 (47–61); P<0.001 |
| New T1 hypointense lesions | ||||
| n | — | — | 908 | 899 |
| Mean (95% CI) | — | — | 4.4 (4.1–4.8) | 2.1 (1.9–2.4) |
| Reduction, %; P-value | — | — | — | 52 (45–58); P<0.001 |
| % change from baseline in T2 hyperintense lesion volume | ||||
| n | 193 | 198 | 908 | 899 |
| Mean (SD); P-value | 27.3 (107.8) | –11.1 (12.1); P<0.0001 | 8.6a | 0.2a; P<0.001 |
| % change from baseline in T1 hypointense lesion volume | ||||
| n | 180 | 187 | 886 | 881 |
| Mean (SD); P-value | 18.0 (110.4) | –10.5 (25.7); P<0.0001 | 33.4a | 22.8a; P<0.001 |
| % mean change from baseline in whole brain volume | ||||
| n | 194 | 198 | 907 | 899 |
| Mean (SD); P-value | –0.74 (0.90) | –0.79 (0.83); P=0.33 | –0.585a | –0.559a; P<0.001 |
Notes: Results are presented for patients in the efficacy analysis population who had a post-baseline scan.41,42 Results from the daclizumab 300 mg treatment arm have been reported,41 but are not included in this table comparing efficacy outcomes of the 150 mg dose.
SD not reported. In both the DECIDE and SELECT studies, between treatment group differences were evaluated using ordinal logistic regression models (new Gd+/Gd+ lesions), negative binomial regression models (new or newly enlarging T2 lesions, new T1 hypointense lesions), or analysis of covariance model based on ranks (T2 hyperintense and T1 hypointense lesion volume, whole brain volume). Each of the models included adjustments for baseline factors. The statistical models are detailed in the original articles.41,42 SELECT data adapted with permission from Elsevier (The Lancet, 2013, 381, 2167–75).
Abbreviations: RMS, relapsing multiple sclerosis; IM, intramuscular; IFN, interferon; Gd+, gadolinium-enhancing; SD, standard deviation; CI, confidence interval.