Table 2.
Clinical endpoints at 2 years across ethnic subgroups (integrated analysis of DEFINE and CONFIRM)
| Endpoint | Black patientsa | Hispanic patientsa | Asian patientsb | ITT populationb | ||||
|---|---|---|---|---|---|---|---|---|
| Placebo (n = 19) | DMFc (n = 10) | Placebo (n = 23) | DMFc (n = 31) | Placebo (n = 70) | DMFc (n = 66) | Placebo (n = 771) | DMFc (n = 769) | |
| ARR | ||||||||
| Adjusted relapse rate (95% CI) | 0.27 (0.13–0.55) | 0.01 (0.00–0.29) | 0.49 (0.14–1.68) | 0.15 (0.04–0.56) | 0.21 (0.05–0.93) | 0.14 (0.03–0.66) | 0.37 (0.33–0.42) | 0.19 (0.16–0.22) |
| Rate ratio vs. placebo (95% CI) | 0.05 (0.00–1.07) | 0.31 (0.10–0.95) | 0.64 (0.30–1.34) | 0.52 (0.43–0.62)d | ||||
| PPR | ||||||||
| Estimated proportion relapsed, % | 38 | 0 | 34 | 18 | 40 | 28 | 44 | 28 |
| Hazard ratio vs. placebo (95% CI) | 0.07 (0.00–0.33) | 0.55 (0.07–1.28) | 0.66 (0.35–1.24) | 0.57 (0.48–0.69)d | ||||
| Disability progression | ||||||||
| Estimated proportion with CDP at 12 weeks, % | 57 | 43 | 30 | 8 | 25 | 20 | 22 | 15 |
| Hazard ratio vs. placebo (95% CI) | 0.53 (0.02–1.39) | 0.17 (0.00–0.60)e | 0.71 (0.32–1.58) | 0.68 (0.52–0.88)f | ||||
ARR annualized relapse rate, CDP confirmed disability progression, CI confidence interval, PPR proportion of patients relapsed
aARR, PPR, and proportion with CDP analyzed using Bayesian methodology (CI denotes credible interval)
bARR, PPR, and proportion with CDP analyzed using classical methodology (CI denotes confidence interval)
cDMF denotes delayed-release dimethyl fumarate (DMF; also known as gastro-resistant DMF)
d p < 0.001
eLower CI value was rounded to zero
f p < 0.005