STUDY 4: O’Connor et al. (2009)4
Randomized, parallel-group, multicenter, phase 3 study |
Patients |
Treatment arms/study duration |
n=2244
(RRMS)
|
- GA, 20 mg daily; n=448
- IFNβ-1b, 0.25 or 0.5 mg every other day; n=897
- Clinical outcomes were assessed quarterly for
2.0-3.5 years
|
Primary endpoint: Relapse risk, defined as new or recurrent neurological symptoms separated by at least 30
days from the preceding event and that lasted at least 24 h. It was assessed by the Andersen–Gill model for
time to recurring events, which includes correction for the interdependency of multiple event.
Results
- There were no differences between interferon beta-1b and Glatiramer Acetate with respect to
relapse risk
Table: Outcome variables and relapse risk
|
500 µg IFNB-1b vs |
250 µg IFNB-1b vs |
|
Glatiramer Acetate |
Glatiramer Acetate |
| HR (95%CI) |
p* |
HR (95%CI) |
p* |
Primary analysis (unadjusted) |
0.98 (0.82-1.18) |
0.43 |
1.06 (0.89-1.26) |
0.73 |
With covariate adjustment† |
1.00 (0.83-1.19) |
0.48 |
1.06 (0.89-1.27) |
0.74 |
Per-protocol analysis A‡ |
1.00 (0.83-1.20) |
0.50 |
1.06 (0.89-1.27) |
0.74 |
Per-protocol analysis B§ |
0.91 (0.74-1.11) |
0.18 |
0.95 (0.78-1.15) |
0.80 |
IFNB-1b=interferon beta-1b. EDSS=expanded disability status sales. *One-sided p value. †Pre-planned,
excluding observation time after a major protocol violation or a 3-months interval in which less than
50% of study drug was taken. ‡Baseline covariates: sex, age, disease duration, EDSS, number of
relapses in previous year, numbers of gadolinium-enhancing lesion, and T2 lesion volume. §Post-hoc,
excluding observation time after a major protocol violation or a 3-month interval in which less than
100% of drug dose was taken.
Both doses had similar clinical effects to Glatiramer Acetate. Although a difference in the adverse event
profiles of interferon beta-1b and Glatiramer Acetate was observed, the overall tolerability to both drugs was
similar.4