Table 2 Efficacy outcomes
RBX2660 (n = 142) | Historical control (n = 75) | |
|---|---|---|
Recurrence-free rates at 8 weeks post-treatment for evaluable population, % (n/total) | ||
Rate, % (n/total) | 79 (112/142) | 31 (23/75) |
Age | ||
≥ 65 years | 75 (63/84) | 20 (9/45) |
< 65 years | 85 (49/58) | 47 (14/30) |
Sex | ||
Female | 82 (72/88) | 33 (16 /48) |
Male | 74 (40/54) | 26 (7/27) |
Number of prior CDI episodes1 | ||
≤ 3 CDI episodes | 75 (54/72) | 33 (22/67) |
> 3 CDI episodes | 83 (58/70) | 20 (1/5) |
Laboratory test for enrollment1 | ||
PCR | 77 (73/95) | 31 (19/61) |
EIA | 81 (26/32) | 29 (2/7) |
Other2 | 87 (13/15) | 50 (2/4) |
Antibiotic at enrolling CDI episode1 | ||
Vancomycin | 79 (92/117) | 29 (13/45) |
Fidaxomicin | 50 (3/6) | 25 (1/4) |
Metronidazole | 100 (8/8) | 20 (1/5) |
Other3 | 82 (9/11) | 50 (9/18) |
Sustained CDI recurrence-free rates, % (n/total) | ||
6 months post-treatment | 97 (109/112) | NC |
12 months post-treatment | 95 (101/106) | NC |
24 months post-treatment | 91 (88/97) | NC |