Table 3. Primary Outcome of Annual Rate of Decline for Forced Vital Capacity (FVC) at Week 52 and at the End of the ISABELA 1 and ISABELA 2 Trials.
| Annual rate of decline for FVC | 600 mg of Ziritaxestat | 200 mg of Ziritaxestat | Placebo | Between-group difference (95% CI), mLa | ||||
|---|---|---|---|---|---|---|---|---|
| No. of patients | Least-squares mean (95% CI), mL |
No. of patients | Least-squares mean (95% CI), mL |
No. of patients | Least-squares mean (95% CI), mL |
600 mg of Ziritaxestat vs placebo |
200 mg of Ziritaxestat vs placebo |
|
| At 52 wk | ||||||||
| ISABELA 1 | 174 | −124.6 (−178.0 to −71.2) | 175 | −173.9 (−225.7 to −122.2) | 174 | −147.3 (−199.8 to −94.7) | 22.7 (−52.3 to 97.6) | −26.7 (−100.5 to 47.1) |
| ISABELA 2 | 259 | −173.8 (−209.2 to −138.4) | 260 | −174.9 (−209.5 to −140.2) | 258 | −176.6 (−211.4 to −141.8) | 2.8 (−46.9 to 52.4) | 1.7 (−47.4 to 50.8) |
| Pooled results (ISABELA 1 and 2) | 428 | −156.5 (−186.2 to −126.7) | 431 | −173.7 (−202.7 to −144.7) | 422 | −165.7 (−194.9 to −136.4) | 9.2 (−32.5 to 50.9) | −8.0 (−49.2 to 33.1) |
| At end of the trials (ISABELA 1 and 2) | ||||||||
| Pooled results | 428 | −161.0 (−187.4 to −134.5) | 431 | −174.4 (−200.0 to −148.7) | 422 | −169.0 (−195.0 to −143.0) | 8.0 (−29.0 to 45.1) | −5.4 (−41.9 to 31.1) |
| Pirfenidone | 151 | −194.3 (−238.2 to −150.3) | 154 | −217.9 (−259.5 to −176.3) | 149 | −189.0 (−231.6 to −146.3) | −5.3 (−66.6 to 56.0) | −29.0 (−88.6 to 30.6) |
| Nintedanib | 146 | −132.4 (−176.2 to −88.6) | 151 | −132.2 (−175.2 to −89.2) | 147 | −163.1 (−205.7 to −120.5) | 30.7 (−30.4 to 91.9) | 30.9 (−29.7 to 91.5) |
| Neither treatment | 131 | −155.1 (−204.8 to −105.3) | 126 | −168.4 (−217.5 to −119.3) | 126 | −149.1 (−199.5 to −98.6) | −6.0 (−76.9 to 64.9) | −19.3 (−89.7 to 51.1) |
a
A positive difference in values indicates that patients taking ziritaxestat deteriorate less than those taking placebo.