Table 6.
Impact of patient population and use of central-read vs local-read endoscopy on efficacy outcomes in OCTAVE Sustain.
| OCTAVE Sustain | ||||||
|---|---|---|---|---|---|---|
| Central-read endoscopy, anti-TNF-naïve and anti-TNF-experienced patients | Local-read endoscopy, anti-TNF-naïve populationa | |||||
| Placebo | Tofacitinib 5 mg BID | Difference [95% CI] | Placebo | Tofacitinib 5 mg BID | Difference [95% CI] | |
| [N = 198] | [N = 198] | [N = 106] | [N = 108] | |||
| Remission at Week 52, n [%] | 22 [11.1] | 68 [34.3] | 23.2*** [15.3–31.2] | 14 [13.2] | 51 [47.2] | 34.0*** [22.6–45.4] |
| Clinical remission at Week 52, n [%] | 22 [11.1] | 68 [34.3] | 23.2*** [15.3–31.2] | 14 [13.2] | 52 [48.1] | 34.9*** [23.5–46.4] |
| Mucosal healing at Week 52, n [%] | 26 [13.1] | 74 [37.4] | 24.2*** [16.0–32.5] | 17 [16.0] | 53 [49.1] | 33.0*** [21.3–44.8] |
| Clinical response at Week 52, n [%] | 40 [20.2] | 102 [51.5] | 31.3*** [22.4–40.2] | 26 [24.5] | 60 [55.6] | 31.0*** [18.6–43.5] |
| Placebo | Tofacitinib 10 mg BID | Difference [95% CI] | Placebo | Tofacitinib 10 mg BID | Difference [95% CI] | |
| [N = 198] | [N = 197] | [N = 106] | [N = 96] | |||
| Remission at Week 52, n [%] | 22 [11.1] | 80 [40.6] | 29.5*** [21.4–37.6] | 14 [13.2] | 48 [50.0] | 36.8*** [24.9–48.7] |
| Clinical remission at Week 52, n [%] | 22 [11.1] | 81 [41.1] | 30.0*** [21.9–38.2] | 14 [13.2] | 49 [51.0] | 37.8*** [25.9–49.7] |
| Mucosal healing at Week 52, n [%] | 26 [13.1] | 90 [45.7] | 32.6*** [24.2–41.0] | 17 [16.0] | 54 [56.3] | 40.2*** [28.1–52.3] |
| Clinical response at Week 52, n [%] | 40 [20.2] | 122 [61.9] | 41.7*** [32.9–50.5] | 26 [24.5] | 63 [65.6] | 41.1*** [28.6–53.6] |
***p < 0.0001 vs placebo. Data are full analysis set with non-responder imputation.
aBased on data from baseline of induction studies.
BID, twice daily; CI, confidence interval; N, number of evaluable patients; n, number of patients with efficacy response; TNF, tumour necrosis factor.