Median time and time to the 25th percentile to initial and continued pain improvement from baseline in patients with PsA receiving tofacitinib 5 mg BID or placebo-to-tofacitinib 5 mg BID (pooled across OPAL Broaden and OPAL Beyond); tofacitinib 5 mg BID, placebo-to-tofacitinib 5 mg BID or adalimumab 40 mg Q2W (OPAL Broaden only)
| Pooled across OPAL Broaden and OPAL Beyond | OPAL Broaden | |||||||
| Tofacitinib 5 mg BID (N=236) | Placebo→tofacitinib 5 mg BID at month 3 (N=118) | Log-rank test, p value* | Tofacitinib 5 mg BID (N=107) | Adalimumab 40 mg Q2W (N=105) | Placebo→tofacitinib 5 mg BID at month 3 (N=52) | Log-rank test, p value (tofacitinib)* | Log-rank test, p value (adalimumab)* | |
| Time to ≥30% pain improvement, days (95% CI) | ||||||||
| Initial improvement | ||||||||
| Median | 55.0 (29.0 to 57.0) | 106.0 (64.0 to 115.0) | 0.0132 | 57.0 (29.0 to 57.0) | 29.0 (17.0 to 57.0) | 113.0 (57.0 to 169.0) | 0.0465 | 0.011 |
| 25th percentile | 15.0 (15.0 to 16.0) | 29.0 (15.0 to 37.0) | 15.0 (15.0 to 28.0) | 15.0 (NE) | 19.0 (15.0 to 57.0) | |||
| Continued improvement | ||||||||
| Median | 60.0 (57.0 to 85.0) | 126.0 (113.0 to 173.0) | 0.0067 | 64.0 (57.0 to 113.0) | 57.0 (29.0 to 85.0) | 168.0 (112.0 to 252.0) | 0.1791 | 0.045 |
| 25th percentile | 16.0 (15.0 to 28.0) | 58.0 (29.0 to 106.0) | 18.0 (15.0 to 33.0) | 15.0 (15.0 to 17.0) | 47.0 (15.0 to 112.0) | |||
| Time to ≥50% pain improvement, days (95% CI) | ||||||||
| Initial improvement | ||||||||
| Median | 85.0 (57.0 to 92.0) | 169.0 (120.0 to 189.0) | 0.0068 | 64.0 (57.0 to 92.0) | 57.0 (29.0 to 157.0) | 171.0 (113.0 to 253.0) | 0.0328 | 0.1028 |
| 25th percentile | 29.0 (27.0 to 31.0) | 57.0 (29.0 to 106.0) | 29 (20.0 to 31.0) | 26 (15.0 to 29.0) | 57 (15.0 to 113.0) | |||
| Continued improvement | ||||||||
| Median | 171.0 (90.0–NE) | NE (247.0–NE) | 0.005 | 176.0 (85.0–NE) | 169.0 (60.0–NE) | 253.0 (169.0–NE) | 0.2892 | 0.1991 |
| 25th percentile | 51.0 (29.0 to 57.0) | 115.0 (88.0 to 169.0) | 56.0 (28.5 to 58.0) | 29.0 (15.0 to 56.0) | 113.0 (29.0 to 169.0) | |||
Median time to initial/continued improvement was estimated via a non-parametric Kaplan-Meier method.
‘Initial’ improvement was defined as the first post-baseline day with a pain improvement of ≥30% or ≥50% relative to baseline. ‘Continued’ improvement was defined as the first post-baseline visit where there was pain improvement of ≥30% or ≥50% relative to baseline that was maintained up to the next visit (ie, two consecutive observations).
*Versus placebo switching to tofacitinib 5 mg BID at month 3.
BID, twice daily; N, total number of patients in that group; NE, not estimable, as the time was beyond duration of the study; PsA, psoriatic arthritis; Q2W, once every 2 weeks.