Table 1.
Baseline characteristics and efficacy endpoints (SELECT-COMPARE/SELECT-NEXT)
| Time point | Key endpoints | csDMARD-IR (SELECT-COMPARE and SELECT-NEXT integrated analysis) |
|||
|---|---|---|---|---|---|
| Moderate |
Severe |
||||
| UPA 15mg (n = 209) | Placebo (n = 195) | UPA 15 mg (n = 649) | Placebo (n = 671) | ||
| Baseline | Age, mean (s.d.), years | 53.7 (12.6) | 54.5 (12.4) | 54.9 (11.6) | 54.1 (12.3) |
| Female, n (%) | 161 (77.0) | 157 (80.5) | 529 (81.5) | 517 (77.0) | |
| Duration since diagnosis, mean (s.d.), years | 7.5 (7.4) | 7.3 (6.7) | 8.0 (7.9) | 8.2 (8.2) | |
| DAS28(CRP), mean (s.d.) | 4.6 (0.4) | 4.6 (0.4) | 6.2 (0.7) | 6.1 (0.7) | |
| HAQ-DI, mean (s.d.) | 1.2 (0.6) | 1.2 (0.6) | 1.7 (0.6) | 1.7 (0.6) | |
| Pain VAS (0–100), mean (s.d.) | 52.5 (21.4) | 48.4 (21.6) | 69.8 (18.2) | 68.9 (17.9) | |
| mTSS, mean (s.d.) | 34.295 (48.662) (n = 144) | 29.952 (45.085) (n = 125) | 34.369 (50.805) (n = 492) | 37.431 (53.254) (n = 518) | |
| Week 12 | ACR20, % response (95% CI) | 63.6 (57.1, 70.2)*** | 33.8 (27.2, 40.5) | 71.2 (67.7, 74.7)*** | 37.0 (33.3, 40.6) |
| ACR50, % response (95% CI) | 41.6 (34.9, 48.3)*** | 14.4 (9.4,19.3) | 44.1 (40.2, 47.9)*** | 15.1 (12.3, 17.8) | |
| ACR70, % response (95% CI) | 21.5 (16.0, 27.1)*** | 4.1 (1.3, 6.9) | 24.7 (21.3, 28.0)*** | 5.5 (3.8, 7.2) | |
| DAS28(CRP) ≤ 3.2, % response (95% CI) | 61.7 (55.1, 68.3)*** | 28.7 (22.4, 35.1) | 40.7 (36.9, 44.5)*** | 10.3 (8.0, 12.6) | |
| DAS28(CRP) < 2.6, % response (95% CI) | 41.1 (34.5, 47.8)*** | 14.9 (9.9, 19.9) | 25.1 (21.8, 28.5)*** | 4.6 (3.0, 6.2) | |
| ΔDAS28(CRP), mean (95% CI) | −1.817 (−2.000, −1.634)*** | −0.779 (−0.966, −0.592) | −2.546 (−2.671, −2.422)*** | −1.175 (−1.296, −1.054) | |
| ΔHAQ-DI, mean (95% CI) | −0.43 (−0.51, −0.35 [n = 191])*** | −0.23 (−0.32, −0.15 [n = 183]) | −0.67 (−0.72, −0.61 [n = 622])*** | −0.31 (−0.36, −0.25 [n = 635]) | |
| ΔPain VAS (0–100), mean (95% CI) | −25.0 (−28.6, −21.4 [n = 191])*** | −6.9 (−10.6, −3.2 [n = 183]) | −32.8 (−35.1, −30.5 [n = 624])*** | −16.1 (−18.4, −13.8 [n = 635]) | |
| Week 26 (SELECT-COMPARE only) | ΔmTSS ≤0, % response (95% CI)] | 89.8 (84.6, 95.1 [n = 128]) | 83.3 (76.5, 90.2 [n = 114]) | 81.6 (78.1, 85.2 [n = 457])** | 73.9 (70.0, 77.8 [n = 479]) |
| Δ mTSS [mean (95% CI) | −0.166 (−0.394, 0.061 [n = 128])* | 0.128 (−0.099, 0.354 [n = 114]) | 0.362 (0.001, 0.722 [n = 457])*** | 1.130 (0.778, 1.482 [n = 479]) | |
Where scores were not available for all patients in that group, the total number of patients included in the analysis [n] is specified.
*
Nominal P < 0.05,
**
nominal P < 0.01 and
***
nominal P < 0.001 for comparison of UPA vs placebo (continued conventional synthetic DMARD).
Δ: change from baseline; ACR20: ACR response criteria; csDMARD-IR: inadequate response to prior conventional synthetic DMARD; DAS28: 28-joint count DAS; HAQ-DI: HAQ disability index; mTSS: modified total sharp score; UPA: upadacitinib.