Table 2.
Baseline characteristics and efficacy endpoints (SELECT-MONOTHERAPY)
| Time point | Key endpoints | csDMARD-IR (SELECT-MONOTHERAPY) |
|||
|---|---|---|---|---|---|
| Moderate |
Severe |
||||
| UPA 15mg (n = 72) | Placebo (n = 73) | UPA 15 mg (n = 144) | Placebo (n = 143) | ||
| Baseline | Age, mean (s.d.), years | 52.7 (14.1) | 54.3 (11.5) | 55.4 (11.1) | 55.8 (10.9) |
| Female, n (%) | 53 (73.6) | 59 (80.8) | 120 (83.3) | 120 (83.9) | |
| Duration since diagnosis, mean (s.d.), years | 5.1 (5.0) | 5.9 (7.1) | 8.6 (10.1) | 5.8 (6.4) | |
| DAS28(CRP), mean (s.d.) | 4.6 (0.4) | 4.5 (0.5) | 6.1 (0.7) | 6.2 (0.7) | |
| HAQ-DI, mean (s.d.) | 1.1 (0.6) | 1.1 (0.6) | 1.7 (0.6) | 1.7 (0.6) | |
| Week 14 | ACR20, % response (95% CI) | 59.7 (48.4, 71.1)** | 37.0 (25.9, 48.1) | 72.2 (64.9, 79.5)*** | 43.4 (35.2, 51.5) |
| DAS28(CRP) ≤ 3.2, % response (95% CI) | 59.7 (48.4, 71.1)** | 32.9 (22.1, 43.7) | 36.8 (28.9, 44.7)*** | 12.6 (7.2, 18.0) | |
| DAS28(CRP) < 2.6, % response (95% CI) | 40.3 (28.9, 51.6)*** | 15.1 (6.9, 23.3) | 22.2 (15.4, 29.0)*** | 4.9 (1.4, 8.4) | |
| ΔDAS28(CRP), mean (95% CI) | −1.79 (−2.09, −1.49 [n = 65])*** | −0.78 (−1.09, −0.47 [n = 64]) | −2.55 (−2.80, −2.31 [n = 131])*** | −1.46 (−1.70, −1.22 [n = 130]) | |
| ΔHAQ-DI, mean (95% CI) | −0.47 (−0.59, −0.36 [n = 65])** | −0.22 (−0.34, −0.11 [n = 65]) | −0.74 (−0.85, −0.63 [n = 133])*** | −0.37 (−0.48, −0.25 [n = 130]) | |
Where scores were not available for all patients in that group, the total number of patients included in the analysis [n] is specified. Pain VAS scores were not available for SELECT-MONOTHERAPY.
*
Nominal P < 0.05,
**
nominal P < 0.01 and
***
nominal P < 0.001 for comparison of UPA vs placebo (continued MTX).
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; UPA: upadacitinib.