Summary of efficacy and safety. Values are n or n (%) unless otherwise specified.
| Variables | Placebo | JNJ-40346527 100 mg Twice Daily | p |
|---|---|---|---|
| Efficacy endpoints among patients in the mITT population* | |||
| Improvement from baseline in DAS28-CRP at Week 12, primary endpoint | 31 | 61 | |
| Mean (SD) | 1.42 (1.187) | 1.15 (1.186) | 0.30** |
| Median (IQR) | 1.32 (0.50–2.29) | 0.99 (0.38–1.76) | |
| Major secondary endpoints | |||
| ACR20 response at Week 12 | 13/31 (41.9%) | 30/61 (49.2%) | 0.66*** |
| DAS28-CRP response at Week 12 | 20/31 (64.5%) | 34/61 (55.7%) | 0.50*** |
| Additional efficacy endpoints | |||
| Proportion of patients with HAQ-DI improvement ≥ 0.25 at Week 12 | 17/32 (53.1%) | 39/63 (61.9%) | 0.51*** |
| HAQ-DI improvement at Week 12 | 32 | 63 | |
| Mean (SD) | 0.27 (0.466) | 0.39 (0.579) | |
| Median (IQR) | 0.25 (−0.13–0.56) | 0.38 (0.13–0.63) | 0.21† |
| CRP % improvement at Week 12 | 32 | 63 | 0.35† |
| Mean (SD) | −60.22 (339.171) | −19.67 (117.571) | |
| Median (IQR) | 23.07 (−20.71–72.68) | 22.87 (−63.48–58.35) | |
| Summary of AE among treated patients | |||
| Patients treated, n | 32 | 63 | |
| Patients with AE‡ | 16 (50.0) | 37 (58.7) | — |
| Common AE, > 5% of patients | |||
| Blood lactate dehydrogenase increased | 1 (3.1) | 9 (14.3) | |
| Abdominal pain upper | 3 (9.4) | 1 (1.6) | |
| Urinary tract infection | 2 (6.3) | 1 (1.6) | |
| Patients with serious AE‡ | 3 (9.4) | 1 (1.6) | — |
| Serious AE | |||
| Gastroesophageal reflux disease | 0 | 1 (1.6) | |
| Femur fracture | 1 (3.1) | 0 | |
| Myositis | 1 (3.1) | 0 | |
| Calculus ureteric | 1 (3.1) | 0 | |
| Thrombophlebitis | 1 (3.1) | 0 | |
↵* All randomized patients who had received ≥ 1 study agent administration and who had baseline and ≥ 1 postbaseline values.
↵** P value derived using ANCOVA model with treatment as a fixed factor and baseline DAS28-CRP as a covariate.
↵*** P values derived using Fisher’s exact test.
↵† P values derived using rank ANCOVA with treatment as fixed effect and baseline score as a covariate.
↵‡ Percentages calculated with the number of patients in each treatment group as denominator, n is the number of patients experiencing ≥ 1 AE, not the number of events, and AE were coded using Medical Dictionary for Regulatory Activities 15.0. mITT: modified intent-to-treat; DAS28: 28-joint Disease Activity Score; CRP: C-reactive protein; IQR: interquartile range; ACR20: ≥ 20% improvement in the American College of Rheumatology response criteria; HAQ-DI: Health Assessment Questionnaire–Disability Index; AE: adverse events.