Baseline demographic and clinical characteristics
| Characteristic | Pooled placebo (N=27) | MOR103 | ||
|---|---|---|---|---|
| 0.3 mg/kg (N=24) | 1.0 mg/kg (N=22) | 1.5 mg/kg (N=23) | ||
| Age (years) | 53.8 (12.7) | 57.4 (8.3) | 49.0 (12.7) | 53.0 (9.9) |
| Body mass index (kg/m2) | 26.3 (3.5) | 26.3 (3.6) | 26.1 (4.6) | 25.7 (4.7) |
| Female, n (%) | 19 (70.4) | 21 (87.5) | 17 (77.3) | 18 (78.3) |
| Caucasian, n (%) | 27 (100) | 24 (100) | 22 (100) | 23 (100) |
| DAS28-ESR | 4.88 (0.41) | 4.88 (0.54) | 4.78 (0.66)* | 4.87 (0.38) |
| CRP (mg/L)† | 18.2 (20.0) | 23.1 (20.8) | 11.7 (12.6) | 18.0 (30.1) |
| ESR (mm/h) | 28.7 (14.8) | 28.1 (12.2) | 21.9 (12.0) | 24.9 (14.4) |
| Swollen joints | 6.3 (3.2) | 5.5 (2.3) | 7.3 (4.7) | 6.7 (2.5) |
| Tender joints† | 9.4 (7.0) | 8.0 (4.7) | 12.3 (7.6) | 11.3 (5.8) |
| RF positive,‡ n/N (%) | 25/26 (96.2) | 21/24 (87.5) | 19/21 (90.5) | 19/23 (82.6) |
| Anti-CCP positive,§ n/N (%) | 17/25 (68.0) | 16/21 (76.2) | 16/21 (76.2) | 16/22 (72.7) |
| Prior medication,¶ n (%) | ||||
| Systemic corticosteroids | 18 (66.7) | 21 (87.5) | 13 (59.1) | 16 (69.6) |
| DMARD** | 21 (77.8) | 18 (75.0) | 15 (68.2) | 20 (87.0) |
| TNF inhibitor | 2 (7.4) | 1 (4.2) | 0 (0.0) | 0 (0.0) |
| Concomitant medication at baseline, n (%) | ||||
| Systemic corticosteroids | 19 (70.4) | 20 (83.3) | 13 (59.1) | 15 (65.2) |
| DMARD** | 26 (96.3) | 22 (91.7) | 17 (77.3) | 21 (91.3) |
| MTX | 21 (77.8) | 18 (75.0) | 14 (63.6) | 19 (82.6) |
Data are presented as mean (SD) unless otherwise indicated. For RF and anti-CCP positive, percentages were calculated on the number of patients with data, not on the full cohort size.
*One patient had missing data.
†p<0.05 for differences in mean values between groups by Kruskal–Wallis test.
‡Defined as >13.9 IU/mL.
§Defined as >5 U/mL.
¶Medication in the 3 months prior to screening.
**Conventional (non-biological) DMARDs.
CCP, cyclic citrullinated peptide; CRP, C-reactive protein; DAS, Disease Activity Score; DMARD, disease-modifying antirheumatic drug; ESR, erythrocyte sedimentation rate; MTX, methotrexate; RF, rheumatoid factor; TNF, tumour necrosis factor.