Efficacy outcomes at weeks 4 and 8
| Outcome | Pooled placebo (N=27) | MOR103 | ||||||
|---|---|---|---|---|---|---|---|---|
| 0.3 mg/kg (N=24) | 1.0 mg/kg (N=22) | 1.5 mg/kg (N=23) | ||||||
| Week 4 | Week 8 | Week 4 | Week 8 | Week 4 | Week 8 | Week 4 | Week 8 | |
| Response assessments, n (%) | ||||||||
| EULAR | ||||||||
| Good | 1 (3.7) | 1 (3.7) | 3 (12.5) | 1 (4.2) | 5 (22.7) | 7 (31.8) | 1 (4.3) | 2 (8.7) |
| Moderate | 1 (3.7) | 6 (22.2) | 6 (25.0) | 7 (29.2) | 10 (45.5) | 6 (27.3) | 15 (65.2) | 11 (47.8) |
| None | 20 (74.1) | 15 (55.6) | 14 (58.3) | 13 (54.2) | 6 (27.3) | 6 (27.3) | 7 (30.4) | 10 (43.5) |
| Missing | 5 (18.5) | 5 (18.5) | 1 (4.2) | 3 (12.5) | 1 (4.5) | 3 (13.6) | 0 (0.0) | 0 (0.0) |
| p Value* | – | – | 0.06 | 0.91 | 0.0002 | 0.019 | 0.0001 | 0.2565 |
| ACR | ||||||||
| ACR20 | 2 (7.4) | 5 (18.5) | 6 (25.0) | 3 (12.5) | 15 (68.2)† | 7 (31.8) | 7 (30.4) | 6 (26.1) |
| ACR50 | 1 (3.7) | 2 (7.4) | 1 (4.2) | 0 (0.0) | 5 (22.7) | 4 (18.2) | 2 (8.7) | 0 (0.0) |
| ACR70 | 0 (0.0) | 0 (0.0) | 1 (4.2) | 0 (0.0) | 1 (4.5) | 2 (9.1) | 0 (0.0) | 0 (0.0) |
| Missing | 5 (18.5) | 5 (18.5) | 1 (4.2) | 3 (12.5) | 1 (4.5) | 2 (9.1) | 0 (0.0) | 0 (0.0) |
| Additional efficacy assessments, change from baseline in mean values (SD) | ||||||||
| DAS28 | 0.2 (0.8) | −0.1 (0.9) | −0.2 (1.1) | −0.3 (0.9) | −1.1 (0.9)† | −1.0 (1.3)‡ | −0.6 (0.7)‡ | −0.6 (0.9) |
| Swollen joints | 0.1 (3.5) | −0.8 (3.6) | −1.7 (2.4)‡ | −1.9 (2.2) | −3.5 (5.1)‡ | −4.1 (4.4)‡ | −3.3 (3.2)‡ | −3.3 (3.1)‡ |
| Tender joints | 2.0 (6.4) | 2.1 (8.0) | 0.1 (7.1) | 0.3 (5.0) | −4.8 (3.2)§ | −6.8 (4.1)† | −3.7 (6.2)‡ | −4.0 (5.3)§ |
| ESR (mm/h) | 2.8 (12.5) | 0.9 (13.1) | 8.8 (24.5) | 2.0 (16.6) | −6.3 (12.5) | −0.7 (17.4) | −2.5 (17.7) | −0.6 (14.3) |
| Pain | −3.3 (16.5) | −8.0 (16.1) | −8.6 (22.8) | −4.1 (23.1) | −17.4 (17.2)‡ | −13.4 (20.9) | −11.4 (11.5) | −9.5 (11.9) |
| HAQ-DI | −0.45 (0.54) | −0.44 (0.54) | −0.21 (0.41)‡ | −0.21 (0.56) | −0.53 (0.52) | −0.51 (0.56) | −0.31 (0.24) | −0.25 (0.22) |
| Physician GA | −3.0 (15.7) | −3.5 (16.3) | −0.6 (19.7) | −4.7 (20.0) | −18.0 (19.6)‡ | −18.1 (22.6)‡ | −7.8 (10.8) | −6.5 (13.4) |
| Patient GA | −3.0 (16.1) | −8.2 (17.5) | −2.7 (20.5) | −4.5 (21.9) | −16.6 (15.6)‡ | −13.3 (24.7) | −6.0 (17.7) | −4.0 (18.3) |
| FACIT fatigue scores | 3.0 (8.1) | 4.3 (9.1) | 2.7 (9.2) | 2.1 (5.6) | 9.1 (10.2)‡ | 9.4 (12.6) | 3.1 (6.0) | 4.7 (7.1) |
*p Values for pairwise comparisons with pooled placebo group determined by Cochran–Mantel–Haenszel test (missing values not included).
†p<0.0001 for pairwise comparisons with pooled placebo group. Fisher's exact test was used for ACR response (missing values not included) and ANCOVA was used for additional efficacy assessments.
‡p<0.05 for pairwise comparisons with placebo group by ANCOVA.
§p<0.001 for pairwise comparisons with placebo group by ANCOVA.
ACR, American College of Rheumatology; ANCOVA, analysis of covariance; DAS28, Disease Activity Score-28 joints; ESR, erythrocyte sedimentation rate; EULAR, European League Against Rheumatism; FACIT, Functional Assessment of Chronic Illness Therapy; GA, global assessment of disease activity; HAQ-DI, Health Assessment Questionnaire-Disability Index.