Table 5 Summary of ACR20 and ACR50 responses and DAS28-CRP based on concomitant medication at and after week 52 (efficacy full analysis set)
Efficacy parameter | Sirukumab 50 mg q4w | Sirukumab 100 mg q2w |
|---|---|---|
ACR20 response | ||
Methotrexate | ||
Week 52a | 29/44 (65.9) | 34/42 (81.0) |
Week 52b | 29/36 (80.6) | 34/38 (89.5) |
Week 16, posttreatment phaseb | 32/36 (88.9) | 32/38 (84.2) |
DMARDs (including methotrexate) | ||
Week 52a | 31/49 (63.3) | 34/44 (77.3) |
Week 52b | 31/38 (81.6) | 34/38 (89.5) |
Week 16, posttreatment phaseb | 33/38 (86.8) | 32/38 (84.2) |
Corticosteroid (oral) | ||
Week 52a | 2/7 (28.6) | 8/11 (72.7) |
Week 52b | 2/3 (66.7) | 8/9 (88.9) |
Week 16, posttreatment phaseb | 3/3 (100.0) | 9/9 (100.0) |
Corticosteroid (oral, intramuscular) | ||
Week 52a | 4/11 (36.4) | 11/15 (73.3) |
Week 52b | 4/6 (66.7) | 11/12 (91.7) |
Week 16, posttreatment phaseb | 5/6 (83.3) | 12/12 (100.0) |
No DMARD and corticosteroid | ||
Week 52a | 7/11 (63.6) | 8/12 (66.7) |
Week 52b | 8/8 (100.0) | 8/10 (80.0) |
Week 16, posttreatment phaseb | 8/8 (100.0) | 8/10 (80.0) |
ACR50 response | ||
Methotrexate | ||
Week 52a | 21/44 (47.7) | 24/42 (57.1) |
Week 52b | 21/36 (58.3) | 24/38 (63.2) |
Week 16, posttreatment phaseb | 23/36 (63.9) | 27/38 (71.1) |
DMARDs (including methotrexate) | ||
Week 52a | 22/49 (44.9) | 24/44 (54.5) |
Week 52b | 22/38 (57.9) | 24/38 (63.2) |
Week 16, posttreatment phaseb | 23/38 (60.5) | 27/38 (71.1) |
Corticosteroid (oral) | ||
Week 52a | 0/7 (0) | 6/11 (54.5) |
Week 52b | 0/3 (0) | 6/9 (66.7) |
Week 16, posttreatment phaseb | 1/3 (33.3) | 8/9 (88.9) |
Corticosteroid (oral, intramuscular) | ||
Week 52a | 1/11 (9.1) | 9/15 (60.0) |
Week 52b | 1/6 (16.7) | 9/12 (75.0) |
Week 16, posttreatment phaseb | 2/6 (33.3) | 11/12 (91.7) |
No DMARD and corticosteroid | ||
Week 52a | 7/11 (63.6) | 8/12 (66.7) |
Week 52b | 7/8 (87.5) | 8/10 (80.0) |
Week 16, posttreatment phaseb | 7/8 (87.5) | 8/10 (80.0) |
DAS28-CRP score | ||
All, n | 61 | 61 |
Week 52,b n | 47 | 52 |
Mean (SD) | 2.4 (1.07) | 2.3 (1.03) |
Week 16, posttreatment phase, nb | 61 | 60 |
Mean (SD) | 2.5 (1.17) | 2.4 (1.19) |
Methotrexate, n | 44 | 42 |
Week 52, nb | 36 | 38 |
Mean (SD) | 2.5 (1.09) | 2.5 (0.94) |
Week 16, posttreatment phase, nb | 44 | 41 |
Mean (SD) | 2.5 (1.10) | 2.6 (1.18) |
Corticosteroid (oral, intramuscular), n | 11 | 15 |
Week 52, nb | 6 | 12 |
Mean (SD) | 3.0 (1.69) | 1.9 (0.97) |
Week 16, posttreatment phase, nb | 11 | 15 |
Mean (SD) | 3.0 (1.59) | 2.1 (0.89) |