The proportions of patients achieving selected efficacy endpoints at Week 24, Week 76, and Week 128. Values are n (%).
| Week 24a | Week 76b | Week 128c | |||||||
|---|---|---|---|---|---|---|---|---|---|
| 4 mg, n = 108 | 4:8 mg, n = 61 | 8 mg, n = 32 | 4 mg, n = 108 | 4:8 mg, n = 61 | 8 mg, n = 32 | 4/4 mg, n = 79 | 4:8/4 mg, n = 47 | 8/4 mg, n = 18 | |
| ACR20 | 87 (81) | 38 (62) | 24 (75) | 77 (71) | 41 (67) | 19 (59) | 61 (77) | 27 (57) | 13 (72) |
| ACR50 | 53 (49) | 12 (20) | 18 (56) | 53 (49) | 25 (41) | 14 (44) | 46 (58) | 14 (30) | 8 (44) |
| ACR70 | 29 (27) | 5 (8) | 9 (28) | 31 (29) | 11 (18) | 8 (25) | 22 (28) | 8 (17) | 4 (22) |
| ACR/EULAR Boolean remission | 17 (16) | 1 (2) | 3 (9) | 21 (19) | 5 (8) | 3 (9) | 15 (19) | 3 (6) | 3 (17) |
| HAQ-DId | 47 (44) | 25 (41) | 22 (69) | 55 (51) | 29 (48) | 22 (69) | 39 (49) | 19 (40) | 10 (56) |
| DAS28-CRP ≤ 3.2 | 64 (59) | 15 (25) | 18 (56) | 63 (58) | 23 (38) | 14 (44) | 47 (59) | 17 (36) | 10 (56) |
| DAS28-CRP < 2.6 | 43 (40) | 5 (8) | 13 (41) | 56 (52) | 13 (21) | 7 (22) | 37 (47) | 12 (26) | 7 (39) |
| DAS28-ESR ≤ 3.2 | 38 (35) | 5 (8) | 12 (38) | 45 (42) | 15 (25) | 9 (28) | 39 (49) | 12 (26) | 5 (28) |
| DAS28-ESR < 2.6 | 27 (25) | 1 (2) | 7 (22) | 30 (28) | 10 (16) | 4 (13) | 27 (34) | 6 (13) | 4 (22) |
| CDAI ≤ 2.8 | 24 (22) | 1 (2) | 9 (28) | 27 (25) | 6 (10) | 5 (16) | 22 (28) | 5 (11) | 4 (22) |
| SDAI ≤ 3.3 | 24 (22) | 1 (2) | 7 (22) | 27 (25) | 6 (10) | 5 (16) | 23 (29) | 3 (6) | 4 (22) |
4/4 mg = 4 mg baricitinib for weeks 24–76 and weeks 76–128. 4:8/4 = 4 mg baricitinib through Week 28 or 32, then 8 mg through Week 76 and 4 mg for weeks 76–128. 8/4 mg = 8 mg baricitinib for weeks 24–76 and 4 mg for weeks 76–128.
↵a Observed data for patients entering OLE at Week 24 according to the treatment(s) received in the first OLE.
↵b Nonresponse imputed for discontinuing prior to Week 76, but not for dose escalation.
↵c Among patients entering additional OLE, nonresponse imputed for discontinuing prior to Week 128.
↵d Patients achieving minimum clinically important difference (≥ 0.3): improvement relative to Week 0. ACR: American College of Rheumatology; ACR20: ACR 20% improvement; ACR50: ACR 50% improvement; ACR70: ACR 70% improvement; CDAI: Clinical Disease Activity Index; DAS28-CRP: Disease Activity Score for 28 joints based on the C-reactive protein level; DAS28-ESR: DAS28 based on the erythrocyte sedimentation rate; EULAR: European League Against Rheumatism; HAQ-DI: Health Assessment Questionnaire–Disability Index; OLE: open-label extension; SDAI: Simplified Disease Activity Index.