Safety summary for weeks 0–24, weeks 24–76, and weeks 76–128. Data are n (%) [IR].
| Blinded Period, Weeks 0–24 Randomized Dose | First OLE, Weeks 24–76 (4 mg or 8 mg) | Second OLE, Weeks 76–128 (4 mg throughout) | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| 4:8 mg | ||||||||||
| 2 mg | 4 mg | 8 mg | 4 mg | Pre-rescue | Post-rescue | 8 mg | 4/4 mg | 4:8/4 mg | 8/4 mg | |
| n = 52, PYE = 23.6 | n = 52, PYE = 23.2 | n = 50, PYE = 22.4 | n = 108, PYE = 102.8 | n = 61, PYE = 6.1 | n = 61, PYE = 50.7 | n = 32, PYE = 27.5 | n = 79, PYE = 78.1 | n = 47, PYE = 43.0 | n = 18, PYE = 17.3 | |
| SAE | 3 (6) [12.7] | 0 | 4 (8) [17.7] | 17 (16) [16.5] | 1 (2) [16.5] | 6 (10) [11.8] | 6 (19) [21.8] | 5 (6) [6.4] | 3 (6) [7.0] | 0 |
| TEAE | 31 (60) [131.6] | 32 (62) [138.6] | 36 (72) [159.0] | 68 (63) [66.1] | 14 (23) [230.6] | 42 (69) [82.9] | 20 (63) [72.7] | 41 (52) [52.5] | 25 (53) [58.2] | 10 (56) [57.8] |
| Study discontinuations due to AE | 1 (2) [4.2] | 1 (2) [4.3] | 1 (2) [4.4] | 8 (7) [7.8] | 1 (2) [16.5] | 1 (2) [2.0] | 3 (9) [10.9] | 1 (1) [1.3] | 2 (4) [4.7] | 0 |
| Infections | 14 (27) [59.4] | 13 (25) [56.3] | 14 (28) [61.8] | 38 (35) [37.0] | 8 (13) [131.7] | 25 (41) [49.3] | 12 (38) [43.6] | 24 (30) [30.7] | 13 (28) [30.3] | 5 (28) [28.9] |
| Herpes zoster* | 0 | 0 | 0 | 6 (6) [5.8] | 0 | 1 (2) [2.0] | 2 (6) [7.3] | 1 (1) [1.3] | 0 | 0 |
| Serious infections | 2 (4) [8.5] | 0 | 1 (2) [4.4] | 5 (5) [4.9] | 1 (2) [16.5] | 1 (2) [2.0] | 2 (6) [7.3] | 2 (3) [2.6] | 2 (4) [4.7] | 0 |
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. Pre-rescue includes all AE that began or worsened on or before the date of dose escalation. Post-rescue includes all AE that began or worsened after the date of dose escalation.
↵* Among the cases of herpes zoster, 5 patients were receiving concomitant steroid and 5 patients were not receiving concomitant steroid. IR: incidence rate; AE: adverse event; OLE: open-label extension; PYE: patient-years of exposure; n: no. patients treated with stated dose regimen in the study period or no. patients with event; TEAE: treatment-emergent AE; SAE: serious AE.