Safety and laboratory summary weeks 0–12 and weeks 0–24
| Weeks 0–12 | Weeks 0–24 | |||||
|---|---|---|---|---|---|---|
| Placebo (N=228) | Baricitinib 2 mg QD (N=229) | Baricitinib 4 mg QD (N=227) | Placebo (N=228) | Baricitinib 2 mg QD (N=229) | Baricitinib 4 mg QD (N=227) | |
| Treatment exposure—no of patient-year | 50.4 | 52.3 | 51.0 | 89.8 | 97.7 | 96.4 |
| Safety data† | ||||||
| SAEs‡ | 8 (4) | 4 (2) | 4 (2) | 11 (5) | 6 (3) | 12 (5) |
| Any adverse event after the start of therapy | 133 (58) | 122 (53) | 135 (60) | 161 (71) | 154 (67) | 162 (71) |
| Discontinuation from study due to adverse event | 8 (4) | 7 (3) | 8 (4) | 10 (4) | 10 (4) | 12 (5) |
| Infections | 53 (23) | 45 (20) | 66 (29) | 79 (35) | 70 (31) | 96 (42) |
| Herpes zoster | 0 | 3 (1) | 3 (1) | 0 | 4 (2) | 3 (1) |
| Serious infections | 3 (1) | 1 (<1) | 2 (<1) | 4 (2) | 2 (<1) | 4 (2) |
| Malignancies | 0 | 0 | 1 (<1) | 0 | 0 | 1 (<1) |
| NMSC | 0 | 0 | 1 (<1) | 0 | 0 | 1 (<1) |
| MACE§ | 2 (<1) | 0 | 0 | 2 (<1) | 0 | 0 |
| GI perforations | 0 | 0 | 0 | 0 | 0 | 0 |
| Laboratory data | ||||||
| LSM change from baseline¶ | ||||||
| Haemoglobin, mmol/L | 0.01 (0.03) | −0.08 (0.03) | −0.15 (0.03)*** | 0.05 (0.04) | −0.01 (0.04) | −0.12 (0.04)** |
| Neutrophils, 103 cells/mm3 | −0.15 (0.11) | −0.69 (0.11)*** | −0.76 (0.11)*** | −0.25 (0.15) | −0.68 (0.13)* | −0.72 (0.13)* |
| Lymphocytes, 103 cells/mm3 | −0.01 (0.04) | 0.04 (0.04) | −0.05 (0.04) | 0.06 (0.05) | −0.01 (0.05) | −0.05 (0.05) |
| Platelets††, 109/L | −1 (4) | 5 (3) | 24 (3)*** | −1 (5) | 13 (4)* | 27 (4)*** |
| ALT, U/L | −1.1 (0.8) | 1.7 (0.8)* | 3.0 (0.8)*** | −1.0 (0.9) | 2.4 (0.8)** | 4.3 (0.8)*** |
| Creatinine, µmol/L | 1.0 (0.6) | 4.0 (0.5)*** | 5.1 (0.6)*** | 1.8 (0.7) | 5.2 (0.6)*** | 5.5 (0.6)*** |
| CK, U/L | −7 (5) | 37 (5)*** | 64 (5)*** | −2 (15) | 35 (13) | 78 (13)*** |
| LDL, mmol/L | 0.01 (0.04) | 0.19 (0.04)** | 0.22 (0.04)*** | 0.02 (0.05) | 0.22 (0.05)** | 0.24 (0.05)** |
| HDL, mmol/L | 0.01 (0.02) | 0.16 (0.02)*** | 0.21 (0.02)*** | 0.01 (0.02) | 0.17 (0.02)*** | 0.20 (0.02)*** |
*p≤0.05, **p≤0.01 and ***p≤0.001 versus placebo by analysis of covariance.
†Data displayed are n (%) of patients, up to the time of rescue.
‡SAEs reported using conventional ICH definitions. Table does not describe events that were serious for the reason of protocol definition. The protocol required that adverse events or laboratory abnormalities leading to permanent discontinuation of study drug be designated as SAEs.
§MACE was defined as cardiovascular death, myocardial infarction or stroke positively adjudicated by an independent cardiovascular evaluation committee.
¶LSM change from baseline (SE) at week 12 or at week 24.
††Incidence of protocol-defined thrombocytosis in patients with platelet counts >600 000 cells/mm3.
ALT, alanine transaminase; CK, creatine kinase; GI, gastrointestinal perforations; HDL, high-density lipoprotein; ICH, International Conference on Harmonisation; LDL, low-density lipoprotein; LSM, least squares mean; MACE, major adverse cardiovascular event; N, number of patients randomised and treated; NMSC, non-melanoma skin cancer; QD, once daily; SAEs, serious adverse events.