Safety and laboratory data, weeks 0–24
| Variables | TOFA, n=156 | BARI, n=138 | P value |
| Safety data | |||
| Serious adverse events, n (%) | 10 (6.4%) | 4 (2.9%) | 0.15 |
| Any adverse event after start of therapy, n (%) | 56 (35.9%) | 31 (22.5%) | 0.04 |
| Infection, n (%) | 37 (23.7%) | 23 (16.7%) | 0.13 |
| Herpes zoster, n (%) | 2 (1.3%) | 5 (3.6%) | 0.18 |
| Serious infection, n (%) | 2 (1.3%) | 2 (1.5%) | 0.90 |
| Cancer, n (%) | 0 (0.0%) | 0 (0.0%) | 1.00 |
| Major adverse cardiovascular event, n (%) | 0 (0.0%) | 0 (0.0%) | 1.00 |
| Venous thromboembolism, n (%) | 0 (0.0%) | 0 (0.0%) | 1.00 |
| Laboratory data—median change from baseline | |||
| Haemoglobin (g/L) | 1.5 (−4.0–8.8) | 0.5 (−7.0–8.0) | 0.21 |
| Neutrophils (/μL) | −857 (−2057–268) | −817 (−2170–47) | 0.67 |
| Lymphocytes (/μL) | 111 (−172–458) | 232 (−134–621) | 0.10 |
| Alanine aminotransferase (IU/L) | 2 (−4–9) | 5 (−1–10) | 0.09 |
| Creatinine (mg/dL) | 0.06 (0.00–0.12) | 0.08 (0.03–0.13) | 0.11 |
| Creatine phosphokinase (IU/L) | 30 (4–65) | 39 (4–70) | 0.51 |
Adverse events, infection or laboratory abnormalities leading to permanent discontinuation of the JAK inhibitor are designated as serious adverse events.
The data shown are numbers and percentages of patients with adverse events.
Laboratory values are reported as the least-squares-mean change from baseline at week 24.
BARI, baricitinib; CDAI, Clinical Disease Activity Index; JAK, Janus kinase; TOFA, tofacitinib.