Table 1

Safety and laboratory data, weeks 0–24

VariablesTOFA, n=156BARI, n=138P 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.