Table 4

Infection by worst CTCAE grade during placebo-controlled period up to week 24

Placebo (N=1070)Baricitinib 4 mg (N=997)Baricitinib 2 mg (N=479)
Total patientsPatients (%) with overall infectionPatients (%) with serious infectionTotal patientsPatients (%) with overall infectionPatients (%) with serious infectionTotal patientsPatients (%) with overall infectionPatients (%) with serious infection
Neutropenia* CTCAE Grade1029957477
0 (≥2×109 cells/L)985 (95.7)279 (28.3)16 (1.6)853 (89.1)313 (36.7)13 (1.5)438 (91.8)146 (33.3)6 (1.4)
1 (<2 and ≥1.5×109 cells/L)34 (3.3)10 (29.4)074 (7.7)32 (43.2)1 (1.4)22 (4.6)7 (31.8)1 (4.5)
2 (<1.5 and ≥1.0×109 cells/L)9 (0.9)0027 (2.8)11 (40.7)014 (2.9)2 (14.3)0
3 (<1.0 and ≥0.5×109 cells/L)1 (0.1)1 (100.0)†03 (0.3)1 (33.3)‡03 (0.6)1 (33.3)0
4 (<0.5×109 cells/L)000000000
Lymphopenia CTCAE Grade1059988477
0 (≥1.1×109 cells /L)710 (67.0)201 (28.3)12 (1.7)704 (71.3)246 (34.9)8 (1.1)349 (73.2)116 (33.2)5 (1.4)
1 (<1.1 and ≥0.8×109 cells /L)233 (22.0)65 (27.9)2 (0.9)205 (20.7)81 (39.5)2 (1.0)87 (18.2)29 (33.3)1 (1.1)
2 (<0.8 and ≥0.5×109 cells /L)103 (9.7)30 (29.1)1 (1.0)71 (7.2)31 (43.7)3 (4.2)35 (7.3)9 (25.7)1 (2.9)
3 (<0.5 and ≥0.2×109cells /L)13 (1.2)3 (23.1)1 (7.7)§8 (0.8)4 (50.0)1 (12.5)¶6 (1.3)2 (33.3)0
4 (<0.2×109 cells /L)000000000
  • *Neutrophil data not available for the JADC study.

  • †Upper respiratory tract.

  • ‡Pharyngitis.

  • §Pyelonephritis.

  • ¶Herpes zoster.

  • Only on-treatment laboratory value and events (overall infection, serious infection) are included. Data shown for patients with available post-baseline assessments.

  • CTCAE, Common Terminology Criteria for Adverse Events.