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Variables Placebo-4mg (6 studies, to Week 24)2mg-4mg-extended, 4 Studies Placebo Baricitinib 4 mg Baricitinib 2 mg Baricitinib 4 mg All-bari-RA Temporary interruption because of AE ≥ 0.2 EAIR for 4 mg–treated patients in placebo-4 mg, n (EAIR) Skin and subcutaneous tissue disorders 2 (0.5) 6 (1.5) 2 (0.4) 5 (0.8) 26 (0.4) Respiratory thoracic and mediastinal disorders 2 (0.5) 5 (1.2) 6 (1.1) 6 (1.0) 49 (0.7) Surgical and medical procedures 2 (0.5) 4 (1.0) 4 (0.7) 8 (1.3) 65 (1.0) AE: adverse events; EAIR: exposure-adjusted incidence rates; bari: baricitinib; RA: rheumatoid arthritis.
- Table 5 (Corrected).
Changes in selected laboratory values and clinical chemistry (weeks 0–24).a
Treatment-emergent shifts, n/NAR (%) Placebo-4 mg (6 studies, to Week 24) Placebo-2 mg-4 mg (4 studies, to Week 24) Placebo Baricitinib 4 mg Placebo Baricitinib 2 mg Baricitinib 4 mg LDLb, ≥ 130 mg/dl 70/517 (13.5) 243/577 (42.1)* 35/225 (15.6) 77/264 (29.2)‡ 89/248 (35.9) HDLb, ≥ 60 mg/dl 85/442 (19.2) 229/458 (50.0)* 37/197 (18.8) 90/214 (42.1)‡ 93/201 (46.3) Triglycerides, ≥ 500 mg/dl 7/979 (0.7) 5/943 (0.5) 5/497 (1.0) 5/444 (1.1) 1/444 (0.2) Creatinineb > 1 ULN 21/989 (2.1) 29/951 (3.0) 12/484 (2.5) 12/444 (2.7) 18/441 (4.1) > 1.5× ULN 4/1010 (0.4) 5/964 (0.5) 1/495 (0.2) 0/452 5/450 (1.1)□ CPKb > ULN 89/954 (9.3) 337/893 (37.7)* 52/494 (10.5) 103/451 (22.8)‡ 167/438 (38.1)□ > 2.5× ULN 14/1021 (1.4) 52/950 (5.5)* 10/538 (1.9) 14/476 (2.9) 33/470 (7.0)□ > 5× ULN 5/1028 (0.5) 11/956 (1.2) 5/543 (0.9) 5/476 (1.1) 8/474 (1.7) Hemoglobin < LLN 193/747(25.8) 204/696 (29.3) 100/407 (24.6) 91/343 (26.5) 102/360 (28.3) < 10 g/dl 63/1040 (6.1) 60/968 (6.2) 28/536 (5.2) 33/462 (7.1) 35/467 (7.5) < 8 g/dl 2/1059 (0.2) 1/988 (0.1) 1/544 (0.2) 2/477 (0.4) 0/474 (0) Neutrophilsb, < 1000 cells/mm3 1/1029 (0.1) 3/957 (0.3) 1/544 (0.2) 3/477 (0.6) 1/474 (0.2) Lymphocytes, < 500 cells/mm3 10/1052 (1.0) 8/987 (0.8) 2/541 (0.4) 6/476 (1.3) 3/473 (0.6) Platelets < LLN 28/1030 (2.7) 16/967 (1.7) 12/523 (2.3) 6/466 (1.3) 5/462 (1.1) > 600,000/mm3 14/1055 (1.3) 23/983 (2.3) 9/542 (1.7) 7/472 (1.5) 13/473 (2.7) Patients with any postbaseline elevation, n/N (%)a ALT > 1 ULN 134/932 (14.4) 221/902 (24.5) 59/469 (12.6) 66/431 (15.3) 100/435 (23.0) ≥ 3× ULN 14/1058 (1.3) 15/987 (1.5) 2/544 (0.4) 7/474 (1.5) 6/474 (1.3) ≥ 5× ULN 4/1059 (0.4) 7/988 (0.7) 0/544 3/477 (0.6) 4/474 (0.8) ≥ 10× ULNc 0/1059 2/988 (0.2) 0/544 1/477 (0.2) 1/474 (0.2) ↵* p < 0.05 for baricitinib 4 mg versus placebo.
↵‡ p < 0.05 for baricitinib 2 mg versus placebo.
↵□ p < 0.05 for baricitinib 2 mg versus 4 mg. P value from Cochran-Mantel-Haenszel test stratified by study.
↵a Data up to rescue. Lipid samples were collected at weeks 0 (baseline), 12, and 24, and other hematology/clinical assessments were collected at weeks 0, 1, 2, 4, 8, 12, 14, 16, 20, and 24. National Cholesterol Education Program Adult Treatment Panel III guidelines (2002) were used for lipids19. Common Terminology Criteria for Adverse Events v3.0 were used for other laboratory variables20.
↵b There were differences in laboratory assay methodologies and only the laboratory data collected using the same methodology were pulled, therefore the number of patients at risk can differ slightly across analytes.
↵c Of the 3 cases of ALT ≥ 10× ULN, 1 patient had cholecystitis (study RA-BEGIN), 1 patient was receiving isoniazid treatment (study RA-BEGIN), and 1 patient started methotrexate within 6 months of randomization (study RA-BEAM). ALT: alanine aminotransferase; CPK: creatine phosphokinase; HDL: high-density lipoprotein; LDL: low-density lipoprotein; LLN: lower limit of normal; NAR: number at risk; ULN: upper limit of normal.
