Variables | Placebo-4 mg (6 studies, to Week 24) | 2 mg-4 mg-extended, 4 studies | |||
---|---|---|---|---|---|
Placebo | Baricitinib 4 mg | Baricitinib 2 mg | Baricitinib 4 mg | All-bari-RA | |
TEAE in ≥ 2% of 4 mg–treated patients in placebo-4 mg, n (EAIR) | |||||
Nasopharyngitis | 67 (17.0) | 68 (16.6) | 39 (7.0) | 53 (8.8) | 433 (6.5) |
Upper respiratory tract infection | 46 (11.7) | 52 (12.7) | 52 (9.4) | 56 (9.3) | 356 (5.4) |
Urinary tract infection | 31 (7.9) | 43 (10.5) | 37 (6.7) | 49 (8.1) | 336 (5.1) |
Headache | 36 (9.1) | 41 (10.0) | 40 (7.2) | 31 (5.1) | 202 (3.0) |
Blood creatine phosphokinase increased | 7 (1.8) | 39 (9.5)* | 24 (4.3) | 41 (6.8)† | 217 (3.3) |
Bronchitis | 37 (9.4) | 39 (9.5) | 30 (5.4) | 38 (6.3) | 360 (5.4) |
Hypercholesterolemia | 14 (3.6) | 34 (8.3)* | 13 (2.3) | 28 (4.6)† | 172 (2.6) |
Nausea | 20 (5.1) | 32 (7.8) | 21 (3.8) | 21 (3.5) | 162 (2.4) |
Pharyngitis | 18 (4.6) | 28 (6.8) | 25 (4.5) | 24 (4.0) | 183 (2.8) |
Diarrhea | 39 (9.9) | 25 (6.1) | 28 (5.0) | 21 (3.5) | 154 (2.3) |
Anemia | 24 (6.1) | 25 (6.1) | 12 (2.2) | 15 (2.5) | 140 (2.1) |
Hypertension | 22 (5.6) | 24 (5.9) | 25 (4.5) | 25 (4.1) | 198 (3.0) |
Influenza | 12 (3.0) | 22 (5.4) | 12 (2.2) | 21 (3.5) | 187 (2.8) |
Arthralgia | 20 (5.1) | 22 (5.4) | 20 (3.6) | 25 (4.1) | 142 (2.1) |
Gastroenteritis | 11 (2.8) | 21 (5.1) | 14 (2.5) | 23 (3.8) | 146 (2.2) |
Cough | 21 (5.3) | 21 (5.1) | 20 (3.6) | 21 (3.5) | 156 (2.4) |
Back pain | 28 (7.1) | 20 (4.9) | 28 (5.0) | 24 (4.0) | 207 (3.1) |
RA | 30 (7.6) | 15 (3.7)* | 15 (2.7) | 23 (3.8) | 158 (2.4) |
Temporary interruption because of AE ≥ 0.2 EAIR for 4 mg–treated patients in placebo-4 mg, n (EAIR) | |||||
Infections and infestations | 52 (13.4) | 67 (16.6) | 58 (10.5) | 68 (11.3) | 542 (8.2) |
Gastrointestinal disorders | 8 (2.1) | 11 (2.7) | 7 (1.3) | 11 (1.8) | 79 (1.2) |
Blood and lymphatic system disorders | 4 (1.0) | 7 (1.7) | 2 (0.4) | 4 (0.7) | 50 (0.8) |
Investigations | 7 (1.8) | 3 (0.7) | 6 (1.1) | 7 (1.2) | 61 (0.9) |
Vascular disorders | 0 | 3 (0.7) | 5 (0.9) | 2 (0.3) | 16 (0.2) |
Cardiac disorders | 1 (0.3) | 2 (0.5) | 3 (0.5) | 2 (0.3) | 23 (0.3) |
General disorders and administration site conditions | 1 (0.3) | 2 (0.5) | 2 (0.4) | 5 (0.8) | 19 (0.3) |
Musculoskeletal and connective tissue disorders | 4 (1.0) | 2 (0.5) | 5 (0.9) | 8 (1.3) | 52 (0.8) |
Hepatobiliary disorders | 2 (0.5) | 1 (0.2) | 3 (0.5) | 1 (0.2) | 17 (0.3) |
Immune system disorders | 0 | 1 (0.2) | 0 | 1 (0.2) | 1 (0.0) |
Injury, poisoning, and procedural complications | 1 (0.3) | 1 (0.2) | 4 (0.7) | 6 (1.0) | 42 (0.6) |
Neoplasms benign, malignant and unspecified (including cysts and polyps) | 1 (0.3) | 1 (0.2) | 1 (0.2) | 2 (0.3) | 16 (0.2) |
Nervous system disorders | 2 (0.5) | 1 (0.2) | 1 (0.2) | 1 (0.2) | 16 (0.2) |
Renal and urinary disorders | 2 (0.5) | 1 (0.2) | 3 (0.5) | 2 (0.3) | 16 (0.2) |
Reproductive system and breast disorders | 0 | 1 (0.2) | 1 (0.2) | 0 | 10 (0.2) |
Permanent discontinuation because of AE ≥ 0.2 EAIR for 4 mg–treated patients in placebo-4 mg, n (EAIR) | |||||
Infections and infestationsa | 7 (1.8) | 21 (5.1)* | 9 (1.6) | 22 (3.6) | 130 (1.9) |
Investigations | 2 (0.5) | 7 (1.7) | 4 (0.7) | 7 (1.1) | 44 (0.7) |
Cardiac disorders | 1 (0.3) | 3 (0.7) | 1 (0.2) | 0 | 11 (0.2) |
Blood and lymphatic system disorders | 0 | 2 (0.5) | 5 (0.9) | 3 (0.5) | 36 (0.5) |
General disorders and administration site conditions | 0 | 2 (0.5) | 2 (0.4) | 1 (0.2) | 9 (0.1) |
Immune system disorders | 0 | 2 (0.5) | 1 (0.2) | 2 (0.3) | 2 (0.0) |
Hepatobiliary disorders | 1 (0.3) | 2 (0.5) | 3 (0.5) | 2 (0.3) | 19 (0.3) |
Neoplasms (benign, malignant, and unspecified, including cysts and polyps) | 3 (0.8) | 2 (0.5) | 3 (0.5) | 9 (1.5) | 51 (0.8) |
Ear and labyrinth disorders | 0 | 1 (0.2) | 0 | 1 (0.2) | 1 (0.0) |
Gastrointestinal disorders | 4 (1.0) | 1 (0.2) | 3 (0.5) | 1 (0.2) | 18 (0.3) |
Musculoskeletal and connective tissue | 6 (1.5) | 1 (0.2) | 1 (0.2) | 2 (0.3) | 13 (0.2) |
Nervous system disorders | 0 | 1 (0.2) | 0 | 1 (0.2) | 8 (0.1) |
Reproductive system and breast disorders | 0 | 1 (0.2) | 0 | 1 (0.2) | 2 (0.0) |
Skin and SC tissue disorders | 2 (0.5) | 1 (0.2) | 1 (0.2) | 0 | 4 (0.1) |
↵* p < 0.05 for baricitinib 4 mg versus placebo.
↵† p < 0.05 for baricitinib 2 mg versus 4 mg. Adverse events are anchored in exposure-adjusted incidence rates (EAIR) of patients treated with 4 mg in placebo-4 mg. EAIR were calculated as the no. unique patients with an event per 100 patient-years (PY) of overall exposure time.
↵a Most infections were due to herpes zoster. TEAE: treatment-emergent AE; SC: subcutaneous; RA: rheumatoid arthritis.