Tofacitinib 5 mg BID (n = 1123) | Tofacitinib 10 mg BID (n = 3358) | All tofacitinib (n = 4481) | |
---|---|---|---|
AEs, n (%) [IRs; patients with events per 100 patient-years; 95% CI] | |||
AEs | 1015 (90.4) [98.69; 92.71, 104.96] | 3021 (90.0) [118.54; 114.35, 122.84] | 4036 (90.1) [112.83; 109.38, 116.37] |
SAEs | 346 (30.8) [8.16; 7.31, 9.07] | 997 (29.7) [9.37; 8.80, 9.98] | 1343 (30.0) [9.03; 8.55, 9.53] |
Discontinued due to AEs | 315 (28.0) [6.67; 5.95, 7.45] | 805 (24.0) [6.83; 6.36, 7.32] | 1120 (25.0) [6.78; 6.39, 7.20] |
Dose reduction or temporary discontinuation due to AEs | 518 (46.1) [16.85; 15.43, 18.36] | 1329 (39.6) [15.70; 14.87, 16.57] | 1847 (41.2) [16.01; 15.29, 16.76] |
Dose reduction only | 75 (14.5) | 86 (6.5) | 161 (8.7) |
Temporary discontinuation only | 372 (71.8) | 1147 (86.3) | 1519 (82.2) |
Dose reduction and temporary discontinuation | 71 (13.7) | 96 (7.2) | 167 (9.0) |
Permanent discontinuationa | 275 (53.1) | 615 (46.3) | 890 (48.2) |
AEs, n (%) [EAERs; patients with events per 100 patient-years] Most frequently reported AEs by SOC (≥ 20% in any treatment group) and within-SOC preferred term (≥ 5% in any treatment group) | |||
Infections and infestations | 738 (65.7) [15.90] | 2299 (68.5) [20.04] | 3037 (67.8) [18.84] |
Upper respiratory tract infection | 228 (20.3) [4.91] | 614 (18.3) [5.35] | 842 (18.8) [5.22] |
Nasopharyngitis | 138 (12.3) [2.97] | 518 (15.4) [4.51] | 656 (14.6) [4.07] |
Urinary tract infection | 166 (14.8) [3.57] | 453 (13.5) [3.94] | 619 (13.8) [3.84] |
Bronchitis | 143 (12.7) [3.08] | 434 (12.9) [3.78] | 577 (12.9) [3.58] |
Herpes zoster | 119 (10.6) [2.56] | 386 (11.5) [3.36] | 505 (11.3) [3.13] |
Sinusitis | 70 (6.2) [1.50] | 242 (7.2) [2.10] | 312 (7.0) [1.93] |
Influenza | 81 (7.2) [1.74] | 199 (5.9) [1.73] | 280 (6.2) [1.73] |
Pharyngitis | 58 (5.2) [1.24] | 148 (4.4) [1.29] | 206 (4.6) [1.27] |
Musculoskeletal and connective tissue disorders | 447 (39.8) [9.63] | 1373 (40.9) [11.96] | 1820 (40.6) [11.29] |
Rheumatoid arthritis | 111 (9.9) [2.39] | 309 (9.2) [2.69] | 420 (9.4) [2.60] |
Back pain | 109 (9.7) [2.34] | 301 (9.0) [2.62] | 410 (9.1) [2.54] |
Arthralgia | 88 (7.8) [1.89] | 271 (8.1) [2.36] | 359 (8.0) [2.22] |
Osteoarthritis | 66 (5.9) [1.42] | 196 (5.8) [1.70] | 262 (5.8) [1.62] |
Gastrointestinal disorders | 406 (36.2) [8.74] | 1045 (31.1) [9.10] | 1451 (32.4) [9.00] |
Diarrhea | 74 (6.6) [1.59] | 218 (6.5) [1.90] | 292 (6.5) [1.81] |
Nausea | 57 (5.1) [1.22] | 175 (5.2) [1.52] | 232 (5.2) [1.43] |
Investigations | 404 (36.0) [8.70] | 1007 (30.0) [8.77] | 1411 (31.5) [8.75] |
Blood creatine phosphokinase increased | 91 (8.1) [1.96] | 249 (7.4) [2.17] | 340 (7.6) [2.11] |
ALT increased | 63 (5.6) [1.35] | 122 (3.6) [1.06] | 185 (4.1) [1.14] |
Blood creatinine increased | 60 (5.3) [1.29] | 116 (3.5) [1.01] | 176 (3.9) [1.09] |
Injury, poisoning, and procedural complications | 267 (23.8) [5.75] | 783 (23.3) [6.82] | 1050 (23.4) [6.51] |
Fall | 70 (6.2) [1.50] | 217 (6.5) [1.89] | 287 (6.4) [1.78] |
Nervous system disorders | 232 (20.7) [4.99] | 687 (20.5) [5.98] | 919 (20.5) [5.70] |
Headache | 67 (6.0) [1.44] | 203 (6.0) [1.76] | 270 (6.6) [1.67] |
Respiratory, thoracic, and mediastinal disorders | 223 (19.9) [4.80] | 671 (20.0) [5.84] | 894 (20.0) [5.54] |
Cough | 65 (5.8) [1.40] | 203 (6.0) [1.76] | 268 (6.0) [1.66] |