From: Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis
Double-blind studya | Open-label extension studyb | |||||||||
IR per 100 patient-years (95 % CI) | 0 − 3 months | 3 − 6 months | 6 − 9 months | 9 − 12 months | Total 12 months | 0 − 3 months | 3 − 6 months | 6 − 9 months | 9 − 12 months | Total 12 months |
ADA 40 mg Q2W (blinded study) to tofacitinib 10 mg BID (extension study) | ||||||||||
ADA 40 mg Q2W | Tofacitinib 10 mg BID | |||||||||
N = 204 | N = 187 | N = 177 | N = 163 | N = 204 | N = 145 | N = 130 | N = 124 | N = 121 | N = 145 | |
DCs due to AEs | 16.3 (9.0, 29.5) | 19.2 (9.6, 38.4) | 6.7 (2.1, 20.7) | 4.1 (0.6, 29.3) | 12.9 (8.6, 19.4) | 10.0 (4.2, 24.0) | 9.6 (3.1, 29.9) | 3.3 (0.5, 23.6) | 12.0 (3.9, 37.2) | 8.8 (5.0, 15.6) |
Serious AEs | 8.9 (4.0, 19.9) | 16.8 (8.0, 35.2) | 6.7 (2.2, 20.7) | 8.2 (2.1, 32.9) | 10.3 (6.5, 16.3) | 16.1 (8.0, 32.2) | 16.2 (6.8, 39.0) | 6.7 (1.7, 26.7) | 8.0 (2.0, 31.8) | 13.0 (8.1, 20.9) |
Serious infections | 0 | 4.8 (1.2, 19.1) | 2.2 (0.3, 15.8) | 0 | 1.7 (0.5, 5.2) | 4.0 (1.0, 15.9) | 0 | 3.3 (0.5, 23.7) | 4.0 (0.6, 28.1) | 2.9 (1.1, 7.9) |
Tofacitinib 10 mg BID (blinded study) to tofacitinib 10 mg BID (extension study) | ||||||||||
Tofacitinib 10 mg BID | Tofacitinib 10 mg BID | |||||||||
N = 201 | N = 184 | N = 173 | N = 157 | N = 201 | N = 146 | N = 128 | N = 122 | N = 109 | N = 146 | |
DCs due to AEs | 16.7 (9.3, 30.2) | 22.2 (11.6, 42.7) | 6.8 (2.2, 21.1) | 0.0 (0.0, 0.0) | 13.3 (8.8, 20.0) | 13.9 (6.6, 29.1) | 3.3 (0.5, 23.2) | 10.5 (3.4, 32.5) | 4.4 (0.6, 31.5) | 9.1 (5.2, 16.0) |
Serious AEs | 20.1 (11.6, 34.5) | 12.3 (5.1, 29.6) | 9.1 (3.4, 24.2) | 8.7 (2.2, 34.8) | 13.7 (9.1, 20.6) | 18.0 (9.4, 34.6) | 9.9 (3.2, 30.6) | 14.0 (5.3, 37.3) | 4.4 (0.6, 31.5) | 13.4 (8.3, 21.5) |
Serious infections | 4.6 (1.5, 14.2) | 2.4 (0.3, 17.3) | 4.5 (1.1, 18.1) | 4.3 (0.6, 30.7) | 4.0 (1.9, 8.4) | 5.9 (1.9, 18.4) | 3.3 (0.5, 23.2) | 3.5 (0.5, 24.8) | 4.4 (0.6, 31.5) | 4.5 (2.0, 10.1) |
Double-blind studyb | Long-term extension studyb | |||||||||
Mean change from baseline (SD) | Month 1 | Month 3 | Month 6 | Month 9 | Month 12 | Month 1 | Month 3 | Month 6 | Month 9 | Month 12 |
ADA 40 mg Q2W (blinded study) to tofacitinib 10 mg BID (extension study) | ||||||||||
ADA 40 mg Q2W | Tofacitinib 10 mg BID | |||||||||
N = 142 | N = 142 | N = 141 | N = 138 | N = 132 | N = 132 | N = 126 | N = 118 | N = 118 | N = 110 | |
Absolute lymphocyte count, cells/mm3 | 0.4 (0.6) | 0.4 (0.6) | 0.4 (0.6) | 0.4 (0.6) | 0.4 (0.7) | 0.5 (0.8) | 0.2 (0.6) | 0.0 (0.6) | -0.0 (0.6) | -0.0 (0.6) |
N = 142 | N = 144 | N = 144 | N = 140 | N = 137 | N = 139 | N = 131 | N = 125 | N = 122 | N = 115 | |
Total cholesterol, mg/dL | 8.3 (26.4) | 6.7 (30.1) | 2.8 (29.4) | -0.1 (29.7) | 3.2 (33.9) | 22.8 (33.2) | 24.5 (38.2) | 18.9 (36.4) | 20.8 (35.6) | 18.8 (37.7) |
N = 140 | N = 141 | N = 142 | N = 139 | N = 134 | N = 1 | N = 3 | N = 121 | N = 2 | N = 107 | |
LDL, mg/dL | 3.2 (20.5) | 2.5 (24.9) | 0.5 (24.3) | -3.5 (23.1) | -1.8 (27.0) | 18.9 (N/A) | -6.2 (57.8) | 6.2 (30.2) | 36.0 (25.5) | 8.6 (31.9) |
N = 142 | N = 144 | N = 143 | N = 140 | N = 135 | N = 1 | N = 3 | N = 122 | N = 2 | N = 108 | |
HDL, mg/dL | 3.3 (9.2) | 3.4 (10.0) | 1.6 (11.3) | 3.3 (11.5) | 5.6 (10.5) | 20.9 (N/A) | 13.1 (24.5) | 11.9 (11.8) | 10.5 (30.4) | 8.8 (12.3) |
N = 142 | N = 144 | N = 143 | N = 140 | N = 135 | N = 1 | N = 5 | N = 122 | N = 3 | N = 108 | |
Triglycerides, mg/dL | 7.8 (49.9) | 2.8 (41.2) | 2.7 (45.8) | -0.1 (58.7) | -6.0 (48.9) | 5.3 (N/A) | 2.0 (53.2) | 4.7 (57.1) | 8.0 (13.6) | 3.1 (54.8) |
Tofacitinib 10 mg BID (blinded study) to tofacitinib 10 mg BID (extension study) | ||||||||||
Tofacitinib 10 mg BID | Tofacitinib 10 mg BID | |||||||||
N = 142 | N = 141 | N = 141 | N = 138 | N = 129 | N = 134 | N = 131 | N = 116 | N = 112 | N = 103 | |
Absolute lymphocyte count, cells/mm3 | 0.2 (0.5) | -0.0 (0.5) | -0.1 (0.6) | -0.1 (0.6) | -0.3(0.6) | -0.1 (0.6) | -0.2 (0.6) | -0.3 (0.6) | -0.3 (0.6) | -0.3 (0.6) |
N = 145 | N = 142 | N = 141 | N = 136 | N = 131 | N = 136 | N = 134 | N = 122 | N = 117 | N = 106 | |
Total cholesterol, mg/dL | 28.7 (29.2) | 27.4 (31.7) | 30.0 (34.3) | 29.3 (36.6) | 32.8 (37.2) | 30.6 (33.9) | 27.6 (38.8) | 22.5 (42.2) | 23.7 (36.3) | 29.7 (32.7) |
N = 141 | N = 139 | N = 137 | N = 133 | N = 123 | N = 0 | N = 5 | N = 117 | N = 4 | N = 100 | |
LDL, mg/dL | 18.7 (25.6) | 19.1 (25.5) | 20.7 (31.0) | 19.8 (31.1) | 20.0 (31.8) | N/A | 9.8(28.4) | 13.1 (35.8) | 16.3(42.5) | 20.7 (30.7) |
N = 145 | N = 142 | N = 141 | N = 136 | N = 127 | N = 0 | N = 5 | N = 121 | N = 4 | N = 103 | |
HDL, mg/dL | 8.0 (12.4) | 6.1 (14.1) | 7.7 (17.9) | 7.1 (15.4) | 8.2 (15.7) | N/A | 16.1 (19.0) | 8.6 (19.1) | 7.9 (3.9) | 9.0 (15.2) |
N = 145 | N = 142 | N = 141 | N = 136 | N = 127 | N = 0 | N = 7 | N = 121 | N = 4 | N = 103 | |
Triglycerides, mg/dL | 9.2 (65.0) | 8.4 (69.4) | 13.0 (87.3) | 12.3 (91.0) | 15.0 (83.3) | N/A | 25.5 (69.2) | 12.9 (84.8) | 6.6 (61.7) | 7.5 (70.1) |