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Table 3 Adverse events and change from baseline in selected laboratory variables during the phase 3 double-blind study [10] and the open-label extension study [13]

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)
  1. aIncludes patients who were treated with adalimumab (ADA) 40 mg every 2 weeks (Q2W) or tofacitinib 10 mg twice daily (BID) from baseline in the blinded study, regardless of whether they entered the extension study. bIncludes all patients who completed treatment with ADA 40 mg Q2W or tofacitinib 10 mg BID in the blinded study and then switched treatment and completed 12 months of the extension study. Please see “Methods” for important exceptions. AE adverse event, CI confidence interval, DC discontinuation, HDL high-density lipoprotein, IR incidence rate, LDL low density lipoprotein, N/A not available