Table 3.
IRs (number of patients with events/100 patient-years) for AEs of special interest
| Monotherapy*† n=1543 |
Combination therapy*‡ n=2631 |
|||
| Tofacitinib 5 mg twice daily n=496 |
Tofacitinib 10 mg twice daily n=1047 |
Tofacitinib 5 mg twice daily n=775 |
Tofacitinib 10 mg twice daily n=1856 |
|
| Exposure, patient-years | 1788.61 | 3344.8 | 2740.54 | 5656.52 |
| Patients with AEs, n (%) | 465 (93.8) | 919 (87.8) | 687 (88.6) | 1649 (88.8) |
| Discontinuations due to AEs, n (%) | ||||
| Unique patients with events, n | 126 (25.4) | 201 (19.2) | 212 (27.4) | 452 (24.4) |
| IR/100 patient-years (95% CI) | 7.13 (5.94 to 8.49) | 6.06 (5.25 to 6.96) | 7.82 (6.80 to 8.95) | 8.06 (7.33 to 8.84) |
| SAEs | ||||
| Unique patients with events, n | 150 | 257 | 207 | 544 |
| IR/100 patient-years (95% CI) | 9.42 (7.98 to 11.06) | 8.41 (7.41 to 9.50) | 8.36 (7.26 to 9.58) | 10.75 (9.86 to 11.69) |
| Serious infections | ||||
| Unique patients with events, n | 43 | 83 | 60 | 188 |
| IR/100 patient-years (95% CI) | 2.42 (1.75 to 3.26) | 2.49 (1.98 to 3.09) | 2.22 (1.70 to 2.86) | 3.35 (2.89 to 3.86) |
| Prior GC use at baseline | ||||
| Unique patients with events, n | 28 | 40 | 35 | 126 |
| IR/100 patient-years (95% CI) | 2.77 (1.84 to 4.01) | 2.63 (1.88 to 3.58) | 2.59 (1.80 to 3.60) | 4.21 (3.51 to 5.02) |
| No prior GC use at baseline | ||||
| Unique patients with events, n | 15 | 43 | 25 | 62 |
| IR/100 patient-years (95% CI) | 1.95 (1.09 to 3.22) | 2.37 (1.72 to 3.20) | 1.86 (1.20 to 2.74) | 2.36 (1.81 to 3.02) |
| Adjudicated opportunistic infections (excluding TB) | ||||
| Unique patients with events, n | 6 | 9 | 7 | 24 |
| IR/100 patient-years (95% CI) | 0.34 (0.12 to 0.73) | 0.27 (0.12 to 0.51) | 0.26 (0.10 to 0.53) | 0.43 (0.27 to 0.63) |
| Herpes zoster | ||||
| Unique patients with events, n | 67 | 81 | 71 | 220 |
| IR/100 patient-years (95% CI) | 4.12 (3.19 to 5.23) | 2.55 (2.02 to 3.17) | 2.79 (2.18 to 3.51) | 4.19 (3.65 to 4.78) |
| Prior GC use at baseline | ||||
| Unique patients with events, n | 44 | 42 | 36 | 120 |
| IR/100 patient-years (95% CI) | 4.89 (3.55 to 6.56) | 2.91 (2.10 to 3.94) | 2.81 (1.97 to 3.89) | 4.32 (3.58 to 5.17) |
| No prior GC use at baseline | ||||
| Unique patients with events, n | 23 | 39 | 35 | 100 |
| IR/100 patient-years (95% CI) | 3.16 (2.01 to 4.75) | 2.24 (1.60 to 3.07) | 2.76 (1.92 to 3.84) | 4.04 (3.29 to 4.91) |
| Adjudicated TB | ||||
| Unique patients with events, n | 3 | 5 | 4 | 12 |
| IR/100 patient-years (95% CI) | 0.17 (0.04 to 0.49) | 0.15 (0.05 to 0.35) | 0.15 (0.04 to 0.37) | 0.21 (0.11 to 0.37) |
| MACE§ | ||||
| Unique patients with events, n | 9 | 7 | 13 | 28 |
| IR/100 patient-years (95% CI) | 0.53 (0.24 to 1.00) | 0.21 (0.08 to 0.43) | 0.54 (0.29 to 0.92) | 0.50 (0.33 to 0.72) |
| NMSC | ||||
| Unique patients with events, n | 9 | 12 | 10 | 46 |
| IR/100 patient-years (95% CI) | 0.51 (0.23 to 0.97) | 0.36 (0.19 to 0.63) | 0.37 (0.18 to 0.67) | 0.83 (0.60 to 1.10) |
| Malignancies (excluding NMSC) | ||||
| Unique patients with events, n | 18 | 26 | 35 | 45 |
| IR/100 patient-years (95% CI) | 1.01 (0.60 to 1.59) | 0.78 (0.51 to 1.14) | 1.28 (0.89 to 1.78) | 0.80 (0.58 to 1.07) |
| Prior GC use at baseline | ||||
| Unique patients with events, n | 11 | 11 | 19 | 23 |
| IR/100 patient-years (95% CI) | 1.09 (0.54 to 1.95) | 0.72 (0.36 to 1.29) | 1.39 (0.83 to 2.16) | 0.76 (0.48 to 1.15) |
| No prior GC use at baseline | ||||
| Unique patients with events, n | 7 | 15 | 16 | 22 |
| IR/100 patient-years (95% CI) | 0.90 (0.36 to 1.86) | 0.83 (0.46 to 1.36) | 1.17 (0.67 to 1.90) | 0.83 (0.52 to 1.26) |
| Lymphoma | ||||
| Unique patients with events, n | 1 | 1 | 3 | 6 |
| IR/100 patient-years (95% CI) | 0.06 (0.00 to 0.31) | 0.03 (0.00 to 0.17) | 0.11 (0.02 to 0.32) | 0.11 (0.04 to 0.23) |
*Data as of January 2016, ongoing at time of analysis, database not locked.
†Patients received monotherapy throughout the LTE studies without concomitant csDMARDs.
‡Patients initiated and remained on background csDMARDs for the duration of their participation in the LTE study or had one break of ≤28 days from csDMARDs.
§Data for MACE are based on adjudicated events: tofacitinib 5 mg twice daily monotherapy n=480; tofacitinib 10 mg twice daily monotherapy n=1087; tofacitinib 5 mg twice daily with background csDMARDs n=707; tofacitinib 10 mg twice daily with background csDMARDs, n=1856.
AE, adverse event; csDMARD, conventional synthetic disease-modifying antirheumatic drug; GC, glucocorticoid; IR, incidence rate; LTE, long-term extension; MACE, major adverse cardiac event; NMSC, non-melanoma skin cancer; SAE, serious adverse event; TB, tuberculosis.