Table 4.
Tofacitinib 5 mg b.i.d., n (%) | Tofacitinib 10 mg b.i.d., n (%) | |
---|---|---|
Median duration of exposure, days (range) | 365 (139–372) | 365 (7–370) |
Week 0–16 | n = 47 | n = 47 |
---|---|---|
AEs | 27 (57.4) | 28 (59.6) |
Serious AEs | 0 | 1 (2.1) |
Discontinuations due to AEs | 0 | 1 (2.1) |
Most common AEs (≥5% of patients in any group) | ||
Nasopharyngitis | 9 (19.1) | 8 (17.0) |
Headache | 1 (2.1) | 3 (6.4) |
Influenza | 3 (6.4) | 0 |
Decreased hemoglobin | 0 | 3 (6.4) |
Weeks 0–52† | Total n = 94 | |
---|---|---|
AEs | 78 (83.0) | |
Serious AEs | 4 (4.3) | |
Discontinuations due to AEs | 8 (8.5) | |
Most common AEs (≥5% of patients) | ||
Nasopharyngitis | 28 (29.8) | |
Herpes zoster (serious and non‐serious) | 16 (17.0)‡ | |
Psoriasis | 9 (9.6) | |
Tinea pedis | 9 (9.6) | |
Influenza | 6 (6.4) | |
Increased blood creatine phosphokinase | 5 (5.3) | |
Decreased hemoglobin | 5 (5.3) |
†AEs occurring up to day 372 are included. ‡Three cases were serious. AEs, adverse events; SAS, safety analysis set.