Table 3.
Safety with tofacitinib modified-release 11 mg once daily plus methotrexate during the open-label phase*
| Tofacitinib modified-release 11 mg once daily plus methotrexate (N=694)* | |
| Adverse events | 362 (52.2) |
| Serious adverse events | 20 (2.9) |
| Severe adverse events | 25 (3.6) |
| Discontinuations due to adverse events | 41 (5.9) |
| Temporary discontinuation or dose reduction due to adverse events | 86 (12.4) |
| Most common (≥2% of patients) adverse events by MedDRA preferred term | |
| Nasopharyngitis | 35 (5.0) |
| Upper respiratory tract infection | 33 (4.8) |
| Nausea | 20 (2.9) |
| Urinary tract infection | 19 (2.7) |
| Headache | 17 (2.4) |
| Hypertension | 17 (2.4) |
| Diarrhoea | 16 (2.3) |
| Alanine aminotransferase increased | 16 (2.3) |
| Dizziness | 15 (2.2) |
| Adverse events of special interest | |
| Serious infections | 5 (0.7) |
| All herpes zoster (serious and non-serious)†‡ | 4 (0.6) |
| Malignancies excluding non-melanoma skin cancer† | 2 (0.3) |
| Interstitial lung disease§ | 1 (0.1) |
| Non-melanoma skin cancer† | 1 (0.1) |
| MACE† | 0 |
| Opportunistic infections† | 0 |
| Gastrointestinal perforation or obstruction† | 0 |
| Tuberculosis | 0 |
| Pulmonary embolism | 0 |
| Deep vein thrombosis | 0 |
| Deaths | 0 |
Data are n (%) of patients.
Except for the number of adverse events, patients were counted once per treatment in each row. Serious adverse events were defined as any untoward medical occurrence at any dose that results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, or results in congenital anomaly. Severe adverse events were those that interfered significantly with the patient’s usual function, as determined by the investigator.
*Events are counted up to 28 days beyond the last dose.
†Reviewed by an external adjudication committee; malignancies excluding non-melanoma skin cancer were metastatic thyroid cancer and prostate cancer; the non-melanoma skin cancer was basal cell carcinoma.
‡All herpes zoster events reported involved one or two adjacent dermatomes and were non-serious.
§Reviewed by an internal adjudication committee.
MACE, major adverse cardiovascular events; MedDRA, Medical Dictionary for Regulatory Activities; n, number of patients with an event; N, number of patients who entered the open-label phase and received tofacitinib plus methotrexate.