Table 4 Patient-level serious adverse events from switch to +3 months
From: Switching from adalimumab to tofacitinib in the treatment of patients with rheumatoid arthritis
Serious AE | Days after first tofacitinib dose in the extension study | Action taken (tofacitinib dosing) | Outcome |
|---|---|---|---|
ADA 40 mg Q2W (blinded study) to tofacitinib 10 mg BID (extension study), N = 107 | |||
Suicide (n = 1) | 1a | Permanently withdrawn | Death |
Osteonecrosis (n = 1) | 23 | Temporarily withdrawn | Recovered |
Post-operative abscess (n = 1) | 44 | Dose not changed | Recovered |
Infectious peritonitis/appendicitis/intervertebral disc disorder (n = 1 each; same patient) | 44/46/51 | Permanently withdrawn | Recovered |
Autoimmune hepatitis (possible drug-induced liver injury; n = 1) | 55 | Permanently withdrawn | Recovered |
Fractured ischium (n = 1) | 109 | Temporarily withdrawn | Recovering |
Spondylolisthesis/stenosis/lung malignancy (n = 1 each; same patient) | 117/117/132 | Not applicable | Deathb |
Fractured femur (n = 1) | 134 | Temporarily withdrawn | Recovered |
Tofacitinib 10 mg BID (blinded study) to tofacitinib 10 mg BID (extension study), N = 126 | |||
Sinusitis (n = 1) | 13 | Permanently withdrawn | Recovered |
Dyspnea/tendon rupture (n = 1 each; same patient) | 37/53 | Temporarily withdrawn | Recovered |
Cervical dysplasia (n = 1) | 52 | Permanently withdrawn | Recovered |
Malignant melanoma (n = 1) | 85 | Permanently withdrawn | Recovered |
Vertigo (n = 1) | 89 | Dose not changed | Not recovered |
Disseminated herpes simplex (n = 1) | 94 | Permanently withdrawn | Recovered |
Cervical vertebral fracture/fall (n = 1 each; same patient) | 102/102 | Dose not changed | Recovering |
Lung infiltration/atrial fibrillation (n = 1 each; same patient)c | 107/122 | Permanently withdrawn | Recovered/not applicable |
Goiter (n = 1) | 120 | Temporarily withdrawn | Recovered |