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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Suicide (n = 1) 1a Permanently withdrawn Death
Osteonecrosis (n = 1) 23 Temporarily withdrawn Recovered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Infectious peritonitis/appendicitis/intervertebral disc disorder (n = 1 each; same patient) 44/46/51 Permanently withdrawn Recovered
Autoimmune hepatitis (possible drug-induced liver injury; n = 1) 55 Permanently withdrawn Recovered
Fractured ischium (n = 1) 109 Temporarily withdrawn Recovering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Fractured femur (n = 1) 134 Temporarily withdrawn Recovered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Sinusitis (n = 1) 13 Permanently withdrawn Recovered
Dyspnea/tendon rupture (n = 1 each; same patient) 37/53 Temporarily withdrawn Recovered
Cervical dysplasia (n = 1) 52 Permanently withdrawn Recovered
Malignant melanoma (n = 1) 85 Permanently withdrawn Recovered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Disseminated herpes simplex (n = 1) 94 Permanently withdrawn Recovered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Lung infiltration/atrial fibrillation (n = 1 each; same patient)c 107/122 Permanently withdrawn Recovered/not applicable
Goiter (n = 1) 120 Temporarily withdrawn Recovered
  1. Includes patients who completed treatment with adalimumab (ADA) 40 mg every 2 weeks (Q2W) or tofacitinib 10 mg twice daily (BID) in the blinded study (or discontinued treatment for reasons other than a tofacitinib-related serious adverse event (AE)) and then enrolled in the extension study and switched treatment with minimal washout (≤2 weeks after their last dose of study drug in the blinded study). aUnknown whether the patient took study drug on this day. bDue to lung malignancy. cAtrial fibrillation (day 122) occurred after drug discontinuation (day 107)