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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a retrospective case series of 187 patients from two UK specialist centres, three patients (2 women and 1 man; aged 20−42 years) developed systemic sarcoidosis following treatment with alemtuzumab for multiple sclerosis (MS) [not all outcomes stated].
Case 1: The woman, who had relapsing MS, received IV alemtuzumab 12 mg/day for 5 consecutive days, followed by 12 mg/day for 3 consecutive days 12 months later. Thirty five months after the initiation of alemtuzumab therapy, she developed therapy-associated autoimmune hypothyroidism. Three years and eight months following the first dose of alemtuzumab, a further relapse was noted. She again received alemtuzumab 12 mg/day for 3 consecutive days, resulting in inactive disease. Four years later (at the age of 42 years), she...