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Reporting on Adverse Clinical Events

In a retrospective case series, 10 adult patients (mean age = 59 years) with ipilimumab-induced hypophysitis (eg, decreased levels of pituitary and secondary target hormones) were identified. All 10 patients had advanced melanoma; 9 were male. Nine patients received standard therapy with ipilimumab (3 mg/ kg every 3 weeks) and 1 patient received higher doses (10 mg/kg) with maintenance dosing every 3 months. Three patients also received dacarbazine prior to ipilimumab, and 1 patient received pembrokizumab 8 months after therapy. The mean onset of symptoms was 9 weeks (range = 7-13 weeks) after the first dose of ipilimumab and typically included fatigue, headache, and nausea. Four patients required hospitalization and one was admitted with documented hyponatremia. The pituitary-adrenal axis and pituitary-thyroid axis were affected in the majority of patients. Treatment included, when necessary, replacement steroids and/or levothyroxine. All patients had almost immediate resolution of symptoms with hormone replacement. In 3 patients in whom ipilimumab was continued, the next dose was delayed until symptoms resolved. On follow-up all patients remained on hormone replacement. The authors concluded that these patients developed ipilimumabinduced hypophysitis and recommended that early detection and monitoring be implemented as the morbidity associated with the reaction is severe. The authors developed guidelines for monitoring which included serum levels of morning cortisol, thyroid stimulating hormone, and free-thyroxine-4 at baseline and the start of every cycle. Monitoring should be continued for at least 4 months after initiating therapy. Patients who have been treated with other immune check-point regulators may need more frequent monitoring. Ipilimumab [“Yervoy”] Lam et al (T Lam, Department of Diabetes and Endocrinology, Westmead Hospital, Corer of Darcy and Hawkesbury Road, Westmead, Sydney, New South Wales 2145, Australia; e-mail: Tess0508@gmail.com) Ipilimumab-induced hypophysitis in melanoma patients: an Australian case series. Intern Med J 45:1066–1073 (Oct) 2015