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Resolution of severe ipilimumab-induced hepatitis after antithymocyte globulin therapy.

Case Report A 60-year-old white man presented in January 2008 with a superficial spreading melanoma on the right anterior chest wall. Wide local excision was undertaken, and histopathologic analysis revealed a Breslow thickness of 1.2 mm, with Clark level III invasion, no ulceration, and 10 mitoses/mm. A micrometastatic deposit was found in a single sentinel lymph node removed from the right axilla. The patient reported no significant past history but had an intermittent alcohol intake of 20 to 80 g per day. He consented to participate in MSLT II (Multicenter Selective Lymphadenectomy Trial II) and was randomly assigned to axillary observation. In May 2009, an abnormal lymph node was detected on screening ultrasound, and axillary lymph node clearance was undertaken. Two of 22 lymph nodes were positive for melanoma, the largest deposit being 0.5 mm in diameter. In July 2009, after consent was obtained, the patient was enrolled onto the CA184-029/EORTC 18071 trial (Adjuvant Immunotherapy With Anti-CTLA-4 Monoclonal Antibody [Ipilimumab] Versus Placebo After Complete Resection of High Risk Stage III Melanoma: A Randomized, Double-Blind Phase 3 Trial of the European Organisation for Research and Treatment of Cancer Melanoma Group). Subsequent unblinding revealed that he had received two infusions of ipilimumab 10 mg/kg intravenously every 3 weeks (Fig 1A, thick arrows). Although the patient was counseled to reduce his alcohol intake, he admitted to episodic intake during the trial period. Ten days after the second dose of ipilimumab, he experienced fever, maculopapular rash, anorexia, and vomiting. Within 3 days, he had developed hepatitis, with serum ALT peaking at 2,521 U/L (normal range, 47 U/L; Fig 1A, first peak, time course of ALT and AST levels in response to medications; Table 1, liver function test LFT values). In accordance with the trial protocol for management of hepatitis, the patient was administered pulse methylprednisolone 500 mg intravenously daily for 9 days, with rapid improvement in LFTs. Repeat viral hepatitis serology and antibodies associated with autoimmune hepatitis (ie, antibodies to smooth muscle, liver-kidney microsomes, and antinuclear antibodies) were all negative. Corticosteroid therapy was complicated by steroid-induced psychosis with predominant hypomania necessitating steroidreductiontooralprednisolone150mgdaily.Thiswasnecessary to allow for treatment adherence and prevent loss of follow-up by the patient. At this point, his ALT levels were stable at 400 U/L. Although the patient’s mood and insomnia slowly improved with the reduction in steroid dose, his condition deteriorated 1 week later, with increasing lethargy, anorexia, and low-grade fever. LFTs again became markedly abnormal (Fig 1A, second peak), and mycophenylate mofetil 1g twice daily was added in accordance with the trial