OBJECTIVE: To describe Evaluation of the Management of Infusion Reactions in Alemtuzumab-treated Patients (EMERALD; NCT02205489), a study evaluating comprehensive alemtuzumab infusion guidance to optimize management of infusion-associated reactions (IARs). BACKGROUND: Most patients receiving alemtuzumab in multiple sclerosis clinical trials experienced mild/moderate IARs during infusion (most commonly headache, rash, pyrexia, nausea); 3[percnt] had serious events. IAR treatment was administered at the investigator's discretion, but treatment algorithms may improve patient management. DESIGN/METHODS: EMERALD is a phase 4, single-arm, open-label, multicenter, multinational study in a planned population of 56 alemtuzumab-naive patients. Duration is approximately 13.5 months over 2 study periods, corresponding with 2 alemtuzumab treatment courses, each with a 24-day follow-up. Patients will receive alemtuzumab 12 mg/day intravenous on 5 consecutive days (Period 1) and on 3 consecutive days 12 months later (Period 2). Pre-infusion medication will be administered the day before each period begins, including H1- and H2-antagonists, and oral methylprednisolone. On day 1 of each period, premedication will be administered 1 hour before infusion (H1- and H2-antagonists, NSAID/antipyretic, intravenous methylprednisolone). Every subsequent infusion day will follow a similar premedication regimen, but with decreasing methylprednisolone until day 5 (Period 1) or day 3 (Period 2). During and after infusion, antihistamine, antipyretic, saline, antiemetic, and/or proton pump inhibitor may be administered as needed. All patients will receive H1- and H2-antagonists after infusion. Safety monitoring will follow the drug label’s risk management plan. Primary endpoint is incidence and type of IARs and serious IARs by toxicity grade, analyzed overall and by 2-hour intervals from the start of infusion to 2 hours after the infusion ends. RESULTS: Patient recruitment began in October 2014. Results of the first period are anticipated in 2015. CONCLUSIONS: EMERALD will provide guidance to optimize IAR management during alemtuzumab administration. Study Supported by: Genzyme, a Sanofi company
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Vermersch et al. (2015) studied this question.