Single-arm study to assess comprehensive infusion guidance for the prevention and management of the infusion associated reactions (IARs) in relapsing-remitting multiple sclerosis (RRMS) patients treated with alemtuzumab (EMERALD)

Abstract

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A national, multi-center study in Germany to assess implementation of infusion management, treatment satisfaction and quality of life in MS patients receiving alemtuzumab

“…Studies on different aspects of alemtuzumab treatment -e.g. efficacy, HRQOL, and infusion reactions -have been previously performed (Cossburn et al, 2011;Frau et al, 2019;Tuohy et al, 2015;Vukusic et al, 2019;Willis et al, 2016). However, real-world implementation of infusion management as an important aspect of safety and quality control of alemtuzumab treatment has not been assessed so far.…”

“…Safety management of drugs in general presents a crucial aspect of pre-clinical and clinical trials. Apart from safety information from randomized controlled trials, case reports, case series and observational studies provide further information on side effects and safety of alemtuzumab (Bianco et al, 2020;Böhm et al, 2020;Cossburn et al, 2011;Cuker et al, 2020;Holmøy et al, 2019;Obermann et al, 2016;Pfeuffer et al, 2016Pfeuffer et al, , 2021Ruck et al, 2018Ruck et al, , 2019Tuohy et al, 2015;Vukusic et al, 2019). Over the last years, side effects occurred raising safety considerations for different drugs after their approval.…”

“…While randomized controlled trials are especially valuable during the initial stage of drug development and approval, observational studies can lend further information on drug effectiveness, tolerability in daily clinical routine, outcomes and health-related quality of life (HRQOL). Various studies on efficacy (Frau et al, 2019;Herman et al, 2021;Tuohy et al, 2015), HRQOL (Herman et al, 2021;Ziemssen et al, 2016), infusion reactions (Vukusic et al, 2019), and therapy-associated autoimmune diseases (Cossburn et al, 2011) have been performed so far. Those real-world data provide crucial information on the use, efficacy, and side effects of alemtuzumab treatment in daily routine and therefore present a meaningful complement to randomized clinical trials.…”

Alemtuzumab‐induced Alopecia areata – a case report and systematic literature review of adverse events associated with Alemtuzumab

“…Systemic corticosteroids, antipyretics or antihistamines can be given during the first three infusion days for prevention or treatment of the IAR [14].…”

Alemtuzumab‐induzierte Alopecia areata – Fallbericht und systematische Literaturübersicht zu Alemtuzumab‐assoziierten kutanen Nebenwirkungen

“…Zur Prophylaxe oder Therapie der IAR können systemische Kortikosteroide, Antipyretika oder Antihistaminika während der ersten drei Infusionstage gegeben werden [14].…”