Infusion-related reactions during Natalizumab treatment: Do we still need a post-infusion observation period?

Sacco, R; Disanto, G; Maraffi, I; Candrian, U; Kamm, Christian Philipp; Rossi, S; Schwegler, G; Gallo, A; Gobbi, C; Zecca, C (2020). Infusion-related reactions during Natalizumab treatment: Do we still need a post-infusion observation period? Multiple Sclerosis and Related Disorders, 38, p. 101523. Elsevier 10.1016/j.msard.2019.101523

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BACKGROUND Natalizumab (NTZ) is a humanized monoclonal antibody used in the treatment of relapsing remitting multiple sclerosis. Although NTZ is usually well-tolerated, infusion-related reactions (IRRs) may occur, and the patients have to be monitored during the infusion and for one hour afterwards. OBJECTIVE To identify frequency and severity of IRRs during NTZ infusions and one-hour post-infusion observation period in a clinical practice setting. METHODS Multicenter, observational study involving three Swiss (Lugano, St. Gallen and Luzern) and two Italian (Milano and Napoli) tertiary MS centers. Predisposing factors to IRRs were investigated using multivariate Cox regression models. RESULTS A total of 11'133 infusions received by 302 MS patients were analyzed (68.9% females, median age 33.6 years, median EDSS 2.5). IRRs occurred in 24 (8%) patients during NTZ infusions and in 7 (2%) during one-hour post-infusion. Only 8 patients needed pharmacological treatment, of whom 7 during NTZ infusion. Age, sex and history of allergies were not associated with risks for IRR. The frequency of post infusion IRRs after the fifth cycle was low compared to that during the first four infusions (0.83% vs 0.06%). CONCLUSION In our cohort, NTZ associated IRR mainly occurred during the infusion period compared to the one-hour observational period. Also, the first IRR exclusively occurred within the first 4 NTZ administrations. However, further multi-center studies with a larger sample size are needed to capture rare and serious events that could emerge during the observational period and to make clinical recommendations.

Item Type:

Journal Article (Original Article)


04 Faculty of Medicine > Department of Head Organs and Neurology (DKNS) > Clinic of Neurology

UniBE Contributor:

Kamm, Christian Philipp


600 Technology > 610 Medicine & health








Chantal Kottler

Date Deposited:

20 Jan 2020 12:39

Last Modified:

16 Apr 2020 01:32

Publisher DOI:


PubMed ID:


Uncontrolled Keywords:

Infusion-related reactions Natalizumab One-hour post-infusion observation period Relapsing-remitting multiple sclerosis




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