TY - JOUR
T1 - Infusion-related reactions during Natalizumab treatment
T2 - Do we still need a post-infusion observation period?
AU - Sacco, R.
AU - Disanto, G.
AU - Maraffi, I.
AU - Candrian, U.
AU - Kamm, C. P.
AU - Rossi, S.
AU - Schwegler, G.
AU - Gallo, A.
AU - Gobbi, C.
AU - Zecca, C.
N1 - Funding Information:
Zecca C, Gobbi C received financial support for scientific activity, congress participation and speaking bureau from Almirall, Biogen, Bayer, CelleGene, Genzyme, Merck-Serono, Novartis, Roche, Teva Pharma. Sacco R, Disanto G, Maraffi I, Candrian U and Schwegler G declare that they have no conflict of interest Kamm CP has received honoraria for lectures as well as research support from Biogen , Novartis, Almirall, Bayer Schweiz AG, Teva, Merck, Sanofi Genzyme, Roche, Celgene and the Swiss MS Society (SMSG). Rossi S acted as an Advisory Board member of Biogen, Bayer Schering, Merck, Teva, Novartis, Genzyme, Mylan and received travel funding from Biogen, Merck, Teva, Novartis, Bayer Schering, Genzyme, Almirall, and received honoraria for consultancy, speaking or writing from Biogen, Merck, Teva, Novartis, Bayer Schering, Genzyme, Roche. She received support for research projects by Teva, Merck and Bayer Schering and is involved as principal investigator in clinical trials for Teva, Novartis, Biogen and Roche. Gallo A received honoraria for speaking and travel grants from Biogen, Sanofi-Aventis, Merck, Genzyme, Teva, and Novartis.
Publisher Copyright:
© 2019
Copyright:
Copyright 2019 Elsevier B.V., All rights reserved.
PY - 2020/2
Y1 - 2020/2
N2 - 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.
AB - 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.
KW - Infusion-related reactions
KW - Natalizumab
KW - One-hour post-infusion observation period
KW - Relapsing-remitting multiple sclerosis
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U2 - 10.1016/j.msard.2019.101523
DO - 10.1016/j.msard.2019.101523
M3 - Article
C2 - 31743848
AN - SCOPUS:85074968239
VL - 38
JO - Multiple Sclerosis and Related Disorders
JF - Multiple Sclerosis and Related Disorders
SN - 2211-0348
M1 - 101523
ER -