A plain language summary of what clinical studies can tell us about the safety of evobrutinib - a potential treatment for multiple sclerosis.


Journal

Neurodegenerative disease management
ISSN: 1758-2032
Titre abrégé: Neurodegener Dis Manag
Pays: England
ID NLM: 101517977

Informations de publication

Date de publication:
Aug 2023
Historique:
medline: 10 7 2023
pubmed: 22 6 2023
entrez: 22 6 2023
Statut: ppublish

Résumé

This summary explains the findings from a recent investigation that combined the results of over 1000 people from three clinical studies to understand the safety of evobrutinib. Evobrutinib is an oral medication (taken by mouth), being researched as a potential treatment for multiple sclerosis (MS). This medication was also investigated in rheumatoid arthritis (RA) and systemic lupus erythematosus (SLE). Over 1000 people have taken evobrutinib as part of three separate phase 2 clinical studies. These studies looked at how much of the drug should be taken, how safe the drug is, and how well it might work for treating a certain medical condition. Evobrutinib was well-tolerated by participants in all three studies. The number of side effects reported by participants taking the medication was very similar to those reported by participants taking the placebo (a 'dummy' treatment without a real drug). The most common side effects in clinical studies were urinary tract infections, headache, swelling of the nose and throat, diarrhoea and blood markers of potential liver damage (these returned to normal once the treatment was stopped). The safety data from all three clinical studies are encouraging and can be used to inform further research into using evobrutinib in MS.

Identifiants

pubmed: 37345645
doi: 10.2217/nmt-2023-0003
doi:

Substances chimiques

evobrutinib ZA45457L1K
Pyrimidines 0

Banques de données

ClinicalTrials.gov
['NCT03233230', 'NCT02975336']

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

207-213

Auteurs

Xavier Montalban (X)

Department of Neurology-Neuroimmunology, Centre d'Esclerosi Múltiple de Catalunya (Cemcat), Vall d'Hebron University Hospital, Barcelona, Spain.

Daniel Wallace (D)

Cedars-Sinai Medical Center, David Geffen School of Medicine, University of California, Los Angeles, CA, USA.

Mark C Genovese (MC)

Division of Immunology & Rheumatology, Stanford University, Palo Alto, CA, USA.

Davorka Tomic (D)

Global Clinical Development, Ares Trading SA, Eysins, Switzerland, an affiliate of Merck KGaA.

Dana Parsons-Rich (D)

Global Clinical Development, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA.
ECD-Early Clinical Development, Pfizer, Cambridge, Massachusetts, USA.

Claire Le Bolay (CL)

Biostatistics, Merck Healthcare KGaA, Darmstadt, Germany.

Amy H Kao (AH)

EMD Serono Inc., Billerica, MA, USA, a healthcare business of Merck KGaA.

Hans Guehring (H)

Global Patient Safety, Merck Healthcare KGaA, Darmstadt, Germany.

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Classifications MeSH