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

Abstract

Immunology; Rheumatology; Systemic lupus erythematosus

Inmunología; Reumatología; Lupus eritematoso sistémico

Immunologia; Reumatologia; Lupus eritematós sistèmic

What is this summary about?: 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.

What were the results?: 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).

What do the results mean?: The safety data from all three clinical studies are encouraging and can be used to inform further research into using evobrutinib in MS.

X Montalban has received speaking honoraria and travel expenses for participation in scientific meetings, has been a steering committee member of clinical trials or participated in advisory boards of clinical trials in the past years with Abbvie, Actelion, Alexion, Biogen, Bristol-Myers Squibb/Celgene, EMD Serono, Genzyme, Hoffmann-La Roche, Immunic, Janssen Pharmaceuticals, Medday, Merck, Mylan, Nervgen, Novartis, Sandoz, Sanofi-Genzyme, Teva Pharmaceutical, TG Therapeutics, Excemed, MSIF and NMSS. D Wallace has received consultant fees from Amgen, Celgene, Eli Lilly, EMD Serono Research & Development Institute, Inc., Billerica, MA, USA (an affiliate of Merck KGaA), Janssen and Merck. MC Genovese is an employee of and has financial interests in Gilead. D Tomic is an employee of Ares Trading SA, Eysins, Switzerland, an affiliate of Merck KGaA, and received stock or an ownership interest from Novartis. D Parsons-Rich was an employee of EMD Serono Research & Development Institute, Inc., Billerica, MA, USA, an affiliate of Merck KGaA, at the time of the study, and is currently an employee of and has received stock from Pfizer. C Le Bolay and H Guehring are employees of Merck Healthcare KGaA, Darmstadt, Germany. A Kao is an employee of and received stock or an ownership interest from EMD Serono Inc., Billerica, MA, USA, a healthcare business of Merck KGaA. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed. The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: this work was supported by Merck (CrossRef Funder ID: 10.13039/100009945). This summary was prepared by Lumanity on behalf of, and funded by, Merck KGaA, Darmstadt, Germany.