In 13 completed randomised controlled and open-label extension trials, the oral Bruton’s tyrosine kinase inhibitor (BTKi) fenebrutinib was generally well tolerated at the highest dose. There were no increases in infection rates. The observed safety profile of fenebrutinib supports testing in phase 3 clinical trials in multiple sclerosis (MS).
Of currently investigated BTKis in MS, fenebrutinib has the largest clinical safety database, allowing for assessment of its potential in MS management. A total of 13 completed phase 2 trials and extensions in rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and chronic spontaneous urticaria (CSU) were analysed [1]. Safety assessments included adverse events (AEs), laboratory results, ECGs, and vital signs. This analysis only included patients who received fenebrutinib at the highest dose of 200 mg twice daily (n=792) or placebo.
In the fenebrutinib and placebo groups, 299 and 278 patients experienced one or more AEs, respectively; these were mostly not serious. AEs reported in >5% of fenebrutinib-treated patients were nasopharyngitis (6%), nausea (5.7%), and headache (5.4%). Serious infections were reported in 6 patients (2%) receiving fenebrutinib and 5 patients (1.8%) receiving placebo. Asymptomatic, reversible grade 2 and 3 alanine aminotransferase elevations were seen in 11 (3.7%) and 3 (1.1%) patients, respectively. Bleeding or bruising was reported in 23 (7.7%) and 9 (3.2%) patients, with no major haemorrhage. AEs generally became less frequent with prolonged exposure during open-label extension trials.
- Oh J, et al. The Safety of Fenebrutinib in a Large Population of Patients With Diverse Autoimmune Indications Supports Investigation in Multiple Sclerosis (MS). S25.005, AAN 2021 Virtual Congress, 17-22 April.
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Table of Contents: AAN 2021
Featured articles
Letter from the Editor
Interview with AAN President Dr James C. Stevens
COVID-19 and Neurology
The neurological impact of COVID-19
Chemosensory dysfunction often persistent after COVID-19
Pandemic results in decreased global stroke care
Stroke uncommon in critically ill COVID-19 patients
Cognitive Impairment and Dementias
Obstructive sleep apnoea associated with lower cognition
NfL is a better marker for neurodegeneration than T-tau
Monoclonal antibody rapidly reduces brain amyloid
Epilepsy
Extraordinary transformation of epilepsy care in Ontario
No neurodevelopmental effects of foetal antiseizure medication
Migraine and Other Headaches
Long-term safety of atogepant as migraine prophylaxis
Multiple Sclerosis
Dysmetabolism may drive MS progression
Predicting long-term prognosis in paediatric MS patients
Neuromuscular Disorders
Functional and survival benefits of AMX0035 in ALS
Parkinson’s Disease and Other Movement Disorders
Autoimmune mechanisms implicated in Parkinson’s disease
Novel non–D2-receptor-binding treatment for Parkinson’s disease psychosis
Troriluzole for spinocerebellar ataxia
Stroke
Can linoleic acid help prevent stroke?
No association between SSRIs and risk of ICH
Other Topics
Vutrisiran for hATTR amyloidosis with polyneuropathy
10 kHz spinal cord stimulation for painful diabetic neuropathy
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