Merck has presented in the last edition of the Congress of the European Academy of Neurology (EAN), the first evidence showing that patients with a autoimmune diseasein this case systemic lupus erythematosus (SLE), treated with Bruton’s tyrosine kinase inhibitor (BTK) evobrutinib can generate a humoral response to vaccination. GM talks to Davorka L. Tomic, Head of Neurology Global Clinical Development at Merckto know all the information about this important advance.
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Ask. What are the main results that have been presented at the EAN Congress on evobrutinib?
Response. In the EAN we have presented the results showing that patients with SLE treated with evobrutinib can trigger a humoral response to vaccination against seasonal influenza. The data revealed that the seroprotection rates of patients treated with evobrutinib in a phase II trial increased from 56.3% to 81.3% after influenza vaccination (compared to 69.6% and 91.3% % of placebo, respectively). The overall humoral immune response to influenza vaccine was similar between patients treated with placebo and evobrutinib for various strains of influenza.
“There is often concern that patients with autoimmune diseases may be immunosuppressed and have a reduced immune response to vaccines“
Q: Why are these results so important?
A. There is often concern that patients with autoimmune diseases may be immunocompromised and have a reduced immune response to vaccines, especially while receiving various disease-modifying therapies. These are the first data available on a vaccine response in patients with an autoimmune disease treated with a BTK inhibitor.
P: Until now, what effect did the administration of BTK inhibitors have on the vaccination of patients with chronic or oncological diseases?
A. Data on the effect of BTK inhibitors on vaccine efficacy and humoral response to vaccination have been limited to cancer patients, with disparate results from different studies. But we know that vaccination considerations are especially crucial for those with autoimmune diseases like multiple sclerosis (MS).
“Inhibition of BTK is thought to suppress autoreactive cells, which preclinical research suggests could be therapeutically useful in certain autoimmune diseases“
P. What is the mechanism of action of evobrutinib and in what diseases is it indicated?
A. Evobrutinib is in clinical development to investigate its potential as a treatment for MS. It is a highly selective oral inhibitor of BTK, which is important in the development and function of various immune cells, including B cells and macrophages. Being a small molecule, it can also penetrate the central nervous system and target B cells and microglia in the brain and spinal cord. It is designed to inhibit primary B cell responses such as proliferation and the release of antibodies and cytokines, without directly affecting T cells. Inhibition of BTK is thought to suppress autoreactive cells, which preclinical research suggests , could be useful from a therapeutic point of view in certain autoimmune diseases.
“We continue to develop the assets in our portfolio and explore internal and external opportunities that could allow us to expand into other potential neuroinflammatory diseases”
Q. What else is Merck currently working on in Neurology?
A. Our line of work is focused on discovering new therapies in which we can apply our scientific experience to address the challenges and needs faced by people living with MS, as well as those living with other chronic diseases such as SLE, myasthenia gravis (MGG), and neuromyelitis optica spectrum disorder (NMOSD). In the MS arena, we are committed to deepening our understanding of evobrutinib, as well as Mavenclad and Rebif. We continue to advance our understanding of its clinical benefit and real-world evidence through ongoing Phase IV and investigator-initiated studies in MS patients.
Q. What is the company’s commitment to Neurology?
A. We continue to develop our portfolio assets and explore internal and external opportunities that could allow us to expand into other potential neuroinflammatory diseases, ultimately allowing us to help more people simply live their lives. We are committed to providing comprehensive patient support through education and community support beyond R&D.
