MS Patient’s Picks of the Week’s News: Zinbryta, Gadolinum, Calcium, Brain’s Defense, Antibiotic
Here are my Picks of the Week’s News, as published by Multiple Sclerosis News Today.
It can only be good for people with relapsing MS in Canada that they now may receive Zinbryta as a treatment.
Health Canada has approved Zinbryta (daclizumab) as a treatment for adults with active relapsing-remitting multiple sclerosis (RRMS), Biogen and AbbVie announced. Zinbryta is a long-acting injection therapy, self-administered monthly, for patients who have had an inadequate response to at least two other MS therapies.
Zinbryta is the first once-monthly, self-administered treatment for MS, and it demonstrated superior efficacy over a widely used interferon. Clinical data showed Zinbryta significantly reduced relapses and brain lesions for up to three years compared to Avonex (interferon beta-1a) intramuscular injection, and has a positive benefit-risk profile with monthly patient monitoring,” Lisa Hickey, vice president and managing director at Biogen Canada, said in a press release.
Zinbryta’s approval by Health Canada was based on data from the global Phase 3 DECIDE (NCT01064401) and Phase 2b SELECT (NCT00390221) clinical trials, in which Zinbryta 150 mg, administered once per month, improved the clinical outcomes of MS disease activity in 2,400 patients with relapsing MS, compared to Avonex (30 mcg administered every week) and a placebo.
Specifically, in both clinical trials, Zinbryta significantly reduced by 45% the annualized relapse rate (ARR) compared to Avonex at up to 144 weeks, and by 54% compared to placebo at 52 weeks.
This is not so good news for those of us with MS who have had a number of MRI scans with the contrast agent known as gadolinium. While it makes the scan easier to read, new data suggests it may add to the duration and severity of the disease.
Certain contrast agents used during magnetic resonance imaging (MRI) may accumulate in specific brain areas and contribute to disease duration and severity in patients with multiple sclerosis (MS), according to a new study published in the Multiple Sclerosis Journal.
The study, “Gadopentetate But Not Gadobutrol Accumulates In The Dentate Nucleus Of Multiple Sclerosis Patients,” was conducted by researchers from Charité – Universitätsmedizin Berlin and the Max Delbrück Center for Molecular Medicine in Germany.
MRI scans are frequently performed using a contrast agent called gadolinium — a rare earth element — that can accumulate in the brain with every scan. Although there is no evidence as to whether these deposits can interfere with the brain, the concern persists among doctors and patients.
The possibility of gadolinium accumulation causing any changes in brain activity is of particular importance to MS patients, who usually develop symptoms as young adults and are submitted to more contrast-enhanced MRI scans during their lives.
“Patients who received a different type of MRI contrast agent — one that is referred to as a macrocyclic contrast agent [Gd-BT-DO3A] — showed no evidence of gadolinium brain deposition,” said Michael Scheel, senior author of the study, in a press release.
I find it most interesting that calcium may have a part to play in myelin formation and, maybe, remyelination as calcium is one of the products of vitamin D.
A specific type of channel that facilitates calcium flow is needed for normal development of cells that produce myelin around nerve fibers.
Researchers now hope to find ways to manipulate calcium channels after an injury that leads to oligodendrocyte-cell dysfunction and to regenerate these cells. Since plenty of drugs targeting calcium channels already exist for other diseases, the team hopes that knowledge from other fields will help advance their research.
A University at Buffalo research team using mice to study myelin damage and regeneration discovered that, when a particular calcium channel worked normally, oligodendrocyte cells matured and myelin was formed.
New discovery in brain defenses, run by the body’s immune system, may provide progress in the fight against MS.
The brain has a system for orchestrating a defense against viral infections, scientists report in a finding that may advance the understanding of disease processes in multiple sclerosis.
The newly discovered system is run by brain immune cells called microglia, and researchers will now focus on understanding how these cells balance the ordered immune reactions so that a virus can be conquered without too much damage to the brain.
The study, “Sensing of HSV-1 by the cGAS–STING pathway in microglia orchestrates antiviral defence in the CNS,” was published in the journal Nature Communications.
Working with the herpes simplex virus, which can cause encephalitis, researchers at Aarhus University in Denmark discovered that when microglia detect a virus in the brain, they turn on an “alarm system,” called cGAS/STING.
Although the cGAS/STING system is present in other brain cells, such as neurons and astrocytes, only microglia are capable of using it to coordinate a defense.
“We have identified and described a communication network that begins in the brain when the cGAS/STING alarm system is activated,” Line Reinert, an associate professor from the Department of Biomedicine at Aarhus University, and the study’s lead author, said in a press release.
“This new knowledge can potentially be utilized to prevent other types of diseases of the brain, where the same alarm system is either not activated or is activated too much,” added Reinert, referring to diseases such as MS, Alzheimer’s, or psychiatric disorders.
It’s a small trial, too small to be significant as far as efficacy, but certainly of more than passing interest.
Promising data from a small Phase 2a clinical trial sponsored by RedHill Biopharma for an antibiotic designed to fight certain infections suggests that adding the drug candidate to interferon treatment reduced relapse rates and brain lesion formation in patients with relapsing forms of multiple sclerosis (MS).
This novel treatment approach was based on studies suggesting that infection caused by the intracellular bacteria Mycobacterium avium subspecies paratuberculosis (MAP) is linked to the development of MS, possibly through MAP-triggered abnormalities of the immune system. The study adds additional support to the theory.
The study recruited 18 patients, of whom 10 completed the entire trial. Patients had been treated with interferon for an average of five years before entering the study.
“Although designed as an exploratory proof-of-concept study in a very small patient population and not powered for efficacy, the study results demonstrate positive safety data and clinical signals, supporting additional studies to better investigate the therapeutic potential of RHB-104 in RRMS,” Ira Kalfus, MD, medical director of RedHill and the CEASE-MS study, said in a press release.
The treatment was generally well-tolerated, but two participants withdrew from the study because of a metallic taste as well as nausea and vomiting.