Biogen Inc. recently announced data that included extended results from its earlier Phase 3b NOVA study on the administration of natalizumab and the evaluation of the drugs Tysabri® and Vumerity. Results of the studies, according to a report in Biospace, were presented at the 37th Congress of ECTRIMS held as a “digital experience” in October 2021.
About the Nova Study
The Nova study, relying on an analysis from the TOUCH program, shows that dosing every six weeks (Q6W) with 300mg of natalizumab IV (brand name Tysabri) for relapsing/remitting MS presents the same level of gastrointestinal tolerability as administering the currently approved Tysabri at 300mg every four weeks (Q4W).
The Q6W dosing resulted in a substantial reduction of the risk of PML (progressive multifocal leukoencephalopathy). PML is an aggressive viral disease of the central nervous system. Patients were able to switch to Q6W after demonstrating one year of stability on Q4W dosing.
The TOUCH data showed that the Q6W regimen reduced PML risk by eighty-eight percent compared to the Q4W dose.
Safety findings were similar in both treatment arms.
Tysabri versus Ocrevus
Reported relapse of MS patients who have been receiving disease-modifying treatment shows substantially less risk with Tysabri (n=835) than with Ocrevus (n=3,497). U.S. data were taken between 2017 through 2020.
Further analysis showed that patients receiving Tysabri treatment would in all probability remain free of relapse for twenty-four months compared to Ocrevus patients expected to remain relapse-free for twelve months.
About Vumerity
A report was presented at the conference based on people beginning Vumerity treatment in comparison to Tecfidera® treatment (safety information here).
GI events were fewer with less severity when patients were treated with Vumerity. GI tolerability was improved during dose titration and maintenance. Titration helps to limit side effects by observing the body’s reaction to a drug. The dose is increased until reaching the target dose or the individual experiences side effects.
About Tysabri
Tysabri is very well-established as a treatment for relapsing MS having been approved in eighty countries and being used by over 233,000 people around the globe. The drug has proven to slow the progression of physical disabilities and prevent the development of brain lesions. Relapses in patients using Tysabri have been less frequent.
Risk Factors to be Considered
- Tysabri (natalizumab) raises the risk of PML (progressive multifocal leukoencephalopathy) which is a rare viral infection in the brain that may cause severe disability or even death.
- The risk associated with PML occurs through previous use of immunosuppressants and prolonged use of Tysabri
- The presence of anti-JC virus antibodies is a risk factor for the development of PML
- Tysabri raises the risk of meningitis and encephalitis resulting from herpes simplex and other viruses.
- Liver injury and liver failure to the extent of requiring transplant have occurred.
About Vumerity®
Vumeritiy, otherwise known as diroximel fumarate, taken orally twice a day has a similarity to Tecfidera but is better tolerated with fewer GI side effects. Vumerity has been FDA approved to treat MS relapses including isolated syndrome, relapsing-remitting (intervals of recurrence and remission), and secondary progressive disease where MS changes result in fewer relapses but an increase in disability.
Common AEs were abdominal pain, flushing, nausea, and diarrhea. Once it enters the body, Vumerity changes to monomethyl fumarate, the active metabolite in dimethyl fumarate. Therefore, Vumerity is contraindicated to patients receiving dimethyl fumarate as well as patients with hypersensitivity to dirosimel fumarate.
Vumerity, similar to Tecfidera, can cause serious side-effects including PML that can cause a severe disability within weeks or months and lead to death.
Please note: important safety and prescribing information about Vumerity is available here.
About Tecfidera
Tecfidera, a/k/a dimethyl fumarate, treats forms of relapsing adult MS and may
- Slow the progression of MS
- Have a positive effect on brain lesions
- Lessen MS relapses
- Have a well-established safety profile
Contraindications are similar to those of Vumerity. Anaphylaxis (allergic reaction) and angioedema (swelling) are among the drug’s severe side effects. PML and low lymphocyte levels may be in evidence during year one of treatment.
About Biogen
Biogen, founded in 1978, has a staff of neuroscience pioneers and developers who deliver innovative therapies to people with neurodegenerative and neurological diseases.
Biogen’s focus is on research programs including but not limited to neuromuscular and movement disorders, immunology, neuropathic pain, and acute neurology.
