March 2019 marked history for multiple sclerosis treatment, as the U.S. Food and Drug Administration approved the first two drugs used to treat secondary-progressive MS.
The FDA signed off on a pill called siponimod on March 26, and three days later, approved another medication called cladribine. While the pills can treat patients with secondary-progressive phase, patients with relapsing-remitting MS can also take them.
“The drugs were approved in the area in which we didn’t have any medication,” said Luka Vlahovic, MD, a board certified neurologist with the CHI Health Neurological Institute. “It sounds very exciting and some preliminary data looks good, but I think we’ll need more validation to use them over a long period of time, five to 10 years, to have a better idea of impact on people’s lives.”
Dr. Vlahovic subspecializes in the diagnosis and treatment of neuroimmunological conditions like multiple sclerosis and neuromyelitis optica. He completed a neuroimmunology fellowship at Stanford University Medical Center before joining the CHI Health Neurological Institute. He’s since started an MS clinic, where patients come to him for expert diagnosis, evaluation and treatment options.
Dr. Vlahovic said those options will soon include siponimod and cladribine. Patients at the CHI Health Neurological Institute will have access to the newly-approved drugs. Dr. Vlahovic said trials showed disability progression slowed for people who took siponimod over a three-month period.
Both siponimod and cladribine have side effects. Patients taking cladribine have an increased risk of malignancies. The medication can also cause teratogenicity for both women and men. Because of this, Dr. Vlahovic said cladribine should be used as a second option and for a strictly-selected group who’ve experienced failure with other treatments.
Dr. Vlahovic said siponimod is similar to another MS medication called fingolimod. Side effects include a low heart rate, an increased risk of infections and macular edema. Diabetic patients should not use siponimod.
“None of these medications are considered to be a cure,” Dr. Vlahovic said. “But with appropriate time management, early initiation therapy and appropriate selection for specific patients, we can really change the course significantly or hopefully connect it almost as a cure.”
In the last 26 years, Dr. Vlahovic said the FDA has approved 16 medications for MS and research continues to evolve.
“The landscape has changed significantly,” Dr. Vlahovic said. “People have much more hope and much better chances for good outcomes.”
The Neurological Institute is also starting a new infusion center for its patients. The center will be a part of the CHI Health Henry Lynch Cancer Center at Immanuel. The Neurological Institute is also applying for its Partners in Care designation through the National MS Society, with the ultimate goal of becoming a comprehensive MS center. Dr. Vlahovic said that could happen as early as 2020.
“I think MS care looks very promising,” Dr. Vlahovic said. “This field was pretty depressing 30 to 40 years ago. Now, we have all these different tools. Beyond big breakthroughs in medications, the focus, and one of the most important things to identify, is biomarkers.”