Oral Steroids Effective in MS
Outcomes for multiple sclerosis patients in relapse who were treated with oral methylprednisolone were no different than those of similar patients who received intravenous steroids, researchers reported here.
After 28 weeks, 16 of 22 patients (72.7%) given oral medication achieved at least a one point improvement in the standard Expanded Disability Status Scale compared with 16 of 23 patients (69.6%) who were treated with the drug IV (P=1.0), according to Cristina Ramo-Tello, MD, a staff neurologist at H. Germans Trias I Pujol Hospital in Badalona, Spain.
“We were able to show that 1,250 mg of oral methylprednisolone given daily for 3 days was not inferior to the bioequivalent 1,000 mg of methylprednisolone daily for 3 days administered intravenously,” Ramo-Tello told MedPage Today at a poster presentation at the American Academy of Neurology meeting.
“We know that corticosteroids improve the rate of recovery from multiple sclerosis relapses,” she said, “but the optimal dose, frequency and duration of treatment, and the route of administration are unknown.”
Generally, she said physicians treat patients with IV methylprednisolone for 3 to 5 days, and then they may taper the steroid dose.
Multiple sclerosis (or MS) is a chronic, often disabling disease that attacks the central nervous system (CNS), which is made up of the brain, spinal cord, and optic nerves. Symptoms may be mild, such as numbness in the limbs, or severe, such as paralysis or loss of vision. The progress, severity, and specific symptoms of MS are unpredictable and vary from one person to another. Today, new treatments and advances in research are giving new hope to people affected by the disease.
MS is Thought to be an Autoimmune Disease
The body’s own defense system attacks myelin, the fatty substance that surrounds and protects the nerve fibers in the central nervous system. The nerve fibers themselves can also be damaged. The damaged myelin forms scar tissue (sclerosis), which gives the disease its name. When any part of the myelin sheath or nerve fiber is damaged or destroyed, nerve impulses traveling to and from the brain and spinal cord are distorted or interrupted, producing the variety of symptoms that can occur.
Most people with MS learn to cope with the disease and continue to lead satisfying, productive lives.
Noting previous trials in which the oral form of the drug was used without compromising outcomes, the researchers enrolled patients at seven hospitals in the Catalonia region of Spain into the phase IV double blind, randomized trial.
“We found no differences in outcomes or in adverse events,” Ramo-Tello said. The side effect profiles for both groups of patients were almost mirror images. Two patients receiving oral methylprednisolone experienced diarrhea; 19 patients on the oral drug experienced insomnia, compared with 14 receiving the intravenous administration.
“This study is confirmation of what we found in our study,” said Marcelo Kremenchutzky, MD, associate professor of neurology at the University of Western Ontario and the London Health Sciences Center in London, Ontario, as he reviewed the poster presentation. He did not participate in the Spanish study.
“We also found that patients do find oral treatment more convenient than intravenous therapy,” Kremenchutzky told MedPage Today. “It’s not inferior. It’s cheaper for the system or the payor depending where they are, and patients do not have any more gastrointestinal side effects with the oral treatment than with intravenous treatment.”
He said that half of Canadian multiple sclerosis centers now use oral therapy in treating patients with relapses.