Patients Prefer Oral Therapy Over Injections
Phase IV data for fingolimod show high levels of patient satisfaction with oral therapy over injectables.
People with relapsing multiple sclerosis reported “greater treatment satisfaction” with oral therapy, rather than staying on or switching to injectable agents, according to new data presented at the 2013 Annual Meeting of the Consortium of Multiple Sclerosis Centers. Specifically, the study showed that patients starting the oral treatment Gilenya (fingolimod) had higher rates of satisfaction than those switching to, or staying on, injectable interferon beta or glatiramer acetate.
Findings come from the US Phase IV randomized, multicenter, open-label study, called EPOC (Evaluate Patient OutComes) that evaluated treatment satisfaction among more than 1,000 MS patients. The study compared Gilenya to interferon beta or glatiramer acetate using a 100-point scale based on the Treatment Satisfaction Questionnaire for Medication (TSQM), a validated tool that measures patient satisfaction with medical treatments. The higher TSQM score, the higher satisfaction.
At six months, adjusted mean treatment global satisfaction subscale scores were 80.4 for Gilenya vs. 61.1 for the injectable disease modifying therapies (DMTs), an increase from baseline by 20.4 vs. 2.9 points, respectively. The mean difference between the two scores was a statistically significant 17.5.
“Neurologists should view the EPOC study as indicating that, in a large real-world setting population of MS patients, the switch from a standard DMT to Gilenya results in significant improvements in self-reported outcomes in a very safe fashion,” said Christopher LaGanke, MD, of North Central Neurology Associates in Cullman, AL, and a study investigator, in an interview with Practical Neurology.
A separate analysis of EPOC indicated that the overall incidence of infection was similar among patients taking Gilenya and patients taking standard injectable DMTs—consistent with results from previous studies. The analysis also found no observed relationship between lymphocyte counts and infection rates.
The reason for the higher satisfaction with Gilenya is more than merely the convenience of a pill, Dr. LaGanke said. “The global satisfaction score was significantly favorable for Gilenya over injectable DMT, with significant differences in not only the convenience subscale, but also the side effect and effectiveness subscales.”
Patients receive their first dose of Gilenya in a hospital setting where heart rhythm can be monitored for at least six hours, according to FDA recommendations. Dr. LaGanke said the survey take this into account and patients still respond favorably to this stipulation.
“The first dose of Gilenya was administered in the clinician’s office or hospital so that the heart rhythm could be assessed for at least six hours,” he said. “This aspect of Gilenya therapy did not result in lower scores of convenience of therapy, as the convenience subscale outcome measure on the Treatment Satisfaction Questionnaire for Medication was the most positive finding in favor of Gilenya over standard injectable DMT use.”
He added that the analysis of the infection rates also shed good news for patients. “All of these favorable results occurred in the absence of a significant difference in infection rates,” Dr. LaGanke said. “The overall and individual infection rates were not related to the WBC or CD4 counts. This follows from the fact that blood measured CBC and CD4 counts do not reflect the body stores of lymphocyte counts because of the unique mechanism of action of Gilenya.”
Secondary outcome measures were overwhelmingly statistically significantly positive in favor of the switch to fingolimod as opposed to remaining on standard DMT.