Switching From MS Injectables to Fingolimod
Editor's Note: While on site at the 6th Cooperative Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS), held in Dallas, Texas, May 28-31, 2014, Medscape correspondent Andrew N. Wilner, MD, spoke with Bruce Cree, MD, PhD, MCR, Associate Professor of Clinical Neurology and Clinical Research Director at the University of California, San Francisco, about patient satisfaction with switching from injectable multiple sclerosis therapies to fingolimod.
Andrew N. Wilner, MD: Dr. Cree, you are here in front of your poster, titled "Patient and Physician Reported Outcomes After Therapy Switched from Interferon or Glatiramer Acetate to Fingolimod." Can you tell us what you found?
Bruce Cree, MD, PhD, MCR: This is an analysis of the EPOC study, looking at the transition of patients who are switched from autoinjectable therapies (the interferons and glatiramer acetate) to fingolimod. In this study, the patients were randomly assigned to either stay on an autoinjectable therapy or to transition over to fingolimod.
It was a 6-month study, and the main goal was to determine therapeutic satisfaction. The tool that was used was a patient-reported outcome, the TSQM (Treatment Satisfaction Questionnaire for Medication). We found that as the patients transitioned to fingolimod away from autoinjectable therapies, their satisfaction with treatment improved. This was driven primarily by a perception of convenience; it was more convenient for the patients.
This study also looked at 2 other patient-reported outcomes of interest. Depression was measured by the Beck Depression Inventory, and fatigue was measured by the Fatigue Severity Scale. Improvements in both of these scales were seen as the patients transitioned to fingolimod from most of the treatments, although it didn't reach the level of statistical significance necessarily for each individual treatment.
The other component was looking at the ways in which physicians assessed how the patients were doing. The instrument that was used was a survey called the Clinical Global Impression of Improvement. Physicians were asked, "How do you think your patient is doing?" and across the board, physicians perceived that their patients had improved after the transition. This study provides information about patient-reported outcomes and clinician-reported outcomes 6 months after a switch from first-line autoinjectable therapy to fingolimod.
What is nice about this study is that it was randomized, so there is a control group of patients who stayed on active treatment. It provides information that I think we all anticipated, which was that treatment satisfaction and clinician-perceived improvement are associated with a transition to an oral disease-modifying therapy.
Dr. Wilner: This oral disease-modifying therapy, fingolimod, is just 1 of 3 that are available. There is also dimethyl fumarate (Tecfidera®) and teriflunomide (Aubagio®). Would it be reasonable to conclude that patient satisfaction would improve also with the other oral therapies?
Dr. Cree: This study only looked at transitioning patients from interferons and glatiramer acetate to fingolimod, so it didn't directly address the question of transitioning patients from an autoinjectable therapy to dimethyl fumarate or to teriflunomide. That being said, it is reasonable to anticipate that similar outcomes might be expected, but you really have to do the studies to figure those sorts of things out.
Each of those other drugs has a unique safety profile that might come into play in a study such as this. For example, with dimethyl fumarate, treatment-related adverse events commonly occur in the first month of therapy that might result in treatment discontinuation. That might be reflected in different therapeutic satisfaction scores with that particular agent.
Similarly with teriflunomide, there is a requirement for doing monthly blood tests to monitor for liver function abnormalities for the first 6 months that a patient is on the drug. That might also change patient perception. I don't know for certain; you would have to do the study to find out.
Editor's Note: While on site at the 6th Cooperative Meeting of the Consortium of Multiple Sclerosis Centers (CMSC) and the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS), held in Dallas, Texas, May 28-31, 2014, Medscape correspondent Andrew N. Wilner, MD, spoke with Bruce Cree, MD, PhD, MCR, Associate Professor of Clinical Neurology and Clinical Research Director at the University of California, San Francisco, about patient satisfaction with switching from injectable multiple sclerosis therapies to fingolimod.
Andrew N. Wilner, MD: Dr. Cree, you are here in front of your poster, titled "Patient and Physician Reported Outcomes After Therapy Switched from Interferon or Glatiramer Acetate to Fingolimod." Can you tell us what you found?
Bruce Cree, MD, PhD, MCR: This is an analysis of the EPOC study, looking at the transition of patients who are switched from autoinjectable therapies (the interferons and glatiramer acetate) to fingolimod. In this study, the patients were randomly assigned to either stay on an autoinjectable therapy or to transition over to fingolimod.
It was a 6-month study, and the main goal was to determine therapeutic satisfaction. The tool that was used was a patient-reported outcome, the TSQM (Treatment Satisfaction Questionnaire for Medication). We found that as the patients transitioned to fingolimod away from autoinjectable therapies, their satisfaction with treatment improved. This was driven primarily by a perception of convenience; it was more convenient for the patients.
This study also looked at 2 other patient-reported outcomes of interest. Depression was measured by the Beck Depression Inventory, and fatigue was measured by the Fatigue Severity Scale. Improvements in both of these scales were seen as the patients transitioned to fingolimod from most of the treatments, although it didn't reach the level of statistical significance necessarily for each individual treatment.
The other component was looking at the ways in which physicians assessed how the patients were doing. The instrument that was used was a survey called the Clinical Global Impression of Improvement. Physicians were asked, "How do you think your patient is doing?" and across the board, physicians perceived that their patients had improved after the transition. This study provides information about patient-reported outcomes and clinician-reported outcomes 6 months after a switch from first-line autoinjectable therapy to fingolimod.
What is nice about this study is that it was randomized, so there is a control group of patients who stayed on active treatment. It provides information that I think we all anticipated, which was that treatment satisfaction and clinician-perceived improvement are associated with a transition to an oral disease-modifying therapy.
Dr. Wilner: This oral disease-modifying therapy, fingolimod, is just 1 of 3 that are available. There is also dimethyl fumarate (Tecfidera®) and teriflunomide (Aubagio®). Would it be reasonable to conclude that patient satisfaction would improve also with the other oral therapies?
Dr. Cree: This study only looked at transitioning patients from interferons and glatiramer acetate to fingolimod, so it didn't directly address the question of transitioning patients from an autoinjectable therapy to dimethyl fumarate or to teriflunomide. That being said, it is reasonable to anticipate that similar outcomes might be expected, but you really have to do the studies to figure those sorts of things out.
Each of those other drugs has a unique safety profile that might come into play in a study such as this. For example, with dimethyl fumarate, treatment-related adverse events commonly occur in the first month of therapy that might result in treatment discontinuation. That might be reflected in different therapeutic satisfaction scores with that particular agent.
Similarly with teriflunomide, there is a requirement for doing monthly blood tests to monitor for liver function abnormalities for the first 6 months that a patient is on the drug. That might also change patient perception. I don't know for certain; you would have to do the study to find out.
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