PHILADELPHIA—After a patient with relapsing-remitting multiple sclerosis (MS) has been on a first-line drug for two years, the factors that most influence neurologists’ decision to consider changing therapies are clinical measures such as relapse rate and Expanded Disability Status Scale (EDSS) score and subclinical measures such as MRI, according to research presented at the 66th Annual Meeting of the American Academy of Neurology. In contrast, quality-of-life measures do not contribute significantly to treatment decisions, the researchers said.
Stephan Schmidt, MD, PhD, a neurologist at Neurologische Gemeinschaftspraxis in Bonn, Germany, and colleagues performed an interim analysis of data from EPIDEM, an ongoing retrospective, noninterventional study that collects cross-sectional data for 5,000 patients at 150 sites in Germany. Eligible patients had received immunomodulatory treatment (ie, interferon beta or glatiramer acetate) continuously during the two years before enrollment. The researchers collected information about demographics, immunomodulatory treatment, EDSS score, MRI, John Cunningham virus (JCV) status, and quality of life (using MSQoL-54).
During the study, the participants’ neurologists were asked whether they were considering a switch to a second-line therapy, and the researchers performed χ2 homogeneity analysis to identify factors that influenced this treatment decision. The study did not document whether patients switched to a second-line therapy, however.
Most Patients Had No Relapses or MRI Activity
The interim analysis included 2,500 patients from October 2011 to April 2013. Patients’ mean EDSS score was 2.2 at the beginning of the period and remained stable. Approximately 65% of patients had been relapse-free during the previous 24 months, and about 35% of patients had had at least one relapse.
MRI data were available for two-thirds of the participants. The mean duration between the documentation visit and the last MRI was 9.4 months. Approximately 74% of patients had neither increased T2 lesion load nor new gadolinium-enhancing T1 lesions, compared with the last MRI. About 23% of patients had increased MRI activity, compared with the last MRI.
The STRATIFY-JCV assay to determine JCV antibody status became available in Germany in May 2011. Neurologists determined the JCV antibody status of 6.1% of participants, and 56.9% of reported test results were positive.
Most Patients Reported Good Health
A total of 2,018 patients underwent MSQoL-54, and 74% of patients rated their general state of health as good to excellent. In addition, 21% of participants rated their overall health as fair, and 2% rated their health as poor.
Neurologists described the course of disease as stable in 81% of patients, improved in 3% of patients, and worse in 15% of patients. In contrast, 57% of patients described their course of disease as stable, 17% as improved, and 24% as worse.
Neurologists considered changing the current treatment regimen for 11% of the patients. The availability of JCV-antibody test results, relapse rate, EDSS score, and MRI activity had the strongest influence when considering second-line therapies. Quality-of-life parameters, treatment duration, disease duration, and number of previous disease-modifying therapies had little or no influence on therapeutic considerations.
—Erik Greb