MRI after One Year of Treatment Helps Predict Long-Term Response to Interferon Beta in Multiple Sclerosis

Thomas S. May, MA

Rhodes, Greece–Magnetic resonance imaging (MRI) of brain lesions at the beginning and

after one year of treatment with Interferon beta (IFN-beta) can help identify patients with

multiple sclerosis (MS) who do not respond to this treatment, according to research

presented here at the 17th Meeting of the European Neurological Society (ENS).

Although previous studies have revealed similar findings, this is the first one that was done in a clinical setting of an MS center and not in a trial, said lead researcher Carlo Pozzilli, MD, of the Multiple Sclerosis Center at St. Andrea Hospital in Rome, Italy.

Dr. Pozzilli’s team conducted a retrospective, post-marketing study involving 345 patients (101 men and 244 women, mean age at baseline 32.9±9.1 years) who had been treated with IFN-beta for an average of four and a half years. At the beginning of the study, subjects had a mean disease duration of 5.5±4.9 years and a median Expanded Disability Status Scale (EDSS) score of 1.5.

The researchers analyzed EDSS scores and MRI scans taken at baseline and after one year of IFN-beta treatment of all patients who completed the study. For subjects who discontinued IFN-beta therapy, the final EDSS score was calculated based on the last neurological assessment during treatment.

Patients with an increase of at least one point on the EDSS score (confirmed in two consecutive visits separated by a six-month interval) were considered to have a “poor clinical response.” Disease activity was determined based on the presence of gadolinium-enhancing (Gd-enhancing) lesions in post-contrast T1-weighted scans and on the accumulation of hyperintense lesions on T2-weighted images.

Patients with a longer disease duration at the beginning of treatment and a higher baseline EDSS than those with a stable level of disability were more likely to have a poor response to IFN-beta therapy (p = 0.04 and p < 0.001, respectively). A relapse within the first year of treatment also was associated with an increased likelihood of poor response over the study period (OR 2, 95% CI 1.3-3.4; p = 0.003). However, the investigators found that MRI data were even stronger predictors of long-term outcome, whereby both the presence of at least one Gd-enhancing lesion at one year (OR 3.4, 95 % CI 2-5.7; p < 0.001) and an increase in T2 lesion burden (OR 8.6, 95% CI 5-14.5; p < 0.001) were related to a poor outcome.

“Early identification of nonresponders may help neurologists in their decision about MS treatment, Dr. Pozzilli said. "These results underline the importance of performing an MRI scan at the end of the first year of treatment with Interferon beta,” he added. “Clinical data did not help, at least in the short term, to predict the outcome,” Dr. Pozzilli noted.

According to Ben W. Thrower, MD, medical director of the MS Center at Shepherd in Atlanta, Georgia, the importance of early immunomodulatory therapy in relapsing-remitting multiple sclerosis (RRMS) has been demonstrated in several clinical trials. “Once such therapy is started, the next step is to monitor efficacy,” he said. Studies such as the ones by Dr. Pozzilli and colleagues are crucial to identifying clinical and paraclinical markers of inadequate responders, Dr. Thrower stressed. They emphasize the need to monitor relapses, disability, and MRI in RRMS patients, he said. “This study also found that a poor treatment response was associated with a longer duration of disease, pointing to a need for early intervention,” Dr. Thrower concluded.

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