A new study suggests that patients with relapsing-remitting multiple sclerosis (RRMS) in whom previous treatment regimens have failed remain stable or show improvement when switched to treatment with natalizumab (Tysabri, Novartis).
In Natalizumab, considered very effective, is still viewed as an alternative treatment because of cases of progressive multifocal leukoencephalopathy that have been reported with treatment.
In this report, the researchers conducted a retrospective medical record review of 39 RRMS patients in whom previous treatments have failed. Patients were followed up for a minimum of 6 months to a maximum of 24 months.
Neurologic examinations and the EDSS were performed every 6 months. Eleven patients were previously treated with glatiramer acetate (Copaxone), 16 with interferon beta-1b (Betaseron), 11 with interferon beta-1a (Avonex: 3 patients; Rebif: 8 patients), and 1 with azathioprine (Imuran). Some patients may have received concomitant steroid treatment.
Participants had a median EDSS score of 3.0 and median counts of T2 lesions and black holes of 18 and 4. The researchers found no statistically significant changes in EDSS scores or MRI changes at 6, 12, 18, and 24 months.
At 24 months, 54% of patients had unchanged T2 counts, whereas 38% had improved counts, and 8% had worsened counts compared with month 0. There were no changes in black holes in most patients.
Overall, 87% of RRMS patients showed stable to improved MRI scans, and 59% had stability or improvement in EDSS scores.
"It's important to know [that there are alternatives] in a disease like MS," Robert P. Lisak, MD, professor of neurology at Wayne State University, Detroit, Michigan, who attended the presentation, told Medscape Neurology.
"If a drug is no longer working or the patient doesn't want to take it, the physician isn't stuck in a position of saying, 'there's nothing I can do for you,'" he added.
The study was supported by the Consortium of Multiple Sclerosis Centers. Mr. Ettensohn has disclosed no relevant financial relationships. Disclosures for coauthors appear in the abstract. Dr. Lisak reports he is part of a group that receives funding from Novartis, makers of natalizumab.Consortium of Multiple Sclerosis Centers (CMSC) 24th Annual Conference and the Third Joint Meeting of Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS): Abstract S35. Presented June 4, 2010.87% of patients who had previously been treated with disease-modifying therapies (DMTs), treatment with natalizumab conferred stability or improvement in magnetic resonance imaging (MRI) scans. In addition, 59% of patients showed stability or improvement in Expanded Disability Status Scale (EDSS) scores.
"We're looking at patients who failed first-line treatment," Marc Ettensohn, a medical student at the University of Louisville in Kentucky, who presented the results, told Medscape Neurology. The stability or improvements in patients in this series, he said, "is saying a lot about the drug and its efficacy. I think this is probably one of the most effective drugs for those who fail first-line treatments."
The results were reported here at the Consortium of Multiple Sclerosis Centers 24th Annual Conference and the Third Joint Meeting of Americas Committee for Treatment and Research in Multiple Sclerosis.
Tried and Failed DMTs
Natalizumab has previously been shown to reduce new or newly enlarging T2-hyperintense lesions (T2 lesions) and improve EDSS scores in treatment-naive RRMS patients. However, most patients receiving natalizumab have received DMTs that have failed.