TORONTO -- Researchers said that after two years of therapy, no new safety signals have emerged among patients using the investigational oral multiple sclerosis drug fingolimod.
In addition, patients who switched to fingolimod from an injected disease-modifying agent achieved disease control, according to Bhupendra Khatri, MD, medical director of the multiple sclerosis center at Aurora St. Luke's Medical Center, Milwaukee.
"For patients on continuous fingolimod, relapse rates and magnetic resonance imaging activity during year two remained at levels seen in year 1 with no new safety findings," Khatri said during a poster presentation here at the annual meeting of the American Academy of Neurology.
Action Points
- Explain to interested patients that after two years of study, the investigational oral multiple sclerosis drug fingolimod appears to be safe and effective in many patients. Note that the drug has not been approved by the FDA.
- Note that this study was published as an abstract and presented at a conference. These data and conclusions should be considered preliminary until published in a peer-reviewed journal.
Khatri reported findings from the extension of TRANSFORMS (the Trial Assessing injectable interferon vs FTY720 Oral in Relapsing-remitting Multiple Sclerosis), in which patients on fingolimod or intramuscular interferon beta-1a were continued on fingolimod doses of 0.5 mg or 1.25 mg for another year of treatment.
Khatri said 882 patients completed the two-year program, with 71% to 73% of the fingolimod patients completing two years free of relapses, compared with 60% of the patients first treated with interferon and then switched to fingolimod (P<0.001).
He said that five new skin cancers were diagnosed during the extension study -- two in each of the continuous fingolimod patients and one in the switched patients -- a rate that was less than observed in the core study, he said. All the cancers were successfully excised.
Three new cases of macular edema were identified -- one in a high-dose fingolimod patient and two among the high-dose, switched patients. All the cases resolved with discontinuation of fingolimod.
In the first 12 months of therapy, two patients died from complications related to overwhelming herpes virus infections. One died from herpes simplex encephalitis after a reported one week delay to diagnosis, and the second died from disseminated herpes zoster (VZV).
This patient was reportedly naive to herpes zoster infection. No additional serious herpes infections were reported in this study, which evaluated the drug for the period of 12 months after the close of blinded clinical trial.
"Switching from interferon beta-1a to fingolimod benefited patients," Khatri said. "The aggregate annualized relapse rate declined by 30 to 36%, and the mean number of new or enlarged T2 lesions decreased by 62% to 63% following switching to fingolimod."
He said that the oral drug was well-tolerated.
"These results are relevant to clinical practice," said Patricia O'Looney, PhD, vice president for biomedical research at the National Multiple Sclerosis Society.
She said that when the new oral drugs for treatment of multiple sclerosis reach the market, doctors will want to know if there are issues in switching patients from interferon to fingolimod.
"This is a key question," she told MedPage Today. "Can you switch and if you switch, what is the impact?" The study, she suggested, indicates such a switch would be feasible.
The study was supported by Novartis Pharma AG, Basel, Switzerland.
Disclosures
Khatri disclosed financial relationships with Teva, Bayer, Pfizer, Medtronics, Biogen Idec, Serono and GlaxoSmithKline.
Other authors on the study disclosed financial relationships with multiple industry sources including Bayer-Schering Pharma, Merck Serono, Novartis, sanofi-aventis, Genzyme, Roche, UBC, VA Pharmaceutical, Biogen-Domp 32, Accorda, Actelion, Allzyme, BaroFold, Bayhill, Blogeb Idec, Boehringer Ingelheim, Eisai, Elan, Genmab, Medicinova, Santhera, Shire, Wyeth, Genentech, Artielle and BioMS.
O'Looney had no disclosures.
Primary Source
American Academy of Neurology
Source Reference: Khatri B, et al "24-month efficacy and safety outcomes from the TRANSFORMS extension study of oral fingolimod (FTY720) in patients with relapsing-remitting multiple sclerosis" AAN 2010; Abstract P03.125.