Glatiramer, interferon beta-1b comparable in early RRMS

Key Points

An investigational 500-mcg dose of interferon beta-1b demonstrated no advantage compared with the approved 250-mcg dose of interferon beta-1b or with glatiramer 20 mg in reducing relapse risk in patients with early relapsing-remitting multiple sclerosis (RRMS), said Paul O'Connor, MD, MS Program Director, St. Michael's Hospital, the University of Toronto, at the 60th Annual Meeting of the American Academy of Neurology, Chicago.

Dr O'Connor presented the findings from the Betaferon/Betaseron Efficacy Yielding Outcomes of a New Dose (BEYOND) study, the purpose of which was to determine whether treatment with interferon beta-1b 500 mcg was safe, tolerable, and more effective than treatment with interferon beta-1b 250 mcg and whether treatment with interferon beta-1b was more tolerable and effective than treatment with glatiramer 20 mg.

BEYOND recruited 2,244 treatment-naïve patients with an Expanded Disability Status Scale (EDSS) score of 0 to 5.0 and ≥1 relapses in the year before enrollment. The trial was unique in that the primary end point was the risk for recurrent relapses, not annualized relapse rate.

Likewise, there were no differences between groups in the annualized relapse rates. "Sixty percent of patients in each group were relapse free during the course of the study," he said.

Adherence was not significantly different among the 3 groups: dropout rates ranged from 13% (interferon beta-1b 250 mcg) to 19% (interferon beta-1b 500 mcg).

Although flu-like symptoms were more common in the interferon beta-1b groups, the occurrence of these symptoms was essentially halved after the first year, said Dr O'Connor.

Systemic reactions were significantly more common in patients assigned to glatiramer "but they reflect the host injection reaction that's known to occur with glatiramer," Dr O'Connor said.

"BEYOND shows unequivocally the irreplaceable value of doing head-to-head studies versus cross comparing studies, which invariably involves looking at a slightly different population of patients using slightly different protocols, making it impossible to do an apples-to-apples comparison," said Dr O'Connor.

Choice of therapy "may boil down to choosing different patterns of side effects," he said. "For some patients, avoidance of particular side effects is of paramount importance when efficacy is the same." Some patients may prefer a drug that requires injections 3 times per week over one that requires daily injection, he said. Others may want to avoid the flu-like symptoms that occur more often with interferon beta preparations, whereas some may want to avoid the injection-site tenderness observed more often with glatiramer.