medwireNews: The DECIDE study shows that 4-weekly daclizumab high-yield process (HYP) reduces disease activity in patients with relapsing–remitting multiple sclerosis (MS) more effectively than weekly interferon beta-1a, albeit at the cost of more adverse effects.
In particular, infections were more common among patients given daclizumab HYP than interferon, at 65% versus 57%, as were cutaneous events, at 37% versus 19%. And elevations in hepatic aminotransferase levels by more than five times the upper limit of normal were also more common, at 6% versus 3%.
“Although most of these events were self-limited, successful management of more serious cases will remain an important aspect of the overall risk–benefit profile of daclizumab HYP”, write Ludwig Kappos (University Hospital, Basel, Switzerland) and study co-authors.
But daclizumab HYP was significantly more effective than the active comparator, the team reports in The New England Journal of Medicine. The primary study endpoint was the adjusted annualised relapse rate, and this was a significant 45% lower in the daclizumab HYP group than the interferon group.
During a median 108.7 weeks of treatment, the 919 patients given subcutaneous daclizumab HYP 150 mg every 4 weeks had a relapse rate of 0.22, compared with 0.39 among the 922 patients given weekly intramuscular interferon 30 µg for a median of 111.4 weeks.
The first secondary endpoint, of new or newly enlarged hyperintense lesions on T2-weighted images at week 96, also favoured daclizumab HYP, at an average of 4.3 versus 9.4 in the interferon group, giving a significant 54% reduction.
However, there was no significant difference for the second-ranked secondary endpoint, with disability progression occurring in 16% of the daclizumab group and 20% of the interferon group.
“Long-term follow-up studies will continue to be important in assessing the treatment effects of multiple sclerosis therapies on disability progression, because studies of even 2 to 3 years’ duration capture only a small fraction of the lifelong treatment that most patients with multiple sclerosis will require”, the researchers comment.
Rates of overall and serious adverse events were similar in both treatment groups, as were rates of the most common adverse events, of nasopharyngitis, headache and upper respiratory tract infection. Influenza-like symptoms, as expected, were more frequent in the interferon than daclizumab HYP group, at 38% versus 10%, despite all patients taking prophylactic treatment for such symptoms during the first 24 weeks of treatment.
But serious adverse events excluding MS relapse were more frequent in the daclizumab HYP group, at 15% versus 10% in the interferon group.
The team therefore concludes that “the net clinical benefit [of daclizumab HYP] will need to be carefully considered by patients and their providers.”
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