NATIONAL HARBOR, MD—Risk of new or additional flu-like symptoms in patients with multiple sclerosis (MS) transitioning from nonpegylated interferon beta-1a to pegylated interferon beta-1a is low, according to a report at the 2016 CMSC Annual Meeting. Scheduled naproxen therapy may be a beneficial prophylactic strategy, according to researchers. “Ninety percent of patients did not experience new or worsening flu-like symptoms,” said Robert T. Naismith, MD, Associate Professor, Washington University School of Medicine, St. Louis, Missouri, and colleagues.
Robert T. Naismith, MD
Dr. Naismith and coinvestigators conducted the ALLOW study, a one-year, phase IIIb open-label, randomized trial to characterize flu-like symptoms in patients with relapsing MS who transitioned from nonpegylated interferon beta-1a to pegylated interferon beta-1a. The study included patients age 18 to 65 with relapsing MS who had been treated with a stable dose of nonpegylated interferon for four months or more prior to screening. Their drug regimen was continued throughout a four-week run-in period for evaluation of flu-like symptoms including influenza-like illness, myalgia, pyrexia, or asthenia on that regimen. All patients were then switched to pegylated interferon beta-1a titrated to 125 μg every two weeks. Patients were randomized one-to-one to continue their current flu-like symptom management or to commence a regimen of naproxen 500 mg twice daily, starting 24 hours before each dose of pegylated interferon beta-1a and continuing for 48 hours after, for the first eight weeks of treatment.
The primary end point was the proportion of patients experiencing new or worsening flu-like symptoms, which was defined as a 2 or more point increase in flu-like symptom score. Secondary end points were flu-like symptom severity over 48 weeks and impact of naproxen, the onset and duration of flu-like symptoms following pegylated interferon beta-1a injection, the incidence of adverse events, and walking as measured by the Patient Determined Disease Steps (PDDS), a self-assessment walking scale that ranges from normal (0) to bedridden (8).
Of 201 patients who were randomized, 81.6% within each arm completed the study. Baseline characteristics were balanced between the two arms. A majority (89.6%) of patients did not experience new or worsening flu-like symptoms during the first eight weeks of following treatment switch. Flu-like symptom severity remained low across all study populations through week 48, with a majority of the symptoms being mild to moderate. Naproxen did not reduce flu-like symptom severity compared with current flu-like symptom management regimen. Following injection, overall flu-like symptom onset occurred between a mean of 12.0 and 12.8 hours and lasted for a mean duration of 13.8 to 17.0 hours. The most common adverse events were injection-site erythema, injection-site reaction, and influenza-like illness. No significant increase in walking disability was reported by patients who completed the study.
This study was sponsored by Biogen.
—Glenn S. Williams