Abstract
Objective:
To assess satisfaction with the serum-free formulation of subcutaneous (sc) interferon (IFN) beta-1a among patients with relapsing multiple sclerosis (MS).
Methods:
Patients with relapsing MS who had been receiving sc IFN beta-1a for at least 6 months, were transitioned to the new formulation, 44 μg three times weekly. Patients were randomized to preventative ibuprofen (400 mg 30–60 minutes prior to injection) or ibuprofen as needed (PRN) for 4 weeks. The primary endpoint was the ‘flu-like’ symptom (FLS) domain score of the validated Multiple Sclerosis Treatment Concern Questionnaire (MSTCQ).
Results:
Of the 117 patients enrolled, 109 (93.2%) completed the study. Neither group’s MSTCQ FLS score showed a clinically meaningful change from baseline to week 4: mean ± SD changes were −1.1 ± 4.4 in the preventative ibuprofen group and 0.8 ± 3.6 in the ibuprofen PRN group. MSTCQ injection system satisfaction and global side-effect scores were unchanged; total and injection-site reaction scores improved moderately in both groups between baseline and week 4.
Conclusions:
Results showed continued or increased levels of satisfaction with the new formulation of sc IFN beta-1a. FLS occurring with the new formulation were generally mild and seldom sufficiently bothersome to require ibuprofen treatment.
Acknowledgements
The authors take full responsibility for the content of the paper but thank Steve Smith, Caudex Medical (supported by Merck Serono S.A. – Geneva, Switzerland, an affiliate of Merck KGaA, Darmstadt, Germany), and Sarah-Jane Loveday (Merck Serono S.A. – Geneva, Switzerland) for assistance in the preparation of the manuscript.
Disclosure
William Camu has received consulting fees from Merck Serono, TEVA Pharma, and Sanofi-Aventis, and research grants from Bayer Schering, Biogen Idec, Merck Serono, TEVA Pharma, and Sanofi-Aventis. Sabine Latour is a salaried employee of Merck Serono S.A. – Geneva. Dieter Pöhlau has received speaker fees from Bayer Schering Pharma, Teva, Aventis, and Biogen Idec. Karim Hadjout and Said Masri have no conflicts of interest to declare.