| الوصف: |
Elena Didenko Pedersen,1,2 Egon Stenager,3,4 JL Vadgaard,5 MB Jensen,6 R Schmid,7 N Meland,8 G Magnussen,9 Jette L Frederiksen10,11 1Akershus University Hospital, Department of Neurology, Loerenskog, Norway; 2Sandvika Nevrosenter, Sandvika, Norway; 3MS Clinic of Southern Jutland, Department of Neurology, Hospital of Southern Denmark, Odense, Denmark; 4Institute of Regional Research, University of Southern Denmark, Odense, Denmark; 5Department of Neurology, Sjællands University Hospital, Roskilde NeuroCenter, Roskilde, Denmark; 6Department of Neurology, Nordsjaellands Hospital, Hilleroed, Denmark; 7MS Clinic, Department of Neurology, Vejle Hospital, Vejle, Denmark; 8Smerud Medical Research, Oslo, Norway; 9Merck Norway, An Affiliate of Merck AB (Merck AB NUF), Oslo, Norway; 10Department of Neurology, Rigshospitalet Glostrup, Faculty of Health and Medical Science, Glostrup, Denmark; 11Institute of Clinical Medicine, Copenhagen University, Copenhagen, Denmark Background: Disease modifying drugs help control the course of relapsing remitting multiple sclerosis (RRMS); however, good adherence is needed for long-term outcomes.Objective: To evaluate patient adherence to treatment with subcutaneous interferon beta-1a using RebiSmart® and assess injection-site reactions and treatment satisfaction.Methods: This prospective, single-arm, open-label, noninterventional multicenter Phase IV trial included disease modifying drug-experienced mobile patients with RRMS. Adherence was measured over 12 weeks. Items 13–23, 35, 37, and 38 of the Multiple Sclerosis Treatment Concerns Questionnaire (injection-site reactions and treatment satisfaction) were recorded at 12 weeks.Results: Sixty patients were recruited (mean age 43.7 [±SD 7.9] years; 83% female; mean years since multiple sclerosis diagnosis 6.7 [SD 4.5]). Adherence data were obtained in 54 patients only due to technical problems with six devices. Over 12 weeks, 89% (n=48) of patients had ≥90% adherence to treatment. Most patients experienced mild influenza-like symptoms and injection-site reactions, and global side effects were minimal. Most patients (78%) rated the convenience as the most important aspect of the device, and most experienced no or mild pain.Conclusion: RRMS patients treated with subcutaneous interferon beta-1a, administered with RebiSmart, demonstrated generally good adherence, and the treatment was generally well tolerated. Keywords: adherence, multiple sclerosis, relapsing remitting MS, subcutaneous interferon beta-1a, RebiSmart, trial |
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