Adherence to, and effectiveness of, subcutaneous interferon beta-1a administered by RebiSmart (R) in patients with relapsing multiple sclerosis: results of the 1-year, observational SMART study

作者：Bayas Antonios^*; Ouallet Jean Christophe; Kallmann Boris; Hupperts Raymond; Fulda Ulrich; Marhardt Kurt

来源：Expert Opinion on Drug Delivery, 2015, 12(8): 1239-1250.

DOI：10.1517/17425247.2015.1057567

• adherence
• autoinjector
• interferon beta
• multiple sclerosis

Background: Patients with multiple sclerosis who have poor adherence to treatment have a higher risk of relapse than adherent patients. This study assessed adherence to, and effectiveness and convenience of, treatment with subcutaneous (sc) interferon (IFN) beta-1a (Rebif, Merck Serono SA) 44 or 22 mu g three times weekly in patients with relapsing multiple sclerosis (RMS) using the RebiSmart (R) electronic, multidose, autoinjector for 1 year.
Study design: European, multicentre, observational study among neurologists: inclusion criteria included RMS, Expanded Disability Status Scale score <= 6, se IFN beta-1a administered by RebiSmart for <= 6 weeks. The primary endpoint was cumulative adherence recorded by RebiSmart.
Results: The safety population included 912 patients, 77.4% (n = 823) of whom completed the Month-12 visit. Mean (+/- standard deviation) cumulative adherence was 97.1 +/- 7.3% (n = 791). The most common reason for missed injection was 'forgot to inject' (37.0%). At Month 12/ED, 79.5% of patients were relapse-free. Of 353 patients who rated the convenience of the device, 68.3% found injecting 'very easy'. No unknown safety issues were detected.
Conclusions: Patients with RMS self-injecting sc IFN beta-1a with RebiSnnart had excellent adherence at Month 12/ED, which was associated with good clinical outcomes and no unexpected safety issues. Patients rated RebiSmart as convenient and easy to use.

• 出版日期2015-8