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PURPOSE: Patients with multiple sclerosis (MS) would benefit from continued long-term treatment with disease-modifying therapies, and autoinjectors may help improve patients' satisfaction with therapy, thereby increasing adherence rates. BETACONNECT® is an autoinjector for interferon beta-1b designed to improve the injection experience for patients. The BetaEval Global study assessed medication intake in patients using BETACONNECT to further investigate the value of this autoinjector. PATIENTS AND METHODS: The BetaEval Global study was a prospective, non-interventional cohort study across multiple European countries in patients with relapsing-remitting MS (RRMS) or clinically isolated syndrome (CIS) who were starting interferon beta-1b treatment. The decision to administer interferon beta-1b was made independently of the study. Patients were assessed at the initial visits and planned follow-up visits at Weeks 4, 12, and 24. The primary outcome variable was compliance with therapy based on the medication possession ratio (MPR). Injections were automatically recorded by the BETACONNECT device or, in some instances, self-reported by the patients. This allowed for a complete dataset that could be used in the calculation of the MPR. RESULTS: Four hundred ninety-eight patients were enrolled and completed 93.9%, 95.2%, and 95.4% of prescribed injections at Weeks 4, 12, and 24, respectively. Similarly, 76.4% (n=318), 76.6% (n=297), and 81.1% (n=284) of patients completed at least 80% of their prescribed injections. Median scores assessing patient satisfaction with the autoinjector were consistently high across the study. CONCLUSION: Overall, the results from BetaEval Global demonstrated that in this cohort of patients with RRMS or CIS on interferon beta-1b, use of the BETACONNECT autoinjector was associated with high rates of compliance, adherence, and patient satisfaction.
RESUMEN
BACKGROUND: The goal of the present cohort study was to review outcomes of patients exposed to interferon beta-1b during pregnancy. METHODS: Pregnancy cases with exposure to interferon beta-1b reported to Bayer's pharmacovigilance (PV) database from worldwide sources from January 1995 through February 2018 were retrieved for evaluation. Only cases where pregnancy outcomes were unknown at the time of reporting (i.e. prospective cases) were included in the analysis of this retrospective cohort study. RESULTS: As of February 2018, 2581 prospective pregnancies exposed to interferon beta-1b were retrieved from the database; 1348 pregnancies had documented outcomes. The majority of outcomes [1106 cases (82.0%)] were live births. Health status was known for 981 live births (no known health status for 125). Most of the prospective pregnancies with known outcomes corresponded to live births with no congenital anomalies [896 cases (91.3%)]. Spontaneous abortion occurred in 160 cases (11.9%). Congenital birth defects were observed in 14/981 live births with known health status [1.4%, 95% confidence interval (CI) 0.78-2.38]. No consistent pattern in the type of birth defect was identified. Rates of both spontaneous abortion and birth defects were not higher than the general population. CONCLUSIONS: These PV data, the largest sample of interferon beta-1b-exposed patients reported to date, suggest no increase in risk of spontaneous abortion or congenital anomalies in women exposed during pregnancy.