Merck Serono reports study results for electronic injection device RebiSmart
M2 Europharma - Sep. 15, 2009
September 15, 2009 - Swiss Merck Serono, a division of German Merck KGaA (ETR: MRK) reported yesterday results from a Phase IIIb study evaluating the suitability and ease of use of RebiSmart, a new electronic, multi-dose device for self-injection of relapsing multiple sclerosis (MS) treatment Rebif in patients with relapsing MS.
The company said that these data were presented at the 25th Congress of the European Committee for the Treatment and Research in Multiple Sclerosis (ECTRIMS).
Based on patient feedback after 12 weeks of use, 72% of patients rated the new RebiSmart device as "very suitable"/"suitable" for subcutaneous self-injection of Rebif (primary endpoint). In addition, 95% of patients rated the device functions as "very easy"/"easy" to use, 59% found the device "much more"/"more" convenient than their current Rebif injection device, 60% requested to keep RebiSmart rather than return to their previous injection device and 61% made use of the possibility to customise the comfort settings (secondary endpoints). A questionnaire assessing safety and tolerability endpoints (MS Treatment Concern Questionnaire (MSTCQ)) showed that flu-like symptoms, injection-site reactions and overall side-effects were largely unchanged compared with the Rebif injection device used prior to entering the trial.
The RebiSmart user trial was an international, multi-centre, single-arm, open-label, 12-week, Phase IIIb study to evaluate the suitability of the new device for self-injection of Rebif, 44 microgram three times a weej, in patients with relapsing MS.
A total of 106 patients were enrolled in the study. Patients were between 18 and 65 years old with relapsing MS (McDonald criteria) and had received Rebif, 44 microgram three times weekly, consistently for 6 weeks or more prior to screening. The disease duration had to be of 3 months or more. At baseline, patients were trained in the use of the device and subsequently self-injected Rebif, 44 microgram three times weekly, for 12 weeks. Assessments were performed at baseline and weeks 2, 4, 8 and 12.
The primary endpoint was the proportion of patients rating the device at week 12 as "very suitable"/"suitable"/"little suitable"/"not at all suitable" for self-injection of Rebif. Secondary endpoints included subscale scores on the MS Treatment Concern Questionnaire and overall evaluation of the device based on a questionnaire. Safety endpoints included the incidence of serious adverse events (AEs). Local reactions at the injection site (including pain, swelling or redness; patient-reported) were recorded on the local tolerability form as part of regular physician follow up.
RebiSmart is approved in the European Union (EU) and is already available in Germany, the United Kingdom and Denmark, as well as in Canada.
(Comments on this story may be sent to
)
Disclaimer The industry news information and articles are for informational purposes only, and are not intended to represent any trends, partnerships, commitments, or research of the Consortium of MS Centers or any of it's members in any way whatsoever, nor should any party be libel in any way to the reader or to any other person, firm or corporation reading this industry news section. Although the CMSC site includes links providing direct access to other Internet sites, CMSC takes no responsibility for the content or information contained on those other sites, and does not exert any editorial or other control over those other sites. CMSC is providing information and services on the Internet as a benefit and service in furtherance of CMSC's nonprofit and tax-exempt status. CMSC makes no representations about the suitability of this information and these services for any purpose.
CMSC Online 
