Patient-rated suitability of a novel electronic device for self-injection of subcutaneous interferon beta-1a in relapsing multiple sclerosis: an international, single-arm, multicentre, Phase IIIb study

<p>Abstract</p> <p>Background</p> <p>Multiple sclerosis (MS) currently requires long-term treatment with disease-modifying drugs, administered parenterally up to once daily. The need for regular self-injection can be a barrier to treatment for many patients. Autoinjectors can help patients overcome problems or concerns with self-injection and could, therefore, improve treatment adherence. This study was performed to assess the suitability of a new electronic device for the subcutaneous (sc) administration of interferon (IFN) beta-1a, 44 mcg three times weekly, for relapsing MS.</p> <p>Methods</p> <p>In this Phase IIIb, multicentre, single-arm study, patients with relapsing MS who had been consistently self-injecting sc IFN beta-1a using an autoinjector for at least 6 weeks were taught to use the new device and self-administered treatment for 12 weeks thereafter. Patient-rated suitability of the device was assessed at the end of Week 12 using the Patient User Trial Questionnaire. Patient satisfaction with, and evaluation of, the injection process was assessed using the MS Treatment Concern Questionnaire. Trainers evaluated the device using the Trainer User Trial Questionnaire.</p> <p>Results</p> <p>At Week 12, 71.6% (73/102) of patients considered the device 'very suitable' or 'suitable' for self-injection; 92.2% (94/102) reported some degree of suitability and only 7.8% (8/102) found the device 'not at all suitable'. At Weeks 4, 8 and 12, most patients reported that injection preparation and clean-up, performing injections and ease of device use in the previous 4 weeks compared favourably with, or was equivalent to, their previous experience of self-injection. Injection-related pain, injection reactions and 'flu-like' symptoms remained stable over the 12 weeks. Each device feature was rated 'very useful' or 'useful' by at least 80% of patients. All trainers and 95.2% (99/104) of patients found device functions 'very easy' or 'easy' to use. Overall convenience was considered the most important benefit of the device.</p> <p>Conclusions</p> <p>Most patients considered the new electronic injection device suitable for the sc injection of IFN beta-1a. They found the device easy to use with useful features, and reported benefits such as overall convenience. The device may, therefore, increase treatment adherence in patients with MS, particularly those with injection-related issues.</p> <p>Trial registration</p> <p>NCT00735007</p

Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study

Background: In a multicentre, single-arm, observational, phase IV study, we evaluated 24-week treatment adherence of relapsing multiple sclerosis (RMS) patients using an electronic auto-injection device (RebiSmart®) for subcutaneous injection of interferon (IFN) β-1a. Methods: A total of 162 adult participants with RMS were enrolled into the study to use RebiSmart® to self-administer IFN β-1a 44 μg three times weekly for a maximum of 96 weeks. The number of administered injections was recorded in the electronic device log. Adherence to treatment was defined as the administration of ≥80 % of expected injections. Cognitive impairment and injection anxiety were assessed via questionnaires. Results: Overall, 91.8 and 82.9 % of participants were adherent to treatment at weeks 12 and 24, respectively. By weeks 12 and 24, 8.2 and 13.9 % of participants had discontinued treatment. There were no statistically significant differences in adherence rates at weeks 12 and 24 according to cognitive impairment status or injection anxiety. By week 24, 69.9 % of participants were less fearful of injection than when they started the study. According to participant evaluations, the absence of a visible needle, comfort settings, and the calendar for tracking the injection schedule were all important features of the RebiSmart® injection system. At week 24, 99.3 % of participants reported that they would like to continue using RebiSmart® as their injector. Conclusions: RebiSmart® use is associated with high treatment adherence, as objectively assessed using electronic injection logs. Future research should examine if RebiSmart® use improves long-term treatment outcomes in RMS. This study was registered with ClinicalTrials.gov as NCT01128075, on May 20, 2010.Medicine, Faculty ofNon UBCMedicine, Department ofNeurology, Division ofReviewedFacult

Adherence to interferon β-1a therapy using an electronic self-injector in multiple sclerosis: a multicentre, single-arm, observational, phase IV study

Abstract Background In a multicentre, single-arm, observational, phase IV study, we evaluated 24-week treatment adherence of relapsing multiple sclerosis (RMS) patients using an electronic auto-injection device (RebiSmart®) for subcutaneous injection of interferon (IFN) β-1a. Methods A total of 162 adult participants with RMS were enrolled into the study to use RebiSmart® to self-administer IFN β-1a 44 μg three times weekly for a maximum of 96 weeks. The number of administered injections was recorded in the electronic device log. Adherence to treatment was defined as the administration of ≥80 % of expected injections. Cognitive impairment and injection anxiety were assessed via questionnaires. Results Overall, 91.8 and 82.9 % of participants were adherent to treatment at weeks 12 and 24, respectively. By weeks 12 and 24, 8.2 and 13.9 % of participants had discontinued treatment. There were no statistically significant differences in adherence rates at weeks 12 and 24 according to cognitive impairment status or injection anxiety. By week 24, 69.9 % of participants were less fearful of injection than when they started the study. According to participant evaluations, the absence of a visible needle, comfort settings, and the calendar for tracking the injection schedule were all important features of the RebiSmart® injection system. At week 24, 99.3 % of participants reported that they would like to continue using RebiSmart® as their injector. Conclusions RebiSmart® use is associated with high treatment adherence, as objectively assessed using electronic injection logs. Future research should examine if RebiSmart® use improves long-term treatment outcomes in RMS. This study was registered with ClinicalTrials.gov as NCT01128075, on May 20, 2010

Escalating Immunotherapy of Multiple Sclerosis

Basic disease-modifying treatment for relapsing forms of active multiple sclerosis (MS) is now available in many countries with high prevalence rates, for this chronic inflammatory disease of the central nervous system. Several lines of evidence support early immunomodulatory treatment with either recombinant interferon-beta or glatiramer acetate, and positive results from phase III trials encourage start of treatment even in patients with clinically isolated syndromes (CIS). However, currently available drugs for basic therapy are only partially effective and patients may still encounter relapses or disease progression. As treatment-refractory, clinically active MS can quickly lead to irreversible neurological disability there is an urgent need for effective escalating strategies. Patients with suboptimal treatment response to basic therapy have been treated with combination therapies, cytotoxic drugs (such as mitoxantrone and cyclophosphamide) or autologous hematopoietic stem cell transplantation. Recently, the monoclonal antibody, natalizumab, was added to this armamentarium. None of these strategies have been vigorously evaluated in large randomized, controlled phase III trials with patients who failed basic therapy. Therefore, the decision to escalate immunotherapy is still based on limited evidence. This article will review potential candidates for intensified immunosuppression and call for innovative study designs to better evaluate escalating immunotherapy in MS

The SunBEAm birth cohort: Protocol design

Background: Food allergy (FA) and atopic dermatitis (AD) are common conditions that often present in the first year of life. Identification of underlying mechanisms and environmental determinants of FA and AD is essential to develop and implement effective prevention and treatment strategies. Objectives: We sought to describe the design of the Systems Biology of Early Atopy (SunBEAm) birth cohort. Methods: Funded by the National Institute of Allergy and Infectious Diseases (NIAID) and administered through the Consortium for Food Allergy Research (CoFAR), SunBEAm is a US population-based, multicenter birth cohort that enrolls pregnant mothers, fathers, and their newborns and follows them to 3 years. Questionnaire and biosampling strategies were developed to apply a systems biology approach to identify environmental, immunologic, and multiomic determinants of AD, FA, and other allergic outcomes. Results: Enrollment is currently underway. On the basis of an estimated FA prevalence of 6%, the enrollment goal is 2500 infants. AD is defined on the basis of questionnaire and assessment, and FA is defined by an algorithm combining history and testing. Although any FA will be recorded, we focus on the diagnosis of egg, milk, and peanut at 5 months, adding wheat, soy, cashew, hazelnut, walnut, codfish, shrimp, and sesame starting at 12 months. Sampling includes blood, hair, stool, dust, water, tape strips, skin swabs, nasal secretions, nasal swabs, saliva, urine, functional aspects of the skin, and maternal breast milk and vaginal swabs. Conclusions: The SunBEAm birth cohort will provide a rich repository of data and specimens to interrogate mechanisms and determinants of early allergic outcomes, with an emphasis on FA, AD, and systems biology