Patients with multiple sclerosis have significant atrophy of both white matter (WM) and gray matter (GM); secondary progressive patients have significantly more atrophy of both WM and GM than do relapsing-remitting patients and a significantly higher lesion load (abnormal WM fraction); lesion load is related to both WM and even more to GM atrophy; lesion load and WM and GM atrophy are significantly related to Expanded Disability Status Scale score and age at onset (suggesting that the younger the age at disease onset, the worse the lesion load and brain atrophy); and GM atrophy is the most significant MRI variable in determining the final disability.

The purpose of this study was to evaluate the quality of life (QoL) of multiple sclerosis (MS) caregivers, and to determine relationships that may exist between caregiver and patient QoL. Patients with definite MS (n=445) and their caregivers (n=445) were required to complete the generic, 36-item short-form (SF-36) Health Survey. Median SF-36 dimension scores ranged from 55 to 100 for caregivers and from 46 to 78 for patients. Although the QoL of MS carers was not as severely affected as that of patients, caregiving was associated with lower mental health, vitality and general health scores, compared to healthy subjects. Multivariate analyses revealed significant differences between the predictors of patient QoL and caregiver QoL. The main predictors of patient QoL were Expanded Disability Status Scale (EDSS) score, MS course, fatigue and depression. Female gender and advanced age were the main predictors of lower QoL in caregivers. In addition, patient BDI score was found to be a significant predictor of almost all caregiver SF-36 dimension scores, while EDSS score, disease duration and course, and patient therapeutic characteristics were found to be predictors of some caregiver SF-36 dimension scores. Therefore, caregiver QoL was significantly influenced by patient characteristics, and supportive strategies for MS caregivers are warranted.

Variables assessable within the first year of treatment significantly influence relapse rate and disability progression in patients with RRMS treated with IFN beta. These findings may help clinicians to make decisions regarding therapy regimen over time, and highlight the need for a prognostic algorithm.

BackgroundIn 2010, the European Medicines Agency (EMA) initiated a pilot project on parallel scientific advice with Health Technology Assessment bodies (HTABs) that allows manufacturers to receive simultaneous feedback from both the European Union (EU) regulators and HTABs on their development plans for medicines.AimsThe present retrospective qualitative analysis aimed to explore how the parallel scientific advice system is working and levels of commonality between the EU regulators and HTABs, and among HTABs, when applicants obtain parallel scientific advice from both a regulatory and an HTA perspective.MethodsWe analysed the minutes of discussion meetings held at the EMA between 2010, when parallel advice was launched, and 1 May 2015, when the cutoff date for data extraction was set. The analysis was based on predefined criteria and conducted at two different levels of comparison: the answers of the HTABs vs. those of the regulators, and between the answers of the participating HTA agencies.ResultsThe analysis was based on 31 procedures of parallel scientific advice. The level of full agreements was highest for questions on patient population (77%), while disagreements reached a peak for questions on the study comparator (30%). With regard to comparisons among HTABs, there was a high level of agreement for all domains.ConclusionsThere is evident commonality, in terms of evidence requirements between the EU regulators and participating HTABs, as well as among HTABs, on most aspects of clinical development. Indeed, regardless of the question content, the analysis showed that a high level of overall agreement was reached through the process of parallel scientific advice.

In a very large observational study, the use of DPP-4i was associated with a reduced risk of HHF when compared with sulphonylureas.