…obiome initiative (McKay et al. Mult Scler Relat Disord 2017;12:1-3). For a recent review of the topic see Glenn & Mowry. J Interferon Cytokine Res 2016;36:347-357. Free full text at www.ncbi.nlm.nih.gov/pmc/articles/PMC5118957/pdf/jir.2015.0177.pdf….
…largely due to the seizures themselves rather than patients intentionally failing to document seizures. Patient self-reported seizure frequency was equally inaccurate in an analysis of data for 100 patients enrolled in phase II, III and IV trials (Blachut et al. Epilepsy Behav 2017;67:122-127). Data were compared to the results of the prior study (Blachut 2015). Overall, patients estimated that their accuracy in documenting seizures was 46-53%. Th…
…ok the unusual steps of continuing its phase II (ONWARD) and III (CLARITY, ORACLE-MS) studies, and maintaining the long-term safety registry (PREMIERE) it had set up in November 2009. The decision to continue collecting information has led to a better understanding of drug safety, new filings with health regulators that uniquely include long-term data, and a new name (Mavenclad). In June 2017, Mavenclad received a positive nod from the Committee f…
…o ocrelizumab 600 mg by infusion every 24 weeks, or subcutaneous interferon-beta-1a 44 mcg three times per week, for 96 weeks. The annualized relapse rate was 0.16 with ocrelizumab versus 0.29 with the interferon (47% reduction). The mean number of gadolinium-enhancing T1 lesions was 95-97%% lower with ocrelizumab. In a pooled analysis, the proportion of patients with 12-week confirmed disability progression was significantly lower with ocrelizuma…
…e in the two trials. The rate of herpes simplex infection was lower in CARE-MS II compared to CARE-MS I (10% vs. 13%). The rates of immune thrombocytopenia purpura (1%) and hepatotoxicity (4%) were the same in the two CARE-MS study populations. Data are generally lacking on the safety of switching from a front-line oral to alemtuzumab, but there are a few theoretical concerns. Liver function testing after teriflunomide or DMF may be advised to red…