Patient Preference for Subcutaneous Versus Intravenous Administration with Every-6-Week Natalizumab (Tysabri®) Dosing: NOVA Phase IIIb Extension Study (Part 2).

INTRODUCTION: Following NOVA (part 1) and the approval of the subcutaneous (SC) route of administration of natalizumab by the European Medicines Agency, an extension phase of the NOVA phase IIIb study (part 2) was initiated to collect patient preference data for SC versus intravenous (IV) dosing in patients receiving every-6-week (Q6W) dosing of natalizumab. This study was performed to evaluate patient preference for SC versus IV natalizumab administration and explore the efficacy, safety, and pharmacology characteristics of both routes of administration. METHODS: In part 2, participants received natalizumab (Tysabri®) 300 mg via IV infusion Q6W for 36 weeks and then were randomized to 48 weeks of crossover treatment (24 weeks SC Q6W and 24 weeks IV Q6W, or vice versa). The primary endpoint was the proportion of participants who indicated a preference for natalizumab SC administration on the Patient Preference Questionnaire. RESULTS: A total of 153 participants were randomized in NOVA part 2. Of 123 with patient preference data, 108 (87.8%) preferred the SC route of administration for natalizumab over the IV route; 102 (82.9%) specified "requires less time in the clinic" as the reason for the SC preference. CONCLUSION: In NOVA (part 2), most participants on Q6W dosing of natalizumab preferred SC administration versus IV administration. CLINICALTRIALS: GOV: NCT03689972. INFOGRAPHIC.

Analysis of the Modified Rankin Scale in Randomised Controlled Trials of Acute Ischaemic Stroke: A Systematic Review.

Background. Historically, most acute stroke clinical trials were neutral statistically, with trials typically dichotomising ordinal scales, such as the modified Rankin Scale. Studies published before 2007 have shown that preserving the ordinal nature of these scales increased statistical power. A systematic review of trials published since 2007 was conducted to reevaluate statistical methods used and to assess whether practice has changed. Methods. A search of electronic databases identified RCTs published between January 2007 and July 2014 in acute ischaemic stroke using an ordinal dependency scale as the primary outcome. Findings. Forty-two RCTs were identified. The majority used a dichotomous analysis (25, 59.5%), eight (21.4%) retained the ordinal scale, and nine (19.0%) used another type of analysis. Conclusions. Trials published since 2007 still favoured dichotomous analyses over ordinal. Stroke trials, where appropriate, should consider retaining the ordinal nature of dependency scales.