European journal of neurology
Comparator Event Rates, Baseline Activity, and Operational Selection Pressure in Relapsing Multiple Sclerosis Trials: A Meta-Epidemiological Analysis
By Pfeuffer S, Masanneck L, Pawlitzki M and 1 others.
Abstract
Background
Reference-arm annualized relapse rates (ARRs) in relapsing multiple sclerosis trials have declined. We examined whether baseline disease activity and the treatment environment during recruitment changed alongside this trend.
Methods
We analyzed 15 treated-reference arms from nine Phase 3 programs. ARR was related to recruitment era, prior-year relapse activity, MRI markers, and an Operational Selection Pressure Index (OSPI) combining recruitment geography with time since ocrelizumab approval. Associations were descriptive; disability outcomes were audited separately.