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Abstract Details

Reported Outcomes for DMTs in Multiple Sclerosis: Relatively Misleading
Multiple Sclerosis
P9 - Poster Session 9 (12:00 PM-1:00 PM)
9-020
To evaluate the effect of using relative risk reduction (RRR) or absolute risk reduction (ARR) and number needed to treat (NNT) to describe ‘relapse rates’ and ‘% of patients with ≥1 relapse’ as outcomes for randomized, phase 3 controlled trials in multiple sclerosis (MS). 
Most randomized, controlled trials and marketing materials utilize relative risk reduction or risk ratios to describe annualized relapse rates and proportion relapse free in MS. These measures do not account for the background event rate. With few comparator trials available, many clinicians and patients likely misinterpret data by using these relative measures to compare the efficacy of disease modifying therapies (DMTs).  One previous report has demonstrated this for annualized relapse rates with data through 2012. Here, we present new trial data for annualized relapse rates. Additionally, we demonstrate that using relative risk when describing the % of patients with ≥1 relapse may be misleading. 

We compiled data for annualized relapse rate and % ≥1 relapse, published to-date, for randomized, controlled MS trials. Using these data, we compared RRR vs. ARR and NNT. 
Recently published trials continue to have lower control annualized relapse rate resulting in apparently large RRR even when ARR remained stagnant. However, this is misleading since declining % of patients with relapses in control groups contributes to this anomaly. This is reflected in an increased RRR for a relapse suggesting an increased proportion who are “relapse free” even when ARR has remained largely unchanged. 
Our patients most commonly express their goal of therapy as “no relapses”. Authors should utilize ARR and NNT when describing drug efficacy for preventing relapses due to declining control event rates. Additionally, head-to-head comparisons are needed to compare treatments for MS.
Authors/Disclosures
Brent Sokola, PharmD (Cleveland Clinic Foundation)
PRESENTER 		No disclosure on file
Wenxin Zhuo (University of Kentucky) No disclosure on file
Jagannadha R. Avasarala, MD, PhD, FÂ鶹´«Ã½Ó³»­ (Kentucky Neuroscience Institute-Dept of Neurology) Dr. Avasarala has received personal compensation in the range of $10,000-$49,999 for serving as a Expert analyst with DOJ.