Author Of 3 Presentations
P0046 - Comparative Effectiveness of Ozanimod Versus Dimethyl Fumarate: Results of a Matching-Adjusted Indirect Comparison (ID 492)
Abstract
Background
Ozanimod is a selective S1P1-5 modulator recently approved in the US for the treatment of relapsing-remitting multiple sclerosis (RRMS). In the absence of head-to-head studies, a matching-adjusted indirect comparison (MAIC) can be used to compare ozanimod with other oral disease-modifying therapies in patients with MS.
Objectives
The objective of this study was to conduct a MAIC of the relative efficacy and safety of ozanimod 1.0 mg with dimethyl fumarate (DMF) 240 mg.
Methods
A systematic literature review was performed to identify clinical studies evaluating the efficacy and safety of ozanimod vs DMF. Individual patient data (IPD) for ozanimod were obtained from the SUNBEAM and RADIANCE Part B trials, and aggregate level data for DMF were obtained from CONFIRM and DEFINE. A MAIC was conducted while adjusting for imbalances between studies by reweighting IPD from ozanimod trials to match the mean baseline characteristics reported in the DMF trials. In the absence of a common comparator between ozanimod and DMF, an unanchored comparison was used. Thus, potential treatment effect modifiers and prognostic factors were included in matching.
Results
After matching, baseline patient characteristics were balanced between ozanimod and DMF patients. Compared with DMF, ozanimod demonstrated improved annualized relapse rate (ARR; rate ratio [RR]: 0.80; 95% CI: 0.67–0.97), proportion of patients relapsed (odds ratio [OR]: 0.66; 95% CI: 0.52–0.83), overall adverse events (AEs; OR: 0.11; 95% CI: 0.08–0.16), serious AEs (OR: 0.27; 95% CI: 0.19–0.39), and discontinuations (OR: 0.11; 95% CI: 0.07–0.17) as well as nonsignificant differences for confirmed disability progression (CDP) at weeks 12 (RR: 0.79; 95% CI: 0.58–1.07) and 24 (RR: 0.89; 95% CI: 0.62–1.26).
Conclusions
After adjustment of baseline patient characteristics, ozanimod demonstrated improved relapse outcomes, lower risks of adverse outcomes, and low discontinuations compared with DMF. There were no significant differences in CDP.
P0047 - Comparative Efficacy and Safety of Ozanimod Versus Teriflunomide for Relapsing-Remitting Multiple Sclerosis: a Matching-Adjusted Indirect Comparison (ID 569)
Abstract
Background
Ozanimod is a selective S1P1-5 modulator recently approved in the US for the treatment of relapsing-remitting multiple sclerosis (RRMS). In the absence of head-to-head studies, a matching-adjusted indirect comparison (MAIC) can be used to compare ozanimod with other oral disease-modifying therapies in patients with MS.
Objectives
The objective of this study was to compare the relative efficacy and safety of ozanimod 1.0 mg and teriflunomide (TEF) 14 mg.
Methods
A systematic literature review was performed to identify clinical trials that evaluated the efficacy and safety of ozanimod and TEF. Individual patient data (IPD) for ozanimod were obtained from the SUNBEAM and RADIANCE Part B trials, and aggregate level data for TEF were obtained from 6 clinical trials. Heterogeneity was observed between the ozanimod and TEF trials with respect to Expanded Disability Status Scale score, gadolinium-enhanced lesions, disease duration from symptom onset, prior relapse and DMT use, age, sex, region, and weight. An unanchored (no common comparator) MAIC was conducted while adjusting for imbalances between studies by weighting IPD from the ozanimod trials to match the mean baseline characteristics reported in the TEF trials. The following outcomes of interest were assessed: annualized relapse rate (ARR), proportion of patients relapsed, confirmed disability progression (CDP) sustained for 12 and 24 weeks, overall adverse events (AEs), serious AEs (SAEs), and discontinuations due to AEs.
Results
After matching, baseline patient characteristics were balanced between ozanimod and TEF. Compared with TEF, ozanimod demonstrated improvements in ARR (rate ratio [RR]: 0.73; 95% CI: 0.62–0.84), proportion of patients relapsed (odds ratio [OR]: 0.56; 95% CI: 0.44–0.70), overall AEs (OR: 0.35; 95% CI: 0.29–0.43), SAEs (OR: 0.53; 95% CI: 0.37–0.77), and discontinuations due to AEs (OR: 0.14; 95% CI: 0.09–0.21) and similar CDP at 12 (RR: 0.80; 95% CI: 0.61–1.05) and 24 (RR: 0.80; 95% CI: 0.59–1.08) weeks.
Conclusions
Ozanimod was associated with improved relapse outcomes and lower risks of AEs over 1–2 years of follow-up compared with TEF, with no differences in CDP.
P1008 - Brain volume loss is an important treatment attribute among RRMS patients: findings from a discrete choice experiment (ID 489)
Abstract
Background
The treatment landscape for relapsing-remitting multiple sclerosis (RRMS) is rapidly evolving, with several novel disease-modifying therapies (DMTs) entering the market and varying substantially in their treatment attributes, including modifying the rate of brain volume loss (BVL). Although research has sought to understand patient preferences for MS treatments, these preferences have not included the importance of BVL.
Objectives
The objective of this study was to assess patient preferences for the benefits and risks associated with common and novel DMTs in RRMS.
Methods
US patients diagnosed with RRMS who had not been administered a therapy typically prescribed in advanced RRMS (alemtuzumab, natalizumab, rituximab, and cladribine) completed an online cross-sectional survey. Preferences were assessed via a discrete choice experiment that presented patients with a series of tasks and asked them to choose between 2 treatment profiles that varied on 7 attributes identified in qualitative research: 2-year disability progression; 1-year relapse rate; rate of BVL; and risks of gastrointestinal (GI) symptoms, flu-like symptoms, infection, and life-threatening side effects. A hierarchical Bayes model was used to estimate attribute-level weighted preferences.
Results
This analysis included 150 patients with RRMS; mean age was 54 years, 84% were female, 31% were employed, 24% were on long-term disability, and 83% were currently taking a prescription medication. Patients were most concerned with reducing the rate of BVL, followed by the risk of infection, risk of flu-like symptoms, slowing the rate of 2-year disability progression, risk of life-threatening event, reducing the 1-year relapse rate, and risk of GI symptoms. Reducing the rate of BVL and risk of infection were approximately twice as important as reducing the 1-year relapse rate and risk of GI symptoms.
Conclusions
In addition to traditional measures of treatment benefit in RRMS, reducing the rate of BVL is a key outcome prioritized by patients for which they are willing to make tradeoffs. These findings suggest that reducing BVL should be considered when physicians engage in shared decision making with their patients.