Author Of 2 Presentations
P0233 - Safety and tolerability of conversion to siponimod in patients with relapsing multiple sclerosis: interim results of the EXCHANGE study (ID 1134)
Abstract
Background
In the USA, siponimod is approved in adults for the treatment of relapsing multiple sclerosis (RMS), including active secondary progressive MS (SPMS). Understanding washout requirements when converting from other disease-modifying treatments (DMTs) to siponimod is important in clinical practice and should be assessed prospectively.
Objectives
To report results from an interim analysis of EXCHANGE (NCT03623243), a prospective, 6 month, multicenter, open-label, single-arm study evaluating safety and tolerability of overlapping effects when converting to siponimod from other DMTs.
Methods
Patients aged 18-65 years with advancing RMS, Expanded Disability Status Scale (EDSS) score of >2.0 to 6.5, and on continuous oral/injectable DMTs for ≥3 months at time of consent were included in the analysis. Patients were immediately converted to siponimod, except those previously on teriflunomide who required 11-14 days’ washout (with cholestyramine or activated charcoal). During days 1-6, siponimod was titrated from 0.25 mg to 2 mg. Primary endpoint was incidence of drug-related adverse events (AEs). About 100 patients are being enrolled in a parallel, novel virtual cohort, with telemedicine tools.
Results
112 patients (1 in the virtual arm; 70.5% female) from 42 centers in the USA were enrolled, completed screening and were eligible for safety analysis (33.9% ongoing; 20.5% discontinued; 45.5% completed). At screening, 74.1% (n=83) of patients had relapsing-remitting MS, 21.4% (n=24) had SPMS, 3.6% (n=4) had primary progressive MS and 0.9% (n=1) had a single demyelinating event; 42.0% (n=47) had ≥1 relapse in the prior 12 months. At baseline, median age was 45.5 years, median time since MS diagnosis was 11.2 years and median EDSS score was 3.5. In the safety analysis set, ≥1 drug-related AE was reported in 34.8% of patients (n=39) (95% confidence interval [CI]: 26.2-44.5); 4.5% (n=5) had ≥1 serious AE and 5.4% (n=6) had ≥1 AE leading to drug discontinuation. In the subgroup of patients who had completed or discontinued from the study (n=74), 40.5% (n=30) (95% CI: 29.5-52.6) had ≥1 drug-related AE. Change from baseline in heart rate to 6 hours post first dose and AEs by prior DMT will be presented.
Conclusions
Conversion from oral/injectable DMTs to siponimod without washout had a good safety and tolerability profile with no unexpected findings. Subsequent analyses will include data on conversion to siponimod from infusible (natalizumab/ocrelizumab) DMTs.
P0835 - A First Look at the Characteristics of Patients with Multiple Sclerosis Initiating Siponimod Therapy in the United States (ID 738)
Abstract
Background
In March 2019, siponimod was approved in the United States (US) for the treatment of relapsing forms of multiple sclerosis (MS) in adults, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. This indication is broader than the secondary progressive MS patient population studied in the pivotal Phase 3 trial.
Objectives
To describe characteristics of siponimod users in the first 10 months following US approval using linked pharmacy and medical administrative claims data.
Methods
Adult patients (≥18 years) in IQVIA’s longitudinal pharmacy claims database with a siponimod claim between 1 Apr 2019 and 29 Feb 2020 (first claim=index date) and ≥2 medical claims with a MS diagnosis occurring ≥30 days apart in IQVIA’s medical claims database were identified. Patient characteristics including comorbid conditions, disability level, MS relapse, durable medical equipment (DME) use, and prior disease modifying therapy (DMT) were assessed during a 1-year baseline period. Disability was assessed through identification of expanded disability status scale (EDSS)-related symptoms, diagnoses and DME claims.
Results
A total of 1,081 siponimod patients were identified. Mean (standard deviation [SD]) age was 53.4 (11.4) years, 76% were female, and mean (SD) Charlson Comorbidity Index score was 0.7 (1.1). Common MS-related comorbidities included depression (19%), urinary tract infection (18%), fatigue (18%), anxiety (13%) and sleep disorders (13%). Most patients had moderate (41%) or severe (21%) disability at siponimod initiation. A MS relapse occurred in 28% of patients in the prior year. DME use was observed in 118 (11%) patients, mostly for wheelchairs (36%) or walkers (32%). Most patients (60%) had no evidence of DMT use in the prior year. Among 430 patients with a prior DMT, 57% used oral medications, 32% used injectables, and 11% were on infusion. The most common DMTs used prior to siponimod were dimethyl fumarate (21%), fingolimod (20%), and glatiramer acetate (19%); 42% of patients with prior DMT use discontinued treatment >60 days before initiating siponimod.
Conclusions
This real-world study of early use of siponimod in MS patients demonstrated use in an older MS patient population with moderate-to-severe disability without relapses in the past year. Most patients had no DMT use in the year prior to siponimod initiation, suggesting siponimod fulfills an unmet need in this population.