Author Of 2 Presentations
P0310 - Cladribine tablets in patients with RRMS and active SPMS after suboptimal response to prior DMD (MASTER-2 and CLICK-MS): initial baseline demographics (ID 129)
Abstract
Background
Although the efficacy and safety of cladribine tablets (CT) 10 mg (3.5 mg/kg cumulative dose over 2 years [yrs]) have been shown in patients (pts) with relapsing forms of multiple sclerosis (MS) in Phase 3 trials, real world data are limited.
Objectives
To examine real-world effectiveness, safety, and pt reported outcomes (PROs) in pts with relapsing-remitting MS (RRMS) and active secondary progressive MS (SPMS) who transition to CT after suboptimal response to prior disease-modifying drugs (DMDs).
Methods
MASTER-2 and CLICK-MS are single arm, observational, 30-month (mo), Phase 4 trials in the US (Timeline: 2019–2023). Eligible pts are adults with RRMS or active SPMS, with suboptimal response to an oral/infusion (MASTER-2) or injectable (CLICK-MS) DMD, meeting criteria for CT 3.5 mg/kg treatment (US Prescribing Information). The primary outcome is 24-mo annualized relapse rate (ARR). Key secondary outcomes are PROs, treatment adherence and satisfaction, ARR in prior 24 mos, MS treatment pattern prior to transition and follow-up if CT are discontinued, and adverse events (AEs). Planned enrollment per study is 200 pts across 50 sites.
Results
Pt enrollment is ongoing for both trials. As of May 2020, 52 pts (mean [standard deviation {SD}] age: 50 [10.6] yrs; 75% female) have baseline data available in MASTER-2 (data not shown for CLICK-MS). Mean (SD) time since diagnosis was 11.8 (7.71) yrs. Most recent DMDs used included teriflunomide (23.1%), dimethyl fumarate (23.1%), fingolimod (19.2%), ocrelizumab (13.5%), natalizumab (9.6%) and alemtuzumab (1.9%). Sixteen pts had 21 relapses within 24 mos prior to enrollment (mean [SD] ARR: 0.21 [0.351]). Mean (SD) baseline PRO scores before starting CT were 50.7 (25.11) for 14-Item Treatment Satisfaction Questionnaire for Medication (Global Satisfaction), 50.0 (9.57) and 41.4 (11.56) for 36-Item Short Form Health Survey (mental and physical component summaries, respectively), 1.4 (1.71) for Beck-Depression Inventory-Fast Screen, 8.9 (4.79) for the Fatigue Impact Scale, and 2.7 (2.31) for Patient Determined Disability Steps scale. Thirty-six treatment emergent AEs (2 serious, but unrelated) were seen in 12 pts in 9.97 pt-yrs to date. Additional MASTER-2 and CLICK-MS pt baseline data will be shown in the presentation.
Conclusions
These studies will report real-world effectiveness and safety data of cladribine tablets in pts with RRMS and active SPMS with suboptimal response to prior oral, infusion, or injectable DMDs.
P0451 - Comparing infection-related outcomes in patients with multiple sclerosis and matched controls using administrative claims data (ID 925)
Abstract
Background
Few population-level risk estimates of infections in patients with multiple sclerosis (MS) exist in the United States.
Objectives
To evaluate the odds of infections associated with MS using the IQVIA™ RWD Adjudicated Claims–US database (1/1/2010–6/30/2019).
Methods
Patients with MS with ≥2 diagnoses (ICD-9-CM/ICD-10-CM: 340.xx/G35) ≥30 days apart were identified. Individuals in the non-MS cohort were required to have 2 diagnoses for any condition. A randomly selected index office visit date meeting the following criteria was selected: index age 18-64, continuous 12-month eligibility pre/post, no pregnancy claims, no antibiotic/antiviral claim 60 days prior, no inpatient residential care/end-stage renal disease facility, and no HIV/HCV. Patients with and without MS were matched 1:1 on age, sex, payer type, Census region, and index year. Infections were defined as likelihood of presence of antibiotics/antivirals claims and inpatient hospitalizations in the 12-month post-index period. Multivariable logistic regression models were used to measure the association of MS diagnosis with presence of antibiotic/antiviral claims and inpatient hospitalizations for infections. Explanatory variables were: age group, sex, payer type, region, index year (2011-2018), and select comorbidities.
Results
A total of 87,755 patients with MS met study inclusion criteria and were matched to 87,755 patients without MS. Mean (SD) age was 47.3 (10.5) years, 75.7% were female, 65.7% had commercial insurance, and 34.3% had self-insured employer insurance. Patients were from the South (32.7%), Midwest (31.3%), Northeast (25.5%) or West (10.5%) regions. Most common outpatient diagnoses of infections in both cohorts were urinary tract infection, acute sinusitis, acute upper respiratory tract infections, acute pharyngitis, and mycoses. A greater proportion of patients with MS vs. without MS had presence of antibiotic/antiviral claims (53.8% vs. 48.2%; p<0.0001) and inpatient hospitalization for infections (3.2% vs. 1.3%; p<0.0001). Compared with the non-MS cohort, patients with MS had significantly higher odds of an antibiotic/antiviral claim (adjusted odds ratio [AOR], 95% confidence interval [CI]: 1.18 [1.16, 1.20]) and significantly higher odds of inpatient hospitalization (AOR, 95% CI: 2.00 [1.86, 2.15]).
Conclusions
These findings highlight the increased odds of infection among the commercially and self-insured patients with MS in the US.