Author Of 2 Presentations
P0320 - Effect of age on effectiveness and discontinuation of subcutaneous interferon beta-1a, and healthcare utilization, in patients with multiple sclerosis (ID 391)
Abstract
Background
Subcutaneous interferon beta-1a (sc IFNβ-1a) is a well-established multiple sclerosis (MS) therapy with cumulative exposure of approximately 1,766,525 patient-years. Previous clinical trials demonstrate that patient age does not impact the efficacy of such therapy for treatment of MS.
Objectives
Using real-world data, we evaluated the effect of age on the effectiveness and discontinuation of sc IFNβ-1a, and healthcare utilization, in patients with MS.
Methods
This cohort study using MarketScan© Databases included adult patients with MS newly initiated with sc IFNß-1a between Jul2010-Dec2015, with at least 6 months’ patient history before initiation (index date), and a recorded diagnosis of MS over the 6 months before or at initiation. Follow-up was until end of study period, end of insurance, or treatment discontinuation. Incidence rate (IR) per 100 person-years was used for discontinuation. Hazard ratio (HR) and 95% confidence internal (CI) were used to compare time to first relapse and discontinuation.
Results
Among 5,340 patients included, 14.5% were aged 18-30y, 27.5% 31-40y, 30.5% 41-50y, and 27.5% were 51+y. Relapse-free probability at 2-y ranged from 91.44% in 18-30y to 92.82% in 51+y. Compared with 18-30y, the HRs for relapse at 2-y (95%CI) were 31-40y: 1.00 (0.70, 1.43), 41-50y: 0.79 (0.55, 1.12), and 51+y: 0.86 (0.60, 1.24). In all age groups, hospitalizations due to MS were ≤0.01 and neurology visits were 0.2 patient per-month (PPM) over 2-y. Mean number (95%CI) of magnetic resonance imaging (MRI) scans performed PPM over 2-y ranged from 0.25 (0.16, 0.34) in 18-30y to 0.14 (0.12, 0.16) in 51y+ and outpatients visits due to MS from 0.68 (0.57, 0.78) to 0.75 (0.67, 0.82). Discontinuation IR at 2-y was 72.06 (65.12, 79.52) in 18-30y and 57.95 (53.76, 62.38) in 51+y. Compared to 18-30y, the HR of discontinuation decreased from 0.89 (0.79, 1.01) in 31-40y to 0.86 (0.76, 0.97) in 51+y.
Conclusions
Data suggest no effect of age on the effectiveness of sc IFNß-1a in the real-world setting, while treatment discontinuation decreased with increasing age. Older MS patients initiating sc IFNß-1a appear to have less active disease, reflected in lower relapses, and undergo MRI scanning less frequently than younger patients.
P0880 - Low discontinuation rate and side-effect burden after switching to cladribine tablets: Canadian experience from the adveva® patient support program (ID 1083)
Abstract
Background
Cladribine tablets were approved in Canada in November 2017. All patients prescribed cladribine tablets in Canada are enrolled upon their consent in the adveva patient support program (PSP), which provides drug education, assistance with reimbursement and patient support services.
Objectives
To examine the demographics and treatment history of patients initiating cladribine tablets in Canada, assess the discontinuation rate over the two-year treatment and describe reported adverse events (AEs).
Methods
Analysis of data routinely collected by adveva nurses and all reported AEs from Dec2017 to Jan2020. Patients were included if they consented to enroll in the adveva PSP. They were contacted at enrollment and periodically therafter. Follow-up stopped when treatment was completed/discontinued.
Results
Overall, 1864 patients enrolled in the program; 1373 were female (74.4%) and mean age was 41.54 years (standard deviation [SD]: 10.34). None of the patients were treatment naïve; most (n=1191; 63.9%) had received only one prior disease modifying drug (DMD). The most recent prior DMDs were glatiramer acetate (23.1%), dimethyl fumarate (20.4%), teriflunomide (16.5%), fingolimod (10.9%), and subcutaneous interferon beta-1a (10.4%). Of 1864 enrolled, 1679 (90.1%) had completed pre-treatment evaluation. Of those, 1415 (84.3%) started year-1. Among those, 483 (34.1%) started year-2 and 394 (27.8%) completed it. Mean time to year-2 initiation was 12.75 (SD: 1.27) months. Among all patients who had started year-1 treatment, 38 (2.69%) reported discontinuation. Among those, 26.3% discontinued within <6 months, 52.6% between 6-12 months and 21.1% at ≥12 months. Main reported reasons were: 28.9% unknown, 21.1% AE other than flu-like syndrome and lymphopenia, 18.4% worsening disease, 10.5% patients decision, and 10.5% family planning/pregnant. A total of 843 patients (59.6%) reported at least one AE. Among the total AEs report (n= 3525)the most frequent were fatigue (8.0%), headache (5.4%), nausea (4.7%), and lymphocytopenia (2.5%).
Conclusions
The Canadian adveva program presented a high enrolment rate. Cladribine tablets were associated with a high continuation rate and most patients successfully self-adminstered the drug. Reported adverse events were not severe.