Author Of 2 Presentations
P0411 - Treatment-emergent adverse events occurring early in the treatment course of cladribine tablets in two phase 3 trials in multiple sclerosis (ID 377)
Abstract
Background
Tolerability and adherence to disease-modifying drugs (DMDs) can be influenced by treatment-emergent adverse events (TEAEs) that start shortly after therapy initiation. One potential advantage of cladribine tablets is its short treatment course which may limit TEAEs; patients who receive the approved 3.5 mg/kg dosage only receive doses for two 4 to 5-day periods per treatment year.
Objectives
To identify TEAEs early in the course of treatment in patients enrolled in the Phase 3 CLARITY and ORACLE-MS clinical trials.
Methods
This was a post hoc analysis of safety populations in CLARITY and ORACLE-MS studies. Patients received cladribine tablets 3.5 mg/kg (cumulative dose over 2 years; N=636) or placebo (N=641). The incidence of early adverse events, TEAEs, serious TEAEs, drug-related TEAEs, and TEAEs leading to discontinuation were summarized based on incidence within 2, 6, and 12 weeks (Wk) after commencement of therapy.
Results
The incidence of TEAEs occurring within the first 2–12Wk of treatment across both trials in both treatment groups was generally low, and the majority of events were mild (placebo: 53.8–68.4%; cladribine tablets: 54.4–68.0%). The most common TEAEs by time epoch after initiating placebo and cladribine tablets 3.5 mg/kg treatment, respectively, were: nausea: 3.3% vs. 4.9% (2Wk), 3.7% vs. 6.4% (6Wk), and 4.5% vs. 8.0% (12Wk); fatigue: 2.0% vs. 1.4% (2Wk), 3.1% vs. 2.5% (6Wk), and 4.4% vs. 3.1% (12Wk); headache: 8.3% vs. 9.0% (2Wk), 11.9% vs. 14.8% (6Wk), and 15.1% vs. 18.4% (12Wk); lymphopenia: 0.0% vs. 2.5% (6Wk) and 0.5% vs. 6.8% (12Wk); leukopenia: 0.0% vs. 1.3% (12Wk). Other endpoints will be shown in the final presentation.
Conclusions
Incidence of TEAEs experienced during the first 12 weeks of treatment with cladribine tablets 3.5 mg/kg in Phase 3 clinical trials was low and mostly mild. Nausea, headache, and lymphopenia were seen more frequently in cladribine tablets-treated patients versus those in the placebo group. These findings suggest that cladribine tablets are generally well tolerated, which may facilitate treatment adherence.
P1056 - Student Outreach Programs as Strategies to Address MS Workforce Shortages in the United States: Results Across 3 States (ID 1172)
Abstract
Background
The demand for neurological care is outpacing the supply of neurologists, and there is a looming shortage of neurologists who specialize in MS (Halpern et al., 2018). Top factors positively affecting a desire to provide care for people living with MS include the ability to improve patient quality of life, the enjoyment of interacting with MS patients, and the perception that MS is a dynamic area with evolving treatment options (Halpern et al., 2014). Other contributing factors include exposure to MS care early in their training, opportunities for clinical fellowships, stimulating medical content, opportunities to work with experienced MS mentors, opportunities to interact with a broad clinical spectrum of patients, exposure to multi-disciplinary care, and opportunities to engage in research (e.g., Teixeira-Poit et al., 2015). To encourage interest in MS careers, the National Multiple Sclerosis Society (NMSS) Workforce Development Committee designed a student outreach program with four components: (1) a basic pathophysiology and clinical presentation of MS; (2) career opportunities and resources discussion; (3) experience presentation of a person living with MS; and (4) intra- and inter-discipline case study discussions. The present study explores the impact of student outreach programs facilitated in North Carolina, South Carolina, and Rhode Island.
Objectives
The student outreach program has five learning objectives including: (1) Describe the basic pathophysiology and clinical presentation of MS; (2) Understand career opportunities and resources; (3) Understand the experience of a person living with MS; (4) Identify MS signs and symptoms; and (5) Discuss the importance of interprofessional collaboration to optimize patient care and quality of life. Our research question is: Does participation in the student outreach program (1) help students understand the five key learning objectives and (2) enhance student interest in pursuing opportunities that can lead to careers in MS patient care?
Methods
We administered surveys to program participants. We conducted univariate, bivariate, and multivariate analyses of survey data. Analyses were performed in Stata.
Results
Across three states, more than 70% of participants strongly agreed that the program helped them learn about: (1) basic neurological structures involved with MS; (2) clinical phenotypes and typical disease courses; (3) clinical presentations and prevalent symptoms; (4) an MS patient’s lived experience; (5) MS signs and symptoms; (6) key clinical problems of MS addressed by their profession; and (7) at least two other disciplines that manage MS symptoms.
Conclusions
Participation in the student outreach program that provides exposure to MS clinical content, exposure to the MS patient experience/perspective, and networking with MS care experts shows promise in generating student knowledge about and interest in MS patient care.