Author Of 2 Presentations
LB1174 - Patient and healthcare professional perspectives of immune dynamics and MS disease-modifying therapies mode of action throughout COVID-19 pandemic (ID 1766)
Abstract
Background
Disease-modifying therapies (DMTs) for relapsing multiple sclerosis (RMS) modulate or deplete immune cells, including T and B cells. Healthcare professionals (HCPs) and patients consider many factors when selecting a DMT in a shared decision model, including efficacy, frequency/route of administration and safety. Patient understanding of mechanisms of action (MoA), and DMT effects on the dynamics and function of the immune system may be challenging to understand and further influenced by the COVID-19 pandemic, including risk interpretation and administration preferences.
Objectives
To assess the involvement of patients in MS treatment selection and the importance for patient understanding of MoA using a patient narrative approach, and to design a preliminary qualitative survey to inform future studies.
Methods
A preliminary qualitative survey was developed to explore factors most important to patients when considering DMTs, including patient understanding of immunological aspects of MS, MoAs, preferences regarding route of administration and provision of MS clinical information. Perspectives were sought from HCPs and patients on how this dialog has changed during the COVID-19 pandemic. The survey was distributed by email to 3 patients and 1 caregiver.
Results
Results are based on survey results and email correspondence from two adults with RMS, and an adolescent with pediatric MS and her caregiver. Overall, respondents felt they understood the general role of the immune system in MS and the role of DMTs but had poorer understanding of B and T cell functions and the impact of DMTs and their MoAs. Safety and efficacy were equally the most important variables when considering a new DMT. Face-to-face discussions between patients and HCPs were preferred to noninteractive materials; HCP authors (3 neurologists and 1 MS physician assistant) agreed that more face-to-face clinic time for dialog is needed. Patient independence was a key factor in preferences for methods of administration. Respondents reported an increase in MoA conversations in light of COVID-19.
Conclusions
While safety and efficacy are important in patients’ considerations of DMTs, there is a clear need to increase understanding of MoAs when starting or switching DMTs; immunological knowledge has become increasingly important during the COVID-19 pandemic. The preliminary qualitative survey can be used to inform future studies of what is needed to improve communication on DMT MoAs.
P0222 - OLIKOS study design: exploring maintained ofatumumab efficacy in relapsing MS patients who transition from intravenous anti-CD20 therapy (ID 1757)
Abstract
Background
Depletion of B cells in patients with relapsing multiple sclerosis (RMS) using anti-CD20 monoclonal antibodies (mAbs) reduces annualized relapse rates and inflammatory lesion activity on magnetic resonance imaging, and delays time to confirmed disability worsening. Anti-CD20 mAbs ocrelizumab and rituximab are administered by intravenous infusion in clinic; ofatumumab is administered subcutaneously with a pre-filled syringe or autoinjector (AI) pen, facilitating self-administration. No outcome data exist relating to transition of patients treated with ocrelizumab or rituximab to ofatumumab.
Objectives
OLIKOS is a 12 month, prospective, single-arm, multicenter phase 3b study that will explore maintained efficacy of ofatumumab in patients with RMS who transition from intravenous anti-CD20 mAb therapy.
Methods
About 100 adults with RMS will be enrolled at 10-20 centers in the USA. Eligible patients will have been previously treated with 2-5 consecutive courses of intravenous ocrelizumab or rituximab (other anti-CD20 mAbs are excluded), with last dose 4-9 months before OLIKOS baseline. Other inclusion criteria are Expanded Disability Status Scale score 5.5 or lower at screening and CD19 B cells depleted to below 1% at baseline. Patients with suboptimal response to anti-CD20 therapy in the previous 6 months (relapse, ≥2 active gadolinium-enhancing [Gd+] lesions, any new/enlarging T2 lesions, clinical worsening), or who discontinued anti-CD20 therapy because of severe infusion-related reactions or recurrent infections, or with progressive disease, will be excluded. All participants will receive subcutaneous ofatumumab 20 mg administered by AI pen on Days 1, 7 and 14, then monthly in Months 1-12. The primary endpoint will be no change or a reduction in Gd+ lesion count at Month 12. Secondary endpoints will be participant retention and changes in immune biomarkers, treatment satisfaction, safety and tolerability at Months 6 and 12. There will be a 6 month interim analysis.
Results
The detailed study design will be presented. OLIKOS will complement the ofatumumab phase 3 program in RMS by generating maintained efficacy, retention and satisfaction data based on monthly subcutaneous drug delivery with the AI pen in patients previously treated with ocrelizumab or rituximab.
Conclusions
OLIKOS will provide important data on the maintained efficacy of ofatumumab in patients with RMS transitioning from intravenous anti-CD20 therapies.