Treatment Fluctuations in Patients with Acetylcholine Receptor Antibody Positive Generalized Myasthenia Gravis on Maintenance Ravulizumab Treatment
Dave Ho1, Katherine Clifford2, Samantha Blum3, Miriam Freimer4, Neelam Goyal2, Tahseen Mozaffar1, Pushpa Narayanaswami5, Srikanth Muppidi2, Anahit Mehrabyan6, Amanda Guidon7, Michael Hehir8, Ali Habib1
1UC Irvine Health, 2Stanford Healthcare, 3UVM, 4The Ohio State University, 5Beth Israel Deaconess Medical Center, 6UNC, 7Massachusetts General Hospital, 8Larner College of Medicine at the University of Vermont
Objective:
To describe a “wearing off” phenomenon between standard maintenance infusions of ravulizumab for a subset of patients with acetylcholine receptor antibody positive generalized myasthenia (AChR gMG).
Background:
Ravulizumab is a monoclonal antibody complement C5 inhibitor approved in April 2022 for the treatment of AChR gMG. CHAMPION MG, the pivotal phase III study, showed sustained improvement at 60 weeks with ravulizumab and demonstrated that scheduled dosing every 8 weeks results in rapid initial improvement followed by sustained symptom control. Complete terminal complement inhibition was sustained throughout 26 weeks of treatment in CHAMPION MG and treatment-related fluctuations were not described. However, some patients in clinical practice have reported a “wearing off” of benefit between treatment cycles.
Design/Methods:
This multicenter case series will identify through record review patients with AChR gMG who have received ravulizumab and report symptom fluctuation despite receiving a loading infusion schedule followed by at least 3 maintenance infusions as standard of care therapy with efficacious response. Patient demographics, symptom characteristics and treatment-specific data will be extracted and analyzed with descriptive statistics. Data regarding age at treatment initiation, disease duration and severity, concomitant and prior therapies, and treatment outcomes will be presented.
Results:
In our clinical practice, 46 patients have undergone treatment with ravulizumab, of whom 16 (35%) report a wearing off before their next scheduled infusion. Detailed longitudinal data will be presented.
Conclusions:
We will present our early clinical experience with ravulizumab in patients with AChR gMG, and provide preliminary characterization of the treatment-related fluctuations observed. We aim to identify any patient specific factors among those that experience this drift in efficacy. This information will provide important insights into this wearing off and the role of ravulizumab in the treatment of AChR gMG.