Change in Concomitant Immunosuppressive Therapies for Generalized Myasthenia Gravis in Patients Receiving Complement C5 Inhibitor Therapies: A Retrospective Analysis of Registry Data
Richard Nowak1, Ali Habib2, Christopher Scheiner3, Lida Zeinali4, Michael Pulley5, Chuang Liu4, Andrew Gordon6, Pushpa Narayanaswami7
1Yale School of Medicine, 2University of California, Irvine, 3University of Tennessee Medical Center, 4Alexion, AstraZeneca Rare Disease, 5University of Florida, 6Northwest Neurology, Ltd., 7Beth Israel Deaconess Medical Center/Harvard Medical School
Objective:
Describe changes in the use of concomitant immunosuppressive therapies (IST) after initiation of eculizumab and/or ravulizumab treatment.
Background:
Complement component 5 (C5) inhibitor therapies (C5ITs) eculizumab and ravulizumab are approved for anti-acetylcholine receptor antibody-positive (AChR-Ab+) generalized myasthenia gravis (gMG). Although ISTs can be effective in gMG, high doses may be associated with adverse events. The global MG SPOTLIGHT Registry is assessing C5IT safety/effectiveness and concomitant IST (con-IST) use in adults with gMG in clinical practice.
Design/Methods:
The current analysis included registry patients who transitioned from eculizumab to ravulizumab, had available con-IST (azathioprine, mycophenolate mofetil, intravenous immunoglobulin/plasma exchange, oral corticosteroid [OCS]) data, and received eculizumab and ravulizumab for ≥1 year. Frequency/type of serious adverse events were assessed.
Results:
Of 226 gMG patients in the MG SPOTLIGHT Registry (Oct-2-2023), 61 transitioned from eculizumab to ravulizumab (male: 60.7%; mean ± SD ages: 56.2 ± 20.4 years [MG diagnosis]; 61.9 ± 16.8 years [eculizumab initiation]; 64.8 ± 17.1 years [eculizumab-to-ravulizumab transition]), with treatment durations of 2.8 ± 1.8 years (eculizumab) and 0.8 ± 0.4 years (ravulizumab). At eculizumab initiation, 61.9%, 35.7%, and 2.4% were receiving 1, 2, and 3 con-ISTs, respectively; after C5IT, the number of con-ISTs used decreased in 16/42 patients (38.1%), increased in 4/42 (9.5%), and was unchanged in 22/42 (52.4%). OCS dose (mg/day) decreased from eculizumab initiation (14.5 ± 15.0; n = 32) to last ravulizumab dose assessed (6.2 ± 7.0). The proportion of patients receiving ≤5 and ≤10 mg/day OCS increased from 37.5% and 62.5%, respectively, to 68.8% and 81.3% after C5IT. C5ITs were well tolerated, consistent with previous analyses, including clinical trial data.
Conclusions:
These descriptive registry results represent clinical practice and demonstrate reduced OCS burden in patients with AChR-Ab+ gMG receiving eculizumab and ravulizumab. No adjustment for confounders was performed. Data for patients receiving ravulizumab only are forthcoming.
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