MG-ADL Subdomain Score Changes With Eculizumab or Ravulizumab: An Analysis of the Global MG SPOTLIGHT Registry
Vern Juel1, Samir Macwan2, Francesco Sacca3, Andrew Gordon4, Lida Zeinali5, James Winkley6, Chuang Liu5, Gary Cutter7, Dubravka Dodig8, Joshua Alpers9, Rup Tandan10
1Duke University, 2Eisenhower Health Center, 3NSRO Department, University of Naples Federico II, 4Northwest Neurology, Ltd., 5Alexion, AstraZeneca Rare Disease, 6Baptist Health Medical Group Neurology, 7University of Alabama at Birmingham, 8University of Toronto/Toronto Western Hospital, 9Erlanger Medical Center, 10University of Vermont Medical Center
Objective:
To assess changes in Myasthenia Gravis Activities of Daily Living (MG-ADL) subdomain scores after complement component 5 (C5) inhibitor therapy (C5IT, eculizumab and ravulizumab) initiation among patients with generalized myasthenia gravis (gMG).
Background:
The global MG SPOTLIGHT Registry (NCT04202341) collects data on real-world clinical safety and effectiveness of the C5ITs eculizumab and ravulizumab in adults with anti-acetylcholine antibody-positive (AChR-Ab+) gMG.
Design/Methods:
MG-ADL subdomain scores were assessed in patients enrolled in the MG SPOTLIGHT Registry who received eculizumab (eculizumab subgroup), ravulizumab (ravulizumab subgroup), or transitioned from eculizumab to ravulizumab (eculizumab-to-ravulizumab subgroup) with data available prior to C5IT initiation and during treatment.
Results:
As of July 1, 2024, 178 Registry patients fulfilled inclusion criteria for analysis (male: 55.7%; mean±SD age at MG diagnosis: 54.7±19.0yrs) with 89, 49, and 40 patients in the eculizumab, ravulizumab, and eculizumab-to-ravulizumab subgroups, respectively. Statistically significant reductions (P<0.05) in mean scores were observed for all MG-ADL subdomains after C5IT initiation. Reductions from prior to C5IT to last assessment during C5IT treatment ranged from 41.0% to 53.0% (ocular), 49.9% to 73.1% (bulbar), 40.7% to 58.6% (respiratory), and 33.7% to 71.4% (limbs) across the 3 subgroups. The proportions of patients with complete or partial improvement in individual MG-ADL subdomains during C5IT treatment were similar between the eculizumab and ravulizumab subgroups: 60.7% and 63.3% (ocular), 58.4% and 59.2% (bulbar), 51.7% and 49.0% (limbs), and 33.7% and 26.5% (respiratory), respectively. Among the eculizumab-to-ravulizumab subgroup, the proportions of patients with complete or partial improvement in individual subdomains were 67.5% (ocular), 67.5% (bulbar), 65.0% (limbs), and 45.0% (respiratory) at last assessment during ravulizumab treatment. Results with extended follow-up will be presented.
Conclusions:
These results from clinical practice show the broad benefit of complement C5 inhibition with eculizumab and ravulizumab in improving ocular, bulbar, respiratory, and limb function as indicated by MG-ADL subdomain score in patients with AChR-Ab+ gMG.
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