Effectiveness and Safety of Transitioning to Ravulizumab from Eculizumab in Patients with Generalized Myasthenia Gravis: Evidence from a Global Registry
Guido Sabatella1, Andrew Gordon2, Pushpa Narayanaswami3, Michael Pulley4, Saida Sharapova1, James Howard5
1Alexion, AstraZeneca Rare Disease, 2Northwest Neurology, Ltd, 3Beth Israel Deaconess Medical Center/Harvard Medical School, 4University of Florida Jacksonville, 5The University of North Carolina at Chapel Hill School of Medicine
Objective:
To assess the effectiveness and safety of transitioning patients with generalized myasthenia gravis (gMG) from eculizumab to ravulizumab treatment in clinical practice using the Myasthenia Gravis Activities of Daily Living (MG-ADL) total score and Myasthenia Gravis Foundation of America (MGFA) classification.
Background:
Complement component 5 inhibitors eculizumab and ravulizumab are approved treatments for acetylcholine receptor-positive (AChR+) gMG and dosed every 2 (Q2W) and 8 (Q8W) weeks, respectively. An Alexion-sponsored global registry is collecting data on eculizumab and ravulizumab effectiveness and safety in patients with gMG.
Design/Methods:
Registry patients who transitioned from eculizumab to ravulizumab were included if they had effectiveness outcome data (eg, MG-ADL total scores, MGFA classifications) at 3 time points: before initiating and during eculizumab treatment and after transitioning to ravulizumab treatment. Descriptive statistics were performed and are presented as mean (standard deviation [SD]). Safety was assessed by collecting frequency of serious adverse events.
Results:
Of the 204 registry patients enrolled, 53 (26%; 62% male) transitioned from eculizumab to ravulizumab. Mean (SD) patient age was 63.6 (16.2) years at eculizumab initiation and 66.7 (16.0) years at transition to ravulizumab. For 21 patients who had MG-ADL total scores at all 3 time points, a 5.0-point reduction from 8.3 (3.7) to 3.3 (4.1) was observed after 32.8 (20.0) months of eculizumab treatment. After transitioning to ravulizumab, MG-ADL total scores remained stable at 3.1 (3.2) after 5.2 (2.7) months of ravulizumab treatment. In patients with MGFA classifications at all 3 time points (n=21), improvements were noted during eculizumab treatment and remained stable over 5.5 (2.9) months after transitioning to ravulizumab. No new safety signals were reported in patients who transitioned from eculizumab to ravulizumab.
Conclusions:
These initial results from a global registry represent clinical practice and suggest that transitioning from Q2W eculizumab to Q8W ravulizumab is safe and effective for patients with AChR+ gMG.