Ravulizumab Shows Sustained Efficacy, Safety in Adults With Myasthenia Gravis

Ravulizumab is associated with sustained efficacy and safety through 164 weeks for the treatment of acetylcholine receptor antibody-positive (AChRAb+) generalized myasthenia gravis (gMG), according to study results presented at the 2024 American Academy of Neurology (AAN) annual meeting, held from April 13 to 18, 2024, in Denver, Colorado.

Ravulizumab is a long-acting terminal complement inhibitor that demonstrated efficacy and safety through week 26 for the treatment of AChRAb+ gMG during a phase 3 randomized, double-blind, placebo-controlled trial, CHAMPION MG.

In the open-label extension of CHAMPION MG (ClinicalTrials.gov Identifier: NCT03920293), patients (N=161) could enroll in the extension trial to receive blind induction (n=83) or bridging (n=78) intravenous ravulizumab therapy at week 26 followed by 3000 to 3600 mg weight-based ravulizumab dosing every 8 weeks through year 4. For this study, researchers used the Myasthenia Gravis–Activities of Daily Living (MG-ADL) and Quantitative Myasthenia Gravis (QMG) instruments to evaluate efficacy outcomes.

The patients who entered the open-label extension received an average treatment duration of an estimated 2 years up to week 164.

The improvements in MG-ADL scores observed among patients who received ravulizumab during the placebo-controlled period of the trial were maintained during the extension period from baseline to week 164 (least-squares mean difference [LSMD], -4.0; 95% CI, -5.3 to -2.8; P <.0001).

The patients who switched from placebo to ravulizumab exhibited rapid improvements in MG-ADL scores from baseline that were maintained through week 138 (LSMD, -2.1; 95% CI, -3.3 to -0.9; P <.0001).

Both patients who continued using ravulizumab from CHAMPION MG and those who switched to ravulizumab from placebo exhibited QMG total score improvements.

Ravulizumab was well-tolerated, and no meningococcal infections were observed.

“Ravulizumab, administered every 8 weeks, demonstrated clinically meaningful sustained improvements in MG symptoms and was well tolerated for up to 164 weeks in adults with AChRAb+ gMG,” the researchers concluded.

Disclosures: This research was supported by Alexion, AstraZeneca Rare Disease. Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of disclosures.