The following is a summary of “Improvement of fatigue in generalised myasthenia gravis with zilucoplan,” published in the February 2024 issue of Neurology by Weiss et al.
Researchers performed a retrospective study investigating the influence of fatigue in myasthenia gravis (MG) using the Quality of Life in Neurological Disorders (Neuro-QoL) Short Form Fatigue scale’s transformed T-score method for standardized assessment.
They conducted a phase 3 study (NCT04115293) where adults with acetylcholine receptor autoantibody-positive generalized MG (MG Foundation of America Disease Class II–IV) were randomly assigned 1:1 to receive either daily subcutaneous zilucoplan 0.3 mg/kg or placebo for 12 weeks. Those who completed the RAISE study could continue with zilucoplan 0.3 mg/kg in an open-label extension study, RAISE-XT (NCT04225871). In a subsequent analysis, the long-term impact of zilucoplan was accessed on fatigue in RAISE patients who enrolled in RAISE-XT, focusing on changes in Neuro-QoL Short Form Fatigue T-scores and fatigue severity levels from the baseline of RAISE to Week 60.
The results showed that the mean Neuro-QoL Short Form Fatigue T-scores increased from baseline to Week 12 in the zilucoplan group (total of 86 participants), showing a clinically significant difference compared to the placebo group (total of 88 participants; mean difference: -3.61 [P=0.0060]). Improvements persisted up to Week 60. By Week 12, a higher proportion of patients on zilucoplan (34 out of 86, 47.2%) experienced improvements in at least one level of fatigue severity compared to those on placebo (23 out of 88, 28.4%; P=0.017). By Week 60, most patients (55 out of 84, 65.5%) reported mild fatigue or none.
They concluded that zilucoplan significantly improved fatigue scores and severity compared to placebo in RAISE, with these benefits lasting through week 60 of RAISE-XT.
Source: link.springer.com/article/10.1007/s00415-024-12209-3