Discussion
anti-AChR, fatigue
EVENT
The interim results of this long-term extension of the CHAMPION MG study demonstrate that the benefits of ravulizumab are sustained through 60 weeks in patients with anti-AChR antibody-positive gMG. In patients who received ravulizumab during the RCP, improvements in activities of daily living, muscle strength, fatigue, and quality of life were seen by Week 1 and sustained through 60 weeks of treatment.There was a rapid and sustained beneficial response to ravulizumab in patients who switched from placebo to ravulizumab in the OLE, consistent with that observed for patients treated with ravulizumab during the RCP [The criteria for response in the CHAMPION MG study were an improvement of ≥ 3 points on the MG-ADL scale or ≥ 5 points in the QMG score; both exceed the minimal clinically important difference generally accepted for these measures (i.e. ≥ 2 points on the MG-ADL scale and ≥ 3 points in the QMG score) [Changes to immunosuppressant use were permitted only during the OLE. During the OLE period assessed in the interim analysis (up to 34 weeks of ravulizumab treatment) several patients were able to decrease or discontinue their corticosteroid use, suggesting that adults with gMG who are treated with ravulizumab may be able to reduce their regular corticosteroid dosage, and hence lessen the adverse-event burden associated with such treatment.During the RCP, the proportion of patients experiencing a clinical deterioration event was approximately halved in the ravulizumab group compared with the placebo group [The results of this interim analysis support the efficacy of the weight-based dosing regimen with an 8-week dosing interval. This regimen is used for other approved indications and has been shown to provide immediate, sustained, and complete C5 inhibition over the whole dosing interval [The safety profile of ravulizumab in the long-term extension period was consistent with that in the 26-week RCP [The findings of the CHAMPION MG study of ravulizumab are consistent with those of the REGAIN study of eculizumab in anti-AChR antibody-positive gMG [Strengths of the CHAMPION MG study have been previously described [In conclusion, the interim analysis demonstrates that patients who initiated ravulizumab at RCP baseline sustained their improvements for up to 60 weeks, while patients who switched from placebo to ravulizumab at OLE baseline achieved a rapid and sustained improvement in their MG symptoms, consistent with that observed in patients who initiated ravulizumab treatment at the start of the study. The study also demonstrates that ravulizumab has the potential to decrease the rate of clinical deteriorations. The safety profile was consistent with the known safety profile of ravulizumab and no new safety signals were identified. Overall, these findings support the sustained clinical effectiveness and long-term safety of ravulizumab, administered every 8 weeks, in adults with anti-AChR antibody-positive gMG.