Ravulizumab reduces clinical deteriorations in patients with generalized myasthenia gravis: Results from the CHAMPION MG study

Topic:

Clinical Trials

Poster Number: 148

Author(s):

Renato Mantegazza, MD, Fondazione IRCCS Istituto Neurologico Carlo Besta, Andreas Meisel, MD, NeuroCure Clinical Research Center, Charité Universitätsmedizin Berlin, Tuan Vu, MD, University of South Florida, Djillali Annane, MD, Raymond Poincaré Hospital (AP-HP), Garches, France, Masahisa Katsuno, MD, Nagoya University Graduate School of Medicine, Nagoya, Japan, Rasha Aguzzi, Alexion, AstraZeneca Rare Disease, Boston, MA, USA, Kathleen N Beasley, Alexion, AstraZeneca Rare Disease, Boston, MA, USA, James Howard, MD, FAAN, The University of North Carolina at Chapel Hill

“Background: _x000D_
The efficacy and safety of ravulizumab in adults with anti-acetylcholine receptor antibody-positive (AChR Ab+) generalized myasthenia gravis (gMG) were demonstrated in the 26-week, randomized controlled period (RCP) and ongoing open-label extension (OLE) of the CHAMPION MG study (NCT03920293). _x000D_
Objective: _x000D_
To assess ravulizumab’s efficacy in reducing acute clinical-deterioration events._x000D_
Methods: _x000D_
Adults with AChR Ab+ gMG were randomized to ravulizumab or placebo for 26 weeks. Patients completing the RCP could enter the OLE and receive ravulizumab for up to 4 years. Clinical deterioration of MG was defined as myasthenic crisis (weakness severe enough to necessitate intubation or to delay extubation following surgery); significant symptomatic worsening; or administration of rescue therapy if the patient’s health was in jeopardy. Clinical-deterioration events were assessed in an interim analysis of data up to Week 60. _x000D_
Results: _x000D_
The RCP and interim OLE analysis sets comprised 175 patients (ravulizumab, 86; placebo, 89) and 161 patients (ravulizumab-ravulizumab, 83; placebo-ravulizumab, 78), respectively. During the RCP, fewer clinical-deterioration events occurred in the ravulizumab group (10 events in 8 patients [9.3%]) versus the placebo group (26 events in 15 patients [16.9%]). A substantial reduction in clinical-deterioration events (5 events in 4 patients [4.8%]) was reported in patients who switched from placebo to ravulizumab for the OLE. In the year before study entry, the clinical-deterioration rate in the study population was 44.4/100 patient-years (PY). The rate in patients receiving placebo during the RCP was 61.6/100 PY (+38.8% vs pre-study; p=0.2860); in patients receiving ravulizumab (RCP and OLE) the rate was 17.8/100 PY (-59.8% vs pre-study levels [p=0.0019] and -71.1% vs placebo [p=0.0011])._x000D_
Conclusions: _x000D_
Ravulizumab treatment was associated with numerically fewer clinical-deterioration events versus placebo in patients with AChR Ab+ gMG. When patients were switched from placebo to ravulizumab, there was a statistically significant reduction in the exposure-adjusted clinical-deterioration event rate.”_x000D_