The goal of this observational study is to evaluate the efficacy and safety of consolidation therapy with corticosteroids and/or immunosuppressants combined with efgartigimod in patients with generalized myasthenia gravis after the acute exacerbation.
Study Type
OBSERVATIONAL
Enrollment
130
Proportion of patients achieving and maintaining minimal symptom expression (MSE) for at least 4 months after first attaining MSE status at any time during the consolidation therapy period within 2 months.
The MG-ADL is an 8-item patient-reported scale to assess MG symptoms and their effects on daily activities. The scale comprises 2 items on daily life activities and 6 items on symptoms. The MG-ADL total score range is 0-24, with higher scores indicative of greater disease severity. A patient was considered achieving MSE if there was a 1 or 0 on the MG-ADL total score ≥4 consecutive months after first attaining MSE status at any time during the consolidation therapy period within 2 months.
Time frame: Consolidation baseline up to Month 6
Proportion of patients achieving both minimal symptom expression (MSE) and a daily corticosteroid dose ≤5 mg at Month 12.
The MG-ADL is an 8-item patient-reported scale to assess MG symptoms and their effects on daily activities. The scale comprises 2 items on daily life activities and 6 items on symptoms. The MG-ADL total score range is 0-24, with higher scores indicative of greater disease severity. A patient was considered achieving MSE if there was a 1 or 0 on the MG-ADL total score.
Time frame: Consolidation baseline up to Month 12
Proportion of patients with MGFA Post-Intervention Status (MGFA-PIS) at Month 6 and Month 12
Time frame: Consolidation baseline up to Month 6 AND Month 12
Change from baseline in MG-ADL scores at Month 6 and Month 12
The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported scale to assess MG symptoms and their effects on daily activities. The scale comprises 2 items on daily life activities and 6 items on symptoms. The MG-ADL total score range is 0-24, with higher scores indicative of greater disease severity.
Time frame: Consolidation baseline up to Month 6 AND Month 12
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change from baseline in QMG scores at Month 6 and Month 12
The Quantitative Myasthenia Gravis (QMG) scale quantifies disease severity based on impairments of body functions and structures as defined by the International Classification of Disability and Health. The QMG scale consists of 13 items that measure endurance or fatigability, and accounts for fluctuations in disease state. The QMG total score range is 0-39, with higher scores indicative of greater disease severity.
Time frame: Consolidation baseline up to Month 6 AND Month 12
Proportion of patients achieving minimal symptom expression (MSE) at Month 6
Time frame: Consolidation baseline up to Month 6
Proportion of patients achieving minimal symptom expression (MSE) with daily corticosteroid dose ≤5 mg at Month 6
Time frame: Consolidation baseline up to Month 6
Incidence of acute exacerbations, impending myasthenic crisis, or myasthenic crisis events during the study period
Time frame: Consolidation baseline up to Month 12
Types and frequencies of adverse events (AEs) and serious adverse events (SAEs) during the study period
Time frame: Consolidation baseline up to Month 12