Drug updated on 9/4/2024
Dosage Form | Injection (intravenous; 400 mg/20 mL [20 mg/mL]) |
Drug Class | Neonatal Fc receptor blockers |
Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- Indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
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Summary
- Vyvgart (efgartigimod alfa-fcab) is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.
- This summary is based on the review of two systematic review(s)/meta-analysis(es). [1-2]
- Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score: Efgartigimod significantly improved MG-ADL scores with a mean change of -2.17 points (95% CI -2.67, -1.67; p < 0.001) compared to placebo. Rozanolixizumab 7mg/kg and 10mg/kg showed superior efficacy, with mean differences (MD) ranging from 2 to 3.72 and the highest rank probability (83%) according to SUCRA.
- Quantitative Myasthenia Gravis (QMG) Score: Efgartigimod significantly improved QMG scores with a mean change of -3.46 (95% CI -4.53, -2.39; p < 0.001). Batoclimab 340mg and 680mg demonstrated greater reductions in QMG scores compared to placebo and other monoclonal antibodies, with MD ranging from 4.11 to 9.31 and SUCRA values of 93% and 97%, respectively.
- In the meta-analysis reviewed, belimumab demonstrated the highest SUCRA value for safety outcomes (89.8%), indicating a better safety profile relative to rozanolixizumab at doses of 7mg/kg (RR 0.08, 95%CrI 0.01 to 0.94) and 10mg/kg (RR 0.08, 95%CrI 0.01 to 0.86).
- The safety profile of efgartigimod was not detailed in terms of specific adverse events; however, it was implied that belimumab had a more favorable safety profile compared to rozanolixizumab, which was associated with a higher incidence of adverse events.
- There is no population types or subgroups information available in the reviewed studies.
Product Monograph / Prescribing Information
Document Title | Year | Source |
---|---|---|
Vyvgart (efgartigimod alfa-fcab) Prescribing Information. | 2024 | argenx BV, Zwijnaarde, Belgium |
Systematic Reviews / Meta-Analyses
Document Title | Year | Source |
---|---|---|
Efficacy of innovative therapies in myasthenia gravis: a systematic review, meta-analysis and network meta-analysis. | 2023 | European Journal of Neurology |
Efficacy and safety of the innovative monoclonal antibodies in adults with generalized myasthenia gravis: a Bayesian network analysis. | 2023 | Frontiers in Immunology |