[Pubmed] Post-hoc analyses from the ADAPT clinical study demonstrate aggregate sustained benefit of Efgartigimod in gene
Posté : 19 oct. 2024 12:00
J Neurol Sci. 2024 Oct 4;466:123264. doi: 10.1016/j.jns.2024.123264. Online ahead of print.
ABSTRACT
OBJECTIVES: This post-hoc analysis evaluates the long-term efficacy of efgartigimod versus placebo in adult patients with generalized myasthenia gravis (gMG) with acetylcholine-receptor autoantibodies (AChR-Ab+), based on data from the ADAPT RCT and its open-label extension ADAPT+.
METHODS: Changes from baseline in Quantitative Myasthenia Gravis (QMG) and Myasthenia Gravis-Activities of Daily Living (MG-ADL) scores were assessed by treatment group over the ADAPT (up to 20 weeks) and ADAPT+ time horizon (extended to 64 weeks for efgartigimod group patients). Response to treatment was defined as (Meriggioli, 2009 [3])5-point reduction in QMG or (Meriggioli, 2009 [3])3-point reduction in MG-ADL vs. baseline values.
RESULTS: AChR-Ab+ patients treated with efgartigimod spent a substantially greater percentage of time in response in ADAPT based on at least a 5-point change in QMG compared to the placebo group (44 % versus 13 % respectively, p = 0.0034). Analyses based on a 3-point change in MG-ADL in ADAPT showed the percentage of time in response was nearly double for efgartigimod versus placebo (59 % versus 30 % respectively, p = 0.010). These trends were also maintained using different response definitions, as well as in patients with and without prior immune therapy exposure and by time from diagnosis (
Source: https://pubmed.ncbi.nlm.nih.gov/3942636 ... t9+e462414