Apr 19, 2024
In the realm of treating gMG, the quest for safer and more effective therapeutic options is a perpetual endeavor. Amidst this pursuit, the interim results of the ADAPT-SC+ study shed light on the long-term safety, tolerability, and efficacy of SC efgartigimod PH20.
The ADAPT-SC+ study (NCT04818671), building upon the findings of its predecessor, ADAPT-SC, and the ADAPT+ open-label extension (OLE) study, delved into the realm of SC administration of efgartigimod PH20. Participants received efgartigimod PH20 SC in cycles of four once-weekly injections, with subsequent cycles initiated at least 28 days apart based on clinical evaluation. The Myasthenia Gravis Activities of Daily Living (MG-ADL) score served as the benchmark for assessing clinical efficacy. The study identified predominantly mild to moderate adverse events (AEs), with the most frequent being injection site erythema (29.1%), COVID-19 (22.3%), and headache (20.1%). Notably, injection site reactions remained manageable, did not necessitate treatment cessation, and showed a decline in occurrence with successive cycles, dropping from 34.6% (n=62/179) in Cycle 1 to 11.5% (n=14/122) in Cycle 6. Analysis revealed significant enhancements from baseline throughout the treatment course, exemplified by notable improvements in the MG-ADL total score (−4.1 [0.27%]), Myasthenia Gravis Quality of Life 15-Item Questionnaire, Revised (MG-QoL15r) (−5.1 [0.44%]), and EuroQoL 5-Dimension, 5-Level (EQ-5D-5L) (13.8 [1.54%]) as early as Cycle 1. These improvements persisted consistently and reproducibly up to Cycle 9. Remarkably, the observed enhancements paralleled those documented with efgartigimod IV during the ADAPT/ADAPT+ trials, suggesting robust and comparable therapeutic efficacy.
Conclusion: The interim analysis of the ADAPT-SC+ trial illuminates the considerable promise of subcutaneous efgartigimod PH20 as a well-tolerated and effective therapeutic avenue for gMG. With its favorable long-term safety profile and notable clinical advancements echoing those observed with efgartigimod IV, subcutaneous efgartigimod PH20 emerges as a beacon of optimism in the realm of gMG treatment. It offers patients a pathway to enhanced quality of life and symptom management. As research unfolds, the journey towards expanding the therapeutic arsenal for gMG enters a new phase, heralding brighter prospects for patients and caregivers alike.
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