Long-term safety, tolerability, and efficacy of subcutaneous efgartigimod PH20 in generalized myasthenia gravis: final results from a phase 3 open-label extension study (ADAPT-SC+).

What was studied

This was an open-label extension of a phase 3 study. It was in adults with generalized myasthenia gravis. They got efgartigimod PH20 as shots under the skin. The dose was 1000 mg, in cycles of 4 weekly shots. 180 people got at least 1 dose. They were followed for a mean of 2.6 years.

What they found

Most people had at least 1 adverse event. The most common were injection site reactions, COVID-19 and headache. Injection site reactions were mild or moderate. No new safety signals showed with more frequent dosing. MG-ADL scores improved fast. Most people reached a meaningful gain at some point. This held with or without AChR antibodies.

What it means for patients

The team says the data show long-term safety and tolerability. They also show lasting effect. They say it broadens options to tailor care.

Why it is not certain yet

This study had no comparison group. Everyone knew they got the drug. Only people from earlier studies took part. The data come from one extension study. This text uses the abstract and nothing else.

Source

Long-term safety, tolerability, and efficacy of subcutaneous efgartigimod PH20 in generalized myasthenia gravis: final results from a phase 3 open-label extension study (ADAPT-SC+).

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