Vivgart Hytrulo (efgartigimod alfa and hyaluronidase), an approved treatment for generalized myasthenia gravis (gMG) that is injected under the skin or subcutaneously, has been shown to be more effective than intravenous treatment Vivgart in reducing IgG antibodies. It seems to have the same effect as (Efgarti Gimod Alpha). cause illness.
That is, according to data from ADAPT-SC (NCT04735432)a noninferiority Phase 3 clinical trial that tested whether Vyvgart Hytrulo is no worse than Vyvgart, and its open-label extension ADAPT-SC+ (NCT04818671)evaluating the long-term safety and efficacy of Vibgart Hytrulo in adults with gMG.
Both treatments were well-tolerated and provided similar benefits, but Vibgart Hytrulo is easier to administer, typically within 2 minutes, after patients and caregivers have received adequate training. It should be. Intravenous infusions take about an hour and must be administered by a trained medical professional.
The findings are detailed in the study.Subcutaneous efgartigimod PH20 for generalized myasthenia gravis: interim analysis of a phase 3 randomized non-inferiority trial (ADAPT-SC) and a long-term open-label extension trial (ADAPT-SC+)” was published. neurotherapeutics. The research was funded by Argenxsells both treatments.
Like Vyvgart, Vyvgart Hytrulo tested positive for a type of autoreactive IgG antibody that targets acetylcholine receptors (AChRs), interfering with nerve and muscle communication and causing symptoms of muscle weakness and fatigue. Approved for adults with gMG.
This treatment blocks the action of the neonatal Fc receptor (FcRn) protein, which normally helps stabilize IgG antibodies circulating in the blood. Blocking FcRn speeds up the degradation of IgG antibodies, including the autoreactive antibodies that cause MG, reducing their levels and alleviating MG symptoms.
Comparison of subcutaneous Vibgart Hytrulo and intravenous Vibgart
ADAPT-SC included 110 adults with gMG who were randomized to receive either 1,000 mg of Vibgart Hytrulo four times a week or 10 mg/kg of Vibgart for 4 weeks. Assigned.
As reported, Vyvgart Hytrulo was as effective as Vyvgart in reducing total IgG antibodies one week after the last dose (mean reduction, 66.4% vs. 62.2%).
consistent with data from Adapt (NCT03669588)When Vibgart was tested against placebo, approximately two-thirds (69.1%) of patients treated with Vibgart Hytrulo experienced clinically meaningful improvements in MG Activities of Daily Living (MG-ADL) scores. and quantitative MG (QMG) score was 65.5%. MG-ADL is a patient-reported disease severity measure and QMG is a physician-reported severity measure.
After the initial ADAPT-SC study, 105 patients participated in the ongoing ADAPT-SC+ extension study, of which 73 Adapt+ (NCT03770403)an open label extension to ADAPT. ADAPT-SC+ allowed patients to continue or start Vibgart Hytrulo four cycles per week for up to three years, allowing us to collect more data on how well they tolerated and responded over time.
Of the 178 patients, 164 received at least one dose of Vibgart Hytrulo. 14 did not require treatment or received no treatment. At data cutoff, 160 of the remaining 164 patients (97.6%) were still participating in the study. Of these, 142 started their second treatment cycle and 105 started their third treatment cycle. The average follow-up period was 169.7 days, or approximately 5.5 months.
As announced at last year’s academic conference, Vibgart-Hytrulo has been shown to reduce the impact of MG on daily functioning, as evidenced by an average reduction in MG-ADL scores of approximately 4 points by the first three treatment cycles. Consistently decreased. Similar results were seen in patients with anti-AChR antibodies, who comprised 81.7% of the study population.
Approximately one-third of patients had an MG-ADL score of 0 or 1 at any time during the treatment cycle, suggesting minimal symptoms, ranging from the first 30.2% to the third. It was 35.9%. The greatest improvement coincided with the greatest decrease in circulating IgG antibody levels, which occurred after 4 weeks.
Most patients (88%) appeared to be sufficiently trained to self-administer treatment, and by cycle 3, nearly 60% were able to administer treatment at home. Additionally, 71.2% of patients indicated that they preferred subcutaneous administration over intravenous administration. Vivgart-Hitorulo was well tolerated. The most common side effects are injection site reactions, which are mild or moderate in severity and resolve over time.
“The results of ADAPT-SC and ADAPT-SC+ demonstrate safety and efficacy similar to that observed in the placebo-controlled ADAPT study,” the researchers wrote.
