TOPLINE:
The monoclonal antibody nipocalimab improves scores related to activities of daily living in a dose-dependent manner, lowers relevant autoantibody levels, and has an acceptable safety and tolerability profile in patients with generalized myasthenia gravis (gMG), results of a phase 2 trial suggested.
METHODOLOGY:
The double-blind phase 2 study (Vivacity-MG) included 68 adults with gMG, most (94.1%) positive for anti-acetylcholine receptor (anti-AChR) autoantibodies, who had inadequate response to ongoing standard-of-care (SOC) therapy at 38 sites in eight countries.Subjects were randomized to receive infusions of placebo every 2 weeks (Q2W) or one of four regimens of nipocalimab, a human, antineonatal Fc receptor monoclonal antibody designed to inhibit IgG (5 mg/kg every 4 weeks [Q4W], 30 mg/kg Q4W, 60 mg/kg Q2W, or 60 mg/kg single dose) over 8 weeks in addition to SOC therapy.Researchers collected blood and serum samples and assessed total IgG levels, levels of anti-AChR and anti–muscle-specific kinase autoantibodies, and antidrug antibodies and neutralizing antibodies to nipocalimab.The primary efficacy endpoint was change to day 57 in total MG-Activities of Daily Living (MG-ADL) scores, with researchers analyzing dose response with a linear trend test.The primary safety outcome was treatment-emergent adverse events (TEAEs).
TAKEAWAY:
In the 83.8% of patients who completed treatment to day 57, there was a significant linear trend in the MG-ADL total score (P=.03) for the 5 mg/kg Q4W, 30 mg/kg Q4W, and 60 mg/kg Q2W groups (changes were not statistically significant compared with placebo, but the authors noted the study wasn’t powered to compare each nipocalimab group with placebo).The overall incidence of TEAEs was similar between the combined nipocalimab group (83.3%) and placebo group (78.6%) with no TEAEs leading to death or discontinuations; the most frequent TEAEs in the combined nipocalimab group were diarrhea, headache, and nasopharyngitis (11.1% each), but all were mild or moderate.The percentage of infections in the combined nipocalimab group was comparable with that in the placebo group with the most common infection being nasopharyngitis.Treatment with nipocalimab resulted in a marked, rapid, and dose-dependent reduction in serum total IgG levels (with a maximal reduction [83%] in the 60 mg/kg Q2W dose group) and corresponding dose-dependent reductions in anti-AChR autoantibodies.
IN PRACTICE:
“This study provides class I evidence that for patients with gMG, nipocalimab was well-tolerated, and it did not significantly improve MG-ADL at any individual dose but demonstrated a significant dose response for improved MG-ADL across doses,” wrote the authors, adding a phase 3 confirmatory study for nipocalimab in the treatment of gMG is ongoing.
SOURCE:
The study was carried out by Carlo Antozzi, MD, Neurological Institute Foundation C. Besta, Milan, Italy, and colleagues. It was published online on December 21, 2023, in Neurology.
LIMITATIONS:
Each study treatment group was relatively small, treatment duration (8 weeks) was short, and some study assessments were interrupted by COVID-19.
DISCLOSURES:
The study was funded by Momenta Pharmaceuticals, Inc., which is now part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Antozzi has received a travel grant from Biogen; see paper for disclosures of other authors.
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