Imaavy Outperforms Other FcRn Blockers in Sustained gMG Symptom Control

Results of an indirect treatment comparison (ITC) demonstrated that Imaavy (nipocalimab-aahu; Johnson & Johnson, New Brunswick, NJ) treatment was associated with consistent and sustained improvement in generalized myasthenia gravis (gMG) symptoms in individuals aged ≥12 years with anti-acetylcholine receptor (AChR) and anti- muscle-specific receptor tyrosine kinase (MuSK) antibody positive gMg. These results were presented at the 11th Congress of the European Academy of Neurology (EAN). The analysis, which incorporated data from the phase 3 VIVACITY-MG3 study (NCT04951622), compared outcomes across published phase 3 studies of other FcRn blockers and evaluated Myasthenia Gravis Activities of Daily Living (MG-ADL) scores over a 24-week period.

Using both population-adjusted and placebo-anchored ITC methods, researchers compared Imaavy with other marketed neonatal fragment crystallizable receptor (FcRn) blockers in the absence of head-to-head trial data. At week 1, the onset of early symptom relief with Imaavy treatment was found to be similar to that of comparators. Through week 24, Imaavy showed sustained, consistent gMG disease control and—compared with the other FcRn blockers—numerically greater or statistically significant improvement in MG-ADL scores.

In the population-adjusted analysis:

• Compared with 1 other FcRn blocker, Imaavy treatment showed a mean difference of -2.36 at week 8 (95% CI, -3.56 to 1.16; P=.001), which continued through week 24 (P<.05).
• Compared with another FcRn blocker, at week 10, Imaavy treatment showed a mean difference of -2.38 at 1 comparator dose (95% CI, -3.57 to -1.18; P<.001) and -3.14 with another comparator dose (95% CI, -4.15 to -2.14; P<.001), with the trend continuing through week 14 (P<.001).

In the placebo-anchored analysis:

• Compared with 1 FcRn blocker, Imaavy treatment showed a -1.24 greater MG-ADL change from baseline at week 8 (95% CI, -2.78 to 0.30), -1.13 at week 18 (95% CI, -2.77 to 0.50), -1.44 at week 20 (95% CI, -3.21 to -0.33), -1.79 at week 22 (95% CI, -4.16 to 0.59), and -2.89 at week 24 (95% CI, -5.67 to -0.12)

“These analyses provide useful population-adjusted comparative data and add to the body of evidence supporting the use of Imaavy for the treatment of gMG for certain patients,” said Saiju Jacob, MD, Professor in the Department of Immunology and Immunotherapy at University of Birmingham, UK. “The significantly greater mean improvements on MG-ADL scores with Imaavy reflect important new evidence of the ongoing need for sustained disease control in a chronic condition like gMG.”