Johnson & Johnson's New 'Compelling Data' Shows Sustained Symptom Improvement In Muscular Disease Patients

Johnson & Johnson JNJ on Tuesday announced results from additional analyses of the Phase 3 Vivacity-MG3 study and the ongoing open-label extension (OLE), evaluating the long-term efficacy and safety of nipocalimab in a broad population of antibody-positive adults with generalized myasthenia gravis (gMG).

Patients treated with nipocalimab plus standard of care (SOC) maintained improvements in their MG-ADL (activities of daily living) and QMG (quantifies disease severity) scores over 84 weeks with sustained reductions in total immunoglobulin G (IgG).

Nipocalimab demonstrated a mean change in MG-ADL of -5.64 (p<0.001) after 60 weeks in the OLE for study participants receiving nipocalimab and SOC, and -6.01 (p<0.001) mean change for study participants who transitioned from placebo and SOC to nipocalimab and SOC.

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In the antibody-positive population, 45% of patients receiving steroids at the OLE baseline were able to decrease or discontinue steroids at the time of this data cut by more than half of the baseline dose.

• Among these patients, the mean dose of prednisone decreased from 23 to 10 mg daily.

Nipocalimab had a consistent and tolerable safety profile throughout the OLE phase.

Additional findings from the Phase 3 Vivacity-MG3 study indicate that patients treated with nipocalimab plus SOC achieved statistically significant improvements in their QMG score by -4.9 versus placebo plus SOC (p<0.001) over weeks 22 and 24.

Patients in the nipocalimab plus SOC treatment group were four times more likely to sustain symptom improvement at 20 weeks than the placebo plus SOC group, as measured by a three- or greater-point improvement on the QMG score.

Results show significantly more patients treated with nipocalimab (36.4%) versus placebo (10.5%, p<0.001) spent greater than 75% of the study duration, demonstrating improvements in the QMG score.

A reduction of more than three points in the QMG score indicates a decrease in the severity of the patient’s symptoms due to improvements in muscle strength, allowing patients to carry out important daily activities such as swallowing and chewing.

Price Action: JNJ stock is down 0.21% at $150.31 at the last check on Tuesday.

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