The PETUNIA (Pregnancy Enhanced Tracking with Neonatal and Infant Assessment) study was unveiled in a poster session at the 2026 AANEM Annual Meeting in Orlando, Florida. The trial-in-progress presentation outlined a worldwide effort to monitor outcomes for pregnant individuals who receive nipocalimab.
Generalized myasthenia gravis (gMG) is an autoimmune disorder that often affects women of childbearing age. Because the disease is driven by pathogenic IgG antibodies, any medication that changes IgG behavior raises concerns about fetal safety.
Nipocalimab is an FcRn blocker that prolongs IgG circulation by inhibiting the neonatal Fc receptor. The same receptor mediates transfer of maternal IgG across the placenta, making it essential to assess whether drug exposure influences infant immunity.
Traditional single-product pregnancy registries have struggled to enroll enough participants for rare conditions like gMG. PETUNIA adopts a more robust pharmacovigilance model that pairs routine exposure reports with structured follow-up questionnaires, aiming to improve data completeness.
Study design and methodology
PETUNIA is a global, non-interventional, single-arm investigation that will capture both prospective and retrospective reports of nipocalimab exposure from the drug’s first approval through 2036. Cases are drawn from Johnson & Johnson’s safety database.
To qualify, a pregnancy must involve at least one dose administered within two weeks before the estimated conception date or at any point during gestation. The protocol excludes exposures that ended more than two weeks before conception or that occurred in an interventional trial.
Participants are followed with four targeted questionnaires: a baseline form, a pregnancy-outcome survey, a neonatal and early-infant assessment at three months, and a one-year infant outcomes questionnaire.
Endpoints and analysis plan
Primary endpoints include rates of maternal complications such as fetal growth restriction, hypertensive disorders (pre-eclampsia, gestational hypertension, HELLP, eclampsia), placental abruption, and small-for-gestational-age infants, as well as serious neonatal infections and major non-chromosomal congenital anomalies.
Secondary outcomes cover live birth, spontaneous abortion, stillbirth, preterm delivery, intrapartum and postpartum hemorrhage, and fetal, neonatal, or infant death.
The study aims to enroll at least 162 pregnancies, with a minimum of 50 prospectively reported cases. Analyses will calculate proportions with 95% confidence intervals, stratifying prospective from retrospective reports to limit selection bias.
At the time of the AANEM presentation, PETUNIA’s registration on ClinicalTrials.gov was still pending and no NCT identifier had been assigned.
Regulatory approvals and dosing regimen
Approval of the drug followed a key phase-3 trial that demonstrated significant improvement in MG-ADL scores compared with placebo.
Patients received a 30-mg/kg intravenous loading dose, then 15 mg/kg bi-weekly infusions throughout the treatment period.
U.S. regulators granted initial approval for adults and adolescents with anti-AChR or anti-MuSK antibodies, expanding treatment options for this population.
Rationale for enhanced pharmacovigilance
Analytical methods will calculate outcome proportions with confidence intervals, then compare them to rates observed in the broader myasthenia gravis cohort and the general obstetric population.
The trial-in-progress poster was presented at the 2026 American Association of Neuromuscular Electrodiagnostic Medicine (AANEM) Annual Meeting and MGFA Scientific Session in Orlando, Florida. Eligible cases must have documented exposure to at least 1 dose of nipocalimab either immediately prior to pregnancy, within 2 weeks before the estimated date of conception, or at any point during pregnancy. Reports are followed using 4 structured TFUQs: a baseline questionnaire, a pregnancy-outcome questionnaire, a neonatal and early infant outcomes questionnaire administered at 3 months, and an infant outcomes questionnaire at 12 months, with corresponding live births assessed through the first year of life.
