Evidence map›Paper›PMID 41111019›Full record

ArticleAnnals of the rheumatic diseases2026

Blocking the neonatal Fc receptor as a novel approach to prevent cardiac neonatal lupus: a proof-of-concept study.

Philip M Carlucci, Mala Masson, Bettina F Cuneo, Justin S Brandt, Angus B Worthing, Peter Izmirly, Nicola Fraser, Nalani Sachan, Mary T Donofrio, Robert Clancy and 1 more

Abstract readCase Reports
In one paragraph

Article in Annals of the rheumatic diseases, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. [Sjögren's disease and pregnancy].Zeitschrift fur Rheumatologie · 2026
    Review
  2. Arrhythmias in Autoimmune Diseases: Immune-Mediated Mechanisms and Management.Journal of cardiovascular development and disease · 2026
    Review
  3. Review
  4. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Philip M CarlucciNYU Langone Health, New York, NY, USA. Electronic address: philip.carlucci@nyulangone.org.
Mala MassonNYU Langone Health, New York, NY, USA.
Bettina F CuneoUniversity of Arizona College of Medicine, Tucson, AZ, USA.
Justin S BrandtNYU Langone Health, New York, NY, USA.
Angus B WorthingArthritis and Rheumatism Associates, Washington, DC, USA.
Peter IzmirlyNYU Langone Health, New York, NY, USA.
Nicola FraserNYU Langone Health, New York, NY, USA.
Nalani SachanNYU Langone Health, New York, NY, USA.
Mary T DonofrioChildren's National Hospital, Washington DC, USA.
Robert ClancyColumbia University College of Physicians and Surgeons, New York, NY, USA.
Jill P BuyonNYU Langone Health, New York, NY, USA.

Funding

Autoimmune Drivers and Protectors Team Science (ADAPTS)U01AI176244 · NIAID · OKLAHOMA MEDICAL RESEARCH FOUNDATION · PI JUDITH A JAMES, Jeffrey C Rathmell · 2023 to 2026
$5.1M
Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)R01HD100929 · NICHD · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI BUYON, JILL P, CUNEO, BETTINA FRANCESCA · 2020 to 2024
$3.5M
Translational Basic and Clinical Research Training in RheumatologyT32AR069515 · NIAMS · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Jill P Buyon, Jose U. Scher · 2017 to 2026
$2.9M
Atrioventricular Block Elimination by Rozanolixizumab TreatmentR01AR087521 · NIAMS · NEW YORK UNIVERSITY SCHOOL OF MEDICINE · PI Justin Brandt, Jill P Buyon · 2025 to 2026
$1.5M
RESEARCH REGISTRY FOR NEONATAL LUPUS-264942220N01AR042220 · NIAMS · HOSPITAL FOR JOINT DISEASES ORTHO INST · 1994 to 2003
$148k
NIAID NIH HHS U01 AI176244NIAMS NIH HHS N01 AR042220NIAMS NIH HHS R01 AR087521NIAMS NIH HHS T32 AR069515NICHD NIH HHS R01 HD100929
6 · The paper itself

Abstract

objectivesNovel biologic agents targeting the neonatal Fc receptor (FcRn) offer a promising strategy to prevent cardiac neonatal lupus (cardiac-NL) in pregnant patients with high-titre anti-SSA/Ro52 kD or 60 kD autoantibodies via dual effects: reducing serum immunoglobin G (IgG) levels and inhibiting placental transfer. This study was initiated to assess the feasibility of FcRn blockade as prophylactic therapy for recurrent cardiac-NL.

methodsA 34-year-old pregnant patient with systemic lupus erythematosus and 3 prior consecutive pregnancies complicated by neonatal lupus (1 cutaneous, 1 fatal cardiac-NL at 20 weeks, 1 cardiac-NL delivered at 32 weeks and neonatal cutaneous NL), each despite hydroxychloroquine 400 mg daily, was treated with weekly subcutaneous infusions of 560 mg rozanolixizumab (humanised IgG4 monoclonal antibody against FcRn) from gestational weeks 14 to 28 (to cover the vulnerable period of fetal cardiac injury) through a compassionate use designation. The patient performed home fetal heart rhythm monitoring thrice daily with weekly echocardiograms.

resultsMaternal anti-SSA/Ro52 kD and 60 kD autoantibodies, total IgG, and subclasses IgG1, 2, 3 decreased by about 65% at gestational week 22, with a return to near baseline levels by week 34. The pregnancy was uncomplicated, resulting in a spontaneous vaginal delivery of a healthy neonate at 37 weeks. At delivery, cord blood and maternal IgG levels were normal, obviating the need for rescue intravenous immune globulin. The neonate had a normal echocardiogram and electrocardiogram but developed a rash consistent with neonatal lupus at 5 weeks of life. There were no serious adverse events.

conclusionsThe successful application of FcRn blockade to prevent recurrent cardiac-NL sets a precedent for a multicentre study.

Indexed as

Antibodies, Monoclonal, HumanizedHistocompatibility Antigens Class ILupus Erythematosus, SystemicPregnancy ComplicationsReceptors, FcAdultAutoantibodiesFemaleHumansImmunoglobulin GInfant, NewbornPregnancyProof of Concept StudyRibonucleoproteinsAntibodies, Monoclonal, HumanizedAutoantibodiesFc receptor, neonatalHistocompatibility Antigens Class IImmunoglobulin GReceptors, FcRibonucleoproteins

Identifiers

PMID41111019
PMCPMC13561532

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.