Breakthrough Clinical Results
NYU Langone Health researchers found that rozanolixizumab, a neonatal Fc receptor (FcRn) inhibitor, can prevent congenital heart block in newborns of mothers with anti-SSA/Ro antibodies. In a study of one pregnant mother with systemic lupus erythematosus and high levels of these antibodies, weekly injections of rozanolixizumab from week 14 to 28 of pregnancy blocked the transfer of harmful autoantibodies across the placenta. The baby was born without heart complications, and the mother experienced no serious side effects. The promising results have led to a federally funded multicenter trial called AVERT to further assess the drug's effectiveness.
Key Highlights
- Rozanolixizumab prevents congenital heart block in a high-risk pregnancy.
- The drug blocks autoantibody transfer across the placenta.
- A multicenter trial (AVERT) is planned to further investigate the drug's effectiveness.
- Rozanolixizumab is already FDA-approved for myasthenia gravis.
Incidence and Prevalence
Latest Estimates of Incidence and Prevalence of Congenital Heart Block
Congenital complete heart block (CCHB) affects approximately 1 in 15,000-22,000 live births globally. This condition is typically associated with structural congenital heart disease or maternal collagen vascular diseases.
Up to 90% of cases of congenital heart block without anatomical abnormalities are attributed to maternal systemic lupus erythematous or Sjögren's disease. Interestingly, 50% of mothers of affected infants are asymptomatic at the time of diagnosis.
The recurrence rate in subsequent pregnancies following the birth of a child with CHB is approximately 19%. This highlights the importance of monitoring subsequent pregnancies in mothers who have previously had a child with this condition.
Congenital Heart Block carries substantial mortality and morbidity, with more than 60% of affected children requiring lifelong pacemakers.
Regional variations exist in the presentation of CHB. For instance, the frequency of isolated congenital heart block is about 50% in Japanese anti-Ro/SSA positive neonatal lupus infants, similar to the frequency among Caucasians. However, Japanese infants with neonatal lupus erythematosus (NLE) have a lower frequency of photosensitivity and subacute cutaneous LE lesions compared to their Caucasian American counterparts.
Genetic factors also play a role in the epidemiology of CHB. The HLA-DR3 phenotype, found in the great majority of Caucasian mothers of NLE infants, is absent in Japanese mothers. However, Japanese and Caucasian children with CHB are often identical to their mothers in their alleles of HLA-DRB1, DQA1, and DQB1 loci.
A 2001 study from Finland identified 101 children with isolated congenital heart block and 55 with isolated heart block detected after the newborn period, though population-based incidence rates were not provided.
The majority of Japanese infants with NLE develop annular, erythematous or edematous lesions which have also been reported in association with Sjögren's syndrome, indicating potential regional variations in clinical presentation.
Other Drugs Being Trialed with the Same MoA as Rozanolixizumab
Based on the available information, there is insufficient data to identify other drugs being trialed for the same indication using the same mechanism of action (MoA) as rozanolixizumab. The information needed to address this query, including details about rozanolixizumab's mechanism of action, its targeted indication, and comparable drugs in clinical trials, is not available in the provided sources.
Similarly, there is no information available regarding the intervention models being used in clinical trials for drugs that target the same mechanism of action as rozanolixizumab.
Without specific data on rozanolixizumab's mechanism of action (which may involve neonatal Fc receptor blockade based on related queries) or its therapeutic indication, a comprehensive comparison with other drugs in development cannot be provided.