Celeste Krewson

COVID-19 has resulted in short-term effects on contraceptive needs and access, along with reproductive outcomes, according to a recent study.

Healthcare systems have been significantly affected by the pandemic, as resources were stressed, and services weakened. The World Health Organization (WHO) released a survey revealing nearly all countries’ healthcare systems suffered from the pandemic, with lower-income countries suffering further.

Infectious disease outbreaks often affect patterns of sexual activity. During the Ebola outbreak, family planning decreased 6% in Sierra Leone, 65% in Liberia, and 51% in Guinea. Ebola survivors were not offered means of contraception following the outbreak, despite the acknowledgment that unwanted pregnancies should be avoided during an outbreak.

Investigators saw a need to examine how COVID-19 has affected access to reproductive health services. They conducted a study with the goal of forming empirical evidence to help healthcare professionals make model-based estimates on the services needed.

In the 3-phase study, investigators conducted an electronic bibliographic database search. The first phase consisted of initial limited searches of PubMed, then an assessment of words used in the title and abstract of the papers collected. In the next phase, a new search was conducted using the identified keywords and index terms. Finally, reference lists from the papers were reviews for relevant sources.

There were 28 peer-reviewed documents gathered, and 43 not peer-reviewed. COVID-19’s effects on contraception were discussed in 55 of these documents, discussing demand, provision, access, or reproductive outcomes.

In some papers, declines in contraceptive services were seen at the beginning of the pandemic, with improvements occurring in the following months. Others, however, recorded continuing declines in available services. By November 2020, about half of available services were back to pre-COVID levels.

Reduced services during the pandemic included disruptions to the provision of contraceptive services, reduced availability or stockouts, and healthcare services being unable to offer provider-administered methods. Access varied based on population, and 1 in 3 women aged 18 to 30 years in Ghana, Kenya, Uganda, and Zimbabwe who needed family planning services had their access to these services affected by COVID-19.

Fear of infection, lack of transport, travel-related restrictions, cost, increased waiting times, and limited home visits by health workers all contributed to limiting access to contraceptive services. In adolescents, isolation and closure of schools compounded these issues.

Investigators noted that all but 1 study indicated some aspect of contraceptive services declining during COVID-19. As the impact varied between studies, investigators concluded that further studies should be conducted on how the pandemic affected contraceptive services.

This article originally appeared on Contemporary OB/GYN.

Polis CB, Biddlecom A, Singh S, Ushie BA, Rosman L, Saad A. Impacts of COVID-19 on contraceptive and abortion services in low- and middle-income countries: a scoping review, 

 (2022);30(1).doi:10.1080/26410397.2022.2098557

Articles

In a recent study, it was found that access to contraceptive services declined during the COVID-19 pandemic.

Contraceptive Access Negatively Impacted by COVID-19

The US Food and Drug Administration (FDA) has granted ABX1100(Aro Biotherapeutics) a Rare Pediatric Drug (RPD) designation.

ABX1100 is an investigational Centyrin-siRNA conjugate used to treat Pompe disease by targeting the Gys1 gene. This reduces glycogen buildup in the muscles, making ABX1100 a novel treatment.

Pompe disease is a rare but often fatal disease, capable of manifesting as early as infancy. A mutation in the acid alpha glucosidase enzyme causes glycogen to break down in muscle cells, weakening and debilitating muscles over time.

“Pompe disease affects patients of all ages but can be particularly devastating in children,” said Mittie Doyle, MD, FACR, chief medical officer of Aro Biotherapeutics. “We are committed to developing ABX1100 for children that suffer from Pompe disease in order to provide these pediatric patients with a new therapeutic option.”

RPD designation is given to drugs which treat serious and life-threatening diseases in pediatric patients. A Pediatric Review Voucher is offered to companies granted an RPD by the FDA, giving them priority review, reduced review time, and potential expedited product approval.

Aro Biotherapeutics is dedicated to developing genetic medications which target tissues using Centyrins, a proprietary protein technology. They are working alongside industry partners to develop therapeutics using Centyrins to target tissues for the treatment of a wide variety of diseases.

“Obtaining RPD designation from the FDA represents an important step for Aro towards our goal of developing novel, tissue targeted genetic medicines for patients with rare diseases, and we are very pleased by the FDA’s recognition of the potential of ABX1100 in the pediatric Pompe community,” said Sue Dillon, PhD, cofounder and CEO of Aro Biotherapeutics.

This article originally appeared on Contemporary Pediatrics.

Aro biotherapeutics receives FDA rare pediatric drug designation for ABX1100 for the treatment of Pompe disease. Business Wire. September 15, 2022. Accessed September 16, 2022. 

https://www.businesswire.com/news/home/20220915005101/en/Aro-Biotherapeutics-Receives-FDA-Rare-Pediatric-Drug-Designation-for-ABX1100-for-the-Treatment-of-Pompe-Disease

Aro Biotherapeutics’ ABX1100, used to treat Pompe disease, was granted a Rare Pediatric Drug designation by the FDA.

ABX1100 Given Rare Pediatric Drug Designation by FDA

Two doses of an mRNA COVID-19 vaccine in mothers reduces the risk of infants aged less than 6 months being hospitalized by COVID-19, according to a recent study.

COVID-19 has a high chance of leading to complications in infants too young to receive the vaccine. To combat risks, investigators studied the effects of transplacental transfer of antibodies from maternal vaccination.

Infants hospitalized from COVID-19 between July 1, 2021, and March 8, 2022, were enrolled in a case-control test-negative design alongside infants hospitalized without COVID-19. Case infants were compared with control infants during the delta and omicron variants, with over 500 case infants during omicron, over 300 during Delta, and over 500 control infants between both variants.

About 15% of case infants had been born to mothers who were fully vaccinated, compared to about 30% of control infants. Intensive care was needed in 113 of the case infants and 64 of the control infants. Two case units born to unvaccinated mothers died from COVID-19.

Maternal vaccination saw a 52% effectiveness against hospitalization from COVID-19 overall, 80% during the delta period, and 38% during the omicron period. Effectiveness was almost 70% in cases of maternal vaccination after the first 20 weeks of pregnancy, and 38% during the first 20 weeks of pregnancy.

Halasa NB, Olson SM, Staat MA, et al. Overcoming Covid-19 investigators. maternal vaccination and risk of hospitalization for Covid-19 among infants. 

 2022;387(2):109-119. doi: 10.1056/NEJMoa2204399

Infants of fully vaccinated mothers had fewer cases of hospitalization from COVID-19 than those unvaccinated.


Maternal Vaccination Cut the Risk of COVID-19 Hospitalization for Infants

Dupilumab (Dupixent; Sanofi and Regeneron) is safe and effective in treating atopic dermatitis (AD) in pediatric patients, according to a recent review.

Trials have proven dupilumab to be safe and effective for pediatric use, but proper analysis of real world dupilumab use has not been recorded.

To determine the long-term efficacy of dupilumab, researchers gathered medical records from March 2017 to September 2022 of pediatric patients with moderate to severe AD.

Information on patients’ demographics, body surface area (BSA), Eczema Area and Severity Index (EASI), and Investigator's Global Assessment (IGA) were collected.

Almost 90 patients were observed, and all saw a 75% improvement in EASI after at least 1 year of dupilumab use, with about 60% of patients seeing a 90% improvement.

Improvements were also seen in BSA and IGA. Patients with a positive history of atopy saw a greater improvement in BSA from weeks 12 to 24.

Adverse events were seen in about 14% of patients, with the most common being conjunctivitis and joint pain. No serious adverse events were observed.

Pagan AD, David E, Ungar B, Ghalili S, He H, Guttman-Yassky E. Dupilumab improves clinical scores in children and adolescents with moderate to severe atopic dermatitis: areal-world, single-center study. 

 2022;10(9):2378-2385. doi: 10.1016/j.jaip.2022.06.014

Improvements in atopic dermatitis symptoms were seen in children taking dupilumab, with minimal adverse events.

Dupilumab Is Safe and Effective for Long-term Use in Kids

School-aged children can self-swab to receive their own COVID-19 test results, according to a recent study.

Clinical researchers from Emory University School of Medicine, Atlanta, and Children’s Healthcare of Atlanta conducted a study with 197 children. The children were shown a 90 second video on how to self-swab, then were given written instructions with pictures included.

Once instructed, the children began to self-swab. A healthcare worker then collected a second sample with a different swab for each child.

Both samples were sent to a clinical laboratory. There, it was found that about 98% of positive results and about 98% of negative results matched between the children’s self-swabs and the healthcare worker’s swabs. Both samples had a similar rate of detections, identifying 44% of symptomatic, positive cases of COVID-19.

Children aged less than 8 years often needed more assistance than those aged over 8 years, with about 22% of younger children needing assistance compared to about 6% of older children Once assistance was given, both groups saw an even detection rate.

“Seeing how closely the results line up between the children and trained health care workers is a strong indicator that these age groups are fully capable of swabbing themselves if given proper instruction,” said Jesse Waggoner, MD, assistant professor of infectious diseases at Emory University School of Medicine and one of the lead authors on the study.

In the recent environment, schools are often having children take repeated COVID-19 tests. In many instances, trained professionals are not available for these students. Self-swabbing will expand access to COVID-19 testing for school-aged children.

NIH-funded pediatric COVID-19 testing study finds school-aged children can self-swab. National Institutes of Health. August 26, 2022. Accessed August 29, 2022. 

https://www.nih.gov/news-events/news-releases/nih-funded-pediatric-covid-19-testing-study-finds-school-aged-children-can-self-swab

In a recent study, children were successfully able to self-swab and receive their own COVID-19 test results after basic instructions.

Children Can Do Swabbing for COVID-19 Tests

The infliximab (IFX) biosimilar CT-P13 (Remsima) is equally effective and safe as its reference drug at treating inflammatory bowel diseases (IBDs) while also being more cost effective, according to a recent study.

IBDs are a few of many chronic conditions which have had treatment affected by biological drugs, but the cost of biologics has risen in the past 2 decades. Biosimilars have proven to be a safe and effective alternative, both in adults and in pediatric patients.

Biosimilars, “highly similar” version of their reference drugs, have seen more use as the price of biologics rises or as patents expire. Clinical trials have primarily been used to prove their safety and effectiveness in adults. Recently, however, more data on the safety and effectiveness of biosimilars in pediatric patients has been recorded.

The European Society of Pediatric Gastroenterology, Hepatology and Nutrition found CT-P13 can be used as a reliable alternative to IFX in pediatric patients. Other pediatric studies have shown IFX biosimilars to be similarly safe and effective to the reference drug. As these studies were of a small sample size and varying follow-up lengths, more data is needed to confirm their accuracy.

In the pediatric population, there is a concern about the interchangeability between the CT-P13 biosimilar and the IFX reference drug. The safety of non-medical switching between the IFX drug to a biosimilar was tested in a systematic review, analyzing 44 studies consisting of 3 randomized controlled trials, 40 observational trials, and 1 case series. There were no negative impacts recorded on safety, efficacy, or immunogenicity, but the small number of randomized controlled trials leaves the data unconclusive.

Long term, biosimilars will reduce the cost of biologic therapy, making treatment more affordable and accessible. They are 15% to 45% cheaper than their reference drugs, and in Europe the price reductions on certain biosimilars have reached 80%.

Currently, biosimilars are deemed a safe and effective substitute for treatment of IBDs. Further studies will be necessary to fill in the gaps in the data that is currently available.

The article originally appeared on Contemporary Pediatrics.

1. Dipasquale V, Cucinotta U, Romano C. Biosimilars in pediatric IBD: updated considerations for disease management. 

Although further studies are needed to confirm the long-term effects, recent studies have shown the infliximab biosimilar to be a safe, effective, and cost reducing treatment for inflammatory bowel diseases.