Miranda Hester

Ms. Hester is Content Specialist with Contemporary OB/GYN and Contemporary Pediatrics.

 the indication for STELARA® (ustekinumab) to treat moderate-to-severe plaque psoriasis in children aged 6 to 11 years.

 The drug targets interleukin (IL)-12 and IL-23, which is key to moderating the overactive inflammatory response. The drug is given as an injection under the skin 4 times a year, following 2 starter doses.

The approval of the drug was based on the results from the CADMUS Junior study, which was an open-label, single-arm, multicenter phase 3 clinical trial. The study included 44 children who had moderate-to-severe plaque psoriasis and 77% of them had clear or almost clear skin at week 12, after receiving 2 doses. The study results showed that 84% achieved a Psoriasis Area and Severity Index (PASI) 75 response and 64% achieved a PASI 90 response.

Overall, the safety in the pediatric population was similar to the safety results seen in the adult population. Common adverse events include nasal congestion, sore throat, itching, tiredness, and headache. One potentially mitigating factor in the study was that the participants were aware that they were receiving ustekinumab.

1. Janssen Johnson. US Food and Drug Administration approves STELARA® (ustekinumab) for treatment of pediatric patients with moderate to severe plaque psoriasis. Prnewswire.com. Published July 30, 2020. Accessed July 31, 2020. 

https://www.prnewswire.com/news-releases/us-food-and-drug-administration-approves-stelara-ustekinumab-for-treatment-of-pediatric-patien

Articles

The US Food and Drug Administration (FDA) has approved STELARA for treating moderate-to-severe plaque psoriasis in children.

 FDA expands approval of STELARA to treat pediatric plaque psoriasis

The human papillomavirus (HPV) vaccine has been a public health victory and some countries are close to making cervical cancer a thing of the past because of it. However, in the United States, the uptake of the vaccine is largely dependent on parents. A report that aims to quantify parental intentions to start and complete the HPV vaccine in the United States 

Investigators did a cross-sectional study that used data from the adolescent component of the 2017-2018 National Immunization Survey. The study participants were parents or caregivers of US teenagers aged 13 to 17 years. The study’s primary outcome was the parent’s intent to vaccinate the teenager for HPV in the next year. The secondary outcomes were the prevalence of reasons that were given for the lack to either initiate or finish the HPV vaccine series and the relationship between being given a recommendation to vaccinate and the intent to initiate the HPV vaccine series.

The survey was completed by 82,297 parents or caregivers. Among their children, 30,558 were had received no HPV vaccine doses and 9073 had received only one HPV vaccine dose. Fifty-eight percent of the parents to unvaccinated children who also had data on parental intent said that they had no intention of initiating the vaccine. Among the parents who had initiated the series and had data on parental intent, 23.5% said that they did not intend to complete the HPV vaccine series.

Among the reasons given for the lack of intent to initiate the HPV vaccine series was safety concerns (22.8%); a lack of recommendation from a health care provider (22.2%) was the most frequent reason given for parents who did not intend to finish the HPV vaccine series. Among the unvaccinated adolescents, 60.6% of the parents who had a recommendation from a health care provider and data available on parental intent had no intent to begin the HPV vaccine series.

The researchers concluded that a lack of parental intent to start and finish the HPV vaccine series remains a major public health concern in the United States. Two ways to improve the HPV vaccination coverage in the country should include targeting vaccine safety concerns as well as strong, clear recommendations from health care providers.

1. Sonawane K, Zhu Y, Montealegre JR, et al. Parental intent to initiate and complete the human papillomavirus vaccine series in the USA: a nationwide, cross-sectional survey. 

. July 21, 2020. Epub ahed of print. doi:10.1016/s2468-2667(20)30139-0

The human papillomavirus (HPV) vaccine is the key to a major public health victory, but the vaccine coverage has been less than effective. A report offers some answer to how parental intent has made an impact.

Parents and health care providers need to cheerlead the HPV vaccine for their teens

Breaking a bone is a painful experience and the opioid epidemic has left fewer long-term pain relief options. A 

 takes a look at whether nonsteroidal anti-inflammatory drugs such as ibuprofen hinder bone healing.

Investigators performed a prospective, randomized, parallel, single-blinded study that included skeletally immature children who had long bone fractures. The children were randomized into either a group that was treated with weight-based ibuprofen, the intervention group, or treated with weight-based acetaminophen, the control group. Children in both groups were permitted oxycodone for breakthrough pain.

There were 192 children enrolled in the study and 95 patients with 97 fractures completed the 6-month follow-up. There were 46 children with 47 fractures in the control group and 49 patients with 50 fractures in the group treated with ibuprofen. No patient achieved healing at 1 to 2 weeks. By 6 weeks after the fracture, 37 of the 45 children in the control group and 46 of the 50 children in the ibuprofen group had healed fractures. At 10 to 12 weeks, 46 of the children in the control group had healed fractures and all of the children in the ibuprofen group had healed fractures. Every child’s fracture was healed by 6 months. In the control group, health was achieved at an average of 40 days in the control group and 31 days in the ibuprofen group. Oxycodone was used for breakthrough pain for 2.4 days in the control group and 1.9 days for the ibuprofen group.

The investigators concluded that ibuprofen effectively manages pain due to fracture in children. Additionally, using ibuprofen doesn’t impair fracture healing.

1. Nuelle JA, Coe KM, Oliver HA, Cook JL, Hoernschemeyer DG, Gupta SK. Effect of NSAID use on bone healing in pediatric fractures. 

. July 22, 2020. Epub ahead of print. doi:10.1097/bpo.0000000000001603

A bone fracture is a painful experience and ibuprofen may be used to treat the pain. A report examines whether it could inhibit bone healing.

Does ibuprofen inhibit healing after a fracture?

When a child presents with abdominal pain and chronic nonbloody diarrhea, inflammatory bowel disease (IBD) would show up on the differential diagnosis. An 

 evaluates 4 different strategies to find which ones are effective.

The investigators ran a prospective cohort study of children aged 6 to 18 years who were given a standardized diagnostic workup in a secondary or tertiary care hospital. Each participant was assessed for symptoms, C-reactive protein (>10 mg/L), hemoglobin, and fecal calprotectin (≥250 μg/g). Participants who had rectal bleeding or perianal disease were excluded from the study.

The cohort included 193 participants and 22 of them had IBD. The basic prediction model used symptoms only. The addition of blood and stool markers increased the area under curve from 0.718 to 0.930 and 0.967. When combined, symptoms, blood, and stool markers did better than all other strategies. Doing a triage with a strategy that includes symptoms, blood markers, and calprotectin will result in 14 of 100 patients undergoing endoscopy. Three of those who undergo endoscopy will not have IBD and no patient with IBD will be missed.

Investigators concluded that using symptoms, blood, and stool markers to diagnose patients with nonbloody diarrhea is the best strategy. Using this to diagnose will allow clinicians to use endoscopy only with children who are at high risk of IBD.

1. Van de Vijver E, Heida A, Ioannou S, et al. Test strategies to predict inflammatory bowel disease among children with nonbloody diarrhea. 

. July 21, 2020 Epub ahead of print. doi:10.1542/peds.2019-2235

When diagnosing inflammatory bowel disease (IBD), pediatricians may want to avoid using endoscopy. Here’s a look at how 4 alternate strategies work.

Author | Miranda Hester

Articles

FDA expands approval of STELARA to treat pediatric plaque psoriasis

Parents and health care providers need to cheerlead the HPV vaccine for their teens

Does ibuprofen inhibit healing after a fracture?

Comparing diagnostic strategies for IBD