Get caught up with Contemporary Pediatrics! This list helps you navigate our top stories from the week, all in one place.
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Thank you for visiting the Contemporary Pediatrics® website. Take a look at some of our top stories from last week (Monday, December 2, to Friday, December 6, 2024), and click on each link to read and watch anything you may have missed.
Click the link below and watch our first episode of our COVID-19 Therapy Roundtable discussion, in collaboration with our sister publications Contagion and Contemporary OB/GYN. Our panels of experts highlight different therapies around COVID-19 treatment and prevention, and offer practical clinical pears surrounding the infectious disease.
Our panel of clinicians includes:
Our next episode of this roundtable series will be posted Wednesday, December 11 on ContemproaryPediatrics.com.
Click here to watch the first episode, which runs 11 minutes.
Teva Pharmaceuticals has reported positive phase 3 results for fremanezumab (Ajovy) in preventing episodic migraine in children and adolescents aged 6 to 17 years. The SPACE trial (NCT04530110), a 12-week, randomized, placebo-controlled study, demonstrated significant efficacy compared to placebo and a safety profile consistent with adult populations.
Key findings include a reduction in monthly migraine days (-2.5 vs -1.4; P = 0.0210), monthly headache days (-2.6 vs -1.5; P = 0.0172), and a higher proportion of patients achieving a ≥50% reduction in migraines (47.2% vs 27.0%; P = 0.0016). Benefits were consistent across age groups and genders. The safety profile was favorable, with adverse event rates comparable between fremanezumab (55%) and placebo (49%), and low discontinuation rates (≤1%).
This milestone addresses the rising incidence of pediatric migraines, which affects up to 15% of adolescents but has seen limited innovation in treatment options. Fremanezumab, already approved for adult migraine prophylaxis, is the first CGRP-pathway treatment to demonstrate statistically significant efficacy and safety for episodic migraine prevention in pediatric patients. Further studies are ongoing to assess its use in chronic migraines and long-term safety.
Click here for full study details.
PIF Partners has announced that its investigational therapy 101-PGC-005 ('005) has received Rare Pediatric Disease Designation from the FDA for systemic juvenile idiopathic arthritis (sJIA) flares. The treatment, a Type IA prodrug of dexamethasone targeting CD206+ macrophages, is also undergoing phase 3 trials in India for COVID-19-induced acute respiratory distress syndrome.
Systemic juvenile idiopathic arthritis is a rare, severe autoinflammatory disease affecting children under 16, characterized by spiking fevers, rash, joint inflammation, and organ involvement. The FDA's designation promotes the development of treatments for serious pediatric diseases, reflecting '005's potential to address the unmet needs in sJIA.
In a study that assessed 3 randomized clinical trials of adolescents with moderate-to-severe atopic dermatitis (AD) who were treated with upadacitinib, results demonstrated sustained efficacy responses through 76 weeks to go along with a favorable safety profile. These results were published in JAMA Dermatology.
In the Measure Up 1 (NCT03569293), Measure Up 2 (NCT03607422), and AD Up (NCT03568318) trials—ongoing, double-blind, placebo-controlled phase 3 randomized clinical trials featuring adolescents aged 12 to 17 years with moderate to severe AD—once-daily upadacitinib, 15 mg or 30 mg, was superior to placebo alone (Measure Up 1 and Measure Up 2 trials) or with topical corticosteroids (AD Up trial) through 16 weeks, and was sustained through 52 weeks during blinded extension phases of the studies.
To further evaluate the once-daily JAK inhibitor, the study investigators sought to assess the efficacy of upadacitinib, 15 mg and 30 mg, with or without topical corticosteroids, in the same patient population through 76 weeks.
Click here for study results and full data points.
A pair of supplemental Biologics License Applications (sBLAs) have been submitted to the FDA for Johnson & Johnson's guselkumab (Tremfya) to treat moderate-to-severe plaque psoriasis (PsO) in children aged 6 years and up and to treat active juvenile psoriatic arthritis (jPsA) in children aged 5 years and older, Johnson & Johnson recently announced.
According to the announcement, the PsO submission is backed by data from the phase 3 PROTOSTAR study (NCT03451851) that featured pediatric patients with moderate-to-severe plaque PsO. In addition, the submission is based on bridging pharmacokinetic (PK) data from the phase 3 Voyage 1 (NCT02207231) and Voyage 2 (NCT02207244) studies in adult patients.
Recognize & Refer: Hemangiomas in pediatrics
July 17th 2019Contemporary Pediatrics sits down exclusively with Sheila Fallon Friedlander, MD, a professor dermatology and pediatrics, to discuss the one key condition for which she believes community pediatricians should be especially aware-hemangiomas.
