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Colleen Sloan, PA-C, RDN is a board-certified PA and registered dietitian. 

Articles

 and joined the MJH Life Sciences team in December 2019. She graduated from Youngstown State University in 2019 with a bachelor's degree in journalism and a minor in political science. Prior to graduating, Morgan worked as the editor-in-chief of her college newspaper. She went on to work as an assignment editor at a broadcast news station in Youngstown, Ohio before joining 

 You can reach her at mpetronelli@mjhlifesciences.com.

Discover essential nutrition tips for young athletes to enhance performance, hydration, and recovery before, during, and after sports activities.

Sports nutrition 101: What young athletes should eat and drink

. He joined the brand in March of 2023 as an editor before being promoted to senior editor in January 2024. Fitch graduated from Youngstown State University in Youngstown, Ohio in 2020 with a degree in telecommunications and journalism. He started his career as a news and sports videographer before becoming an on-air sports anchor at the NBC-affiliated news station in Youngstown. Fitch briefly worked as a national content writer for a Chicago-based national television station before joining the 

team. He can be reached at: jfitch@mjhlifesciences.com.

FDA approves first generic iron sucrose injection for treating iron deficiency anemia in CKD patients aged 2 years and older.

FDA approves first generic iron sucrose injection for iron deficiency anemia in CKD

Brensocatib was granted FDA priority review in February 2025 for the small molecule, oral, reversible inhibitor.

FDA approves brensocatib to treat adolescents with non-cystic fibrosis bronchiectasis

FDA accepts priority review of gepotidacin, a first-in-class oral antibiotic, for treating uncomplicated urogenital gonorrhea in patients ≥12 years.

FDA accepts priority review for gepotidacin as oral treatment for gonorrhea

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When a newborn or his mother is too ill for him to nurse, the pediatrician can do much to help her pump properly, maintain her milk supply, initiate breastfeeding, and more.

Challenges in breastfeeding: Maternal considerations

**Editor's Note** Please note that starting January 1, 2025, we will be switching to an online-exclusive publication process. This will allow us to publish case submissions quicker without having to deal with the variables that come along with print publication. All cases will still be eligible for print publication consideration, but publication in our print magazine is not guaranteed and will be up to the editor's discretion. 

Do you have a puzzling pediatric case that you’d like to share with the readers of 

We are looking for intriguing diagnoses that have stumped the experts—a diagnostic “Puzzler”—to help our physicians enhance their day-to-day practices. If you have such a story to tell, tell us.

Here’s what to do: Before you begin, we suggest that first you review the Puzzler 

https://www.contemporarypediatrics.com/case-studies

. Please note the specific style required for writing Puzzler manuscripts.

Next, prepare a draft of your case, including a summary of the presenting symptoms, a case overview, a 

table of the differential diagnosis (MANDATORY)

, and the special aspects of your case that qualify it as a Puzzler, and send it to us. Please note that the differential diagnosis table should also be discussed in the body text. We’ll review your draft and let you know what you need to add or revise before we send the manuscript to peer review for evaluation.

Puzzlers vary in length, and we suggest a minimum of 1,200 words up to a maximum of 2,000 words, but that is because of the complexity of some cases and whether some patients returned for many assessments before their diagnoses were determined. Also, some authors describe the pathophysiology of the differentials in great detail. Please also note no more than 3 authors are allowed per article.

What's most important is to show us the process that you used to analyze the case, including:

Why you decided to order certain tests and why you did not order others.

Peer consultations or why you elected to contact other specialists.

Lab values including vital signs or blood tests.

Labs and values if your patient was attended to in the emergency department or other hospital departments such as radiology or neurology.

Discussion related to the possible diagnoses.

Final diagnosis, treatment, prognosis, and follow-up.

Remember to indicate numbered citations within the body of the text and include a complete list of corresponding literature/references at the end of the manuscript. (Do not use any citation management programs or unlink them.) 

Limit references to 25. No references (unless it is a seminal study) can be older than 10 years.

We prefer primary research as references, but some cases are so obscure that authors will need to pull from a variety of sources. However, 

. Be advised that peer reviewers are adamant that the disease/disorder you describe was actually diagnosed and not determined by index of suspicion on the basis of ruling out various differentials. We use AMA11 as our publication style, which uses superscript citation numbers and a corresponding numbered reference list. Please create your citations and references in this style.  Check this recent article posted online at 

https://www.contemporarypediatrics.com/view/the-rx-of-adhd

 for examples of reference style. IMPORTANT NOTE WITH AMA 11TH EDITION: PLEASE PUT DOI OR WEBSITES/URLS AT THE END OF THE REFERENCE LINE.

When you send your draft manuscript, also 

. These image files must be high-resolution jpg or tiff files (minimum of 300 dpi) and as large in size as possible. We suggest a minimum of 7 horizontal inches. The images must be original photos with clear permissions to use, not images from copyrighted sources. Send as separate attachments with your e-mail submission; do not embed images into your manuscript document.

After we receive your manuscript, our editors and peer reviewers will review your draft and let you know if we accept your submission for publication. 

Puzzler is one of the departments for which we receive the most submissions, so it may be several months after submission before you receive feedback from us.

If we do accept your submission for publication, we will contact you with further instructions.

Send your submissions in Microsoft Word format to 

, via e-mail to mpetronelli@mjhlifesciences.com

Guidelines for PUZZLER, Contemporary Pediatrics

Recent 24-week data from the ADmirable study reinforce the safety and efficacy of lebrikizumab-lbkz (Ebglyss; Eli Lilly) in adolescents and adults with moderate to severe 

 (AD), including individuals with pigmented skin tones. Findings were shared via an oral presentation from Eli Lilly at the Revolutionizing Atopic Dermatitis (RAD) conference and represent the latest update in ongoing efforts to evaluate treatment performance across diverse patient populations.

Lebrikizumab-lbkz, a biologic targeting IL-13 

approved by the FDA on September 13, 2024

 is currently indicated for patients 12 years or older with moderate to severe AD whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.

According to the company, the study included adults and adolescents 12 years or older with a weight of at least 40 kg who identified as Black or African American, Asian, American Indian or Alaska Native, or Native Hawaiian or Other Pacific Islander. All participants had moderate to severe AD and pigmented skin as measured by the Fitzpatrick skin phototype scale. 

At week 24, 78% of participants achieved at least a 75% improvement from baseline in the Eczema Area and Severity Index (EASI-75), including more than 88% of those with Fitzpatrick skin types V and VI. Among those who had responded to treatment by week 16, 63% achieved a high bar of deep skin response as measured by at least 90% improvement in their eczema extent and severity (EASI-90), according to Eli Lilly. In addition, 73% of week 16 responders successfully transitioned to a once-monthly maintenance dose. 

Improvement in itch symptoms was also observed, with 60% of patients achieving a reduction of 4 points or more on the Peak Pruritus Numerical Rating Scale. Among participants with postinflammatory hyperpigmented lesions at baseline, 64% had visible improvement in hyperpigmentation at 24 weeks based on assessments with the PDCA-Derm scale, a dermatologic evaluation tool used in patients with skin of color. 

The safety profile in ADmirable was consistent with previous phase 3 studies of lebrikizumab, and no new safety signals were identified.

Andrew Alexis, MD, MPH, professor of clinical dermatology and vice chair for diversity and inclusion in the Department of Dermatology at Weill Cornell Medicine, dermatologist at New York-Presbyterian/Weill Cornell Medical Center, and lead ADmirable investigator, discussed the implications of these results in the Q&A interview below. 

 Can you highlight and provide the findings from recent 24-week data of lebrikizumab-lbkz and explain the makeup of the trial and the study population?

In this analysis presented at RAD, we presented the 24-week efficacy and safety outcomes of lebrikizumab in adult and adolescent patients with moderate to severe AD and skin of color, a historically underrepresented patient population in clinical trials, for which important data gaps and health care disparities exist. The study included innovative measures of postinflammatory pigment alteration associated with AD using a novel scale called PDCA. Lebrikizumab improved AD signs and symptoms (including itch) through 24 weeks of treatment across Fitzpatrick skin phototypes, with continued improvement from weeks 16 to 24.

Of note, postinflammatory hyperpigmentation, assessed through PDCA-Derm, improved in almost two-thirds of patients by week 24.

The favorable safety profile of lebrikizumab was also demonstrated with no new safety signals.

How crucial are these data among a wide-ranging group of patients with varying skin tones? 

 These data support the efficacy and safety of lebrikizumab in patients with skin of color and Fitzpatrick skin phototypes IV to VI. Being able to communicate to patients [with] AD with skin of color that treatment with lebrikizumab can not only improve the signs and symptoms of AD but can also result in improvement in AD-associated postinflammatory pigment changes is extremely impactful and very relevant to this patient population. Sharing these data can help build trust that translates into greater adherence to therapy and improved outcomes for patients with skin of color, who have historically not been well represented in clinical trials. 

 Since its approval in 2024, what has the reception to this treatment been, and can you speak to the overall treatment landscape for pediatric atopic dermatitis? 

Lebrikizumab has been a welcome addition to our therapeutic armamentarium. Being able to offer more treatment options including this safe and efficacious IL-13–specific antagonist, the second agent to be approved in this class, has helped opened the door to more individualized care through shared decision-making. 

Additional options for our pediatric patient population include the recently FDA-approved targeted topical agents 

roflumilast 0.15% cream (approved for 6 years or older)

, which have also been a huge step forward.

 Is there anything else you would like to include?

Overall, this is an exciting time in the field of AD in that we are able to offer our patients so many more treatment options than just a few years ago. The targeted nature of our current treatment options (eg, biologics, JAK inhibitors, phosphodiesterase-4 inhibitors, and an aryl hydrocarbon receptor agonist) has ushered in a new era in the management of AD that is rooted in our improved understanding of the pathomechanisms of this complex disorder. 

Alexis A, Moiin A, Waibel J, et al. Efficacy and safety of lebrikizumab in adult and adolescent patients with skin of color and moderate-to-severe atopic dermatitis: final 24-week results from the phase 3b, open-label ADmirable study. Presented at: Revolutionizing Atopic Dermatitis Conference 2025; June 6-7, 2025; Nashville, TN. 

Kunzmann K. FDA approves lebrikizumab for atopic dermatitis in patients 12 years and older. 

. September 13, 2024. Accessed June 25, 2025. https://www.contemporarypediatrics.com/view/fda-approves-lebrikizumab-atopic-dermatitis-patients-12-years-older

Lebrikizumab demonstrated efficacy and safety in patients with skin of color and moderate to severe atopic dermatitis in the ADmirable trial. Trial investigator Andrew Alexis, MD, MPH, reacts. 

News

Andrew Alexis, MD, MPH, highlights positive lebrikizumab-lbkz data for atopic dermatitis

On June 10, 2025, Arcutis Biotherapeutics 

announced that the first infant was enrolled in the INTEGUMENT-INFANT study

, a phase 2 clinical trial evaluating investigational roflumilast cream 0.05% for atopic dermatitis (AD) in children aged 3 months to under 2 years. The open-label study will assess the safety and tolerability of once-daily treatment in approximately 35 infants with mild to moderate AD over a 4-week period.

Roflumilast, a topical phosphodiesterase-4 inhibitor, is already approved in various formulations and concentrations for several dermatologic indications across older pediatric and adult populations. The cream formulation has been approved in concentrations of 0.3% and 0.15% and is currently under FDA review for the 0.05% concentration in children aged 2 to 5 years.

Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, emphasized the burden of AD in infants and the lack of approved treatment options. “Enrolling the first child in this study is a meaningful step forward and builds on our mission to address unmet needs in pediatric dermatology,” Burnett stated at the time of enrollment.

Mercedes E. Gonzalez, MD, board-certified pediatric dermatologist; clinical assistant professor at Florida International University Herbert Wertheim School of Medicine and the Phillip Frost Department of Dermatology at Miller School of Medicine; medical director at Pediatric Skin Research in Miami, Florida; and an investigator in the INTEGUMENT-INFANT trial, expands on the significance of the study in the Q&A below. 

What do treatment options currently look like for populations younger than 2 years who have AD?

Today, infants under 2 years with AD face a significant gap in FDA-approved treatment options. While topical corticosteroids are often prescribed as first-line treatment, there are limited FDA-approved treatment options.

Generally speaking, how much of an impact does AD have on this younger age group, and is it more or less frequent in this group compared with other pediatric age groups?

AD impacts 9.6 million children in the United States,

 and up to 60% of children with AD develop symptoms within their first year.

 The disease in this age group often presents as red, scaly patches on the cheeks, chin, and scalp, which can severely disrupt sleep and increase the risk of skin infections.

How encouraging is it that there is a treatment study being conducted in this age group, and do providers feel this is a group that needs a treatment indication?

Enrolling the first infant in this study represents an important milestone in our efforts to better understand potential treatment options for this underserved population. Given the chronic nature of AD and the lack of existing approved therapies for infants, we are encouraged by the opportunity.

Is there anything else you would like to include related to this study, roflumilast, or AD in the younger populations?

AD in infants is more than just a skin condition; it can disrupt development, sleep, and quality of life for the entire family. Despite the high prevalence, early onset, and serious impact of AD, there are very few topical or systemic therapies approved for infants. This means new clinical research is critically important for this age group.

The planned infant trial of roflumilast seeks to build on the multiple approved indications and ongoing trials of the topical AD treatment across varying age groups.

Currently, roflumilast is approved for the following indications, according to Arcutis

Roflumilast foam 0.3% is approved to treat plaque psoriasis of the scalp and body in adults and pediatric patients 12 years or older. 

Click here for more on this indication, which was approved by the FDA on May 22, 2025.

Roflumilast foam 0.3% is approved to treat seborrheic dermatitis in adults and pediatric patients 9 years or older. 

Click here for more on this indication, which was approved by the FDA on December 15, 2025.

Roflumilast cream 0.3% is approved for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years or older. 

Roflumilast cream 0.05% is being studied for mild to moderate AD in infants aged 3 months to under 2 years in a new phase 2 trial.

John Cahill

Articles

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