Therapeutics & Pipeline

Dupilumab and Growth in Severe Pediatric Atopic Dermatitis

<![CDATA[Risks of Under-Treating Severe Atopic Dermatitis in Children]]>
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By Amara Osei

The growth evidence for dupilumab (Dupixent; Sanofi and Regeneron) in children with severe atopic dermatitis (AD) comes from post hoc analyses, so a height advantage over placebo remains unproven. The cited material provides no sample size, height trajectory, effect estimate, follow-up interval or adverse-event rate, leaving the size of the proposed benefit undefined.

Eingun James Song, MD, a dermatologist, director of clinical research and co-chief medical officer at Frontier Dermatology, discussed the issue in a Dermatology Times Expert Perspectives custom video series. He centered the counseling on whether families adequately weigh undertreatment, rather than treating biologic safety as the only question.

What risks accompany under-treatment?

Song said: “We could talk about the risks or some of the safety concerns of any particular medication, whether it’s a cream, a pill, or a shot, but we also need to focus on the risk of under-treating a disease.” The same balance therefore applies to creams, oral medicines and injections, not only to biologics.

He cited higher risks in children whose severe AD remains uncontrolled for:

  • Type 2 inflammatory comorbidities: asthma, food allergies and nasal polyps.
  • Neuropsychiatric comorbidities: anxiety, ADHD (attention-deficit/hyperactivity disorder) and depression.

The commentary reports associations rather than evidence that treating AD prevents these conditions. That distinction matters because Song’s argument rests on reducing uncontrolled disease, yet the discussion supplied no treatment-effect estimates for the comorbidities.

Can early treatment affect growth?

Song said children with severe disease may be smaller and might have grown taller had effective intervention arrived at the right time. This is a hypothesis about timing and disease control, not a demonstrated causal effect of dupilumab.

He described his approach as balancing the risk of overtreatment against the risk of undertreatment. That balance becomes more demanding when an intervention may influence both inflammation and growth, but the source did not quantify either side of the equation.

How should families understand biologics?

Song rejected the idea that a biologic is inherently safer or more dangerous than another treatment. In his view, manufacture in a living system does not, by itself, determine comparative safety.

He cited insulin and vaccines as familiar medicines derived from living organisms. For families with AD, however, he often uses an allergy shot as the most useful explanatory analogy, while acknowledging that the comparison is not exact.

What can the post hoc growth analyses establish?

The findings are post hoc analyses (analyses conducted after the original study analysis), not prospective studies designed and statistically powered to show height differences between children receiving dupilumab and placebo. A dedicated trial could improve certainty, but delaying an effective medication creates logistical and ethical concerns.

Song identified several measures that could strengthen subsequent research:

  • Objective biomarkers beyond bone alkaline phosphatase, a laboratory marker of bone formation.
  • DEXA (dual-energy X-ray absorptiometry) imaging.
  • Height and weight measurements.
  • Control for topical corticosteroid use, sleep and diet.

He emphasized capturing as much growth data as possible. These additions would address some, but not necessarily all, alternative explanations for observed growth differences.

Is the effect drug-specific, class-wide or due to disease control?

Song framed the central unresolved question: “Is this more of a drug effect? Is it a class effect?” Providers first need to establish that the apparent growth benefit is real before assigning its cause.

He noted that interleukin-13 (IL-13) inhibitors, interleukin-31 (IL-31) blockers and Janus kinase (JAK) inhibitors might show similar growth benefits as approvals extend to younger children. Trials designed to capture growth data should determine whether any benefit belongs to a particular drug, extends across drug classes, or mainly reflects better disease control.

Song called this the most important question. The next evidentiary step is prospective, confounder-controlled follow-up that can distinguish a drug-specific effect from a class effect or improved disease control; until then, growth remains a plausible benefit under study, not an established effect of dupilumab.

Source: dermatologytimes.com

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Amara Osei

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Correspondent covering technology and product news in Clinical dermatology, inflammatory skin disease and biologics at Derm Field.

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