Dupilumab effective for atopic dermatitis in young children with, without comorbidities
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Key takeaways:
- Dupilumab is approved for atopic dermatitis in children aged 6 months and older.
- Patients on dupilumab did not have any serious treatment-emergent adverse events.
Infants and young children with atopic dermatitis experienced improvements in signs and symptoms with dupilumab treatment regardless of other type 2 comorbidities, according to a study published in Advances in Therapy.
The safety of this treatment was consistent with the biologic’s known safety profile as well, Mark Boguniewicz, MD, allergist-immunologist, National Jewish Health, and colleagues wrote.
Dupilumab (Dupixent; Sanofi/Regeneron) has been approved to treat moderate to severe AD in children aged 6 months and older as well as in children who have asthma and eosinophilic esophagitis.
The LIBERTY AD PRESCHOOL Part B randomized, double-blind, placebo-controlled phase 3 clinical trial comprised children aged 6 months to 5 years with moderate to severe AD that was inadequately controlled with topical therapy or who could not receive topical therapy because it was considered medically inadvisable.
In this post hoc analysis, the researchers focused on 162 patients (mean age, 3.1 years; 61% boys). Among the 161 with at least one atopic comorbidity at baseline, 41 (26%) had asthma, 71 (44%) had allergic rhinitis (AR) and 110 (68%) had food allergy.
The cohort included 83 who received subcutaneous dupilumab and 79 who received a matched placebo every 4 weeks for 16 weeks. Dupilumab doses included 200 mg for those with a baseline body weight between 5 kg and less than 15 kg and 300 mg for those between 15 kg and less than 30 kg. Patients also received hydrocortisone acetate 1% cream each day.
Efficacy
Percentages of patients who achieved Investigator Global Assessment (IGA) scores of 0 or 1 at 16 weeks included 25% of those with asthma on dupilumab vs. 0% of those with asthma on placebo (P = .03), and 29% of those who did not have asthma on dupilumab vs. 5% of those who did not have asthma on placebo (P = .0005).
Similarly, percentages of patients who achieved IGA scores of 0 or 1 at 16 weeks included 26% of those with AR on dupilumab vs. 0.1% of those with AR on placebo (P = .006) and 29% of those who did not have AR on dupilumab vs. 7% of those who did not have AR on placebo (P = .005).
Percentages of patients who achieved IGA scores of 0 or 1 also included 26% of those with food allergy on dupilumab vs. 2% of those with food allergy on placebo (P = .0007) and 32% of those who did not have food allergy on dupilumab vs. 9% of those who did not have food allergy on placebo.
Also at week 16, percentages of patients who achieved at least a 75% improvement in Eczema Area and Severity Index (EASI 75) scores included 55% of those with asthma who used dupilumab vs. 5% of those with asthma who used placebo (P = .001) and 52% of those who did not have asthma on dupilumab vs. 13% of those who did not have asthma on placebo (P < .0001).
Percentages of patients who achieved EASI 75 additionally included 54% of those with AR on dupilumab vs. 3% of those with AR on placebo (P < .0001) and 52% of those without AR on dupilumab vs. 17% of those on placebo (P = .001).
Results also included 46% of those on dupilumab vs. 8% of those on placebo with food allergy (P < .0001), along with 68% of those on dupilumab vs. 18% of those on placebo who did not have food allergy (P = .0005) who achieved EASI 75.
Patients who achieved a 4-point or higher reduction in Worst Scratch/Itch Numeric Rating Scale (WSI-NRS) scores at week 16 included 43% of those on dupilumab vs. 9% of those on placebo (P = .008), both with AR, and 52% of those on dupilumab vs. 9% of those on placebo (P < .0001), both without AR.
Percentages of patients who achieved these reductions in WSI-NRS scores also included 46% of those on dupilumab vs. 8% of those with food allergy on placebo (P = .0002), both with food allergy, and 52% of those on dupilumab vs. 10% of those on placebo, both without food allergy (P = .004).
Finally, 31% of patients on dupilumab vs. 14% of those on placebo, both with asthma, and 53% of those on dupilumab vs. 7% of those on placebo (P < .0001), both without asthma, achieved a 4-point or more reduction in WSI-NRS scores.
Safety
Patients tolerated dupilumab well through 16 weeks, and the safety profile was acceptable and consistent with the known safety profile for the biologic, the researchers said.
Among patients who did not have food allergy, there were more treatment-emergent adverse events in the placebo group than in the treatment group.
Overall, the researchers continued, there were more treatment-emergent adverse events among the placebo group than in the treatment group for the patients who did not have any type 2 comorbidities.
There were more patients with asthma, food allergy or AR who had serious treatment-emergent adverse events with placebo compared with patients who did not have these comorbidities as well.
None of the patients who received dupilumab experienced any serious treatment-emergent adverse events , the researchers continued. Compared with those who received dupilumab, more patients with type 2 comorbidities who received placebo reported severe treatment-emergent adverse events .
The groups of patients with and without type 2 comorbidities had similar numbers of treatment-emergent adverse events that led to discontinuation and severe treatment-emergent adverse events as well.
Among the patients who did not have any type 2 comorbidities, more patients in the placebo vs. dupilumab group reported infections and infestations.
Additionally, there were more patients who reported serious and severe infections among patients who did and did not have asthma and food allergy on placebo and among patients with AR on placebo compared with patients on dupilumab.
There were more patients reporting adjudicated non-herpetic skin infection events among patients with AR who received placebo compared with patients who received dupilumab as well.
However, more patients who received dupilumab reported conjunctivitis cluster events, keratitis cluster events at posterior blepharitis compared with patients on placebo, regardless of type 2 comorbidities.
More patients with asthma, food allergy and AR in the dupilumab vs. placebo group reported angioedema. None of the patients in the dupilumab or placebo groups who did not have any type 2 comorbidities reported angioedema.
One patient discontinued treatment with dupilumab because of an adverse event.
Conclusions
Based on these findings, the researchers concluded that infants and young children safely experienced consistent and clinically meaningful improvements in their AD with dupilumab regardless of any type 2 comorbidities that they may or may not have.
Reference:
- Research shows medication effective in treatment of children with atopic dermatitis. https://www.nationaljewish.org/about-us/news/press-releases/2024-news/research-shows-medication-effective-in-treatment-of-children-with-atopic-dermatitis. Published Dec. 4, 2024. Accessed Dec. 9, 2024.
Perspective
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In my experience, dupilumab works very well in patients with or without additional type 2 comorbidities, so the results of this study are not very surprising. From a practical perspective, this means that doctors can feel comfortable prescribing dupilumab to treat AD regardless of comorbidities, although its efficacy in other type 2 inflammatory diseases such as asthma may be worth considering, nevertheless. Next steps in this research may include validating the results in real-world usage and to continue to work to identify other factors that may predict differential responses to dupilumab.
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