AD Improvement Following Combo Therapy Not Affected by Comorbidities

Atopic comorbidities did not affect outcomes among pediatric patients with atopic dermatitis (AD) who were on a treatment regimen of dupilumab (Dupixent) plus topical corticosteroids (TCS), according to data presented at this year’s American Academy of Allergy Asthma & Immunology meeting in San Antonio.

Among children aged 6 months to 5 years living with moderate to severe AD, clinical outcomes following the combination treatment were evaluated for potential influence from 3 caregiver-reported type 2 comorbidities—asthma, allergic rhinitis, and food allergies—and compared between participants who did and did not have these comorbidities.

The LIBERTY AD PRESCHOOL study population was randomized 1:1 to dupilumab every 4 weeks (n = 83), with dose based on baseline weight (≥5 to <15 kg, 200 mg; ≥15 to <30 kg, 300 mg), or placebo (n = 79), both plus TCS. Safety end points considered were treatment-emergent adverse events (TEAEs), serious TEAEs, TEAE leading to discontinuation, and severe TEAE, and Investigator’s Global Assessment (IGA) score (0 = clear, 4 = severe AD) and Eczema Area and Severity Index gauged symptom improvement after 16 weeks. Disease severity and comorbidity history were similar between the groups at baseline.

Among the patients who did or did not have comorbid asthma, allergic rhinitis, or food allergies, the following results were seen at week 16 among patients receiving the combination of dupilumab plus TCS:

• IGA score of 0 or 1:
  • 23.8% with asthma vs 29.0% without
  • 24.3% with allergic rhinitis vs 30.4% without
  • 25.4% with food allergies vs 33.3% without
• EASI improvement of at least 75%:
  • 52.4% vs 53.2%, respectively
  • 54.1% vs 52.2%, respectively
  • 44.1% vs 75.0%, respectively
• At least a 4-point drop in daily worst itch score:
  • 34.6% vs 52.7%
  • 46.2% vs 49.6%
  • 47.9% vs 48.6%

Stark differences were seen when comparing the above with results seen among the patients receiving placebo plus TCS:

• IGA score of 0 or 1:
  • 0.0% with asthma vs 5.4% without
  • 0.1% with allergic rhinitis vs 7.2% without
  • 1.8% with food allergies vs 9.3% without
• EASI improvement of at least 75%:
  • 4.5% vs 13.1%, respectively
  • 3.2% vs 17.3%, respectively
  • 7.5% vs 19.1%, respectively
• At least a 4-point drop in daily worst itch score:
  • 13.6% vs 7.0%
  • 8.6% vs 9.1%
  • 8.3% vs 10.5%

“Overall safety was consistent with the known dupilumab safety profile,” the study authors wrote, “with dupilumab with concomitant TCS being equally efficacious in improving AD signs in children ages 6 months to 5 years with and without a history of atopic comorbidities.”

Illustrating this point, they also presented their TEAE data:

• No serious TEAEs or TEAEs leading to treatment discontinuation were reported in any of the patients receiving dupilumab plus TCS.
• Only 5 instances of severe TEAEs were reported in the combo treatment group, with 2 each being seen among patients who did not have asthma, did not have allergic rhinitis, and had food allergies.

Further, overall rates of TEAEs were consistently lower in the combination vs placebo group regardless of comorbidity presence:

• Asthma: 77.3% (placebo) vs 76.2% (dupilumab)
• No asthma: 73.2% vs 59.7%, respectively
• Allergic rhinitis: 75.7% vs 67.6%
• No allergic rhinitis: 73.2% vs 60.9%
• Food allergies: 71.4% vs 69.5%
• No food allergies: 81.8% vs 50.0%

Reference

Boguniewicz M, Sher LD, Paller AS, Chen Z, Shah P, Marco AR. Dupilumab efficacy in children with atopic dermatitis aged 6 months to 5 years with and without atopic comorbidities. Presented at: American Academy of Allergy Asthma & Immunology Annual Meeting; February 24-27, 2023; San Antonio, TX. https://bit.ly/3J3pA3R