Itch Relief

A total of 367 children (6-11 years of age) in Trial 8 (16 weeks) with severe atopic dermatitis inadequately controlled with topical prescription therapies were randomized to DUPIXENT + TCS or placebo + TCS. This study compared both weight-tiered and non-weight-tiered dosing regimens. From these results, the recommended dosing for children aged 6-11 years is as follows: Patients ≥30 kg but <60 kg received 200 mg Q2W after a 400 mg loading dose. Patients 15 kg but <30 kg received 300 mg Q4W after a 600 mg loading dose. An endpoint included the reduction in itch as defined by ≥4-point improvement in Peak Pruritus NRS at Week 161,2

Clinically Meaningful Itch Relief in Children

6-11 years
Significant itch reduction (≥4-point improvement in Peak Pruritus NRS) with DUPIXENT + TCS at Week 16 in Trial 8 (secondary endpoint)1,2,a,b
  1. Full Analysis Set includes all subjects randomized.
  2. In the primary analyses of the efficacy endpoints, subjects who received rescue treatment or with missing data were considered nonresponders.
  3. At Day 1, subjects (baseline weight <30 kg) received 600 mg of DUPIXENT.
  4. At Day 1, subjects (baseline weight ≥30 kg) received 400 mg of DUPIXENT.

Pruritus NRS assesses the average itch intensity over the previous 24 hours3

A patient-reported measure that uses a 0- to 10-point scale, with which patients are asked3:


"On a scale of 0 to 10, how would you rate your itch overall (on average) during the previous 24 hours?"

None
The Worst
Imaginable

A reduction of at least 4 points in pruritus NRS from baseline is a clinically meaningful change.1

EASI, Eczema Area and Severity Index; NRS, numerical rating scale.

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References:
  1. DUPIXENT Prescribing Information.
  2. Data on file, Regeneron Pharmaceuticals, Inc.
  3. Phan NQ, Blome C, Fritz F, et al. Assessment of pruritus intensity: prospective study on validity and reliability of the visual analogue scale, numerical rating scale and verbal rating scale in 471 patients with chronic pruritus. Acta Derm Venereol. 2012;92(5):502-507.