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SUSTAINED DISEASE REMISSION, ITCH REDUCTION, AND STEROID USE AT WEEK 36

More patients achieved sustained remission with DUPIXENT vs placebo
at Week 361,a
18% DUPIXENT +
OCS Taper
vs
6% Placebo +
OCS Taper

proportion of patients who achieved sustained remission at Week 36
(primary endpoint; 95% CI: 12.2% [-0.8, 26.1])

This data analysis for the primary endpoint did not meet statistical significance.

aThe primary endpoint of sustained remission consisted of 3 components: complete remission and off OCS by Week 16, no rescue therapy from baseline to Week 36, and no disease relapse after completing OCS taper to Week 36. Complete remission was defined as the absence of new lesions and epithelialization of old lesions. During OCS taper, participants were permitted to increase their OCS dose once (subsequent dose increases were considered rescue therapy). Rescue therapy could include a second increase of OCS dose during the taper period, use of OCS after completion of the OCS taper/Week 16, or initiation of high-potency TCS, systemic nonsteroidal immunosuppressive medication, or immunomodulating biologic therapy. Disease relapse was defined as appearance of ≥3 new lesions/month (blisters, eczematous lesions, or urticarial plaques) or ≥1 large (>10 cm in diameter) eczematous lesion or urticarial plaque that did not heal within 1 week.

  • During the 36-week treatment period, rescue therapy was received by 53% of patients treated with DUPIXENT vs 79% with placebo1
Clinically meaningful itch improvement (≥4-point reduction in Peak
Pruritus NRS score) with DUPIXENT vs placebo at Week 361
38% DUPIXENT +
OCS Taper
vs
11% Placebo +
OCS Taper

proportion of patients who achieved ≥4‑point reduction in Peak Pruritus NRS score
at Week 36 (secondary endpoint; 95% CI: 27.8% [11.6, 43.4])

Definitive conclusions cannot be made for these results. Data were not multiplicity controlled.

Steroid use in the DUPIXENT clinical trial1

  • Median cumulative dose of OCS at Week 36 was 2.8 g in patients treated with DUPIXENT vs 4.1 g with placebo

Peak Pruritus NRS assesses the average itch intensity over the previous 24 hours.2

It is a patient-reported measure that uses a 0- to 10-point scale, with which patients are asked:

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

0 - None

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9

10 - The Worst
Imaginable

NRS, numerical rating scale; OCS, oral corticosteroids; TCS, topical corticosteroids.

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