The efficacy of Adbry was assessed in three randomized, double-blind, placebo-controlled trials (Trial 1 [ECZTRA 1], Trial 2 [ECZTRA 2], and Trial 3 [ECZTRA 3]; NCT 03131648, 03160885, and 03363854, respectively):
- A total of 1934 patients
- 18 years of age and older
- Moderate-to-severe atopic dermatitis not adequately controlled by topical medication(s)
Disease severity was defined by:
- An Investigator's Global Assessment (IGA) score of ≥3 in the overall assessment of atopic dermatitis lesions on a severity scale of 0 to 4
- Eczema Area and Severity Index (EASI) score of ≥16 on a scale of 0 to 72
- Minimum body surface area (BSA) involvement of ≥10 %
- The proportion of subjects with an IGA of 0 or 1 ("clear" or "almost clear") at Week 16
- An EASI-75 (improvement of at least 75% in EASI score from baseline) at Week 16
- The reduction of Worst Daily Pruritus NRS (weekly average) of at least 4 points on the 11-point itch NRS from baseline to Week 16
Responders defined as achieving the primary endpoints of IGA 0 or 1 or EASI-75 at Week 16. Nonresponders at Week 16 and subjects who lost clinical response during the maintenance period were placed on open-label treatment with Adbry 300 mg every other week and optional use of TCS.
Placebo responders continued on placebo to maintain blind participation and were not included in analyses after Week 16.
Responders defined as achieving the primary endpoints of IGA 0 or 1 or EASI-75 at Week 16. Subjects who did not achieve clinical response at Week 16 received Adbry 300 mg every other week+TCS for another 16 weeks.
A midpotency TCS (ie, mometasone furoate 0.1% cream) was dispensed at each dosing visit. The subjects were instructed to apply a thin film of the dispensed TCS as needed, once daily, to active lesions from Week 0 to Week 32, and were to discontinue treatment with TCS when control was achieved. An additional, lower-potency TCS or TCI could be used at the investigator's discretion on areas of the body where use of the supplied TCS was not advisable, such as areas of thin skin.