Introduction <p>Primary results of the JADE DARE trial (NCT04345367) demonstrated that abrocitinib was superior to dupilumab in reducing the signs and symptoms of moderate-to-severe atopic dermatitis (AD). This post hoc analysis evaluated the efficacy and safety of abrocitinib in patients with moderate-to-severe AD who were responders or nonresponders to dupilumab using various definitions of response.</p> Methods <p>Data included dupilumab-treated patients from JADE DARE who switched to abrocitinib 200&#xa0;mg when enrolled in the ongoing JADE EXTEND trial (NCT03422822). For this analysis, various response criteria at Week 26 of JADE DARE were defined post hoc based on Investigator’s Global Assessment (IGA), Eczema Area and Severity Index (EASI), Peak Pruritus Numerical Rating Scale (PP-NRS), and Dermatology Life Quality Index (DLQI) scores or responses. Efficacy was analyzed at Week 12 of JADE EXTEND based on patients’ fulfillment of the various response criteria at Week 26 of JADE DARE. EASI scores and percentage changes from baseline in EASI and PP-NRS at Week 26 in JADE DARE were compared with the corresponding scores and percentage changes at Week 12 in EXTEND. Safety was assessed.</p> Results <p>Of 365 dupilumab-treated patients in JADE DARE, 316 were enrolled in JADE EXTEND and 312 received abrocitinib 200&#xa0;mg. Most dupilumab responders for IGA, EASI, PP-NRS, and DLQI at DARE Week 26 maintained their responses 12&#xa0;weeks after switching to abrocitinib, while a considerable proportion of IGA, EASI, PP-NRS, or DLQI dupilumab nonresponders gained response after switching to abrocitinib. Lower EASI scores and greater percentage changes from baseline in EASI and PP-NRS scores were observed with abrocitinib at EXTEND Week 12 than with dupilumab at DARE Week 26. No new safety signals were observed.</p> Conclusion <p>Abrocitinib 200&#xa0;mg may be an effective treatment option for patients with moderate-to-severe AD who do not achieve an optimal response with dupilumab treatment.</p> Clinical Trial Registration <p>Clinicaltrials.gov: NCT04345367 (JADE DARE) and NCT03422822 (JADE EXTEND).</p>

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Switching from Dupilumab to Abrocitinib in Patients With Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of Efficacy After Treatment With Dupilumab in JADE DARE

  • Jonathan I. Silverberg,
  • Eric L. Simpson,
  • Andrew E. Pink,
  • Stephan Weidinger,
  • Gary Chan,
  • Pinaki Biswas,
  • Claire Clibborn,
  • Erman Güler

摘要

Introduction

Primary results of the JADE DARE trial (NCT04345367) demonstrated that abrocitinib was superior to dupilumab in reducing the signs and symptoms of moderate-to-severe atopic dermatitis (AD). This post hoc analysis evaluated the efficacy and safety of abrocitinib in patients with moderate-to-severe AD who were responders or nonresponders to dupilumab using various definitions of response.

Methods

Data included dupilumab-treated patients from JADE DARE who switched to abrocitinib 200 mg when enrolled in the ongoing JADE EXTEND trial (NCT03422822). For this analysis, various response criteria at Week 26 of JADE DARE were defined post hoc based on Investigator’s Global Assessment (IGA), Eczema Area and Severity Index (EASI), Peak Pruritus Numerical Rating Scale (PP-NRS), and Dermatology Life Quality Index (DLQI) scores or responses. Efficacy was analyzed at Week 12 of JADE EXTEND based on patients’ fulfillment of the various response criteria at Week 26 of JADE DARE. EASI scores and percentage changes from baseline in EASI and PP-NRS at Week 26 in JADE DARE were compared with the corresponding scores and percentage changes at Week 12 in EXTEND. Safety was assessed.

Results

Of 365 dupilumab-treated patients in JADE DARE, 316 were enrolled in JADE EXTEND and 312 received abrocitinib 200 mg. Most dupilumab responders for IGA, EASI, PP-NRS, and DLQI at DARE Week 26 maintained their responses 12 weeks after switching to abrocitinib, while a considerable proportion of IGA, EASI, PP-NRS, or DLQI dupilumab nonresponders gained response after switching to abrocitinib. Lower EASI scores and greater percentage changes from baseline in EASI and PP-NRS scores were observed with abrocitinib at EXTEND Week 12 than with dupilumab at DARE Week 26. No new safety signals were observed.

Conclusion

Abrocitinib 200 mg may be an effective treatment option for patients with moderate-to-severe AD who do not achieve an optimal response with dupilumab treatment.

Clinical Trial Registration

Clinicaltrials.gov: NCT04345367 (JADE DARE) and NCT03422822 (JADE EXTEND).