530 - Treatment efficacy in patients with moderate-to-severe atopic dermatitis who switched from dupilumab to abrocitinib in JADE EXTEND, a phase 3 long-term extension study
Bibliographic record
Abstract
Abstract Background Abrocitinib, an oral, once-daily, Janus kinase 1–selective inhibitor, and dupilumab, an anti–interleukin 4 receptor α monoclonal antibody, have been approved for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The efficacy of abrocitinib and dupilumab as monotherapy or in combination with medicated topical therapy has been demonstrated in multiple phase 3 clinical trials. As is the case with many therapies, some patients with AD may need to discontinue treatment with dupilumab (due to inadequate efficacy, intolerable side-effects, patient choice, or other reasons) and switch to other systemic therapies. Objective To evaluate the long-term treatment response in patients with moderate-to-severe AD who switched from dupilumab to abrocitinib, as it is valuable information for prescribers and patients to consider when making treatment decisions. Methods The phase 3 JADE COMPARE trial (NCT03720470) evaluated the efficacy of abrocitinib (100 mg or 200 mg once daily) and dupilumab (300 mg every 2 weeks) versus placebo in combination with topical medicated therapy in patients with moderate-to-severe AD through week 16. After a wash-out period, dupilumab-treated patients from JADE COMPARE who enrolled in the ongoing long-term extension trial JADE EXTEND (NCT03422822; clinical data cutoff: Sept 25, 2021) were randomised to receive double-blinded treatment with abrocitinib 100 mg or 200 mg. This post hoc analysis evaluated the response to dupilumab through week 16 in JADE COMPARE and thereafter in JADE EXTEND following a switch to abrocitinib through week 104 of total treatment duration/week 84 of abrocitinib treatment. Assessments included Investigator’s Global Assessment score of 0 (clear) or 1 (almost clear) with a ≥2-point improvement from baseline (IGA 0/1), ≥75% or ≥90% improvement from baseline in Eczema Area and Severity Index (EASI-75 or EASI-90), ≥4-point improvement from baseline in Peak Pruritus Numerical Rating Scale score (PP-NRS4; PP-NRS used with permission from Regeneron Pharmaceuticals, Inc., and Sanofi), and a PP-NRS score of 0 or 1 (PP-NRS 0/1). JADE EXTEND data are presented as observed; patients with missing data at a visit were excluded. Analyses included both dupilumab responders and non-responders. Results Overall, 242 patients were treated with dupilumab in JADE COMPARE (mean age: 37 years; IGA score 4: 33%). Of those, 203 enrolled in JADE EXTEND and received abrocitinib 200 mg (n=73) or abrocitinib 100 mg (n=130). After 16 weeks of treatment with dupilumab in JADE COMPARE, the proportion of responders was 39% for IGA 0/1, 66% for EASI-75, 39% for EASI-90, 57% for PP-NRS4, and 24% for PP-NRS 0/1. As early as 2 weeks after switching to abrocitinib (200 mg/100 mg) in JADE EXTEND, the proportion of responders was observed to increase in a dose-dependent manner, respectively, for IGA 0/1 (61%; 51%), EASI-75 (90%; 85%), EASI-90 (60%; 54%), PP-NRS4 (81%; 72%), and PP-NRS 0/1 (47%; 37%). Long-term efficacy was observed out to week 84 (Figure). Conclusions In patients with moderate-to-severe AD who received prior treatment with dupilumab, switching to abrocitinib resulted in dose-dependent increases in the proportion of responders as early as week 2 after treatment with abrocitinib. This efficacy continued to be observed long-term through week 84 of abrocitinib treatment.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.002 | 0.001 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.002 | 0.002 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.001 | 0.000 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.001 | 0.002 |
| Insufficient payload (model declined to judge) | 0.002 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".