Abstract
BACKGROUND: JADE REAL was a global, prospective, multicenter, open-label expanded access protocol study that integrated the rigorous follow-up, safety, and efficacy assessments of a clinical trial with dosing flexibility and ability to use concomitant topical therapies to simulate real-world management of atopic dermatitis (AD).
OBJECTIVE: The study aimed to provide access to abrocitinib for patients with moderate-to-severe AD without adequate treatments available.
METHODS: Eligible patients received abrocitinib 100 mg or 200 mg once daily per investigator's discretion. Dose could be adjusted during treatment. Safety and exploratory efficacy endpoints were assessed.
RESULTS: Of 312 patients, 120 (38.5%) and 192 (61.5%) received an initial dose of abrocitinib 100 mg and 200 mg, respectively. TEAEs were reported in 78.2% of patients. TEAEs led to dose change in 39 patients (12.5%); 12 (3.8%) had a dose escalation and 27 (8.7%) had a dose reduction. Rapid improvements in AD severity progressed up to 72 weeks among observed patients.
CONCLUSION: Most patients continued their initial dose of abrocitinib. TEAEs accounted for a minority of documented dose reductions; instead, investigators may have determined that the patients' disease could be maintained at a lower dose. These findings support clinical decision-making around dose selection and modification.
TRIAL REGISTRATION: NCT04564755.
| Original language | English |
|---|---|
| Article number | 2712186 |
| Number of pages | 10 |
| Journal | The journal of dermatological treatment |
| Volume | 37 |
| Issue number | 1 |
| Early online date | 7 Aug 2026 |
| DOIs | |
| Publication status | E-pub ahead of print - 7 Aug 2026 |
Keywords
- Humans
- Dermatitis, Atopic/drug therapy
- Female
- Male
- Prospective Studies
- Severity of Illness Index
- Pyrimidines/administration & dosage
- Treatment Outcome
- Adult
- Adolescent
- Dermatologic Agents/administration & dosage
- Dose-Response Relationship, Drug
- Young Adult
- Child
- Middle Aged
- Sulfonamides
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