Late-Breaking Data: Flexible Dosing of Abrocitinib for AD Shows Real-World Promise

Image Credit: © DermNet

The Revolutionizing Atopic Dermatitis (RAD) 2025 meeting in Nashville, Tennessee, showcased a wide range of innovations in the management of atopic dermatitis (AD). Among the highlights was a poster presentation detailing the findings of the JADE REAL study, an expanded access protocol that investigated flexible dosing of abrocitinib in patients with moderate to severe AD. This global, open-label study aimed to simulate real-world treatment patterns, providing clinicians with practical insights into the use of Janus kinase 1 (JAK1)-selective inhibition in a diverse patient population.¹

Study Overview and Design

JADE REAL (NCT04564755) was initiated in 2020 and completed in September 2024.² It enrolled 312 patients aged ≥12 years with moderate to severe AD who lacked adequate treatment options. The study permitted initiation on either 100 mg or 200 mg of oral abrocitinib once daily (QD), with the flexibility to adjust the dose throughout the treatment period based on patient response and tolerability. The protocol also allowed the use of concomitant topical therapies as needed.

This adaptive design reflects a shift toward individualized therapy, allowing clinicians to escalate or reduce dosage in response to clinical need, rather than adhering to rigid protocols common in randomized controlled trials.

Patient Demographics and Dosing Patterns

Of the 312 participants, 38.5% (n=120) were initiated on 100 mg and 61.5% (n=192) on 200 mg of abrocitinib. Patient characteristics varied by starting dose. Younger patients (ages 12–17) and older adults (≥65), as well as those identifying as Black/African American or having moderate AD, were more likely to start on the lower 100 mg dose. In contrast, patients aged 18–64, those identifying as Asian, and individuals with severe AD were more frequently started on 200 mg.

Interestingly, the majority of participants remained on their initial dose throughout the study: 65.0% in the 100 mg group and 62.0% in the 200 mg group. Dose modifications occurred in 35.0% and 38.0% of these groups, respectively, with a small subset undergoing more than one dose change.

Safety and Adverse Events

Treatment-emergent adverse events (TEAEs) led to dose reductions in 8.7% (n=27) of participants and dose escalations in 3.8% (n=12). The most commonly reported TEAEs prompting dose reduction included nausea, thrombocytopenia, acne, fatigue, and folliculitis—each affecting about 1% of the cohort. Notably, atopic dermatitis itself was the only adverse event leading to dose escalation in more than 1% of patients.

These results suggest that while adverse effects were not uncommon, they were generally manageable and infrequently necessitated dose changes. This reinforces the potential of abrocitinib as a viable long-term treatment option, particularly when dosing flexibility is maintained.

Clinical Implications

The JADE REAL study provides a meaningful glimpse into how abrocitinib may be used in everyday clinical practice. Unlike traditional clinical trials, this study incorporated elements designed to mimic real-world use, including variable treatment duration, open-label design, and dose flexibility tailored to individual patient needs.

Key takeaways for clinicians include the relative safety of maintaining patients on their initial dose, the importance of monitoring for TEAEs that may necessitate dose adjustment, and the potential value of flexible dosing to optimize outcomes. The results support abrocitinib’s role as a practical, effective treatment for moderate to severe AD across a wide patient demographic.

Conclusion

JADE REAL contributes valuable data to the evolving landscape of AD management. By allowing for dynamic dose adjustments in a real-world–like setting, the study underscores the importance of individualized treatment strategies. As more therapeutic options become available, insights from studies like JADE REAL will be critical in guiding evidence-based, patient-centered care in dermatology.

References

1. Chovatiya R, Zirwas M, Simpson E, et al. Flexible dosing of abrocitinib in patients with moderate to severe atopic dermatitis: Initial results from the real world simulating expanded access protocol study, JADE REAL. Presented at: 2025 Revolutionizing Atopic Dermatitis Conference; June 6-7; 2025; Nashville, TN.
2. Blauvelt A, Silverberg JI, Lynde CW, et al. Abrocitinib induction, randomized withdrawal, and retreatment in patients with moderate-to-severe atopic dermatitis: Results from the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) REGIMEN phase 3 trial. J Am Acad Dermatol. 2022;86(1):104-112. doi:10.1016/j.jaad.2021.05.075