A remittive effect was seen in ~1/3 of Adbry patients who responded at Week 16 but withdrew from treatment3
IGA-0/1: 33% (15/45) EASI-75: 26% (18/70)
Adbry is strongly recommended by AAD and AAAAI guidelines as a systemic therapy for moderate-to-severe atopic dermatitis in adult patients1,2
Visible Results
Results across body areas
High persistency rate
74% of adult patients treated with Adbry remained on therapy at 6 months (n=81)9*
Limitations: This is a real-world study and limitations include the limited number of patients with ~6-month registry visits. Only persistent patients are included in the current analysis.
* Interim analysis of US adults (n=259 at baseline; n=81 with follow-up visit between 5-9 months from Adbry initiation) in the prospective, non-interventional CorEvitas® registry who initiated Adbry from February 2022 to May 2023.
Pivotal Studies + Maintenance of Response
Reach for Clearer Skin and maintained results with Adbry3,10
At baseline, the clinical trial population had significant disease severity10
50%
Moderate atopic dermatitis (IGA 3)§
50%
Severe atopic dermatitis (IGA 4)§
EASI=Eczema Area and Severity Index; IGA=Investigator’s Global Assessment; NRS=Numeric Rating Scale; q2w=every 2 weeks; q4w=every 4 weeks; TCS=topical corticosteroid.
*Patients who received rescue treatment or with missing data were considered nonresponders. †Percentage of patients who achieved response. ‡Patients with baseline worst daily pruritus NRS (weekly average) score ≥4. §Proportion of patients.
Trial designs: The efficacy and safety of Adbry was assessed in 3 randomized, double-blind, placebo-controlled trials with a total of 1934 patients 18 years of age and older, with moderate-to-severe atopic dermatitis not adequately controlled by topical medications. In all ECZTRA 1, 2, and 3 trials, subjects received subcutaneous injections of Adbry 600 mg or placebo on Day 0, followed by Adbry 300 mg or placebo every other week for 16 weeks. In ECZTRA 3, subjects also used TCS as needed. All ECZTRA 1, 2, and 3 trials assessed the primary endpoints of the proportion of subjects with an IGA 0 or 1 at Week 16 and the proportion of subjects with EASI-75 at Week 16. Secondary endpoints included 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.
Itch Relief
Itch reduction was observed with Adbry at 48 hours*, 16 weeks, and up to 3 years3,4,10
Worst daily pruritus NRS (≥4-point reduction) at Week 16
ECZTRA 1 (P=0.002): Adbry 300 mg q2w: 20% (n=594); Placebo: 10% (n=194)
ECZTRA 2 (P<0.001): Adbry 300 mg q2w: 25% (n=563); Placebo: 9% (n=192)
ECZTRA 3 (P=0.039): Adbry 300 mg q2w + TCS: 46% (n=240); Placebo: 35% (n=123)
ECZTRA 1 + 2† monotherapy pooled data (q2w)3
Limitations: Itch reduction as defined by ≥4-point reduction in worst daily pruritus NRS (weekly average) was a prespecified endpoint at Week 16 in each of the pooled studies. This analysis was not prespecified and not adjusted for multiplicity. Conclusions should be made with caution.
*LS means for % improvement from treatment start in Worst Daily Pruritus NRS: 7.4% with Adbry vs 3.6% with placebo at 48 hours.3 †Patients who received rescue treatment or with missing data were considered nonresponders.
Long-Term Results
The ECZTEND OLE study demonstrated long-term results with up to 4 years of data4
Median EASI improvement with Adbry up to 4 years4*†‡
Limitations: Limitations and context associated with the open-label study design and data include decreasing sample size, potential continued involvement of responders, and attrition of nonresponders. Data presented are descriptive in nature and no statistical comparisons are made.
ECZTEND was a phase 3, long-term, 5-year, open-label, single-arm extension trial that evaluated the safety and efficacy of Adbry in patients with AD who participated in the previous Adbry parent trials. Patients were permitted to enter ECZTEND after completion of the parent trial regardless of their treatment response or whether they were treated with Adbry or placebo. Patients received a loading dose followed by 300 mg q2w plus optional TCS as needed.4
Real-World Results
Real-World Evidence
Systematic review and meta-analysis*
Proportion of patients achieving improvement after Adbry12
Limitations: Limitations from real-world data should be considered, including the absence of an unbiased control group and that the frequency of dosing could not be addressed. There are differences in reporting of efficacy and safety outcomes and the time for evaluation, and AE surveillance and reporting in the real world are not as rigorous as RCTs.
Real Patient Case
KALVIN | Real Adbry patient.
Individual results may vary.
Not a clinical trial participant.
Uncontrolled on TCS
- Severe atopic dermatitis diagnosis in childhood
- Lesions on 70% of total body surface area
- Long-term cycling on topical corticosteroids
- Suboptimal control with TCS regimen in adulthood
Kara Gooding is a paid consultant of LEO Pharma, and her experience may not be representative of all healthcare professionals.