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Related Topics

  • Treatment Of Atopic Dermatitis
  • Treatment Of Atopic Dermatitis
  • Severe Atopic Dermatitis
  • Severe Atopic Dermatitis

Articles published on Dupilumab

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  • Research Article
  • 10.25251/5n37g346
Efficacy of Upadacitinib vs Dupilumab Treatment for Moderate‑to‑Severe Atopic Dermatitis: Analysis of Time Spent in Response State From the Level Up Study
  • Nov 10, 2025
  • SKIN The Journal of Cutaneous Medicine
  • Bruno Duarte + 12 more

Introduction & Objectives: Upadacitinib (UPA), a selective oral Janus kinase (JAK) inhibitor, and dupilumab (DUPI), a monoclonal antibody targeting interleukin-4Rα, are both treatments approved for patients with moderate-to-severe Atopic Dermatitis (AD). Results from a phase 3b/4 trial (Level Up NCT05601882) indicated that UPA was superior to DUPI in simultaneously achieving the stringent endpoints of Eczema Area and Severity Index (EASI) improvement of ≥90% from baseline (EASI 90) and a Worst Pruritus Numerical Rating Scale score of 0/1 (WP-NRS 0/1) at Week 16. In this post-hoc analysis, we analyzed the median time (days) spent in response states based on EASI 90 and/or WP-NRS 0/1 in patients either receiving UPA or DUPI over a 16-week period. Materials & Methods: The Level Up study was a phase 3b/4 head-to-head global, randomized, open-label, efficacy assessor blinded, multicenter study comparing UPA vs DUPI in adolescents and adults with moderate-to-severe AD. Patients were randomized to UPA 15 mg or DUPI per its label for 16 weeks of treatment. Patients on UPA 15 mg were dose-escalated to 30 mg starting at Week 4 if they had a <EASI 50 response, or a <4-point WP-NRS improvement from baseline. Patients taking UPA 15 mg who did not achieve EASI 75 starting at Week 8 similarly had their dose increased to 30 mg. Starting at Week 4, rescue with topical therapy was optional and per investigator’s discretion if protocol criteria were met. The current analyses assessed the number and proportion of days patients spent with clear or nearly-clear skin (EASI 90) and/or no/minimal itch (WP-NRS 0/1), with comparisons made at the median (50th percentile) and upper quartile (75th percentile). Missing data at study visits were imputed using non-responder imputation with multiple imputations. Results: Participants included 458 patients receiving UPA and 462 receiving DUPI. Cumulatively over a course of 16 weeks, patients taking UPA vs DUPI spent a greater number of days at EASI 90 and WP-NRS 0/1. Over 16 weeks (112 days), 1 in 2 patients (ie, median or 50th-percentile) spent at least 28.0 days at EASI 90 with UPA vs 0 days with DUPI, while 1 in 4 patients spent at least 64.4 days with UPA vs 25.7 days with DUPI. For days at WP-NRS 0/1 with UPA vs DUPI, 1 in 2 patients spent at least 11.3 vs 0.4 days with no/minimal itch respectively; and 1 in 4 patients (ie, upper quartile or 75th-percentile) spent at least 57.2 vs 17.0 days with UPA vs DUPI, respectively. Similar patterns were observed in the number of days simultaneously achieving both EASI 90 and WP-NRS 0/1, as well the proportion of days spent in these responses. Conclusion: Treatment of moderate-to-severe AD with UPA per label resulted in a greater number or proportion of days spent with EASI 90 and/or WP-NRS 0/1 compared with DUPI over 16 weeks. These results highlight differences in lived day- to-day skin disease and itch symptom burden over the course of treatment and can be used to inform shared decision-making discussions between patients and physicians.

  • Research Article
  • 10.1016/j.jaad.2025.08.020
Decreased risk of reduced linear growth among children with atopic dermatitis receiving dupilumab: A cohort study.
  • Aug 1, 2025
  • Journal of the American Academy of Dermatology
  • Tai-Li Chen + 4 more

Decreased risk of reduced linear growth among children with atopic dermatitis receiving dupilumab: A cohort study.

  • Research Article
  • Cite Count Icon 1
  • 10.1002/jpn3.70106
Cost-utility analysis of sequential therapies for pediatric-onset eosinophilic esophagitis.
  • Jun 9, 2025
  • Journal of pediatric gastroenterology and nutrition
  • José Vicente Arcos-Machancoses + 2 more

Topical corticosteroids, proton-pump inhibitors (PPI) and elimination diets (ED) are equally recommended as first-line therapies for pediatric eosinophilic esophagitis (EoE). Dupilumab (DUP) is usually used for refractoriness. We aim to assess the cost-utility of all potential sequential treatments for EoE. A Markov model under the payer's perspective was used to describe induction, maintenance, and reinductions for nonresponders over 10 years. Dietary options included step-up restriction starting from two foods, and from cow's milk (CM). Topical corticosteroids viscous solutions, or budesonide orodispersible tablets (BOT) were considered. Nonresponsiveness led to esophageal dilation. Simulation parameters were defined by systematic review. We deterministically selected the most cost-effective permutation as reference. Incremental cost-utility ratios (ICUR) of each alternative sequence were compared to a willingness-to-pay (WTP) threshold of €30,000. Sequences with the highest number of quality-adjusted life-years (QALY) and the highest QALY below WTP were probabilistically explored. Sensitivity analysis was performed. PPI-ED(CM)-BOT-DUP was the most cost-effective sequence, resulting in €2373/QALY and 7.20 QALY at the time horizon. DUP-BOT-PPI-ED(CM) gave the uppermost QALY, 7.42, but any iteration was cost-effective, yielding a median ICUR of €323,774/QALY. PPI-BOT-ED(CM)-DUP, however, had a higher chance of being under the WTP (83%), showed a median ICUR of €25,156/QALY and provided 7.31 QALY. An 83% reduction of DUP price was needed to make DUP-BOT-PPI-ED(CM) and PPI-BOT-ED(CM)-DUP equally as efficient. BOT and CM-starting step-up ED are present in both effective and cost-effective sequential treatments for EoE. The option PPI-BOT-ED(CM)-DUP succeeded in approaching the most effective alternative while balancing costs.

  • Research Article
  • Cite Count Icon 1
  • 10.1097/mph.0000000000003018
Dupilumab for Atopic Dermatitis-like Chronic Graft-versus-Host Disease in Three Pediatric Hematopoietic Cell Transplant Recipients.
  • Mar 11, 2025
  • Journal of pediatric hematology/oncology
  • Savannah L Ishee + 3 more

Atopic dermatitis (AD)-like graft-versus-host disease (GVHD) is a chronic form of skin GVHD with features that include erythema, xerosis, scaling, and pruritus. Patients often require treatment with systemic immunosuppression and aggressive topical therapies for relief. Long-term effects of chronic immunosuppression are undesirable and alternative therapies are needed. A retrospective review of 3 patients receiving dupilumab (DUP) for AD-like cGVHD was conducted. Data collected included demographics, transplant history, and GVHD management and outcomes. Information relating to DUP included dose, route, frequency, and safety based on dermatologic reactions, ocular toxicities, and infections. Patients had differing underlying conditions, transplant types, cell sources, and GVHD prophylactic therapies. Three patients received tacrolimus and topical corticosteroids for GVHD treatment, and 1 also received sirolimus and ruxolitinib. After the initial DUP dose, all patients experienced improvement in their GVHD. To date, all patients have complete remission of their skin cGVHD and have weaned off other therapies. No patients experienced dermatologic or ocular toxicities, and no infections were reported. DUP was efficacious and safe for treating AD-like cGVHD in our 3 pediatric patients. Further investigations are warranted to determine the appropriate placement in therapy.

  • Open Access Icon
  • Research Article
  • Cite Count Icon 1
  • 10.25251/skin.9.supp.512
Lebrikizumab Improves Atopic Dermatitis and ​Quality of Life in Patients With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab: ​ Results From the ADapt Trial
  • Jan 13, 2025
  • SKIN The Journal of Cutaneous Medicine
  • Jonathan Silverberg + 23 more

ADapt (NCT05369403), an open-label, Phase 3b, 24-week study, evaluated the efficacy and safety of lebrikizumab (LEB) in patients with moderate-to-severe atopic dermatitis (AD) previously treated with dupilumab (DUPI). Patients must have discontinued DUPI due to inadequate response (non-response, partial response, or loss of response), intolerance or an adverse event (AE), or other reasons. Four or more weeks after discontinuing DUPI, patients received a 500-mg LEB loading dose at Baseline and at Week 2 followed by 250 mg every 2 weeks through Week 16 (Q2W). At Week 16, responders (IGA 0 or 1 with ≥2-point improvement (IGA0,1) or EASI75 [primary endpoint]) received LEB 250 mg once every 4 weeks (Q4W); other patients continued with 250 mg Q2W. Q2W and Q4W data were pooled and analyzed as-observed and with nonresponder/multiple imputation (NRI/MI). Among 86 enrolled patients, 56% discontinued DUPI due to inadequate response, 16% due to intolerance/AEs to DUPI, and 28% for other reasons. For all patients, at Weeks 16 and 24, respectively, proportions of patients achieving: 1) EASI75: 57.4% and 60.0%, as-observed; 50.7% and 52.8% NRI/MI; 2) IGA0,1: 38.7% and 38.2%, as-observed; 35.6% and 36.8%, NRI/MI; 3) Face-IGA 0: 42% and 49%, as-observed; 4) Pruritus NRS ≥4-point improvement 53.2% and 61.5% as-observed; 48.8% and 47.9% NRI/MI; and 5) DLQI ≥4-point improvement 83.0% and 83.0% as-observed. The safety profile was consistent with other LEB Phase 3 trials. Four patients who discontinued DUPI due to conjunctivitis did not report conjunctivitis with LEB. 3.5% of patients reported treatment-emergent conjunctivitis. In DUPI-experienced patients, treatment of moderate-to-severe AD with LEB resulted in meaningful improvements in skin clearance, itch, and quality of life.

  • Open Access Icon
  • Research Article
  • 10.25251/skin.8.supp.451
Switching from Dupilumab to Upadacitinib in Adults and Adolescents with Moderate-to-Severe Atopic Dermatitis and Inadequate Response to Dupilumab: Efficacy and Safety Results from the Phase 3b/4 LEVEL UP Study
  • Nov 18, 2024
  • SKIN The Journal of Cutaneous Medicine
  • Christopher Bunick + 11 more

Atopic dermatitis (AD) is a chronic skin disease characterized by intense itch and eczematous skin lesions. Upadacitinib (UPA), a selective oral Janus kinase (JAK) inhibitor, and dupilumab (DUPI), a monoclonal antibody targeting interleukin-4 and interleukin-13 signaling, are both approved treatments for moderate-to-severe AD. LEVEL UP is a phase 3b/4 efficacy assessor blinded monotherapy study comparing UPA to DUPI for treatment of moderate-to-severe AD in adults and adolescents over a 16-week period (Period 1). Patients not achieving ≥75% improvement in the Eczema Area and Severity Index (EASI 75) from baseline at Week 16 entered an additional 16-week extension phase (Period 2). In Period 2, patients either continued/escalated to UPA 30 mg (UPA/UPA 30) or switched from DUPI to UPA 15 mg (DUPI/UPA), with the potential to escalate to 30 mg based on clinical response. Efficacy for skin and itch outcomes in Period 2 were assessed using observed case analysis while on treatment, without statistical comparisons. Here we report efficacy and safety results for the DUPI/UPA switch group. A total of 355 patients who did not achieve EASI 75 at Week 16 entered Period 2 of the study (DUPI/UPA, N=208). At Week 32, response rates in the DUPI/UPA group were: 79.6%, 58.7%, and 19.9% achieving EASI 75, EASI 90, and EASI 100, respectively; 60.2% achieving WP-NRS improvement ≥4 among those with baseline WP-NRS ≥4; 37.0% achieving WP-NRS 0/1 among those with baseline WP-NRS >1; and 26.8% simultaneously achieving EASI 90 and WP-NRS 0/1 by Week 32. Clinically meaningful outcomes were also observed at an earlier visit (Week 20). No new safety signals through Week 32 were identified compared to the established safety profile of UPA. Most patients with an inadequate response to DUPI at Week 16 experienced clinically meaningful improvements in skin clearance and itch at 4 weeks post-switch to UPA, with additional patients achieving these outcomes by 16 weeks post-switch. These findings suggest that switching from DUPI to UPA is an effective treatment strategy for patients who do not meet moderate or optimal treatment targets with DUPI.

  • Research Article
  • Cite Count Icon 19
  • 10.1093/bjd/ljae404
Efficacy and safety of upadacitinib versus dupilumab in adults and adolescents with moderate-to-severe atopic dermatitis: week 16 results of an open-label randomized efficacy assessor-blinded head-to-head phase IIIb/IV study (Level Up).
  • Oct 23, 2024
  • The British journal of dermatology
  • Jonathan I Silverberg + 13 more

Atopic dermatitis (AD) is a chronic skin disease characterized by intense itch and eczematous skin lesions. Some patients with AD continue to experience flares and substantial clinical burden, despite ongoing systemic treatment. To assess the efficacy and safety of once-daily upadacitinib (UPA), initiated at 15 mg and dose-escalated to 30 mg based on clinical response, compared with dupilumab (DUPI) as per its label, and present the week 16 primary analysis results. Level Up is a phase IIIb/IV global randomized open-label efficacy assessor-blinded study evaluating UPA vs. DUPI in adolescents and adults with moderate-to-severe AD who had an inadequate response to systemic therapy or when use was inadvisable. Patients were randomized to UPA or DUPI for 16 weeks of treatment (period 1). Patients on UPA were started on 15 mg and dose-escalated to 30 mg if they did not achieve an Eczema Area and Severity Index reduction of at least 50% (EASI 50) or a ≥ 4-point Worst Pruritus Numerical Rating Scale (WP-NRS) improvement on or after week 4, or an EASI reduction of at least 75% (EASI 75) on or after week 8. The primary endpoint was simultaneous achievement of an EASI reduction of at least 90% (EASI 90) and WP-NRS 0/1 at week 16. Ranked secondary endpoints included skin and itch responses at varying response levels and timepoints. Safety measures were assessed throughout the study. Superior efficacy in achieving simultaneous EASI 90 and WP-NRS 0/1 response at week 16 was demonstrated with UPA vs. DUPI (19.9% vs 8.9%, respectively; P < 0.001). UPA showed superiority over DUPI for all ranked secondary endpoints, with post hoc analyses exhibiting higher itch response rates as early as day 2. No new safety signals were identified in this period. Treatment of moderate-to-severe AD with UPA, initiated at 15 mg and dose-escalated based on clinical response, demonstrated superiority over DUPI per its label for the primary endpoint of simultaneous achievement of near-complete skin clearance (EASI 90) and little-to-no itch (WP-NRS 0/1) at week 16, with all ranked secondary endpoints demonstrating superiority at varying skin and itch response levels and timepoints. No new safety signals were identified vs. the previously reported safety profiles of UPA and DUPI.

  • Open Access Icon
  • Research Article
  • Cite Count Icon 1
  • 10.33393/grhta.2024.2728
Cost per NNT for upadacitinib in the treatment of patients with moderate-severe atopic dermatitis in Italy
  • Feb 16, 2024
  • Global and Regional Health Technology Assessment
  • Andrea Chiricozzi + 4 more

Background: Targeted systemic therapies, including abrocitinib, baricitinib, dupilumab, tralokinumab and upadacitinib, are new treatments for moderate to severe atopic dermatitis (AD). We evaluated the efficacy and the costs of these targeted systemic therapies in the treatment of adult patients with moderate to severe AD. Methods: The clinical efficacy was assessed considering the results of a previous network meta-analysis (NMA). The analysis involved five therapies approved in Italy for the treatment of moderate to severe AD: abrocitinib (ABR), baricitinib (BAR), dupilumab (DUP), tralokinumab (TRA) and upadacitinib (UPA). According to the NMA, the cost of the treatment was based on the number of administrations dispensed at 16 weeks and the clinical efficacy was measured by the number needed to treat (NNT) compared to placebo using the improvement ≥ 75% (EASI-75) or ≥ 90 (EASI-90) from baseline of the eczema area and severity index (EASI). Only the ex-factory price of the targeted systemic therapies was considered. The cost per NNT was adopted as a cost-effectiveness indicator. Results: At 16 weeks, the cost per NNT based on EASI-75 was lower for UPA 15 mg (€ 6,384.00) compared to BAR 4 mg (€ 11,619.73) and 2 mg (€ 14,524.66), ABR 100 mg (€ 16,265.22), DUP 300 mg (€ 16,115.04) and TRA 300 mg (€ 31,710.24). UPA 15 (€ 8,512.00) also showed the lower cost per NNT based on EASI-90 at 16 weeks compared to BAR 4 mg (€ 14,788.75) and 2 mg (€ 20,862.70), ABR 100 mg (€ 25,922.69), DUP 300 mg (€ 25,992.00) and TRA 300 mg (€ 41,067.36). Conclusions: The findings show that upadacitinib is the most cost-effective option (cost per NNT) for the treatment of moderate to severe atopic dermatitis.

  • Research Article
  • Cite Count Icon 2
  • 10.1093/bjd/ljad498.033
528 - Rapid skin clearance and itch improvement with upadacitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: results from a phase 3b head-to-head clinical trial (Heads Up)
  • Feb 7, 2024
  • British Journal of Dermatology
  • Eric L Simpson + 6 more

Abstract Introduction/Background Atopic dermatitis (AD) is a chronic, recurrent, inflammatory disease characterized by multiple skin manifestations and intense itching that can impact patient quality of life. The effect of upadacitinib (UPA) and dupilumab (DUP) was evaluated in a double-blind, double-dummy, head-to-head phase 3b clinical trial (Heads Up; NCT03738397) of adult patients (age: 18-75 years) with moderate-to-severe AD (Eczema Area and Severity Index [EASI] ≥16; body surface area ≥10%; validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD) ≥3 at screening and baseline; Worst Pruritus Numerical Rating Scale [WP-NRS] ≥4 at baseline) randomized 1:1 to UPA 30 mg orally once-daily (N=348) or DUP 300 mg subcutaneous injection every two weeks after a 600 mg loading dose (N=344). Objective The effects of UPA and DUP on skin clearance and itch improvement are reported here. Methods Skin clearance was assessed by EASI, with response defined as an improvement ≥75% (EASI75), ≥90% (EASI90), and 100% (EASI100) from baseline. Itch intensity was assessed daily by WP-NRS up to week 16, then at study visits up to week 24. Weekly WP-NRS scores were analyzed as a 7-day rolling average up to week 16, then at study visits through week 24. Daily WP-NRS scores were analyzed day-to-day through day 28. Mean percent improvement and the proportion of patients achieving clinically meaningful improvement (≥4-point improvement from baseline) were evaluated. The proportion of patients achieving a state of no/minimal itch (defined as WP-NRS score of 0/1) was evaluated as a post-hoc analysis. Results EASI75/90/100 response rates were significantly greater with UPA versus DUP at week 16 (UPA = 72.4%/61.6%/28.4%, DUP = 62.6%/40.3%/7.9%; P&amp;lt;0.01 for all comparisons), with greater EASI75 and EASI90 rates observed with UPA as early as week 1 (nominal P&amp;lt;0.05). Mean percent improvement in weekly WP-NRS was significantly greater with UPA versus DUP at week 16 (UPA = 67.8%, DUP= 49.6%; P&amp;lt;0.001), with greater improvement observed as early as week 1 (nominal P&amp;lt;0.001). Daily WP-NRS data showed a greater mean percent improvement with UPA versus DUP as early as day 2, the day after the first dose (UPA = 22.0%, DUP = 4.2%; nominal P&amp;lt;0.001). The proportion of patients that achieved clinically meaningful improvement in weekly WP-NRS was significantly greater with UPA versus DUP at week 16 (UPA = 56.1%, DUP = 36.4%; P&amp;lt;0.001), with greater proportions observed as early as week 1 (nominal P&amp;lt;0.001). Daily WP-NRS data showed a greater proportion of patients achieved clinically meaningful improvement with UPA versus DUP as early as day 2 (UPA = 15.3%, DUP = 3.4%; nominal P&amp;lt;0.001). The proportion of patients that achieved a state of no/minimal itch based on weekly WP-NRS was greater with UPA versus DUP at week 16 (UPA = 35.5%, DUP = 16.2%; nominal P&amp;lt;0.001) and at week 1 (nominal P&amp;lt;0.001). Conclusions Skin clearance and itch improvement were consistently better with UPA compared with DUP in adult patients with moderate-to-severe AD, with greater improvements observed as early as week 1 for skin clearance and the day following treatment for itch improvement.

  • Research Article
  • 10.1093/bjd/ljad498.031
526 - Efficacy of upadacitinib vs dupilumab for moderate-to-severe atopic dermatitis: analysis of time spent in itch response state from the Heads Up study
  • Feb 7, 2024
  • British Journal of Dermatology
  • Andrew Blauvelt + 10 more

Abstract Introduction/Background Atopic dermatitis is a chronic inflammatory skin disease characterized by intense and debilitating pruritus – its most burdensome symptom – and requires long-term control. Results from the Heads Up trial (NCT03738397) found that upadacitinib (UPA) 30 mg was superior to dupilumab (DUPI) 300 mg for improving itch as indicated by increases in the percent of improvement from baseline for Worst Pruritus NRS scores (WP-NRS). Objective This analysis compared the proportion of days patients treated with UPA or DUPI spent in itch response states indicated by WP-NRS. Methods Heads Up was a 24-week head-to-head phase 3b multicenter, randomized, double-blind study comparing UPA 30 mg to DUPI 300 mg in adults with moderate-to-severe AD. We compared the proportion of days patients treated with UPA or DUPI spent in an improved-itch state (WP-NRS improvement ≥4 relative to baseline; among patients with baseline WP-NRS ≥4) or a state of no/minimal itch (WP-NRS 0/1; among patients with baseline WP-NRS &amp;gt;1). Results Participants included 673 patients randomized into two groups: those taking UPA (N=342) or DUPI (N=331). At 4 and 16 weeks, patients treated with UPA vs DUPI spent a greater proportion of days in an improved-itch state (week 4: 50.0% vs 19.3%; week 16: 60.4% vs 35.7%), and in a state of no/minimal itch (week 4: 22.1% vs 4.3%; week 16: 34.4% vs 11.4%). Conclusions Treatment of moderate-to-severe AD with UPA 30 mg daily resulted in a greater proportion of days spent with meaningful itch improvement (WP-NRS improvement ≥4) and more time with no/minimal itch (WP-NRS 0/1) compared to treatment with DUPI over 4 and 16 weeks.

  • Open Access Icon
  • Research Article
  • 10.1155/2023/9013756
Exploration of Metabolite Biomarkers to Predict the Efficacy of Dupilumab Treatment for Atopic Dermatitis.
  • Nov 1, 2023
  • Disease markers
  • Shoko Miyamoto + 6 more

Dupilumab (DUP) is the first biological agent used treating atopic dermatitis (AD). Notwithstanding its high cost, the type of patient group for which the drug is effective remains unclear. In this retrospective study, we aimed to identify novel and reliable biomarkers which can be measured before DUP administration and to predict the efficacy of DUP. Serum samples from 19 patients with AD treated with DUP were analysed by metabolome analysis using gas chromatography-mass spectrometry. Total 148 metabolites were detected, and the relative values of the metabolites were compared between the patient group that achieved 75% improvement in Eczema Area and Severity Index 16 weeks after administration of DUP (high responders: HR; n = 11) and that did not (low responders: LR; n = 8). The HR and LR groups had significant differences in the relative values of the eight metabolites (lactic acid, alanine, glyceric acid, fumaric acid, nonanoic acid, ribose, sorbitol, and ornithine), with ribose emerging as the best. Furthermore, we evaluated the serum concentrations of ribose and found that ribose may be a useful metabolite biomarker for predicting the efficacy of DUP in AD.

  • Research Article
  • Cite Count Icon 13
  • 10.1016/j.jaad.2023.10.029
Impact of dupilumab on patch test results and allergic contact dermatitis: A prospective multicenter study
  • Oct 21, 2023
  • Journal of the American Academy of Dermatology
  • Sarah Bocquel + 19 more

Impact of dupilumab on patch test results and allergic contact dermatitis: A prospective multicenter study

  • Open Access Icon
  • Abstract
  • 10.1093/jcag/gwac036.141
A141 DUPILUMAB IMPROVES CLINICAL, SYMPTOMATIC, ENDOSCOPIC, AND HISTOLOGIC ASPECTS OF EOE, REGARDLESS OF PRIOR SWALLOWED TOPICAL STEROID USE
  • Mar 7, 2023
  • Journal of the Canadian Association of Gastroenterology
  • A J Bredenoord + 8 more

BackgroundSwallowed topical corticosteroids (STC) are a first-line treatment for eosinophilic esophagitis (EoE) but are not uniformly effective. Dupilumab (DPL), a fully human monoclonal antibody, blocks the shared receptor component for IL-4/IL-13, key and central drivers of type 2 inflammation. In Parts A and B of the phase 3 LIBERTY-EoE-TREET (NCT03633617) study, weekly DPL 300mg improved clinical, symptomatic, histologic, and endoscopic aspects of EoE and was generally well tolerated in adult and adolescent patients (pts) with EoE.PurposeTo assess the efficacy of weekly DPL 300mg vs placebo (PBO) at Week 24 in pts from Parts A and B with/without prior history of STC use, and from Part B with/without a history of inadequate response, intolerance, or contraindication to STCs.MethodPts who received STCs for EoE within 8 weeks prior to baseline were excluded from the study. Co-primary endpoints at Week 24 were the proportion achieving peak eosinophil count (PEC) ≤6/high-power field (hpf) and the absolute change in Dysphagia Symptom Questionnaire (DSQ) score. Other secondary endpoints at Week 24 included: % change in PEC; absolute change in Histologic Scoring System (HSS) grade and stage scores and Endoscopic Reference Score (EREFS); % change in DSQ score.Result(s)At baseline, in Parts A and B combined, 84/122 (69%) and 87/118 (74%) of DPL- and PBO-treated pts had history of STC use. For pts treated with DPL vs PBO PEC≤6/hpf was achieved by 59.5% vs 3.4% of pts with, and 57.9% vs 12.9% without, prior STC use. Difference vs PBO (95% CI) in the absolute change in DSQ score was −13.27 (−18.03, −8.50) vs −5.21 (−12.41, 2.00) for pts with/without prior STC use. Difference vs PBO (95% CI) for pts with/without prior STC use were: % change in PEC −80.76 (−97.77, −63.75)/−84.87 (−112.16, −57.58); absolute change in EoE-HSS grade −0.77 (−0.87, −0.66)/−0.57 (−0.77, −0.38) and stage −0.77 (−0.87, −0.66)/−0.55 (−0.73, −0.36); absolute change in EREFS −3.86 (−4.70, −3.02)/−2.59 (−4.16, −1.02); % change in DSQ −34.5 (−47.75, −21.22)/-14.9 (−35.21, 5.36). DPL was generally well tolerated in the intent-to-treat population; the most common TEAEs for DPL/PBO were injection-site reactions (37.7/33.3%). In Part B, 38/80 (48%) and 39/79 (49%) of DPL- and PBO-treated pts had inadequate response/intolerance/contraindication to STCs. For DPL vs PBO PEC≤6/hpf was achieved by 55.3% vs 7.7% with, and 61.9% vs 5.0% of pts without, inadequate response/intolerance/contraindication to STC. Difference vs PBO (95% CI) for absolute change in DSQ score was −11.55 (−19.06, −4.04)/−7.08 (−13.75, −0.42) for pts with/without inadequate response/intolerance/contraindication to STCs.Conclusion(s)Conclusion: Regardless of prior STC use, in this pooled analysis from Part A and Part B of the EoE TREET Phase 3 Study, weekly DPL 300mg demonstrated substantial improvements in clinical, histologic, and endoscopic study endpoints at Week 24 in adults and adolescents with EoE.Please acknowledge all funding agencies by checking the applicable boxes belowOtherPlease indicate your source of funding;Research sponsored by Sanofi and Regeneron Pharmaceuticals, Inc.Disclosure of InterestA. Bredenoord Shareholder of: SST, Grant / Research support from: Bayer, Nutricia, SST, Consultant of: Arena Pharmaceuticals, AstraZeneca, Calypso Biotech, Dr Falk, EsoCap, Gossamer Bio, Laborie, Medtronic, RB Pharma, Regeneron Pharmaceuticals, Inc., Robarts Clinical Trials, E. Dellon Grant / Research support from: Research funding; Adare Pharma Solutions, Allakos, GSK, Meritage Pharma, Miraca Life Sciences, Nutricia, Receptos/BMS, Regeneron Pharmaceuticals, Inc., Shire. Educational grant; Allakos, Banner Pharmaceuticals, Holoclara, Consultant of: Abbott, Adare Pharma Solutions, Aimmune Therapeutics, Alivio Therapeutics, Allakos, Arena Pharmaceuticals, AstraZeneca, Banner Pharmaceuticals, Biorasi, Calypso Biotech, Enumeral, EsoCap, Gossamer Bio, GSK, Receptos/BMS, Regeneron Pharmaceuticals, Inc., Robarts Clinical Trials, Salix Pharmaceuticals, Shire/Takeda, A. Lucendo Grant / Research support from: Dr Falk, Regeneron Pharmaceuticals, Inc., Consultant of: Dr Falk, EsoCap, M. Collins Grant / Research support from: Receptos/BMS, Regeneron Pharmaceuticals, Inc., Shire, Consultant of: Allakos, AstraZeneca, BMS, EsoCap, Regeneron Pharmaceuticals, Inc., Shire, A. Khodzhayev Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., X. Sun Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., K. Patel Employee of: Sanofi, B. Beazley Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc., A. Shabbir Shareholder of: Regeneron Pharmaceuticals, Inc., Employee of: Regeneron Pharmaceuticals, Inc.

  • Abstract
  • Cite Count Icon 1
  • 10.1016/j.chest.2022.08.1587
DUPILUMAB TREATMENT LEADS TO SUSTAINED REDUCTIONS IN ORAL CORTICOSTEROID USE IN PATIENTS WITH ORAL CORTICOSTEROID-DEPENDENT SEVERE ASTHMA
  • Oct 1, 2022
  • Chest
  • Mark Gurnell + 13 more

DUPILUMAB TREATMENT LEADS TO SUSTAINED REDUCTIONS IN ORAL CORTICOSTEROID USE IN PATIENTS WITH ORAL CORTICOSTEROID-DEPENDENT SEVERE ASTHMA

  • Open Access Icon
  • Abstract
  • 10.1016/j.jid.2022.05.316
308 Incremental improvements after switching from dupilumab (DUPI) to upadacitinib (UPA) in the Heads Up open-label extension (OLE) study
  • Jul 20, 2022
  • Journal of Investigative Dermatology
  • V.H Prajapati + 10 more

308 Incremental improvements after switching from dupilumab (DUPI) to upadacitinib (UPA) in the Heads Up open-label extension (OLE) study

  • Abstract
  • Cite Count Icon 2
  • 10.1016/j.reval.2022.02.199
Dupilumab safety and efficacy up to 52 weeks in adult and adolescent patients with eosinophilic esophagitis: Results from part A and C of a randomized, placebo-controlled, three-part, phase 3 LIBERTY EoE TREET Study
  • Apr 1, 2022
  • Revue Française d'Allergologie
  • E.S Dellon + 19 more

Dupilumab safety and efficacy up to 52 weeks in adult and adolescent patients with eosinophilic esophagitis: Results from part A and C of a randomized, placebo-controlled, three-part, phase 3 LIBERTY EoE TREET Study

  • Open Access Icon
  • Abstract
  • Cite Count Icon 1
  • 10.1016/j.jaci.2021.12.191
EValuating trEatment RESponses of dupilumab versus omalizumab in Type 2 patients: the EVEREST Trial
  • Feb 1, 2022
  • Journal of Allergy and Clinical Immunology
  • Lucia De Prado Gomez + 11 more

EValuating trEatment RESponses of dupilumab versus omalizumab in Type 2 patients: the EVEREST Trial

  • Open Access Icon
  • Abstract
  • 10.1016/j.chest.2021.07.1677
DUPILUMAB IMPROVES LUNG FUNCTION IN CHILDREN WITH UNCONTROLLED, MODERATE-TO-SEVERE ASTHMA: LIBERTY ASTHMA VOYAGE
  • Oct 1, 2021
  • Chest
  • Leonard Bacharier + 14 more

DUPILUMAB IMPROVES LUNG FUNCTION IN CHILDREN WITH UNCONTROLLED, MODERATE-TO-SEVERE ASTHMA: LIBERTY ASTHMA VOYAGE

  • Open Access Icon
  • Research Article
  • Cite Count Icon 17
  • 10.1016/j.chroma.2021.462489
A generic sample preparation method for the multiplex analysis of seven therapeutic monoclonal antibodies in human plasma or serum with liquid chromatography-tandem mass spectrometry
  • Aug 27, 2021
  • Journal of Chromatography A
  • Mohsin El Amrani + 5 more

A generic sample preparation method for the multiplex analysis of seven therapeutic monoclonal antibodies in human plasma or serum with liquid chromatography-tandem mass spectrometry

  • Open Access Icon
  • Abstract
  • 10.1016/j.jid.2021.02.342
320 Dupilumab in Canadian eczema clinic
  • Apr 19, 2021
  • Journal of Investigative Dermatology
  • N Merati + 2 more

320 Dupilumab in Canadian eczema clinic

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