Treatment of atopic dermatitis with dupilumab in Taiwan: dynamic changes of IgE levels as a potential response biomarker

Huang, Tzu Hung; Chen, Yin-Chun; Lin, Sheng-Yiao; Chiu, Szu-Hao; Yang, Ting‐Ting; Chiu, Li-Wen; Chen, Yangyi; Lan, Cheng‐Che E.

doi:10.1684/ejd.2019.3661

Cited by 9 publications

(9 citation statements)

References 6 publications

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“…In addition, evaluating other parameters, such as inflammatory biomarkers, may help to better identify dupilumab responders. Previous studies have shown that increased eosinophil count and elevated lactate dehydrogenase levels, in addition to increases in serum IgE levels while receiving dupilumab treatment, may serve as markers of poor response 10,11 . A prospective, observational study designed to evaluate the association between the effectiveness of dupilumab and changes in a number of biomarkers in Japanese patients with AD is currently under way 12 …”

Section: Discussionmentioning

confidence: 99%

“…Previous studies have shown that increased eosinophil count and elevated lactate dehydrogenase levels, in addition to increases in serum IgE levels while receiving dupilumab treatment, may serve as markers of poor response. 10,11 A prospective, observational study designed to evaluate the association between the effectiveness of dupilumab and changes in a number of biomarkers in Japanese patients with AD is currently under way. 12 Previous studies have shown that there are a number of differences between Asian patients and patients of other ethnicities in terms of the clinical presentation, genetic predisposition and pathophysiology of AD.…”

Section: Discussionmentioning

confidence: 99%

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The efficacy and safety of dupilumab in Chinese patients with moderate‐to‐severe atopic dermatitis: a randomized, double‐blind, placebo‐controlled study*

Zhao

et al. 2021

Br J Dermatol

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Summary Background Dupilumab is an antibody against interleukin‐4 receptor α, used in the treatment of atopic dermatitis (AD). Objectives To evaluate the efficacy and safety of dupilumab in adult Chinese patients with moderate‐to‐severe AD. Methods In this randomized, double‐blind, placebo‐controlled, parallel‐group, phase III study, conducted between December 2018 and February 2020, patients with AD received dupilumab (300 mg) or placebo once every 2 weeks for 16 weeks, and were followed up for 12 weeks. The primary efficacy endpoint was the proportion of patients with both an Investigator’s Global Assessment score of 0–1 and a reduction from baseline of ≥ 2 points at week 16. Results Overall, 165 patients (mean age 30·6 years; 71·5% male patients) were randomized; 82 patients were randomized to dupilumab and 83 patients were randomized to placebo. At week 16, 26·8% of patients in the dupilumab group and 4·8% of patients in the placebo group achieved the primary endpoint [difference 22·0%, 95% confidence interval (CI) 11·37–32·65; P < 0·001]. Compared with placebo, higher proportions of patients in the dupilumab group achieved ≥ 75% reduction in the Eczema Area and Severity Index score (57·3% vs. 14·5%; difference 42·9%, 95% CI 29·75–55·97; P < 0·001) and had ≥ 3‐point (52·4% vs. 9·6%; difference 42·8%, 95% CI 30·26–55·34; P < 0·001) and ≥ 4‐point (39·0% vs. 4·8%; difference 34·2%, 95% CI 22·69–45·72; P < 0·001) reductions in weekly average daily peak daily pruritus numerical rating scale scores. The incidence of treatment‐emergent adverse events during the treatment period was similar in the two groups. The incidence of conjunctivitis, allergic conjunctivitis and injection site reaction was higher in the dupilumab group than in the placebo group. Conclusions In adult Chinese patients, dupilumab was effective in improving the signs and symptoms of AD and demonstrated a favourable safety profile.

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

The efficacy and safety of dupilumab in Chinese patients with moderate‐to‐severe atopic dermatitis: a randomized, double‐blind, placebo‐controlled study*

Zhao

et al. 2021

Br J Dermatol

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“…Although biomarkers representing the Th2 signature tend to decrease upon dupilumab treatment, the individual degrees of response of biomarkers as well as the rates of clinical improvement vary. [ 40 , 41 ] In addition, it is not fully understood what kinds of biomarkers are responsible for a good/poor clinical outcome of dupilumab treatment.…”

Section: Introductionmentioning

confidence: 99%

Exploration of biomarkers to predict clinical improvement of atopic dermatitis in patients treated with dupilumab

et al. 2020

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Background: Atopic dermatitis (AD) is a common eczematous skin disorder that profoundly reduces the quality of life due to intractable pruritus. Excellent therapeutic success of the anti-interleukin 4 receptor-α antibody dupilumab in clinical trials and a real-world clinical context indicates the crucial roles of interleukin (IL)-4 and IL-13 in the pathogenesis of AD. Along with the clinical improvement in skin scores and pruritus, dupilumab significantly and progressively reduces and normalizes the upregulated expression of T helper type 2 signatures such as Chemokine (C-C motif) ligand (CCL)17, CCL18, CCL22, and CCL26 in the lesional skin of AD. However, no blood/serum biomarkers are known to predict good or poor outcome in patients with AD treated with dupilumab. Methods: Patients are at least 18 years of age and have moderate-to-severe AD with Eczema Area and Severity Index (EASI) ≥16, Investigator's Global Assessment ≥3, and body surface area ≥10%. We are going to enroll more than 130 subjects from 18 medical facilities. Clinical objective findings will be evaluated by EASI. Subjective symptoms will be assessed by Patient-Oriented Eczema Measure, Numerical Rating Scale for Pruritus (Pruritus-NRS), Skin Comfort-NRS, and Treatment Satisfaction-NRS. We will measure 18 blood/serum biomarkers including % eosinophils in blood cell count, lactate dehydrogenase, total IgE, soluble interleukin 2 receptor, CCL17, CCL18, CCL22, CCL26, CCL27, IL-13, IL-22, IL-24, IL-25, IL-31, IL-33, thymic stromal lymphopoietin, periostin, and squamous cell carcinoma antigen-2. The clinical evaluation and biomarker sampling will be performed at 0, 2, 4, 8, and 16 weeks of dupilumab treatment. We will also perform proteomic analysis (of roughly 300 proteins) of the patients’ sera obtained at 0 and 2 weeks of treatment. The primary endpoint is the association between “baseline levels of 18 biomarkers” and “% change from baseline of EASI at 16 weeks of dupilumab treatment.” Discussion: This is the first clinical trial to explore the biomarkers, including potential proteomic markers, most strongly associated with improvement in EASI in patients with moderate-to-severe AD treated with dupilumab for 16 weeks (B-PAD study). A limitation is that we will only enroll Japanese patients.

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“…To precisely monitor the treatment effect and predict the underlying adverse reactions, potential biomarkers or predictors are needed and have been explored. There were controversies about the correlation between serum IgE and the treatment response, some demonstrated that the dynamic changes in serum IgE levels could reflect the response of dupilumab to AD ( 77 ), while others showed that the pooling of data demonstrated a weak correlation between serum IgE and follow-up disease severity after treatment, which indicated that serum IgE was not the best appropriate biomarker of AD ( 58 ). LDH can also serve as a potential serological marker to predict the therapeutic effects of dupilumab ( 78 ).…”

Section: Biomarkers For Monitoring Treatment Effects In Patients With...mentioning

confidence: 99%

Potential biomarkers of atopic dermatitis

2022

Front. Med.

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Atopic dermatitis (AD) is a chronic, recurrent inflammatory skin disease with a wide range of heterogeneity. Accurate biomarkers or predictors are the keys to instructing personalized tailored precise treatment. The development of technology such as transcriptomics, genomics, and proteomics provides novel insights into the possibility to find potential biomarkers. Meanwhile, emerging minimally invasive methods such as tape stripping were used to reveal different profiles of patients’ skin without biopsy. Several potential biomarkers or predictors have been found. In this review, we summarized the current development of potential biomarkers of AD. Nitric oxide synthase 2/inducible nitric oxide synthase (NOS2/iNOS), human beta-defensin-2 (hBD-2), and matrix metalloproteinases 8/9 (MMP8/9) may be the candidate biomarkers for AD diagnosis. Filaggrin (FLG) gene mutation increased the occurrence risk of AD. Fatty-acid-binding protein 5 (FABP5) may serve as an effective biomarker for the atopic march (AM). Squamous cell carcinoma antigen 2 (SCCA2), serum thymus and activation-regulated chemokine (TARC), cutaneous T-cell-attracting chemokine (CTACK), eosinophil-derived neurotoxin (EDN), macrophage-derived chemokine (MDC), lactate dehydrogenase (LDH), and interleukin (IL)-18 can be the candidate biomarkers for disease severity monitoring. IL-17, IL-23, IL-33, and indoleamine 2,3-dioxygenase (IDO1) can be used as predictive biomarkers for AD comorbidities. LDH, TARC, pulmonary and activation-regulated chemokine (PARC), periostin, IL-22, eotaxin-1/3, and IL-8 may be the candidate biomarkers for monitoring treatment effects. There are still unmet needs and a long way to go for more convenient, non-invasive, and effective predictors and biomarkers to better guide personalized precise treatment.

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Treatment of atopic dermatitis with dupilumab in Taiwan: dynamic changes of IgE levels as a potential response biomarker

Cited by 9 publications

References 6 publications

The efficacy and safety of dupilumab in Chinese patients with moderate‐to‐severe atopic dermatitis: a randomized, double‐blind, placebo‐controlled study*

The efficacy and safety of dupilumab in Chinese patients with moderate‐to‐severe atopic dermatitis: a randomized, double‐blind, placebo‐controlled study*

Exploration of biomarkers to predict clinical improvement of atopic dermatitis in patients treated with dupilumab

Potential biomarkers of atopic dermatitis

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