March 2025
Journal of Investigative Dermatology
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Publications (121)
February 2025
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16 Reads
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1 Citation
Journal of Allergy and Clinical Immunology
February 2025
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18 Reads
Respiratory Medicine
January 2025
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10 Reads
Chest
January 2025
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22 Reads
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1 Citation
The Lancet Respiratory Medicine
November 2024
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31 Reads
Background Development of anti-drug antibodies (ADAs) and neutralizing antibodies (NAbs) to monoclonal antibodies may adversely impact pharmacokinetics, efficacy, and/or safety. Objective To describe incidence, titer, and persistence of dupilumab ADAs and NAbs, and their effects on pharmacokinetics, efficacy, and safety in patients with atopic dermatitis (AD). Methods This analysis included seven phase 3 randomized, placebo-controlled (N=2,992) and two long-term open-label extension (N=2,287) trials of subcutaneous dupilumab in adults and pediatric patients with moderate-to-severe AD. ADA, NAb, and dupilumab concentration in serum were assessed using validated immunoassays. ADA impacts on efficacy (EASI) and safety were assessed. Results Treatment-emergent ADAs were observed in up to 8.6% (aged ≥18 years), 16.0% (12-17 years), 5.3% (6-11 years), and 2.0% (6 months to 5 years) dupilumab-treated patients. Among dupilumab-treated patients, ≤3.7% had persistent responses, <1% had high titers (≥10,000), and ≤5.1% were NAb-positive. NAbs were more common in patients with moderate- and high-titer ADA responses. High-titer ADAs, while infrequent, were the variable most associated with lower dupilumab concentrations in serum and loss of efficacy, independent of NAb status. Efficacy was generally similar in ADA-positive and -negative patients. For most patients with high- or moderate-titer ADAs, titers decreased and efficacy improved over time with continued dupilumab treatment. ADA-positive and -negative patients had similar incidences of treatment-emergent and serious treatment-emergent adverse events. One patient with high-titer ADAs developed serum sickness. Conclusion In patients with AD, ADAs and NAbs had minimal impact on dupilumab concentration, efficacy, and safety, except for high-titer ADAs in a small number of patients. Clinical trial registration ClinicalTrials.gov, identifiers (NCT02277743, NCT02277769, NCT02260986, NCT02395133, NCT01949311, NCT03054428, NCT03345914, NCT02612454, and NCT03346434).
October 2024
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6 Reads
October 2024
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3 Reads
October 2024
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4 Reads
October 2024
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3 Reads
Citations (36)
... The record screening, appraisal, and extraction are presented in Figure 1. Summarily, 307 unique reports were screened, 39 full texts were sought for appraisal, and 17 reports included in this systematic review [10,11,[20][21][22][23][24][25][26][27][28][29][30][31][32][33][34]. These include two reports including phase 3 randomized controlled trials [10,11], ten published abstracts reporting on sub-analyses of the two aforementioned clinical trials [20][21][22][23][24][25][26][27][28]30], one observational cohort study [33], and four case reports [29,31,32,34]. ...
- Citing Article
February 2025
Journal of Allergy and Clinical Immunology
... The record screening, appraisal, and extraction are presented in Figure 1. Summarily, 307 unique reports were screened, 39 full texts were sought for appraisal, and 17 reports included in this systematic review [10,11,[20][21][22][23][24][25][26][27][28][29][30][31][32][33][34]. These include two reports including phase 3 randomized controlled trials [10,11], ten published abstracts reporting on sub-analyses of the two aforementioned clinical trials [20][21][22][23][24][25][26][27][28]30], one observational cohort study [33], and four case reports [29,31,32,34]. ...
- Citing Article
October 2024
Chest
... The record screening, appraisal, and extraction are presented in Figure 1. Summarily, 307 unique reports were screened, 39 full texts were sought for appraisal, and 17 reports included in this systematic review [10,11,[20][21][22][23][24][25][26][27][28][29][30][31][32][33][34]. These include two reports including phase 3 randomized controlled trials [10,11], ten published abstracts reporting on sub-analyses of the two aforementioned clinical trials [20][21][22][23][24][25][26][27][28]30], one observational cohort study [33], and four case reports [29,31,32,34]. ...
- Citing Article
October 2024
Chest
... The record screening, appraisal, and extraction are presented in Figure 1. Summarily, 307 unique reports were screened, 39 full texts were sought for appraisal, and 17 reports included in this systematic review [10,11,[20][21][22][23][24][25][26][27][28][29][30][31][32][33][34]. These include two reports including phase 3 randomized controlled trials [10,11], ten published abstracts reporting on sub-analyses of the two aforementioned clinical trials [20][21][22][23][24][25][26][27][28]30], one observational cohort study [33], and four case reports [29,31,32,34]. ...
- Citing Article
October 2024
Chest
... The record screening, appraisal, and extraction are presented in Figure 1. Summarily, 307 unique reports were screened, 39 full texts were sought for appraisal, and 17 reports included in this systematic review [10,11,[20][21][22][23][24][25][26][27][28][29][30][31][32][33][34]. These include two reports including phase 3 randomized controlled trials [10,11], ten published abstracts reporting on sub-analyses of the two aforementioned clinical trials [20][21][22][23][24][25][26][27][28]30], one observational cohort study [33], and four case reports [29,31,32,34]. ...
- Citing Article
October 2024
Chest
... The record screening, appraisal, and extraction are presented in Figure 1. Summarily, 307 unique reports were screened, 39 full texts were sought for appraisal, and 17 reports included in this systematic review [10,11,[20][21][22][23][24][25][26][27][28][29][30][31][32][33][34]. These include two reports including phase 3 randomized controlled trials [10,11], ten published abstracts reporting on sub-analyses of the two aforementioned clinical trials [20][21][22][23][24][25][26][27][28]30], one observational cohort study [33], and four case reports [29,31,32,34]. ...
- Citing Article
October 2024
Chest
... biologic treatment over decades 115 ), safety in vulnerable populations (e.g. very young children, 116 pregnant women 117 or patients with immunodeficiencies 118 ) and safety of combined treatments (e.g. dual biologic therapy 119 ). ...
- Citing Article
September 2024
Journal of the American Academy of Dermatology
... Personalized treatment in COPD has recently focused on the identification of treatable traits [3], with the two most widely acknowledged being dyspnea and exacerbations, highlighted by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) [2], followed by the evidence of blood eosinophilia or type 2 inflammation [4], and potentially the presence of cardiovascular comorbidities [5]. The 2025 GOLD report has included for the first time a monoclonal antibody that blocks the interleukin 4 receptor (anti-IL-4Rα), dupilumab, for patients with chronic bronchitis exacerbating on triple therapy who have blood eosinophil counts at least 300 cells/μL, based on two-phase 3 randomized placebo-controlled trials (RCTs) [6,7]. This signals a new era in COPD management that will likely be followed by additional biologic treatment options for patients with COPD. ...
- Citing Article
May 2024
The New-England Medical Review and Journal
... В ходе двух 52-недельных исследований дупилумаб сохранял благоприятный профиль безопасности, что подтверждает безопасность его длительного применения у педиатрических пациентов в возрасте от 6 до 18 лет [12,29]. По данным A.S. Paller и соавт., дупилумаб показал приемлемый долгосрочный профиль безопасности и устойчивую эффективность у детей в возрасте от 6 мес до 5 лет с недостаточно контролируемым АтД средней и тяжелой степени [30]. ...
- Citing Article
- Full-text available
May 2024
American Journal of Clinical Dermatology
... The vaccination schedule is another important topic of discussion before starting dupilumab therapy in patients under 6 years of age. In fact, regulatory labeling recommends completing all age-appropriate immunizations before initiating dupilumab treatment and thereby avoiding live vaccine administration 10 ...
- Citing Article
February 2024
Pediatric Dermatology
