Dupilumab In Patients Research Articles

Investigation of Blood Count-Based Inflammatory Biomarkers as Predictors of Response to Dupilumab Treatment in Patients with Chronic Rhinosinusitis with Nasal Polyps

Background/Objectives: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a type 2 inflammatory disease often resistant to standard treatments. Dupilumab, a monoclonal antibody targeting the IL-4α receptor, has shown efficacy in CRSwNP, but a significant subset of patients do not respond to this therapy. This study aims to investigate pretreatment complete blood count (CBC)-based inflammatory biomarkers as predictors of response to dupilumab in patients with CRSwNP. Methods: This mono-centric, retrospective, single-arm longitudinal cohort study included 80 patients with uncontrolled CRSwNP who received dupilumab treatment at the Medical University of Graz. Patients were classified into responder and non-responder groups based on a reduction of >1 in nasal polyp score (NPS) and a sinonasal outcome test-22 (SNOT-22) score <40 points at six months. Pretreatment CBC-derived biomarkers, including eosinophil count, neutrophil-to-lymphocyte ratio (NLR), platelet-to-lymphocyte ratio (PLR), and systemic inflammation indices including the aggregate inflammation systemic index (AISI), systemic inflammation index (SII), and systemic inflammation response index (SIRI), were analyzed for their predictive value. Results: Of the 80 patients, 72.5% were classified as responders, while 27.5% were non-responders. A significant positive correlation was found between baseline eosinophil count and NPS reduction (p = 0.027), suggesting that higher eosinophil levels may predict higher NPS reduction in dupilumab treatment. However, no significant associations were observed between NLR, PLR, and systemic inflammation indices with treatment outcomes. Conclusions: Pretreatment eosinophil count may serve as a potential biomarker for predicting nasal polyp reduction in dupilumab treatment of CRSwNP. Other CBC-based inflammatory markers did not show significant predictive value. Further prospective studies are needed to validate these findings and explore additional, reliable biomarkers to optimize treatment outcomes for CRSwNP patients.

S687 Timing and Durability of Dysphagia Symptom Response to Dupilumab in Patients With Eosinophilic Esophagitis: Post-Hoc Analysis of Part C of the LIBERTY EoE TREET Study

S687 Timing and Durability of Dysphagia Symptom Response to Dupilumab in Patients With Eosinophilic Esophagitis: Post-Hoc Analysis of Part C of the LIBERTY EoE TREET Study

Effect of Dupilumab on Radiological Remission in Patients with Chronic Rhinosinusitis with Nasal Polyp: A One Step Forward Toward Clinical Remission.

While achieving complete radiological improvement in patients with nasal polyps is often observed following surgical resection, the impact of biologic therapy, specifically dupilumab, on polyp size is an area of great interest. The objective of this study was to assess the effect of dupilumab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) by assessing nasal polyps using the computed tomography (CT) staging system, Lund-Mackay score (LMS). A two-year prospective cohort study was conducted on 29 patients diagnosed with CRSwNP and asthma and eligible for dupilumab as an add-on therapy. The study involved comprehensive assessments of patients before biologic initiation and after the study. These assessments included clinical, laboratory, and radiological evaluations. Dupilumab treatment reduces LMS across sinuses (p<0.001) and improves nasal obstruction (p=0.001). Blood eosinophil count (BEC) predicts persistent sinus obstruction, doubling the likelihood per unit increase (odds ratio: 1.67, p=0.02). BEC levels identify persistent nasal obstruction (AUC: 76%, p=0.04), with a cutoff point above 255.5 cells per microliter, revealing a sensitivity of 100% and a specificity of 42%. The probability of persistent nasal obstruction at the 20th month is 55%, regardless of prior nasal polyp surgery (p=0.41). Dupilumab led to significant radiological improvements in patients with CRSwNP, demonstrating a potential role of radiological remission, irrespective of prior nasal polyp surgery. Additionally, BEC levels may guide the likelihood of persistent nasal obstruction.

S597 Efficacy and Safety of Dupilumab in Patients With Eosinophilic Esophagitis: Pooled Analysis and a Systematic Review

S597 Efficacy and Safety of Dupilumab in Patients With Eosinophilic Esophagitis: Pooled Analysis and a Systematic Review

Factors Associated With Dupilumab Response in Atopic Dermatitis: A Systematic Review and Meta-Analysis

BackgroundDupilumab was approved for treating moderate-to-severe atopic dermatitis (AD). However, a notable subset of patients remains unresponsive and factors associated with dupilumab response are still limited. ObjectiveTo systematically review and establish factors related to dupilumab response in AD. MethodsWe searched electronic databases, including PubMed/MEDLINE, Embase, Ovid and the Cochrane Center of Controlled Trials, from inception to March 2023. The primary outcome was factors linked to dupilumab response in AD. The odds ratio (OR) and 95% confidence interval (CI) related to a 75% reduction at 12-16 weeks in Eczema Area and Severity Index (EASI) score were synthesized using random-effects meta-analysis. ResultsOf 21 studies involving 5,575 AD patients, 3 were post hoc analyses of phase 3 dupilumab studies, 12 were retrospective, and 6 were prospective studies. Factors associated with favorable responses to dupilumab, defined by the percentage of patients achieving EASI75 at 12-16 weeks, included female with the OR (95% CI) of 2.16 (1.38, 3.38), younger age 2.81 (1.64, 4.81), absence of allergic rhinitis 2.64 (1.07, 6.50), lower body mass index 1.97 (1.18, 3.30), and lower blood eosinophil count 6.47 (3.36, 12.48), with very low certainty of evidence. Age of onset, baseline EASI score, total IgE level, and serum lactate dehydrogenase level were unrelated to dupilumab response. ConclusionFemale, younger age, absence of allergic rhinitis, lower BMI, and lower blood eosinophil count were associated with favorable response to dupilumab in patients with AD. These factors should be taken into account when considering dupilumab therapy in clinical practice.

Impact of Overweight on Response to Dupilumab Treatment in Chronic Rhinosinusitis with Nasal Polyps.

Chronic rhinosinusitis with nasal polyps (CRSwNP) significantly impacts quality of life and often presents therapeutic challenges, with biologics like dupilumab showing promise in managing severe, uncontrolled cases. The aim of this study was to assess the influence of overweight on the effectiveness of dupilumab in patients with uncontrolled CRSwNP. This retrospective study analyzed treatment outcomes of 75 CRSwNP patients receiving dupilumab, categorizing them into underweight/normal-weight (BMI ≤ 24.9 kg/m2) and overweight/obese (BMI ≥ 25 kg/m2) groups. Outcome measures included changes in nasal polyp score (NPS) and sinonasal outcome test (SNOT-22) scores. Results demonstrated that the underweight/normal-weight group experienced significantly greater improvements in NPS and a higher rate of total NPS improvement compared to the overweight/obese group. While SNOT-22 scores improved in both groups, no significant differences were observed. Among patients with comorbid asthma, the underweight/normal-weight subgroup also showed significantly better outcomes, including greater reductions in both NPS and SNOT-22 scores. Multiple regression analysis identified BMI as an independent prognostic factor for NPS outcomes. The findings suggest that overweight/obesity adversely affects the response to dupilumab in CRSwNP, emphasizing the need for personalized treatment strategies considering BMI.

52720 Comparing real-world effectiveness and adverse effects of oral JAK inhibitors versus dupilumab in patients with atopic dermatitis: A population-based cohort study

52720 Comparing real-world effectiveness and adverse effects of oral JAK inhibitors versus dupilumab in patients with atopic dermatitis: A population-based cohort study

Cost per responder analysis of abrocitinib versus dupilumab in moderate to severe atopic dermatitis.

The JADE COMPARE was a multicenter, phase 3 randomized, double-blind, placebo-controlled trial with the objective of comparing the 16-week efficacy and safety of oral abrocitinib 100 or 200 mg once daily, dupilumab 300 mg subcutaneous injection every 2 weeks, or placebo in adults with moderate-to-severe atopic dermatitis (AD). Pharmacoeconomic evaluation of these new drugs for AD is lacking. The objective of our study was to compare the cost per responder of abrocitinib versus dupilumab in patients with AD using the data from the JADE COMPARE trial. The cost per responder was calculated by multiplying the cost of treatment by the number needed to treat for each therapy, as obtained from the JADE COMPARE trial. The 12-week primary endpoint was the Investigator global assessment (IGA) 0/1 and eczema area and severity index improvement of at least 75% (EASI75) response rate. The key secondary end points were itch response (defined as an improvement of ≥4 points in the score on the Peak Pruritus Numerical Rating Scale [PP-NRS; scores range from 0 to 10]) at week 2 and IGA and EASI-75 responses at week 16. The cost per responder model was based on the perspective of the Italian National Health System. Regarding the costs of drugs, ex-factory wholesale purchase prices were used, including the mandatory discounts according to the national legislation (5% discount, plus a further 5% reduction on the discount result). Abrocitinib 100 mg and 200 mg have flat price in Italy. The 12-week IGA 0/1 cost per responder was € 3955.77 and € 2984.94 for abrocitinib 100 mg and 200 mg, respectively, versus € 7467.96 for dupilumab; as for 12-week EASI75 the cost were € 2463.30 and € 2057.58 vs. € 4705.09, respectively. As far as the secondary end points, the costs per responder were always lower for abrocitinib 100 and 200 mg compared to dupilumab, including the PP-NRS (€ 3791.55 and € 2451.22, vs. € 6462.65), the IGA 0/1 at week 16 (€ 6931.05 and € 4854.15 vs. € 8787.85) and the EASI75 at week 16 (€ 3984.75 and € 3381.00 vs. € 5197.45). According to JADE COMPARE trial data, the costs per responder of abrocitinib were considerably lower than dupilumab. The results of the study are limited to the short time frame of JADE COMPARE trial.

Letter to the editor regarding “Cost-effectiveness of benralizumab versus mepolizumab and dupilumab in patients with severe uncontrolled eosinophilic asthma in Spain”

Letter to the editor regarding “Cost-effectiveness of benralizumab versus mepolizumab and dupilumab in patients with severe uncontrolled eosinophilic asthma in Spain”

Long-Term Effectiveness and Reasons for Discontinuation of Dupilumab in Patients With Atopic Dermatitis

Limited data are available on the long-term effectiveness and safety of dupilumab for atopic dermatitis (AD) in daily practice. To evaluate clinical effectiveness and reasons for discontinuation of dupilumab treatment in children, adults, and older adults with AD with up to 5 years of treatment in daily practice. This prospective multicenter cohort study was conducted using the BioDay registry (4 academic and 10 nonacademic hospitals in the Netherlands) to identify patients with AD of all ages who were treated with dupilumab between October 2017 and December 2022. Clinical effectiveness was evaluated by the Eczema Area and Severity Index (EASI), Investigator Global Assessment (IGA), and numeric rating scale (NRS) for pruritus, stratified by children (<18 years), adults (18-64 years), and older adults (≥65 years). In addition, time to response, treatment responders, EASI subscores, second treatment episodes, and thymus- and activation-related chemokine and eosinophil levels were assessed. For patients who discontinued dupilumab, the reason for discontinuation was evaluated. In total, 1286 patients with AD (median [IQR] age, 38 [26-54] years; 726 [56.6%] male) were treated with dupilumab, including 130 children, 1025 adults, and 131 older adults. The median (IQR) follow-up time was 87.5 (32.0-157.0) weeks. Most patients maintained controlled AD, with EASI of 7 or lower and NRS for pruritus of 4 or lower varying between 78.6% and 92.3% and 72.2% and 88.2% for up to 5 years of treatment, respectively, while up to 70.5% of all patients prolonged the dosing interval to mostly 300 mg every 3 or 4 weeks. Mean EASI and NRS for pruritus were 2.7 (95% CI, 1.2-4.2) and 3.5 (95% CI, 2.7-4.3), respectively, after 5 years of treatment. Statistically significant differences between age groups were found over time for EASI and IGA; however, differences were rather small (week 52: EASI, 0.3-1.6; IGA, 0.12-0.26). No statistically significant differences between age groups were found for NRS for pruritus. Median thymus- and activation-related chemokine levels considerably decreased from 1751 pg/mL (95% CI, 1614-1900 pg/mL) to 390 pg/mL (95% CI, 368-413 pg/mL) after 6 months of treatment and remained low. Median eosinophil levels temporarily increased up to week 16, with a subsequently statistically significant decrease over time. In total, 306 patients (23.8%) discontinued dupilumab after a median (IQR) of 54.0 (29.0-110.00) weeks, with adverse events among 98 patients (7.6%) and ineffectiveness among 85 patients (6.6%) as the most frequently reported reasons. Forty-one patients (3.2%) restarted dupilumab, and most of these patients recaptured response. In this cohort study with up to 5 years of follow-up, dupilumab maintained its clinical effectiveness, while two-thirds of patients tapered to a dosing interval of every 3 or 4 weeks. Treatment was discontinued in 23.8% of patients mainly due to adverse events and/or ineffectiveness.

Comparative safety of oral Janus kinase inhibitors versus dupilumab in patients with atopic dermatitis: A population-based cohort study

BackgroundSystemic Janus kinase inhibitors (JAKi) and dupilumab both have emerged as promising therapeutics for atopic dermatitis (AD). While dupilumab has a favorable safety profile, use of oral JAKi has been established in other diseases that carry potential comorbid susceptibilities that influence safety. ObjectiveTo provide real-world evidence of the safety of oral JAKi in AD patients. MethodsThe study used observational data from TriNetX (Cambridge, Massachusetts). Patients with AD treated with either oral JAKi (upadacitinib, abrocitinib, and baricitinib) or dupilumab were enrolled. The two treatment groups were propensity-score matched 1:1 based on demographics, comorbidities, and prior medications. Safety outcomes within two years after the initiation of medications were measured by hazard ratios with 95% confidence intervals. ResultsA total of 14,716 patients were included, with 942 patients treated with oral JAKi and 13,774 with dupilumab. The two treatment groups included 938 patients after matching. Treatment with oral JAKi was not associated with increased risks of mortality, malignancies, major adverse cardiovascular events, venous thromboembolism, renal events, or serious gastrointestinal events. However, patients receiving oral JAKi showed significantly higher risks of skin and subcutaneous tissue infection, herpes infection, acne, cytopenia, and hyperlipidemia, whereas the risk of ophthalmic complications was higher in those receiving dupilumab. ConclusionThis study found that oral JAKi did not exhibit concerning safety issues in treating patients with AD but increased the risk of infections and laboratory abnormalities. Long-term follow-up data are required to validate these findings

Dupilumab in Patients with Atopic Dermatitis: A Multicentric, Long-Term, Real-World Portuguese Study.

Several clinical trials have established the efficacy and safety of dupilumab for treating atopic dermatitis (AD). However, literature remains scarce in reporting the long-term effectiveness, safety, and drug survival of dupilumab in real-world settings. This study aimed to describe the latter outcomes of dupilumab in patients with AD. This Portuguese, multicentric, observational, retrospective study included consecutive adult patients with AD who initiated dupilumab between January 2019 and September 2023, with a follow-up period up to 30months. Drug discontinuation and adverse effects data were used to estimate drug survival. Clinical assessments included the Eczema Area and Severity Index (EASI), pruritus numerical rating scale (NRS), and Dermatology Life Quality Index (DLQI). A total of 312 patients were included in the study, with 56.4% being male (median age of 30years, range 18-83). The 30-month drug survival rate was 82.0%. During the study period, 12.5% of the sample (n = 39 patients) discontinued treatment: 7.3% due to treatment failure, 2.9% due to safety concerns, 1.3% due to complete disease control, 0.6% due to pregnancy, and 0.3% due to lack of compliance. Adverse events not leading to drug discontinuation were noted in 25.6% of the sample (n = 80). Conjunctivitis was the most frequently reported adverse event (17%), followed by facial erythema (9%). At 30months, the mean EASI decreased significantly from 27.30 ± 11.89 at baseline to 2.92 ± 3.96 (p < 0.001), reflecting an overall improvement of 89.3%. Similarly, pruritus NRS decreased from 7.36 ± 1.90 at baseline to 1.74 ± 2.16 at month 30 (p < 0.001), improving by 76.4%, and mean DLQI changed from 18.0 ± 7.09 at baseline to 2.67 ± 3.95 at month 30 (p < 0.001), decreasing by 85.2%. This study increases our current understanding of dupilumab in real-world settings, demonstrating its long-term effectiveness and safety in treating AD.

Therapeutic Modulation of Dupilumab in Patients with Severe Atopic Dermatitis: Clinical Effectiveness in Real Life.

Background: De-escalation strategies have become increasingly used in the treatment of atopic dermatitis (AD) patients with dupilumab. Dose spacing (DS) refers to dose reduction by dosage elongation strategies from 2 to 8 weeks between dupilumab injections, in patients with stable response to treatment or affected by numerous adverse events. Objectives: Investigate safety and clinical effectiveness of DS strategy in AD patients treated with dupilumab. Methods: A retrospective cohort study was conducted on AD patients aged ≥18 years treated with dupilumab undergoing DS. Pre-post analyses were conducted on this cohort, termed cohort A, between effectiveness outcomes at baseline, at 16 weeks of treatment, at the index date identified as the mean follow-up time between dupilumab initiation and DS, and at subsequent two follow-up visits: T1 and T2. Based on the index date, a cohort B of AD patients on dupilumab treatment not experiencing DS was then compared with cohort A for the same outcomes at the same time points. Results: Seventy-three out of 452 patients treated with dupilumab underwent DS. The mean time since treatment initiation was 28.6 months. Mean Eczema Area Severity Index (EASI) from the index date remained stable until the second follow-up visit (T2) 0.2-0.8 with no significant pre-post differences (P > 0.05). Similar considerations can be made for mean number rating scale worst pruritus (NRSp), numerical rating scale disturbs of sleeping/sleeping disturb (NRSsd), mean Dermatology Life Quality Index (DLQI), and EASI Head and Neck. Attainment of relative outcomes remained stable for EASI75, 90, ≤ 7, DLQI ≤ 5, and NRSp ≤ 4. When compared with cohort B, no clinically significant differences were observed in mean reductions in all outcomes analyzed. Conclusions: DS in our study appears to be an effective and safe strategy in treating patients with severe AD after the initial therapeutic response.

Long-term Safety and Efficacy of Dupilumab in Patients With Uncontrolled, Moderate-to-Severe Asthma Recruited From Korean Centers: A Subgroup Analysis of the Phase 3 LIBERTY ASTHMA TRAVERSE Trial.

Long-term data are limited on the safety and efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma from Korea. The current subgroup analysis was designed to evaluate the long-term safety and efficacy of dupilumab in patients enrolled from Korean centers in the parent studies (phase 2b and QUEST) and who participated in the TRAVERSE open-label extension (OLE) study. TRAVERSE was a global, multicenter, OLE study that assessed the safety and efficacy of dupilumab 300 mg every 2 weeks for up to 96 weeks in patients (n = 2,282) with uncontrolled, moderate-to-severe asthma who completed prior dupilumab asthma clinical trials. The primary outcome was the incidence of any treatment-emergent adverse events (TEAEs); the secondary outcomes included annualized severe exacerbation rate, pre-bronchodilator forced expiratory volume in 1 second (pre-BD FEV1), and 5-item Asthma Control Questionnaire (ACQ-5) score. Safety outcomes were consistent with the parent studies and the overall TRAVERSE population; out of 74 patients, 70 experienced ≥ 1 TEAE, and 6 (8.1%) discontinued because of adverse events. During the treatment period, the unadjusted annualized severe exacerbation rate was low (0.470). Improvement in pre-BD FEV1 was seen as early as Week 2 with a mean change from the parent study baseline (PSBL), standard deviation (SD) of 0.42 L (0.47), which was sustained until Week 96. Mean change from PSBL (SD) in ACQ-5 score was -1.32 (0.76) at Week 48. This subgroup analysis of TRAVERSE showed the long-term safety and efficacy of dupilumab in patients with uncontrolled, moderate-to-severe asthma enrolled from Korean centers. ClinicalTrials.gov Identifier: NCT02134028.

Short-, mid- and long-term efficacy of dupilumab in moderate-to-severe atopic dermatitis: a real-world multicentre Italian study of 2576 patients

Abstract Background The efficacy and safety of dupilumab in atopic dermatitis (AD) have been defined in clinical trials but limited real-world evidence on long-term treatment outcomes is currently available to inform clinical decisions. Objectives To describe the long-term effectiveness and safety of dupilumab up to 48 months in patients with moderate-to-severe AD. Methods A multicentre, retrospective, dynamic cohort study was conducted to assess long-term effectiveness and safety of dupilumab in patients with moderate-to-severe AD in a real-world setting. Predictors of minimal disease activity (MDA) optimal treatment target criteria [defined as the simultaneous achievement of a 90% reduction in Eczema Area and Severity Index score, itch-numeric rating scale (NRS) score ≤ 1, sleep-NRS score ≤ 1 and Dermatology Life Quality Index ≤ 1] were investigated. Results In total, 2576 patients were enrolled from June 2018 to July 2022. MDA optimal treatment target criteria were achieved by 506/2309 (21.9%), 769/1959 (39.3%), 628/1247 (50.4%), 330/596 (55.4%) and 58/106 (54.7%) of those that reached 4, 12, 24, 36 and 48 months of follow-up, respectively. Logistic regression revealed a negative effect on MDA achievement for conjunctivitis and food allergy at all timepoints. Adverse events (AEs) were mild and were observed in 373/2364 (15.8%), 166/2066 (8.0%), 83/1291 (6.4%), 27/601 (4.5%) and 5/110 (4.5%) of those that reached 4, 12, 24, 36 and 48 months of follow-up. Conjunctivitis was the most frequently reported AE during the available follow-up. AEs led to treatment discontinuation in &amp;lt; 1% of patients during the evaluated time periods. Conclusions The high long-term effectiveness and safety of dupilumab were confirmed in this dynamic cohort of patients with moderate-to-severe AD, regardless of clinical phenotype and course (persisting or relapsing) at baseline. Further research will be needed to investigate the effect of T helper cell 2 comorbidities and disease duration on the response to dupilumab and other newer therapeutics for AD.

Direct comparative study of anti-IgE and anti-IL4Rα therapy effectiveness in patients with severe allergic and mixed bronchial asthma

Introduction. There is insufficiency of direct comparative studies of genetically engineered biological drugs (GEBD) for severe bronchial asthma (SA) treatment in scientific databases.Aim. To compare omalizumab and dupilumab effectiveness in patients with allergic and mixed SA in real clinical practice.Materials and methods. The direct comparative study included SA patients with an allergic component from regional registry of Sverdlovsk region. The data of patients with allergic (n = 68) and mixed (n = 27) SA treated with omalizumab (n = 62) and dupilumab (n = 33) were analyzed. Therapy effectiveness was determined for 12 months in general group No. 1, allergic asthma group No. 2 and mixed asthma group No. 3 according to the following indicators: asthma control level (ACT), proportion of patients with uncontrolled asthma, need for systemic glucocorticosteroids (SGCS) and short‐acting beta agonists (SABA), basic therapy volume, asthma exacerbations number, emergency calls and hospitalizations, forced expiratory volume in the first second (FEV ), assessment of life quality (AQLQ and SNOT-22). Control evaluation visits were conducted before therapy start, after 4 and 12 months of biologics taking.Results. In general, during the 12 months of targeted therapy in patients receiving omalizumab statistically significant positive dynamics was observed in 12 of the 13 evaluated indicators; in patients receiving dupilumab – in 9 indicators. When analyzing such indicators as, ACT, taking SGCS, exacerbations of SA, FEV , statistically significant positive dynamics was revealed for all 4 indicators in patients receiving omalizumab in group No. 2 and in patients receiving dupilumab in group No. 3.Conclusions. Patients with allergic component of SA respond equally well to therapy with omalizumab and dupilumab. At the same time, a tendency towards the advantage of omalizumab in patients with allergic asthma, and dupilumab in patients with a mixed phenotype of the disease was revealed.

Prevalence of omalizumab-resistant chronic urticaria and real-world effectiveness of dupilumab in patients with omalizumab-refractory chronic urticaria: a single-centre experience.

Chronic urticaria (CU) is characterized by weals (hives) angio-oedema (or both) that last for ≥ 6 weeks, with chronic spontaneous urticaria (CSU) being the most common subtype. Patients with omalizumab-refractory CSU represent an unmet clinical need. In this study, we aimed to assess the prevalence and predictors of omalizumab failure in a large cohort of patients with CU and assess the effectiveness of dupilumab for omalizumab-refractory CU. Of 338 patients with CU, 33 received omalizumab; 69.7% (n = 23) were responders and 30.3% (n = 10) were nonresponders. Bivariate regression demonstrated that female sex [adjusted odds ratio (aOR) 1.53, 95% confidence interval (CI) 1.14-2.06], higher baseline weekly urticaria activity score (aOR 1.05, 95% CI 1.01-1.09) and older age (controlling for sex) (aOR 1.00, 95% CI 1.00-1.01) were associated with omalizumab failure. Of 10 patients with omalizumab-refractory CU, 3 were well controlled with ciclosporin (all children), whereas the 7 adults failed a mean [standard deviation (SD)] of 5.6 (2.6) treatments, including ciclosporin. All seven achieved a complete response with dupilumab, with time to response varying between 1 and 6 months. While our results suggest a favourable efficacy of dupilumab in patients with omalizumab-refractory CU, future confirmatory studies are required.

Prediction of Clinical Response to Dupilumab in Patients with Severe Asthma Using Fractional Exhaled Nitric Oxide Combined with Pulmonary Function Testing

Introduction: This study aimed to assess the effectiveness of fractional exhaled nitric oxide (FeNO) combined with pulmonary function testing (PFT) for predicting the treatment outcome of patients with severe asthma receiving dupilumab. Methods: A total of 31 patients with severe asthma visiting our hospital from January 2022 to June 2023 were included in this study, with 28 patients completing a 16-week course of dupilumab treatment. Baseline clinical data, including demographic information, blood eosinophil counts, serum IgE levels, FeNO, asthma control test (ACT), asthma control questionnaire (ACQ), and other parameters, were collected. A predictive model using a generalized linear model was established. Results: Following the 16-week course of dupilumab treatment, 22 patients showed effective response based on GETE scores, while 6 patients were nonresponders. Notably, significant improvements were observed in clinical parameters such as blood eosinophil counts, serum IgE levels, FeNO, FEV1, FEV1%, ACT, and ACQ in both response groups (p < 0.05). FeNO and pulmonary function tests demonstrated AUC values of 0.530, 0.561, and 0.765, respectively, in predicting the clinical efficacy of dupilumab, which were lower than when FeNO was combined with FEV1%. The combination of FeNO and FEV1% had a sensitivity of 1.000 and specificity of 0.591 in predicting treatment response. Conclusion: The combined assessment of FeNO and FEV1% provides improved accuracy for predicting the clinical efficacy of dupilumab in managing severe asthma. However, further larger scale clinical studies with comprehensive follow-up data are needed to validate the therapeutic efficacy and applicability across diverse patient populations.

A Systematic Evaluation of Dupilumab for Bullous Pemphigoid Treatment

This paper systematically reviews the current articles regarding the use of dupilumab in the treatment of bullous pemphigoid (BP) to evaluate its safety and efficacy. PubMed, Embase, Cochrane Library, and Web of Science databases were searched for publications on dupilumab for BP from inception to 10 March, 2023. A total of 26 studies were included for systematic review. The primary outcome was clinical remission, and the secondary outcomes were recurrence and adverse events. Among 96 patients, 71.8% (n = 69/96) received systemic or topical steroids, immunosuppressants, immunomodulators, intravenous immunoglobulins, antihistamines, plasmapheresis, rituximab, and omalizumab, but none of them were successful. After dupilumab treatment, 66.7% (n = 64/96) of patients achieved complete remission, 25.0% (n = 24/96) had partial remission, 5.2% (n = 5/96) showed no remission, and no patients experienced deterioration. In addition, 1.0% (n = 1/96) and 2.0% (n = 2/96) patients stopped using dupilumab due to adverse reactions and cost, respectively. The average remission time was 4.5 months. 46.2% (n = 25/96) of the patients were followed up with a median follow-up of 8 months and only 2 patients relapsed at 8 and 7 months, respectively. Adverse event was 16.9% (n = 12/71), of which transient eosinophilia was the most common. This study indicates that the dupilumab is a promising treatment for BP with high clinical benefit associated with low recurrence rate, adverse event rate, and mortality. However, a large-scale randomized controlled trial is needed to further confirm the safety and efficacy of dupilumab in patients with BP treatment.

Dupilumab provides sustained effectiveness on patient-reported outcomes and favorable safety in patients with moderate-to-severe atopic dermatitis: Up to 5-year results from the daily practice BioDay registry

BackgroundLong-term daily practice data on patient-reported benefits of dupilumab for atopic dermatitis (AD) remains limited. ObjectiveTo evaluate patient-reported outcome measures (PROMs) and the safety of dupilumab in patients with moderate-to-severe AD over a follow-up period of up to 5 years. MethodsData were extracted from the prospective, multicenter BioDay registry (October 2017 - 2022) of patients with moderate-to-severe AD treated with dupilumab in daily practice. ResultsIn total 1223 patients, 1108 adults and 115 pediatric patients, were included. After ≥1 year of treatment, mean Patient-Oriented Eczema Measure (POEM), Dermatology Life Quality Index (DLQI), Numeric rating scale (NRS)-pruritus ranged between 7.8-8.7, 3.5-4.2, and 2.9-3.1 in adults, respectively, whilst these PROMs ranged between 8.9-10.9, 4.4-6.4, and 3.0-3.7 in pediatric patients, respectively. At follow-up, overall work impairment decreased from 40.1% to 13.3-16.3% in adults. Furthermore, class I obesity and itch-dominant patients generally had less favorable treatment response. Of all patients, 66.8% reported ≥1 adverse event, with conjunctivitis being the most common(33.7%). LimitationsThe overall percentage of missing values for selected PROMs was 26% in adults and 46% in pediatric patients. ConclusionIn addition to favorable safety, dupilumab has demonstrated sustained effectiveness across various PROMs, underscoring the treatment benefits from patients’ perspectives.