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      Real long-term data of dupilumab in atopic dermatitis Translated title: Datos en vida real a largo plazo de dupilumab en dermatitis atópica

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          Abstract

          SUMMARY Objectives: Dupilumab is the first biological drug indicated in atopic dermatitis (AD). The aim of this study is to assess effectiveness and safety of dupilumab in moderate-severe AD in clinical practice, and the quality of life of treated patients. Methods: Descriptive retrospective study was conducted. Effectiveness was measured by SCORingAtopic Dermatitis (SCORAD). Primary endpoint was SCORAD-75; secondary endpoints were SCORAD-90 and “total clearance”, at week 4, 12, 24 and 48. Safety was evaluated according to adverse events profile. Quality of life was assessed by Dermatology Life Quality Index (DLQI) at week 0 and 48. Results: At week 4, 2 patients presented SCORAD-75, none presented SCORAD-90 or clearance. At week 12, 2 patients showed SCORAD-75, 2 SCORAD-90 and one clearance. At weeks 24 and 48, 3 patients presented SCORAD-90 and 3 clearance. All patients presented mild-moderate adverse events. DLQI at week 48 was 0.7. Conclusions: Dupilumab presented adequate effectiveness and safety, improving quality of life of treated patients.

          Translated abstract

          RESUMEN Objetivos: Dupilumab es el primer fármaco biológico con indicación en dermatitis atópica. El objetivo es evaluar la efectividad y la seguridad de dupilumab en dermatitis atópica moderada-grave en la práctica clínica, así como la calidad de vida de los pacientes tratados. Métodos: Se realizó un estudio descriptivo retrospectivo. La efectividad se evaluó mediante el SCORingAtopic Dermatitis (SCORAD). La variable primaria fue SCORAD-75; las variables secundarias fueron SCORAD-90 y "aclaramiento total", en las semanas 4, 12, 24 y 48. La seguridad se evaluó mediante el perfil de eventos adversos. La calidad de vida se evaluó mediante el Dermatology Life Quality Index (DLQI) en las semanas 0 y 48. Resultados: En la semana 4, 2 pacientes presentaron SCORAD-75, ninguno presentó SCORAD-90 o aclaramiento. En la semana 12, 2 pacientes mostraron SCORAD-75, 2 SCORAD-90 y uno aclaramiento. En las semanas 24 y 48, 3 pacientes presentaron SCORAD-90 y 3 aclaramiento. Todos los pacientes presentaron efectos adversos leves-moderados. El DLQI en la semana 48 fue 0,7. Conclusiones: Dupilumab presentó una efectividad y seguridad adecuadas, mejorando la calidad de vida de los pacientes.

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          Dermatology Life Quality Index (DLQI)--a simple practical measure for routine clinical use.

          A simple practical questionnaire technique for routine clinical use, the Dermatology Life Quality Index (DLQI) is described. One hundred and twenty patients with different skin diseases were asked about the impact of their disease and its treatment on their lives; a questionnaire, the DLQI, was developed based on their answers. The DLQI was then completed by 200 consecutive new patients attending a dermatology clinic. This study confirmed that atopic eczema, psoriasis and generalized pruritus have a greater impact on quality of life than acne, basal cell carcinomas and viral warts. The DLQI was also completed by 100 healthy volunteers; their mean score was very low (1.6%, s.d. 3.5) compared with the mean score for the dermatology patients (24.2%, s.d. 20.9). The reliability of the DLQI was examined in 53 patients using a 1 week test-retest method and reliability was found to be high (gamma s = 0.99).
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            Two Phase 3 Trials of Dupilumab versus Placebo in Atopic Dermatitis.

            Background Dupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, inhibits signaling of interleukin-4 and interleukin-13, type 2 cytokines that may be important drivers of atopic or allergic diseases such as atopic dermatitis. Methods In two randomized, placebo-controlled, phase 3 trials of identical design (SOLO 1 and SOLO 2), we enrolled adults with moderate-to-severe atopic dermatitis whose disease was inadequately controlled by topical treatment. Patients were randomly assigned in a 1:1:1 ratio to receive, for 16 weeks, subcutaneous dupilumab (300 mg) or placebo weekly or the same dose of dupilumab every other week alternating with placebo. The primary outcome was the proportion of patients who had both a score of 0 or 1 (clear or almost clear) on the Investigator's Global Assessment and a reduction of 2 points or more in that score from baseline at week 16. Results We enrolled 671 patients in SOLO 1 and 708 in SOLO 2. In SOLO 1, the primary outcome occurred in 85 patients (38%) who received dupilumab every other week and in 83 (37%) who received dupilumab weekly, as compared with 23 (10%) who received placebo (P<0.001 for both comparisons with placebo). The results were similar in SOLO 2, with the primary outcome occurring in 84 patients (36%) who received dupilumab every other week and in 87 (36%) who received dupilumab weekly, as compared with 20 (8%) who received placebo (P<0.001 for both comparisons). In addition, in the two trials, an improvement from baseline to week 16 of at least 75% on the Eczema Area and Severity Index was reported in significantly more patients who received each regimen of dupilumab than in patients who received placebo (P<0.001 for all comparisons). Dupilumab was also associated with improvement in other clinical end points, including reduction in pruritus and symptoms of anxiety or depression and improvement in quality of life. Injection-site reactions and conjunctivitis were more frequent in the dupilumab groups than in the placebo groups. Conclusions In two phase 3 trials of identical design involving patients with atopic dermatitis, dupilumab improved the signs and symptoms of atopic dermatitis, including pruritus, symptoms of anxiety and depression, and quality of life, as compared with placebo. Trials of longer duration are needed to assess the long-term effectiveness and safety of dupilumab. (Funded by Sanofi and Regeneron Pharmaceuticals; SOLO 1 ClinicalTrials.gov number, NCT02277743 ; SOLO 2 ClinicalTrials.gov number, NCT02277769 .).
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              Long-term management of moderate-to-severe atopic dermatitis with dupilumab and concomitant topical corticosteroids (LIBERTY AD CHRONOS): a 1-year, randomised, double-blinded, placebo-controlled, phase 3 trial.

              Dupilumab (an anti-interleukin-4-receptor-α monoclonal antibody) blocks signalling of interleukin 4 and interleukin 13, type 2/Th2 cytokines implicated in numerous allergic diseases ranging from asthma to atopic dermatitis. Previous 16-week monotherapy studies showed that dupilumab substantially improved signs and symptoms of moderate-to-severe atopic dermatitis with acceptable safety, validating the crucial role of interleukin 4 and interleukin 13 in atopic dermatitis pathogenesis. We aimed to evaluate the long-term efficacy and safety of dupilumab with medium-potency topical corticosteroids versus placebo with topical corticosteroids in adults with moderate-to-severe atopic dermatitis.
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                Author and article information

                Journal
                ofil
                Revista de la OFIL
                Rev. OFIL·ILAPHAR
                Organización de Farmacéuticos Ibero-Latinoamericanos (Madrid, Madrid, Spain )
                1131-9429
                1699-714X
                2020
                : 30
                : 1
                : 25-27
                Affiliations
                [1] Puerto Real Cádiz orgnameHospital Universitario de Puerto Real orgdiv1UGC Farmacia España
                Article
                S1699-714X2020000100008 S1699-714X(20)03000100008
                6d2bf6d8-52f2-4df5-9921-b0766978ccbc

                This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License.

                History
                : 03 September 2019
                : 28 August 2019
                Page count
                Figures: 0, Tables: 0, Equations: 0, References: 15, Pages: 3
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                SciELO Spain

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                Originals

                safety,quality of life,Dermatitis atópica,efectividad,effectiveness,dupilumab,Atopic dermatitis,seguridad,calidad de vida

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