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Doctoral Thesis
DOI
https://doi.org/10.11606/T.17.2021.tde-11042022-140938
Document
Author
Full name
Sarah Sella Langer
Institute/School/College
Knowledge Area
Date of Defense
Published
Ribeirão Preto, 2021
Supervisor
Committee
Arruda, Luisa Karla de Paula (President)
Castro, Ana Paula Beltran Moschione
Frade, Marco Andrey Cipriani
Yang, Ariana Campos
Title in Portuguese
Efeito da imunoterapia sublingual com extrato de ácaro em pacientes com dermatite atópica: estudo randomizado duplo-cego placebo-controlado
Keywords in Portuguese
Ácaros de poeira domiciliar
Dermatite atópica
Imunoterapia alérgeno específica
Imunoterapia sublingual
SCORAD
Abstract in Portuguese
Introdução: Sensibilização a ácaros da poeira domiciliar é frequente entre os pacientes com dermatite atópica (DA). Objetivos: Investigar a eficácia da imunoterapia sublingual (ITSL) com extrato de ácaro Dermatophagoides pteronyssinus (Dpt) em pacientes com DA e alérgicos a ácaros. Casuística e Método: Neste ensaio clínico randomizado, duplo-cego, placebo-controlado, recrutaram-se 91 pacientes com idade ≥ 3 anos, com SCORing Atopic Dermatitis (SCORAD) ≥ 15 e prick test e/ou IgE para Dpt positivos. Pacientes foram estratificados de acordo com a idade (<12 e ≥ 12 anos) para receber ITSL ou placebo por 18 meses. O desfecho primário foi a queda de ≥ 15 pontos no SCORAD. Desfechos secundários foram quedas no SCORAD e SCORAD objetivo (OSCORAD), Eczema Area and Severity Index (EASI), escala analógica de sintomas (VAS), escala de prurido; Avaliação global do investigador (IGA) 0/1; e queda ≥ 4 pontos no Dermatology Life Quality Index (DLQI). A terapêutica de base foi mantida, incluindo imunossupressores. Resultados: Sessenta e seis pacientes completaram o estudo (35 ITSL, 31 placebo). Após 18 meses, 74,2% e 58% pacientes em ITSL e placebo, respectivamente, atingiram queda no SCORAD ≥ 15 pontos (risco relativo [RR] 1,28, 95% intervalo de confiança [IC] 0,89-1,83). Queda significante no SCORAD inicial de 55,6% e 34,5% no grupo ITSL e placebo (diferença média 20,4; 95% IC 3,89-37,3); redução significante no O-SCORAD de 56,8% e 34,9% no grupo ITSL e placebo (diferença média 21,3; 95% IC 0,66-41,81); e mais pacientes com IGA 0/1 no grupo ITSL comparado ao placebo (14/35 vs 5/31; RR 2,63, 95% IC 1,09-6,39), foram observados aos 18 meses. Não foram observadas diferenças significantes nos valores de EASI, VAS e DLQI. Conclusão: Nossos resultados sugerem que a ITSL com extrato de ácaro pode ser efetiva como terapia adicional nos pacientes com DA e alérgicos a ácaros.
Title in English
Efficacy of house dust mite sublingual immunotherapy in patients with atopic dermatitis: a randomized, double-blind, placebo-controlled trial
Keywords in English
Allergen immunotherapy
Atopic dermatitis
House dust mite
SCORing atopic dermatitis
Sublingual immunotherapy
Abstract in English
Background: Sensitization to house dust mites (HDM) is frequent in patients with atopic dermatitis (AD). Objectives: The objective of this trial was to investigate the efficacy of sublingual immunotherapy (SLIT) with Dermatophagoides pteronyssinus (Dpt) extract in patients with AD allergic to HDM. Methods: In this randomized, double-blind, placebocontrolled trial, we enrolled 91 patients aged ≥ 3 years, with SCORing Atopic Dermatitis (SCORAD) ≥ 15 and positive skin test and/or IgE to Dpt. Patients were stratified according to age (<12 and ≥ 12 years) to receive HDM SLIT or placebo for 18 months. Primary outcome was a ≥ 15 point decrease in SCORAD. Secondary outcomes were decreases in SCORAD and objective SCORAD (O-SCORAD), Eczema Area and Severity Index (EASI), visual analog scale (VAS) for symptoms, pruritus scale; Investigator´s Global Assesment (IGA) 0/1; and decrease ≥ 4 points in Dermatology Life Quality Index (DLQI). Background therapy was maintained. Results: Sixty-six patients completed the study (35 HDM SLIT, 31 placebo). After 18 months, 74.2% and 58% patients in HDM SLIT and placebo groups, respectively, showed ≥ 15-point decrease in SCORAD (relative risk [RR] 1.28, 95% confidence interval [CI] 0.89-1.83). Significant SCORAD decreases from baseline of 55.6% and 34.5% in HDM SLIT and placebo groups (mean difference 20.4; 95% CI 3.89-37.3); significant O-SCORAD decreases of 56.8% and 34.9% in HDM SLIT and placebo groups (mean difference 21.3; 95% CI 0.66- 41.81); and more patients with IGA 0/1 in HDM SLIT group as compared to placebo group (14/35 vs 5/31; RR 2.63, 95% CI 1.09-6.39), were observed at 18 months. There was no significant difference in EASI, VAS, and DLQI values. Conclusion: Our results suggest that HDM SLIT may be effective in HDM allergic patients as an add-on treatment for AD.
 
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Publishing Date
2022-04-14
 
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