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Efficacy, Safety, and Immunomodulatory Effect of the Intramuscular Administration of Autologous Total Immunoglobulin G for Atopic Dermatitis: A Randomized Clinical Trial

Allergy, Asthma & Immunology Research : AAIR 2020년 12권 6호 p.949 ~ 963
남동호, 예영민, 신유섭, 박해심, 김명은, Kwon Byul, 조수미, 한진주,
소속 상세정보
남동호 ( Nahm Dong-Ho ) - Ajou University School of Medicine Department of Allergy and Clinical Immunology
예영민 ( Ye Young-Min ) - Ajou University School of Medicine Department of Allergy and Clinical Immunology
신유섭 ( Shin Yoo-Seob ) - Ajou University School of Medicine Department of Allergy and Clinical Immunology
박해심 ( Park Hae-sim ) - Ajou University School of Medicine Department of Allergy and Clinical Immunology
김명은 ( Kim Myoung-Eun ) - Ajou University School of Medicine Department of Allergy and Clinical Immunology
 ( Kwon Byul ) - Ajou University School of Medicine Department of Allergy and Clinical Immunology
조수미 ( Cho Su-Mi ) - Ajou University School of Medicine Department of Allergy and Clinical Immunology
한진주 ( Han Jin-Joo ) - Ajou University Institute of Medical Sciences Office of Biostatistics

Abstract


Purpose: The management of patients with atopic dermatitis (AD) is often difficult. We hypothesized that repeated intramuscular administration of autologous total immunoglobulin G (IgG) could induce clinical improvement in patients with AD through immune modulation. This clinical trial was conducted to evaluate the efficacy, safety, and immunomodulatory effect of the intramuscular administration of autologous total IgG in patients with AD.

Methods: In this randomized, double-blind, placebo-controlled trial, 51 adolescent and adult patients with moderate-to-severe AD were randomized to receive 8 weekly intramuscular administrations of autologous total IgG 50 mg (n = 26) or saline (n = 25) over a 7-week period and were followed up to week 16. Changes in the clinical severity score (Eczema Area and Severity Index), affected body surface area, patient-reported Dermatology Life Quality Index (DLQI) score, laboratory biomarkers, and incidence of adverse events from baseline to week 16 were assessed.

Results: The intramuscular administration of autologous total IgG, compared with saline, decreased the clinical severity score (?64.8% vs. ?20.3%, P < 0.001), reduced the affected body surface area (?53.9% vs. ?19.1%, P < 0.001), improved the DLQI score (?35.4% vs. ?14.4%, P = 0.015), increased serum interleukin-10 and interferon-γ levels (P = 0.011 and P = 0.003, respectively), and reduced the incidence of AD exacerbation (11.5% vs. 48.0%, P = 0.004) from baseline to week 16. No serious adverse events were observed.

Conclusions: The intramuscular administration of autologous total IgG provided clinical improvements and a systemic immunomodulatory effect in adolescent and adult patients with moderate-to-severe AD without significant side effects.

키워드

Atopic dermatitis; clinical trial; immunoglobulin G

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