청소년과 성인 아토피피부염 환자에서 dupilumab의 임상효과와 순응도: 한국의 단일 알레르기 클리닉의 실제 진료 상황에서의 관찰 결과 분석
Clinical efficacy and compliance of dupilumab therapy in adolescent and adult patients with atopic dermatitis in real clinical practice: An analysis of data from a single allergy clinic in Korea
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Purpose: Dupilumab (a monoclonal antibody to interleukin-4 receptor alpha) is the first biological agent approved for the treatment of moderate-to-severe atopic dermatitis (AD). We evaluated the clinical efficacy and compliance of dupilumab therapy for AD in real clinical practice. Methods: Medical records of 132 adolescent and adult patients with AD who received at least one dose of dupilumab were retrospectively analyzed. Clinical efficacy of dupilumab was assessed by either changes in eczema area and severity index (EASI) or changes in the requirement of medications from baseline to weeks 16 and 42. Clinical response was determined by the proportion of patients with decreased EASI scores of at least 75% from baseline at week 16 (EASI–75). Clinical remission was defined as a complete withdrawal of all the medications for AD except dupilumab. Results: Dupilumab was administered for 16 weeks (77.3%) and 42 weeks (63.6%) in 132 patients with AD. In patients who received reimbursement from National Healthcare Insurance of Korea (NHIK) for dupilumab therapy, the compliance of dupilumab therapy was 90.2% and 87.8%, and EASI–75 response rate was 92.5% and 100% at weeks 16 and 42, respectively. In patients who received the dupilumab therapy without NHIK reimbursement (self-payment), the compliance of dupilumab therapy was 71.4% and 52.7%, the clinical remission rate was 44.0% and 64.6%, and the median interval of dupilumab therapy was 4 weeks (range, 2–13 weeks) and 5 weeks (2–15 weeks) at weeks 16 and 42, respectively. Conclusion: Dupilumab therapy may be clinically useful in the aspects of efficacy and compliance in patients with AD.
Abstract
Purpose: Dupilumab (a monoclonal antibody to interleukin-4 receptor alpha) is the first biological agent approved for the treatment of moderate-to-severe atopic dermatitis (AD). We evaluated the clinical efficacy and compliance of dupilumab therapy for AD in real clinical practice. Methods: Medical records of 132 adolescent and adult patients with AD who received at least one dose of dupilumab were retrospectively analyzed. Clinical efficacy of dupilumab was assessed by either changes in eczema area and severity index (EASI) or changes in the requirement of medications from baseline to weeks 16 and 42. Clinical response was determined by the proportion of patients with decreased EASI scores of at least 75% from baseline at week 16 (EASI–75). Clinical remission was defined as a complete withdrawal of all the medications for AD except dupilumab. Results: Dupilumab was administered for 16 weeks (77.3%) and 42 weeks (63.6%) in 132 patients with AD. In patients who received reimbursement from National Healthcare Insurance of Korea (NHIK) for dupilumab therapy, the compliance of dupilumab therapy was 90.2% and 87.8%, and EASI–75 response rate was 92.5% and 100% at weeks 16 and 42, respectively. In patients who received the dupilumab therapy without NHIK reimbursement (self-payment), the compliance of dupilumab therapy was 71.4% and 52.7%, the clinical remission rate was 44.0% and 64.6%, and the median interval of dupilumab therapy was 4 weeks (range, 2–13 weeks) and 5 weeks (2–15 weeks) at weeks 16 and 42, respectively. Conclusion: Dupilumab therapy may be clinically useful in the aspects of efficacy and compliance in patients with AD.
참고문헌 (25)
- 남동호, "Personalized Immunomodulatory Therapy for Atopic Dermatitis: An Allergist’s View", Annals of Dermatology, 27(4), pp.355~363 (2015), 대한피부과학회
- Izadi N, "Clinical approach to the patient with refractory atopic dermatitis", Ann Allergy Asthma Immunol, 120, pp.23~33 (2018)
- Beck LA, "Dupilumab treatment in adults with moderate-to-severe atopic dermatitis", N Engl J Med, 371, pp.130~139 (2014)
- Simpson EL, "Two phase 3 trials of dupilumab versus placebo in atopic dermatitis", N Engl J Med, 375, pp.2335~2348 (2016)
- Blauvelt A, "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", Lancet, 389, pp.2287~2303 (2017)
- "Dupixent® (dupilumab) injection, for subcutaneous use: US prescribing information" (2017)[URL]
- Noda S, "The Asian atopic dermatitis phenotype combines features of atopic dermatitis and psoriasis with increased TH17 polarization", J Allergy Clin Immunol, 136, pp.1254~1264 (2015)
- Brunner PM, "Racial differences in atopic dermatitis", Ann Allergy Asthma Immunol, 122, pp.449~455 (2019)
- Tauber M, "Effect of dupilumab on atopic manifestations in patients treated for atopic dermatitis in real-life practice", Br J Dermatol, 180, pp.1551~1552 (2019)
- Faiz S, "Effectiveness and safety of dupilumab for the treatment of atopic dermatitis in a real-life French multicenter adult cohort", J Am Acad Dermatol, 81, pp.143~151 (2019)
- Lee Youngsoo, "Real Clinical Practice Data of Monthly Dupilumab Therapy in Adult Patients With Moderate-to-Severe Atopic Dermatitis: Clinical Efficacy and Predictive Markers for a Favorable Clinical Response", Allergy, Asthma & Immunology Research, 13(5), pp.733~745 (2021), 대한천식알레르기학회[DOI]
- Hanifin JM, "The eczema area and severity index(EASI) : assessment of reliability in atopic dermatitis", Exp Dermatol, 10, pp.11~18 (2001)
- Severity scoring of atopic dermatitis : the SCORAD index, "Consensus Report of the European Task Force on Atopic Dermatitis", Dermatology, 186, pp.23~31 (1993)
- Futamura M, "A systematic review of Investigator Global Assessment(IGA)in atopic dermatitis(AD)trials : many options, no standards", J Am Acad Dermatol, 74, pp.288~294 (2016)
- Halling AS, "Real-world evidence of dupilumab efficacy and risk of adverse events : a systematic review and meta-analysis", J Am Acad Dermatol, 84, pp.139~147 (2021)
- Gu C, "Real-world efficacy and safety of dupilumab in Chinese patients with atopic dermatitis : a single-centre, prospective, open-label study", J Eur Acad Dermatol Venereol, 36, pp.1064~1073 (2022)
- Kychygina A, "Dupilumab-associated adverse events during treatment of allergic diseases", Clin Rev Allergy Immunol, 62, pp.519~533 (2022)
- 손지희, "Clinical Features of Atopic Dermatitis in Adults Are Different according to Onset", Journal of Korean Medical Science, 32(8), pp.1360~1366 (2017), 대한의학회
- 남동호, "Associations of Atopic Dermatitis With Obesity and Unmarried Status in Young Adults: Evidence for Atopic Dermatitis as a Life-Style Disorder With High Social Impact", Allergy, Asthma & Immunology Research, 8(2), pp.89~91 (2016), 대한천식알레르기학회
- Holm JG, "Determinants of disease severity among patients with atopic dermatitis : association with components of the atopic march", Arch Dermatol Res, 311, pp.173~182 (2019)
- Hu Y, "Clinical relevance of eosinophils, basophils, serum total IgE level, allergen-specific IgE, and clinical features in atopic dermatitis", J Clin Lab Anal, 34, pp.e23214~ (2020)
- Morishima Y, "Changes in serum lactate dehydrogenase activity in children with atopic dermatitis", Pediatr Int, 52, pp.171~174 (2010)
- Kato A, "Higher baseline serum lactate dehydrogenase level is associated with poor effectiveness of dupilumab in the long term in patients with atopic dermatitis", J Dermatol, 47, pp.1013~1019 (2020)
- Thaçi D, "Efficacy and safety of dupilumab in adults with moderate-to-severe atopic dermatitis inadequately controlled by topical treatments : a randomised, placebo-controlled, dose-ranging phase 2b trial", Lancet, 387, pp.40~52 (2016)
- Simpson EL, "Efficacy and safety of dupilumab in adolescents with uncontrolled moderate to severe atopic dermatitis : a phase 3 randomized clinical trial", JAMA Dermatol, 156, pp.44~56 (2020)