본문 바로가기
KERD
논문KCI 등재

트랄로키누맙과 두필루맙의 매칭 조정 간접 비교

Matching-adjusted Indirect Comparison (MAIC) of Tralokinumab Versus Dupilumab for the Treatment of Moderate to Severe Adult Atopic Dermatitis

2

조회

0

다운로드

0

인용

0

참고문헌

키워드

주제분류약학

초록

Objective: Atopic dermatitis (AD) is a chronic, recurrent inflammatory skin disease. Both tralokinumab and dupilumab have been recommended in the European Guideline for the treatment of adult patients with severe AD. In Korea, dupilumab has been approved for patients with moderate to severe AD, and reimbursed for those with severe AD. Since there is no clinical trial directly comparing tralokinumab and dupilumab, we conducted indirect comparison to assess the clinical usefulness in patients with AD. Methods: We selected clinical trials for indirect comparison through a systematic literature review. Individual patient data were available for the tralokinumab clinical trial, and aggregated data were available for the dupilumab clinical trial. Therefore, we employed the Matching-Adjusted Indirect Comparison (MAIC) method. The treatment efficacy was assessed based on whether patients achieved a 75% reduction on the Eczema Area and Severity Index (EASI 75) after drug administration. Results: The difference in the proportion of patients achieving EASI 75 between tralokinumab and dupilumab was 4.7% (95% CI: −7.9 to 17.3). Considering the non-inferiority margin for the EASI 75 achievement rate is −10%, tralokinumab is deemed non-inferior to dupilumab as the lower bound of the CI for the difference in the EASI 75 achievement rate between tralokinumab and dupilumab was within −10%. Conclusion: We conducted a MAIC analysis comparing tralokinumab and dupilumab based on EASI 75 achievement. The findings of this study show that tralokinumab is non-inferior to dupilumab and can be implemented in Korean clinical settings with a therapeutic position comparable to dupilumab.

Abstract

Objective: Atopic dermatitis (AD) is a chronic, recurrent inflammatory skin disease. Both tralokinumab and dupilumab have been recommended in the European Guideline for the treatment of adult patients with severe AD. In Korea, dupilumab has been approved for patients with moderate to severe AD, and reimbursed for those with severe AD. Since there is no clinical trial directly comparing tralokinumab and dupilumab, we conducted indirect comparison to assess the clinical usefulness in patients with AD. Methods: We selected clinical trials for indirect comparison through a systematic literature review. Individual patient data were available for the tralokinumab clinical trial, and aggregated data were available for the dupilumab clinical trial. Therefore, we employed the Matching-Adjusted Indirect Comparison (MAIC) method. The treatment efficacy was assessed based on whether patients achieved a 75% reduction on the Eczema Area and Severity Index (EASI 75) after drug administration. Results: The difference in the proportion of patients achieving EASI 75 between tralokinumab and dupilumab was 4.7% (95% CI: −7.9 to 17.3). Considering the non-inferiority margin for the EASI 75 achievement rate is −10%, tralokinumab is deemed non-inferior to dupilumab as the lower bound of the CI for the difference in the EASI 75 achievement rate between tralokinumab and dupilumab was within −10%. Conclusion: We conducted a MAIC analysis comparing tralokinumab and dupilumab based on EASI 75 achievement. The findings of this study show that tralokinumab is non-inferior to dupilumab and can be implemented in Korean clinical settings with a therapeutic position comparable to dupilumab.

참고문헌 (29)

  1. Ceci RLF, "Goldman’s Cecil Medicine, Single Volume, 24: Goldman’s Cecil Medicine (Vol. 1)", pp.2209~2211 (2012), Elsevier Health Sciences
  2. "Healthcare big data system"[URL]
  3. Wollenberg A, "European guideline(EuroGuiDerm)on atopic eczema : part I-systemic therapy", Journal of the European Academy of Dermatology and Venereology, 36(9), pp.1409~1431 (2022)
  4. Bieber T, "Interleukin-13 : Targeting an underestimated cytokine in atopic dermatitis", Allergy, 75(1), pp.54~62 (2020)
  5. Zhang Y, "The efficacy and safety of IL-13inhibitors in atopic dermatitis : A systematic review and metaanalysis", Front Immunol, 13, pp.923362~ (2022)
  6. "Reimbursement criteria-Upadacitinib"[URL]
  7. "Rinvoq approval"[URL]
  8. HIRA, "Guidelines for Evaluating the Economics of Drugs", ~ (2021)
  9. Gutermuth J, "Tralokinumab plus topical corticosteroids in adults with severe atopic dermatitis and inadequate response to or intolerance of ciclosporin A : A placebo-controlled, randomized, phase III clinical trial(ECZTRA 7)", British Journal of Dermatology, 186(3), pp.440~452 (2022)
  10. de Bruin-Weller M, "Dupilumab with concomitant topical corticosteroid treatment in adults with atopic dermatitis with an inadequate response or intolerance to ciclosporin A or when this treatment is medically inadvisable : a placebo-controlled, randomized phase III clinical trial(LIBERTY AD CAFÉ)", British Journal of Dermatology, 178(5), pp.1083~1101 (2018)
  11. Kimball AB, "Interpretation of EASI-75from a patient perspective—a post hoc analysis from a phase 2b trial of dupilumab in adults with moderate-to-severe atopic dermatitis", JAAD, 76(6 Suppl 1), pp.416~ (2017)
  12. Schmitt J, "The Harmonising Outcome Measures for Eczema(HOME)statement to assess clinical signs of atopic eczema in trials", J Allergy Clin Immunol, 134(4), pp.800~807 (2014)
  13. "Reimbursement criteria - Dupilumab"[URL]
  14. 김정은, "2019 Consensus Korean Diagnostic Guidelines to Define Severity Classification and Treatment Refractoriness for Atopic Dermatitis: Objective and Subjective Assessment of Severity", Annals of Dermatology, 31(6), pp.654~661 (2019), 대한피부과학회[DOI]
  15. Wangge G, "The challenges of determining noninferiority margins : a case study of noninferiority randomized controlled trials of novel oral anticoagulants", CMAJ, 185(3), pp.222~227 (2013)
  16. Halmos B, "A matching-adjusted indirect comparison of pembrolizumab+ chemotherapy vs. nivolumab+ipilimumab as first-line therapies in patients with PD-L1 TPS≥1%metastatic NSCLC", Cancers, 12(12), pp.3648~ (2020)
  17. Signorovitch JE, "Comparative effectiveness without head-to-head trials : a method for matching-adjusted indirect comparisons applied to psoriasis treatment with adalimumab or etanercept", Pharmacoeconomics, 28(10), pp.935~945 (2010)
  18. Jackson D, "Alternative weighting schemes when performing matching-adjusted indirect comparisons", Res Synth Methods, 12(3), pp.333~346 (2021)
  19. Signorovitch JE, "Matching-adjusted indirect comparisons: a new tool for timely comparative effectiveness research", Value Health, 15(6), pp.940~947 (2012)
  20. "Non-Inferiority Clinical Trials to Establish Effectiveness Guidance for Industry" (2016)[URL]
  21. Reich K, "Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomized, double-blind, multicentre phase 3trial", Lancet, 400(10348), pp.273~282 (2022)
  22. CADTH, "Clinical review report-Dupilumab.CADTTH Common Drug Review", Canadian Agency for Drugs and Technologies in Health, ~ (2018)
  23. Sedeh FB, "Comparative Efficacy and Safety of Monoclonal Antibodies and Janus Kinase Inhibitors in Moderate-to-severe Atopic Dermatitis : A Systematic Review and Meta-analysis", Acta Derm Venereol, 102 (2022)
  24. Silverberg JI, "Comparative efficacy and safety of systemic therapies used in moderate-to-severe atopic dermatitis : a systematic literature review and network meta-analysis", Journal of the European Academy of Dermatology and Venereology, 35(9), pp.1797~1810 (2021)
  25. Pereyra-Rodriguez, JJ, "Short-term effectiveness and safety of biologics and small molecule drugs for moderate to severe atopic dermatitis : a systematic review and network meta-analysis", Life, 11(9), pp.927~ (2021)
  26. Paolino A, "Non‐biologic systemic treatments for atopic dermatitis: Current state of the art and future directions", Clinical & Experimental Allergy, 53(5), pp.495~510 (2023)
  27. "Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis" (2022)[URL]
  28. Paik PK, "Matching-Adjusted Indirect Comparison(MAIC)of Tepotinib with Other MET Inhibitors for the Treatment of Advanced NSCLC with MET Exon 14 Skipping Mutations", Adv Ther, 39, pp.3159~3179 (2022)

관련 논문AI추천

청소년과 성인 아토피피부염 환자에서 dupilumab의 임상효과와 순응도: 한국의 단일 알레르기 클리닉의 실제 진료 상황에서의 관찰 결과 분석김명은, 남동호, 이영수대한 소아알레르기 호흡기학회 · Allergy Asthma & Respiratory Disease2023 · 제11권 제2호Consensus-Based Guidelines for the Treatment of Atopic Dermatitis in Korea (Part II): Biologics and JAK inhibitors고주연, 고현창, 나찬호, 서영준, 손상욱, 신민경, 안지영, 유박린, 이동훈, 이상은, 이설희, 장용현, 전지현, 한태영, Bae Youin, Choi Sun Young, Cho Sang Hyun, Han Ju Hee, Kim Hye One, Lee Ji Hyun, Lee Yang Won, Woo Yu Ri대한피부과학회 · Annals of Dermatology2025 · 제37권 제4호Effectiveness of Switching From Upadacitinib to Tralokinumab in Patients With Moderate-to-Severe Atopic Dermatitis: A Real-World Clinical PracticeFujimoto Eita, Hagino Teppei, Kanda Naoko, Saeki Hidehisa대한피부과학회 · Annals of Dermatology2025 · 제37권 제2호Real-World Experience of Long-Term Dupilumab Treatment for Atopic Dermatitis in Korea고현창, 나찬호, 노주영, 박귀영, 박영립, 박영민, 박창욱, 박천욱, 배유인, 서영준, 손상욱, 안지영, 양준모, 원종현, 유광호, 유박린, 이동훈, 이상은, 이성열, 이승철, 이양원, 이지현, 장용현, 전지현, 정혜정, 조상현, 한태영대한피부과학회 · Annals of Dermatology2022 · 제34권 제2호난치 아토피피부염 전신 치료에 관한 전문가 의견서 업데이트박 양, 고영일, 김미애, 김우경, 김현정, 나정임, 남동호, 민택기, 성명순, 염혜영, 원종훈, 이동훈, 이미희, 이소연, 이영수, 최미라, 최응호, 난치성아토피피부염 연구팀대한 소아알레르기 호흡기학회 · Allergy Asthma & Respiratory Disease2024 · 제12권 제2호Appropriate Injection Intervals of Dupilumab in Patients With Adult Atopic Dermatitis: A Step Toward Developing Guidelines for Daily Practice김희연, 노형래, 박지혜, 심준호, 오세진, 이동윤, 이종희, 주병현대한피부과학회 · Annals of Dermatology2025 · 제37권 제1호

이 간행물의 다른 논문 (5건)