Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
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Matching-adjusted Indirect Comparison (MAIC) of Tralokinumab Versus Dupilumab for the Treatment of Moderate to Severe Adult Atopic Dermatitis

트랄로키누맙과 두필루맙의 매칭 조정 간접 비교

  • Taekyung Kim (Department of Statistics and Data Science, Department of Applied Statistics, Yonsei University) ;
  • Keun Soo Shin (Market Access, LEO Pharma Inc.) ;
  • Hyojin Kim (RWE, Syneos Health Korea) ;
  • Eugene Kim (RWE, Syneos Health Korea) ;
  • Leejung Choi (RWE, Syneos Health Korea) ;
  • Dong Hun Lee (Department of Dermatology, Seoul National University Hospital)
  • 김태경 (연세대학교 응용통계학과, 통계데이터사이언스학과) ;
  • 신근수 (레오파마 유한회사, 마켓엑세스) ;
  • 김효진 (시네오스헬스 코리아, RWE) ;
  • 김유진 (시네오스헬스 코리아, RWE) ;
  • 최이정 (시네오스헬스 코리아, RWE) ;
  • 이동훈 (서울대학교 병원, 피부과)
  • Received : 2023.07.25
  • Accepted : 2023.09.12
  • Published : 2023.09.30
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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.

Keywords

References

  1. Kim H. Guidelines of Atopic dermatitis and new key player drug. Korea Pharmaceutical Information Center. 2022; Pharm review. Available from: health.kr/Menu.PharmReview/View.asp?PharmReview_IDX=8334. Accessed June 25, 2023.
  2. Ceci RLF, Goldman L, Schafer AI. Goldman's Cecil Medicine. Expert Consult Premium Edition--Enhanced Online Features and Print, Single Volume, 24: Goldman's Cecil Medicine (Vol. 1). Elsevier Health Sciences Expert Consult Premium Edition--Enhanced Online Features and Print, Single Volume, 24: Goldman's Cecil Medicine (Vol. 1), Elsevier Health Sciences, 24th ed. Philadelphia. 2012:2209-11.
  3. HIRA. Healthcare big data system Available from: http://opendata.hira.or.kr/op/opc/olap3thDsInfo.do. Accessed May 17, 2023.
  4. Wollenberg A, Kinberger M, Arents B, et al. European guideline (EuroGuiDerm) on atopic eczema: part I-systemic therapy. Journal of the European Academy of Dermatology and Venereology, 2022;36(9):1409-31. https://doi.org/10.1111/jdv.18345
  5. Bieber T. Interleukin-13: Targeting an underestimated cytokine in atopic dermatitis. Allergy. 2020;75(1):54-62. https://doi.org/10.1111/all.13954
  6. Zhang Y, Jing D, Cheng J, et al. The efficacy and safety of IL-13 inhibitors in atopic dermatitis: A systematic review and meta-analysis. Front Immunol. 2022;13:923362.
  7. HIRA. Reimbursement criteria-Upadacitinib. Available from: https://www.hira.or.kr/rc/insu/insuadtcrtr/InsuAdtCrtrPopup.do?mtgHmeDd=20230401&sno=3&mtgMtrRegSno=0005. Accessed June 22, 2023.
  8. MFDS. Rinvoq approval. Available from: https://nedrug.mfds.go.kr/pbp/CCBBB01/getItemDetailCache?cacheSeq=202004222aupdateTs2023-01-05%2013:31:24.409629b. Accessed July 01, 2023.
  9. HIRA. Guidelines for Evaluating the Economics of Drugs. 2021.
  10. Gutermuth J, Pink AE, Worm M et al. 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. 2022;186(3):440-52. https://doi.org/10.1111/bjd.20832
  11. de Bruin-Weller M, Thaci D, Smith CH, et al. 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 CAFE). British Journal of Dermatology. 2018;178(5):1083-101.
  12. Kimball AB, Yves P, Stephen T, et al. Interpretation of EASI-75 from a patient perspective-a post hoc analysis from a phase 2b trial of dupilumab in adults with moderate-to-severe atopic dermatitis. JAAD. 2017;76(6 Suppl 1):416..
  13. Schmitt J, Spuls PI, Thomas KS, et al. The Harmonising Outcome Measures for Eczema (HOME) statement to assess clinical signs of atopic eczema in trials. J Allergy Clin Immunol. 2014; 134(4):800-7. https://doi.org/10.1016/j.jaci.2014.07.043
  14. HIRA. Reimbursement criteria - Dupilumab. Available from: https://www.hira.or.kr/rc/insu/insuadtcrtr/InsuAdtCrtrPopup.do?mtgHmeDd=20230501&sno=3&mtgMtrRegSno=0004. Accessed July 01, 2023.
  15. Kim JE, Shin MK, Park GH, et al. Consensus Korean Diagnostic Guidelines to Define Severity Classification and Treatment Refractoriness for Atopic Dermatitis: Objective and Subjective Assessment of Severity. Annals of dermatology. 2019;31(6):654-61. https://doi.org/10.5021/ad.2019.31.6.654
  16. Wangge G, Rose KC, De Boer A, et al. The challenges of determining noninferiority margins: a case study of noninferiority randomized controlled trials of novel oral anticoagulants. CMAJ. 2013;185(3):222-7. https://doi.org/10.1503/cmaj.120142
  17. Halmos B, Burke T, Kalyvas C, et al. 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. 2020;12(12):3648.
  18. Signorovitch JE, Wu EQ, Yu AP, et al. Comparative effectiveness without head-to-head trials: a method for matching-adjusted indirect comparisons applied to psoriasis treatment with adalimumab or etanercept. Pharmacoeconomics. 2010;28(10):935-45. https://doi.org/10.2165/11538370-000000000-00000
  19. Jackson D, Rhodes K, Ouwens M. Alternative weighting schemes when performing matching-adjusted indirect comparisons. Res Synth Methods. 2021;12(3):333-46. https://doi.org/10.1002/jrsm.1466
  20. Signorovitch JE, Sikirica V, Erder MH, et al. Matching-adjusted indirect comparisons: a new tool for timely comparative effectiveness research. Value Health. 2012;Sep-Oct(15(6)):940-7. https://doi.org/10.1016/j.jval.2012.05.004
  21. FDA. Non-Inferiority Clinical Trials to Establish Effectiveness Guidance for Industry 2016. Available from https://www.fda.gov/media/78504/download Accessed July 01, 2023.
  22. Reich K, Thyssen JP, Blauvelt A, et al. Efficacy and safety of abrocitinib versus dupilumab in adults with moderate-to-severe atopic dermatitis: a randomized, double-blind, multicentre phase 3 trial. Lancet. 2022;Jul 23(400(10348)):273-82. https://doi.org/10.1016/S0140-6736(22)01199-0
  23. CADTH. Clinical review report-Dupilumab.CADTTH Common Drug Review, Canadian Agency for Drugs and Technologies in Health; Ottawa. 2018 Jul.
  24. Sedeh FB, Henning MA, Jemec GB, et al. 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. 2022;102:adv00764.
  25. Silverberg JI, Thyssen JP, Fahrbach K, et al. 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. 2021;35(9):1797-810. https://doi.org/10.1111/jdv.17351
  26. Pereyra-Rodriguez, JJ, Alcantara-Luna S, Dominguez-Cruz JS, et al. 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. 2021;11(9):927.
  27. Paolino A, Alexander H, Broderick C, et al. Non-biologic systemic treatments for atopic dermatitis: Current state of the art and future directions. Clinical & Experimental Allergy. 2023; 53(5);495-510. https://doi.org/10.1111/cea.14301
  28. NICE. Abrocitinib, tralokinumab or upadacitinib for treating moderate to severe atopic dermatitis. 2022. Available from: https://www.nice.org.uk/guidance/ta814. Accessed July 01, 2023.
  29. Paik PK, Pfeiffer, BM, Vioix H, et al. 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 2022;39:3159-79. https://doi.org/10.1007/s12325-022-02163-9