Dupilumab
證據等級: L3 | 預測適應症: 10 個
## 藥師評估報告
Dupilumab：從異位性皮膚炎到支氣管炎
一句話總結
Dupilumab 原本用於治療中至重度異位性皮膚炎、氣喘及慢性鼻竇炎合併鼻息肉。 TxGNN 模型預測它可能對**支氣管炎 (bronchitis)** 有效， 目前有 **1 個臨床試驗**和 **多篇文獻**支持這個方向。
快速總覽
| 項目 | 內容 |
|---|---|
| 原適應症 | 異位性皮膚炎、氣喘、慢性鼻竇炎合併鼻息肉、嗜伊紅性食道炎 |
| 預測新適應症 | bronchitis、皮膚炎、acne keloid、exanthem (disease)、neonatal dermatomyositis、acrodermatitis chronica atrophicans、amyopathic dermatomyositis、secondary interstitial lung disease specific to childhood associated with a connective tissue disease、hydroa vacciniforme, familial、atopic eczema |
| TxGNN 預測分數 | 99.92% |
| 證據等級 | L3 |
| 台灣上市 | 已上市 |
| 許可證數 | 2 張 |
| 建議決策 | Proceed with Guardrails |
預測適應症詳細分析
1. bronchitis L3 99.92% 主要分析
為什麼這個預測合理？
Dupilumab 是一種人源化單株抗體，可阻斷 IL-4 和 IL-13 的訊號傳遞，
這兩種細胞因子是第二型發炎反應的關鍵介質。支氣管炎，特別是嗜酸性支氣管炎，
涉及類似的發炎機轉。Dupilumab 已核准用於嗜酸性白血球表現型的氣喘，
其對下呼吸道發炎的抑制作用可能延伸至支氣管炎的治療。
</p>
</details>
此預測基於藥物的作用機轉，與現有臨床證據方向一致。
臨床試驗
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT04362501 | PHASE2 | COMPLETED | 33 | Efficacy of Dupilumab for Patients With Chronic Rhinosinusitis Without Nasal Pol... |
相關文獻
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 34597534 | 2022 | Article | The Lancet. Respiratory medici | Long-term safety and efficacy of dupilumab in patients with moderate-to-severe a... |
| 30273510 | 2019 | Article | The Journal of asthma : offici | Dupilumab safety and efficacy in uncontrolled asthma: a systematic review and me... |
| 39904363 | 2025 | Article | Tuberculosis and respiratory d | Pharmacologic Therapies for Preventing Chronic Obstructive Pulmonary Disease Exa... |
| 30196731 | 2018 | Article | Expert opinion on pharmacother | Challenges in the management of asthma associated with smoking-induced airway di... |
| 38488768 | 2024 | Article | Pediatric pulmonology | Novel therapies for eosinophilic pediatric plastic bronchitis. |
| 32428511 | 2020 | Article | Chest | Effects of Anti-T2 Biologic Treatment on Lung Ventilation Evaluated by MRI in Ad... |
2. dermatitis L1 99.71%
臨床試驗（50 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT03884842 | PHASE3 | COMPLETED | 24 | A Two-arm, Placebo-controlled Randomized Clinical Trial to Evaluate the Effect o... |
| NCT03346434 | PHASE2, PHASE3 | COMPLETED | 202 | A Phase 2/3 Study Investigating the Pharmacokinetics, Safety, and Efficacy of Du... |
| NCT05268107 | PHASE4 | RECRUITING | 30 | Ethnic Differences in Mechanisms of Action of Dupilumab |
| NCT04183335 | PHASE3 | COMPLETED | 151 | A Randomized, Double Blind, Placebo-controlled, Multi-center, Parallel Group Stu... |
| NCT05527964 | N/A | COMPLETED | 146 | The Influence of Specific Targeted Therapy on Subject and Family Quality of Life... |
| NCT04244006 | PHASE2, PHASE3 | UNKNOWN | 24 | A Randomized Double-blinded Pilot Study of the Efficacy and Safety of Dupilumab ... |
| NCT06193434 | PHASE1 | COMPLETED | 99 | A Phase 1 FIH, Randomized, Double Blind, Placebo Controlled, SAD/MAD Study to As... |
| NCT02407756 | PHASE2 | COMPLETED | 78 | A Phase 2a Study Investigating the Safety, Pharmacokinetics, Immunogenicity, and... |
| NCT05128383 | PHASE2 | COMPLETED | 20 | An Open-label Proof of Concept Study Regarding the Efficacy and Safety of Dupilu... |
| NCT06687980 | PHASE3 | ACTIVE_NOT_RECRUITING | 138 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to... |
| NCT04066998 | NA | UNKNOWN | 15 | Cytokine Profile of Conjunctivitis, Performed Through Tears Analysis Among Patie... |
| NCT03057860 | N/A | RECRUITING | 2800 | TREATgermany: German National Clinical Registry: Treatment and Medical Care of P... |
| NCT04306965 | PHASE2 | COMPLETED | 10 | Apremilast 30 mg BID Combined With Dupilumab for the Treatment of Recalcitrant M... |
| NCT03411837 | N/A | TERMINATED | 46 | Dupilumab Registry Study |
| NCT05203380 | N/A | COMPLETED | 45 | Neuropsychologic Assessments of Dupilumab-Treated Adolescents With Moderate-to-S... |
| NCT05197023 | PHASE1 | UNKNOWN | 20 | A RANDOMIZED, DOUBLE-BLIND, DOSE-ESCALATION, PLACEBO-CONTROLLED PHASE I CLINICAL... |
| NCT06136767 | N/A | RECRUITING | 400 | Registry for Systemic Eczema Treatments |
| NCT04345367 | PHASE3 | COMPLETED | 727 | A PHASE 3B RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE CONTROLLED MULTI-CENTE... |
| NCT06884891 | PHASE3 | NOT_YET_RECRUITING | 520 | A Multicenter Randomized, Double-blinded, Parallel, Positive-controlled, Phase Ⅲ... |
| NCT04447417 | PHASE4 | COMPLETED | 52 | Open Label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier... |
| NCT06099704 | N/A | ACTIVE_NOT_RECRUITING | 305 | A Prospective, Observational Study of Canadian Patients Receiving Dupixent® for ... |
| NCT07187089 | PHASE4 | WITHDRAWN | 0 | An Open-Label, Single-Arm Study to Assess Growth and Bone Mineral Density in Chi... |
| NCT05649098 | EARLY_PHASE1 | RECRUITING | 30 | Repurposing Dupilumab for Management of Pruritic Genetic Inflammatory Skin Disor... |
| NCT06169527 | N/A | ACTIVE_NOT_RECRUITING | 303 | French Prospective Observational Study of Patients Receiving Dupilumab for Atopi... |
| NCT05070663 | N/A | COMPLETED | 105 | National, Multicentre, Non-interventional, Prospective and Retrospective Study i... |
| NCT03345914 | PHASE3 | COMPLETED | 367 | A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy... |
| NCT03389893 | PHASE4 | TERMINATED | 72 | Effect of Dupilumab (Anti-IL4Rα) on the Host-Microbe Interface in Atopic Dermati... |
| NCT05442645 | N/A | COMPLETED | 80 | Observational Study of Atopic Dermatitis Patients Treated With Dupilumab in Taiw... |
| NCT06687967 | PHASE3 | ACTIVE_NOT_RECRUITING | 142 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to... |
| NCT06004986 | PHASE4 | RECRUITING | 216 | DUPI REDUCE Trial (DUPIlumab Dose REDUCtion in Patients With Controlled Atopic E... |
| NCT01949311 | PHASE3 | COMPLETED | 2733 | An Open-label Study of Dupilumab in Patients With Atopic Dermatitis Who Particip... |
| NCT05602207 | PHASE4 | COMPLETED | 24 | Clinical and Molecular Effects of Abrocitinib in Subjects With Atopic Dermatitis... |
| NCT05436535 | PHASE4 | COMPLETED | 433 | Longitudinal Endotyping Of Atopic Dermatitis Through Transcriptomic Skin Analysi... |
| NCT06477653 | PHASE2 | RECRUITING | 30 | A Pilot Phase 2 Study of the Safety and Efficacy of Dupilumab as Add-on Therapy ... |
| NCT05674695 | N/A | RECRUITING | 2500 | Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis The... |
| NCT04718870 | PHASE4 | COMPLETED | 41 | Open-label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier... |
| NCT07098000 | N/A | ACTIVE_NOT_RECRUITING | 40 | The Role of Confocal Microscopy in Estimating Dupilumab Treatment Response for M... |
| NCT05858619 | PHASE4 | RECRUITING | 15 | Molecular Signatures of Cutaneous Dupilumab Response |
| NCT06192563 | N/A | RECRUITING | 150 | A Prospective Observational Study of Adolescent Patients With Severe Atopic Derm... |
| NCT05394792 | N/A | COMPLETED | 111 | CANadian Effectiveness of UPadacitinib in Adult Moderate-to-severe aTopIc derMat... |
| NCT04287621 | N/A | ACTIVE_NOT_RECRUITING | 718 | Registry of Asthma Patients Initiating DUPIXENT® (RAPID) |
| NCT02277769 | PHASE3 | COMPLETED | 708 | A Phase 3 Confirmatory Study Investigating the Efficacy and Safety of Dupilumab ... |
| NCT05694884 | PHASE2 | UNKNOWN | 75 | A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate th... |
| NCT05624112 | PHASE4 | COMPLETED | 44 | Open-label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier... |
| NCT02647086 | PHASE1 | COMPLETED | 14 | An Open-Label, Drug-Drug Interaction Study to Examine the Effects of Dupilumab o... |
| NCT01385657 | PHASE1 | COMPLETED | 37 | A Randomized, Double-Blind, Placebo-Controlled, Sequential Ascending, Repeated-D... |
| NCT05682976 | N/A | NOT_YET_RECRUITING | 100 | Prospective Multicentre Study on Ophthalmological Adverse Events of Tralokinumab... |
| NCT03736967 | PHASE2 | TERMINATED | 206 | A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study to Assess the Eff... |
| NCT05331755 | N/A | COMPLETED | 120 | Real Life Experience Survey of Dupilumab in the Netherlands |
| NCT07352566 | PHASE4 | NOT_YET_RECRUITING | 10 | Utilization of a Cutaneous Therapy In Situ Microdevice |
相關文獻（20 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 36214355 | 2022 | Article | Journal of cutaneous medicine | Treatment With Dupilumab in Patients With Atopic Dermatitis: Systematic Review a... |
| 30194992 | 2019 | Article | The Journal of allergy and cli | Dupilumab progressively improves systemic and cutaneous abnormalities in patient... |
| 34126094 | 2022 | Article | Journal of the American Academ | Management of inadequate response and adverse effects to dupilumab in atopic der... |
| 38560522 | 2024 | Article | Drug design, development and t | A Review of Dupilumab in the Treatment of Atopic Dermatitis in Infants and Child... |
| 39588375 | 2024 | Article | Frontiers in immunology | Immunogenicity of dupilumab in adult and pediatric patients with atopic dermatit... |
| 28478972 | 2017 | Article | Lancet (London, England) | Long-term management of moderate-to-severe atopic dermatitis with dupilumab and ... |
| 36705657 | 2023 | Article | Dermatitis : contact, atopic, | Dupilumab for Atopic Dermatitis-From Clinical Trials to Molecular and Cellular M... |
| 32892674 | 2020 | Article | Immunotherapy | Dupilumab use in atopic dermatitis and beyond in skin diseases. |
| 35567671 | 2022 | Article | American journal of clinical d | Long-Term Efficacy and Safety of Dupilumab in Adolescents with Moderate-to-Sever... |
| 40246083 | 2025 | Article | Journal of the American Academ | Abrocitinib versus dupilumab: Impact on skin barrier function and proteomics in ... |
| 37100035 | 2023 | Article | Dermatology (Basel, Switzerlan | Dupilumab-Associated Psoriasis and Psoriasiform Manifestations: A Scoping Review... |
| 33428978 | 2021 | Article | Journal of the American Academ | Facial and neck erythema associated with dupilumab treatment: A systematic revie... |
| 39818381 | 2025 | Article | International journal of biolo | AP2M1 as the potential biomarker for prediction of the response of atopic dermat... |
| 25006719 | 2014 | Article | The New England journal of med | Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. |
| 31109652 | 2019 | Article | Journal of dermatological scie | Efficacy and safety of dupilumab monotherapy in adults with moderate-to-severe a... |
| 32822798 | 2021 | Article | Journal of the American Academ | Real-world evidence of dupilumab efficacy and risk of adverse events: A systemat... |
| 38588818 | 2024 | Article | Journal of the American Academ | Dupilumab therapy for atopic dermatitis is associated with increased risk of cut... |
| 35439608 | 2022 | Article | Journal of the American Academ | Phase 3 efficacy and safety of abrocitinib in adults with moderate-to-severe ato... |
| 35503163 | 2022 | Article | American journal of clinical d | Dupilumab Provides Acceptable Safety and Sustained Efficacy for up to 4 Years in... |
| 29471919 | 2018 | Article | Journal of the American Academ | Dupilumab: A review of its use in the treatment of atopic dermatitis. |
3. acne keloid L4 99.61%
相關文獻（1 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 37360650 | 2023 | Article | JAAD case reports | Effects of dupilumab on keloid stabilization and prevention. |
4. exanthem (disease) L1 99.57%
臨床試驗（10 項）
| 試驗編號 | 階段 | 狀態 | 人數 | 主要發現 |
|---|---|---|---|---|
| NCT04447417 | PHASE4 | COMPLETED | 52 | Open Label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier... |
| NCT06012448 | PHASE4 | COMPLETED | 10 | The Immunologic Effects of Dupilumab in the Treatment of Dermal Hypersensitivity... |
| NCT04718870 | PHASE4 | COMPLETED | 41 | Open-label Exploratory Study to Evaluate the Effect of Dupilumab on Skin Barrier... |
| NCT05394792 | N/A | COMPLETED | 111 | CANadian Effectiveness of UPadacitinib in Adult Moderate-to-severe aTopIc derMat... |
| NCT07352566 | PHASE4 | NOT_YET_RECRUITING | 10 | Utilization of a Cutaneous Therapy In Situ Microdevice |
| NCT06461897 | PHASE3 | RECRUITING | 675 | A Phase 3, Open-label, Efficacy-Assessor-Blinded Study, Comparing the Safety and... |
| NCT05601882 | PHASE3 | COMPLETED | 920 | A Phase 3b/4 Randomized, Open-label, Efficacy Assessor Blinded Study, Comparing ... |
| NCT04988022 | PHASE4 | COMPLETED | 44 | Defining Reversal of Keloid Lesions by Th2 Targeting With Dupilumab Treatment |
| NCT07021495 | N/A | RECRUITING | 840 | A Prospective, Multi-Center, Observational Biomarker Real-World Evidence Study f... |
| NCT06389136 | PHASE3 | RECRUITING | 200 | A Phase 3b/4 Randomized, Open-label, Efficacy Assessor-Blinded Study, to Evaluat... |
相關文獻（11 篇）
| PMID | 年份 | 類型 | 期刊 | 主要發現 |
|---|---|---|---|---|
| 40375468 | 2025 | Article | International journal of derma | Dupilumab for the Treatment of Cutaneous Immune-Related Adverse Events: A System... |
| 33207021 | 2021 | Article | Clinical and experimental derm | Skin manifestations of COVID-19 in children: Part 3. |
| 40507326 | 2025 | Article | Cancers | Interleukin-4 and -13 Gene Expression Profiles in Immune-Related Bullous Pemphig... |
| 38008067 | 2023 | Article | Respiration; international rev | Adverse Effects Under Th2 Biologics (Dupilumab and Tezepelumab) in a Patient wit... |
| 37203799 | 2023 | Article | International journal of derma | Detection of novel therapies using a multi-national, multi-institutional registr... |
| 36610660 | 2023 | Article | The Journal of investigative d | IL-4/IL-13 Inhibitors for Atopic Dermatitis Induce Psoriatic Rash Transcriptiona... |
| 38013381 | 2023 | Article | Medicine | The effect of atopic dermatitis in pediatric patients on height: Reflections tri... |
| 35986706 | 2022 | Article | Dermatologic therapy | Successful treatment of secukinumab-resistant palmoplantar pustulosis by Dupilum... |
| 35194901 | 2022 | Article | Dermatologic therapy | De novo pustular psoriasis associated with dupilumab therapy in a young male wit... |
| 35796728 | 2022 | Article | Dermatologic therapy | An uncommon case of lichen spinulosus induced by dupilumab in a patient treated ... |
| 36153663 | 2022 | Article | Dermatologic therapy | Pustular psoriasis appearing in a Chinese woman treated with dupilumab for atopi... |
5. neonatal dermatomyositis L5 99.56%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
6. acrodermatitis chronica atrophicans L5 99.54%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
7. amyopathic dermatomyositis L5 99.53%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
8. secondary interstitial lung disease specific to childhood associated with a connective tissue disease L5 99.52%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
9. hydroa vacciniforme, familial L5 99.50%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
10. severe nonproliferative diabetic retinopathy L5 99.10%
目前尚無針對此適應症的專門臨床研究。此為 TxGNN 模型預測結果，需進一步驗證。
資料來源：DDInter 2.0（原文內容請參閱該網站）
**Helminthiasis** 🟡 Moderate
- 風險包括：感染。必要時應停止治療。
**Vision Disorders** 🟡 Moderate
- 需密切監測。
## 結論與下一步
**決策：Proceed with Guardrails**
**理由：**
Dupilumab 抑制 IL-4/IL-13 的機轉適用於嗜酸性發炎相關的支氣管炎，
已有病例報告支持其在嗜酸性塑型性支氣管炎的療效。需區分支氣管炎的亞型。
**若要推進需要：**
- 區分嗜酸性與非嗜酸性支氣管炎的生物標記
- 針對慢性支氣管炎患者的前瞻性臨床試驗
- 與 COPD 合併嗜酸性白血球增高患者的治療效益評估
---
## 相關藥物報告
- [Acitretin](/drugs/acitretin/) - 證據等級 L3
- [Propantheline](/drugs/propantheline/) - 證據等級 L3
- [Human Immunoglobulin G](/drugs/human_immunoglobulin_g/) - 證據等級 L3
- [Alfacalcidol](/drugs/alfacalcidol/) - 證據等級 L3
- [Dorzolamide](/drugs/dorzolamide/) - 證據等級 L3
---
用 AI 幫我深入分析
想進一步了解這個藥物的老藥新用潛力嗎？點擊下方按鈕，直接開啟 AI 助手進行分析。
Claude：點擊後會複製提問並開啟新視窗，請按 Ctrl+V（Mac: Cmd+V）貼上
ChatGPT：點擊後直接開啟並自動帶入提問
免責聲明
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
本報告僅供學術研究參考，不構成醫療建議。藥物使用請遵循醫師指示，切勿自行調整用藥。任何老藥新用決策需經過完整的臨床驗證與法規審查。
最後審核：2026-02-20 | 審核者：TwTxGNN Research Team
歡迎分享您對本報告的看法、補充資訊或提出問題。討論內容會同步到 GitHub Discussions。 需要 GitHub 帳號才能留言。