{"id":"stopping-dupilumab","rwe":[],"tags":[],"safety":{"boxedWarnings":[],"drugInteractions":[],"commonSideEffects":[{"effect":"Injection site reactions","drugRate":"39%","severity":"Mild to moderate"},{"effect":"Conjunctivitis","drugRate":"16%","severity":"Mild to moderate"},{"effect":"Upper respiratory tract infections","drugRate":"12%","severity":"Mild to moderate"}],"contraindications":["Hypersensitivity to dupilumab or any component of the formulation"],"specialPopulations":{"Geriatric":"No overall differences in safety or effectiveness between elderly and younger patients","Lactation":"Unknown if dupilumab is excreted in human milk","Pediatric":"Approved for use in patients aged 6 years and older","Pregnancy":"Category B (no evidence of harm in animal studies; no adequate human studies)"}},"trials":[],"_chembl":null,"aliases":[],"patents":[{"title":"Human antibodies that bind IL-4Rα","number":"US8784804B2","expiration":"2032-06-15"},{"title":"Methods of treating atopic dermatitis using anti-IL-4Rα antibodies","number":"US9206250B2","expiration":"2033-04-22"}],"pricing":[],"offLabel":[],"timeline":[{"date":"2017-03-28","type":"Approval","milestone":"FDA approval for atopic dermatitis","regulator":"FDA"},{"date":"2018-10-20","type":"Approval","milestone":"FDA approval for asthma","regulator":"FDA"},{"date":"2019-06-26","type":"Approval","milestone":"FDA approval for chronic rhinosinusitis with nasal polyps","regulator":"FDA"},{"date":"2023-01-01","type":"Clinical Trial","milestone":"Phase 3 trial initiation for eosinophilic esophagitis","regulator":"N/A"}],"_dailymed":null,"aiSummary":"Dupilumab is a monoclonal antibody that targets the interleukin-4 receptor alpha subunit, which is involved in the signaling pathways of IL-4 and IL-13. It is primarily used for treating atopic dermatitis, asthma, and chronic rhinosinusitis with nasal polyps. The drug has shown significant efficacy in reducing symptoms and improving quality of life in these conditions. However, it is not approved by the FDA for use in stopping dupilumab, and its discontinuation should be managed carefully to avoid potential rebound effects or worsening of symptoms. Common side effects include injection site reactions, conjunctivitis, and upper respiratory tract infections.","ecosystem":[],"mechanism":{"target":"Interleukin-4 receptor alpha subunit (IL-4Rα)","novelty":"First-in-class monoclonal antibody targeting the IL-4Rα subunit","modality":"Injectable","drugClass":"Monoclonal antibody","explanation":"By inhibiting the IL-4 and IL-13 signaling pathways, dupilumab reduces the activation of immune cells and the production of inflammatory mediators, leading to a decrease in inflammation and associated symptoms.","oneSentence":"Dupilumab is a human monoclonal antibody that binds to the interleukin-4 receptor alpha subunit, blocking the signaling of IL-4 and IL-13, which are key cytokines in type 2 inflammation.","technicalDetail":"Dupilumab specifically binds to the IL-4 receptor alpha subunit (IL-4Rα), preventing the formation of the IL-4 and IL-13 receptor complexes and thus blocking the downstream JAK-STAT signaling pathway."},"_scrapedAt":"2026-03-28T00:09:47.870Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"commercial":{"yoyGrowth":"25%","launchDate":"2017","annualCostUS":"$36,000 per year","currentRevenue":"$6.2 billion (2022)","patientPopulation":"Estimated 1.5 million patients globally","peakSalesEstimate":"$10 billion (2028)"},"references":[],"biosimilars":[],"competitors":["Mepolizumab (GlaxoSmithKline)","Benralizumab (AstraZeneca)","Reslizumab (Teva Pharmaceutical Industries)"],"indications":{"approved":["Atopic dermatitis","Asthma","Chronic rhinosinusitis with nasal polyps"],"offLabel":[],"pipeline":["Eosinophilic esophagitis","Bullous pemphigoid","Chronic spontaneous urticaria"]},"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT06818019","phase":"PHASE4","title":"Withdrawal of Dupilumab in Severe Asthma","status":"NOT_YET_RECRUITING","sponsor":"University Hospital, Toulouse","startDate":"2025-04-02","conditions":"Severe Asthma","enrollment":205},{"nctId":"NCT06017427","phase":"","title":"Evaluation of Patient Satisfaction During Treatment With Dupilumab in Severe and Recurrent Nasosinusal Polyposis Despite Appropriate Medical and Surgical Treatment.","status":"TERMINATED","sponsor":"IHU Strasbourg","startDate":"2023-08-30","conditions":"Chronic Rhinosinusitis With Nasal Polyps","enrollment":32}],"_emaApprovals":[],"_faersSignals":[],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"formularyStatus":[],"_approvalHistory":[],"developmentCodes":[],"ownershipHistory":[],"publicationCount":56,"therapeuticAreas":["Immunology"],"biosimilarFilings":[],"companionDiagnostics":[],"genericManufacturerList":[],"phase":"marketed","status":"active","brandName":"Stopping dupilumab","genericName":"Stopping dupilumab","companyName":"University Hospital, Toulouse","companyId":"university-hospital-toulouse","modality":"Small molecule","firstApprovalDate":"2017","enrichmentLevel":3,"visitCount":0,"regulatoryByCountry":[{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"trialStats":{"total":1,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}