{"id":"ole-fd-adalimumab-mtx","brandName":"OLE FD Adalimumab +/- MTX","genericName":"OLE FD Adalimumab +/- MTX","companyId":"abbott","companyName":"Abbott","phase":"phase_3","status":"active","modality":"Small molecule","aliases":["ABT-D2E7","Humira"],"developmentCodes":[],"firstApprovalDate":null,"firstApprovalCountry":null,"aiSummary":"Adalimumab (Humira) is a fully human monoclonal antibody TNF-α inhibitor developed by Abbott for inflammatory and autoimmune diseases. This profile focuses on the pediatric polyarticular juvenile idiopathic arthritis (pJIA) formulation studied in Phase 3 trials, with or without methotrexate co-therapy. Adalimumab binds TNF-α with high affinity, blocking its interaction with TNF receptors and suppressing the inflammatory cascade central to JIA pathogenesis. The compound has achieved FDA approval across multiple adult and pediatric indications including rheumatoid arthritis, psoriasis, Crohn's disease, and ulcerative colitis, generating peak annual revenues exceeding $16B globally. Clinical differentiation in pediatric JIA derives from demonstrated efficacy in reducing active joint counts and improving functional outcomes, with favorable safety profiles when combined with conventional DMARDs. Abbott's biosimilar competition and patent cliff (US composition patents expired 2023) have driven recent revenue decline, though the pediatric indication and newer formulations (pen/pre-filled syringe) maintain market relevance.","enrichmentLevel":3,"visitCount":0,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Adalimumab is a fully human monoclonal antibody that binds to and neutralizes TNF-alpha, a key pro-inflammatory cytokine. By blocking TNF-alpha, it suppresses the inflammatory cascade underlying autoimmune diseases. The addition of methotrexate (MTX) provides synergistic immunosuppression and is commonly used in combination therapy for rheumatoid arthritis and other inflammatory conditions.","oneSentence":"Adalimumab is a TNF-alpha inhibitor that blocks tumor necrosis factor-alpha signaling to reduce inflammation, with optional methotrexate co-administration to enhance efficacy.","_ai_confidence":"high"},"administration":{},"safety":{"commonSideEffects":[{"rate":"12-20","effect":"Injection site reactions"},{"rate":"7-10","effect":"Upper respiratory tract infections"},{"rate":"5-8","effect":"Headache"},{"rate":"0.1-0.5","effect":"Tuberculosis reactivation"},{"rate":"2-4","effect":"Serious infections"},{"rate":"null","effect":"Malignancy risk"}]},"trials":[],"indications":{"approved":[{"name":"Rheumatoid arthritis (with or without methotrexate)"},{"name":"Polyarticular juvenile idiopathic arthritis"},{"name":"Ankylosing spondylitis"},{"name":"Crohn's disease"},{"name":"Ulcerative colitis"},{"name":"Psoriasis"},{"name":"Psoriatic arthritis"}]},"commercial":null,"patents":[],"timeline":[],"rwe":[],"competitors":[],"ownershipHistory":[],"trialDetails":[],"genericFilers":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"labelChanges":[],"nice":null,"revenue":null,"trialStats":{"total":0,"withResults":0},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":false,"score":3}}