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Etanercept + Methotrexate
Etanercept + Methotrexate is a TNF inhibitor + DMARD combination Small molecule drug developed by Wyeth is now a wholly owned subsidiary of Pfizer. It is currently FDA-approved for Rheumatoid arthritis (moderate to severe, active disease), Polyarticular juvenile idiopathic arthritis.
Etanercept blocks tumor necrosis factor (TNF) to reduce inflammation, while methotrexate suppresses immune cell proliferation; together they synergistically reduce joint inflammation and slow disease progression in rheumatoid arthritis.
Etanercept blocks tumor necrosis factor (TNF) to reduce inflammation, while methotrexate suppresses immune cell proliferation; together they synergistically reduce joint inflammation and slow disease progression in rheumatoid arthritis. Used for Rheumatoid arthritis (moderate to severe, active disease), Polyarticular juvenile idiopathic arthritis.
At a glance
| Generic name | Etanercept + Methotrexate |
|---|---|
| Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer |
| Drug class | TNF inhibitor + DMARD combination |
| Target | TNF-alpha receptor (etanercept); dihydrofolate reductase (methotrexate) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
Etanercept is a TNF receptor fusion protein that binds and neutralizes TNF-alpha, a key inflammatory cytokine. Methotrexate is a disease-modifying antirheumatic drug (DMARD) that inhibits dihydrofolate reductase and reduces proliferation of immune cells. The combination provides complementary anti-inflammatory effects, with methotrexate enhancing etanercept's efficacy and reducing the risk of antibody formation against the biologic.
Approved indications
- Rheumatoid arthritis (moderate to severe, active disease)
- Polyarticular juvenile idiopathic arthritis
Common side effects
- Injection site reactions
- Infections (including serious infections)
- Nausea
- Headache
- Abdominal pain
- Elevated liver enzymes
- Cytopenias (anemia, leukopenia, thrombocytopenia)
Key clinical trials
- Methotrexate Alone vs Methotrexate + Etanercept for Minimal/Low Disease Activity in Juvenile Idiopathic Arthritis (PHASE3)
- Utilization of a Microdevice for Psoriasis and Atopic Dermatitis (PHASE4)
- Multicenter Randomized Double Blind Controlled-study to Assess the Potential of Methotrexate Versus Placebo to Improve and Maintain Response to Anti TNF- Alpha Agents in Adult Patients With Moderate to Severe Psoriasis (PHASE4)
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty (PHASE2)
- Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response (PHASE3)
- COBRA-Slim With or Without Fast Access to TNF Blockade for Remission Induction in Early RA (PHASE4)
- A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
- Clinical Trial Evaluating Methotrexate or Leflunomide + Targeted Therapy Versus Methotrexate or Leflunomide + Sulfasalazine + Hydroxychloroquine in Patients With Rheumatoid Arthritis and Insufficient Response to Methotrexate or Leflunomide (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Etanercept + Methotrexate CI brief — competitive landscape report
- Etanercept + Methotrexate updates RSS · CI watch RSS
- Wyeth is now a wholly owned subsidiary of Pfizer portfolio CI
Frequently asked questions about Etanercept + Methotrexate
What is Etanercept + Methotrexate?
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Related
- Drug class: All TNF inhibitor + DMARD combination drugs
- Target: All drugs targeting TNF-alpha receptor (etanercept); dihydrofolate reductase (methotrexate)
- Manufacturer: Wyeth is now a wholly owned subsidiary of Pfizer — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis (moderate to severe, active disease)
- Indication: Drugs for Polyarticular juvenile idiopathic arthritis
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing