SIMPONI ARIA
SIMPONI ARIA (golimumab) is a tumor necrosis factor (TNF) blocker indicated for the treatment of several chronic inflammatory conditions in adult and pediatric populations. It is approved for adults with moderately to severely active rheumatoid arthritis when used in combination with methotrexate, as well as adults with active ankylosing spondylitis. Additionally, the medication is indicated for patients aged two years and older with active psoriatic arthritis or active polyarticular juvenile idiopathic arthritis. Its therapeutic role focuses on managing the articular inflammation characteristic of these autoimmune disorders.
How SIMPONI ARIA Works
Golimumab is a human monoclonal antibody that targets tumor necrosis factor alpha (TNFα), a cytokine protein that mediates inflammation in the blood and joints. The drug binds to both soluble and transmembrane forms of TNFα, preventing the cytokine from interacting with its receptors and inhibiting its biological activity. By blocking this interaction, golimumab modulates the expression of adhesion proteins and the secretion of proinflammatory cytokines responsible for leukocyte infiltration. This process helps reduce the inflammatory pathophysiology associated with diseases such as rheumatoid arthritis and psoriatic arthritis.
Details
- Status
- Prescription
- First Approved
- 2013-07-18
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
SIMPONI ARIA Approval History
What SIMPONI ARIA Treats
4 indicationsSIMPONI ARIA is approved for 4 conditions since its original approval in 2013. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Juvenile Idiopathic Arthritis
SIMPONI ARIA Boxed Warning
SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI ARIA ( 5.1 ). Discontinue SIMPONI ARIA if a patient develops a serious infection or sepsis ( 5.1 ). Perform test for latent TB; if positive...
WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other opportunistic infections have occurred in patients receiving SIMPONI ARIA ( 5.1 ). Discontinue SIMPONI ARIA if a patient develops a serious infection or sepsis ( 5.1 ). Perform test for latent TB; if positive, start treatment for TB prior to starting SIMPONI ARIA ( 5.1 ). Monitor all patients for active TB during treatment, even if initial latent TB test is negative ( 5.1 ). Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which SIMPONI ARIA is a member ( 5.2 ). SERIOUS INFECTIONS Patients treated with SIMPONI ARIA are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) ] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue SIMPONI ARIA if a patient develops a serious infection. Reported infections with TNF blockers, of which SIMPONI ARIA is a member, include: Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Test patients for latent tuberculosis before SIMPONI ARIA use and during therapy. Initiate treatment for latent tuberculosis prior to SIMPONI ARIA use. Invasive fungal infections including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infec
SIMPONI ARIA Target & Pathway
ProTarget
A pro-inflammatory cytokine that plays a central role in immune responses and inflammation. Excess TNF contributes to autoimmune diseases like rheumatoid arthritis, psoriasis, and inflammatory bowel disease. Blocking TNF reduces inflammation and prevents tissue damage.
Drugs Similar to SIMPONI ARIA
FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
SIMPONI ARIA FDA Label Details
ProIndications & Usage
FDA Label (PDF)SIMPONI ARIA is a tumor necrosis factor (TNF) blocker indicated for the treatment of: Adult patients with moderately to severely active Rheumatoid Arthritis (RA) in combination with methotrexate Active Psoriatic Arthritis (PsA) in patients 2 years of age and older Adult patients with active Ankylosing Spondylitis (AS) Active polyarticular Juvenile Idiopathic Arthritis (pJIA) in patients 2 years of age and older 1.1 Rheumatoid Arthritis (RA) SIMPONI ARIA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthri...
WARNING: SERIOUS INFECTIONS and MALIGNANCY WARNING: SERIOUS INFECTIONS and MALIGNANCY See full prescribing information for complete boxed warning. Serious infections leading to hospitalization or death including tuberculosis (TB), bacterial sepsis, invasive fungal (such as histoplasmosis), and other...
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.