Last reviewed · How we verify
Simponi
At a glance
| Generic name | Simponi |
|---|---|
| Also known as | Golimumab |
| Sponsor | Alvotech Swiss AG |
| Target | Tumor necrosis factor |
| Modality | Biologic |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
Approved indications
- Ankylosing spondylitis
- Juvenile idiopathic arthritis
- Nonradiographic axial spondyloarthritis
- Polyarticular juvenile idiopathic arthritis
- Psoriasis with arthropathy
- Rheumatoid arthritis
- Ulcerative colitis
Common side effects
- Infections
- Upper respiratory tract infection
- Nasopharyngitis
- Injection site reactions
- ALT elevations ≥ 3 × ULN
Serious adverse events
- Sepsis
- Alanine aminotransferase increased
- Aspartate aminotransferase increased
- Tuberculosis
- ALT elevations ≥ 5 × ULN
- Anemia
- CNS demyelination
- Acute liver failure
Key clinical trials
- Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt
- A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis (PHASE2)
- A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (PHASE3)
- A Study of Guselkumab and Golimumab Combination Therapy in Participants With Active Psoriatic Arthritis (PHASE2)
- An Observational Prospective Long-term Exposure Registry of Adult Patients With Moderate-to-Severe Ulcerative Colitis
- Golimumab and Apalutamide for the Treatment of Castration-Resistant Prostate Cancer, TRAMP Study (PHASE2)
- Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population
- Stand UP to Rheumatoid Arthritis (SUPRA) (NA)
Primary sources
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| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |