What Is Simponi?
Simponi (golimumab) is a TNF-alpha blocker. Simponi, alone or in combination with methotrexate, was approved by the FDA on April 24, 2009 for the treatment of moderate to severe rheumatoid arthritis, active psoriatic arthritis (alone or with methotrexate), and active ankylosing spondylitis.
How Is Simponi Administered?
Simponi is given by subcutaneous injection (under the skin) once monthly. It is available in two dosage forms -- an autoinjector, known as the Simponi SmartJect, or as a pre-filled syringe.
What Is TNF-alpha?
TNF-alpha (tumor necrosis factor-alpha) is a cytokine, essentially, a molecular messenger between cells that plays a role in the inflammatory process. Excess TNF-alpha production by the body has been linked to several diseases and conditions, including rheumatoid arthritis (RA).
How Has Simponi (Golimumab) Performed in Clinical Trials?
In clinical trials, patients who received Simponi for either rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis showed improvement in signs and symptoms. The study results were based on more than 2,000 patients involved in five pivotal phase III trials.
What Side Effects Have Been Associated With Simponi?
Simponi can cause serious side effects including:
- serious infections
- lymphoma or other cancers
- new or worsening heart failure
- nervous system problems such as multiple sclerosis
- liver problems
- immune system problems
- low blood counts
Common side effects associated with Simponi include:
- upper respiratory tract infection
- injection site reactions
- high blood pressure
- abnormal liver tests
- flu symptoms
- runny nose
- cold sore
- numb or tingling sensations
- new or worsening psoriasis
Allergic reactions are also possible with Simponi or other TNF blockers.
Simponi is marketed by Centocor Ortho Biotech Inc. More information is available at www.simponi.com.
FDA Approves Monthly Injectable Drug for Treating Three Types of Immune-Related Arthritis. FDA News. April 24, 2009.
Simponi Medication Guide. April 2009.