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SIMPONI

Last Updated: June 04, 2009

Manufacturer:

Centocor Ortho Biotech, Inc.

Pharmacological Class:

TNF blocker

Active Ingredient(s):

Golimumab 50mg/0.5mL; soln for SC inj; preservative-free.

Indication(s):

Moderately to severely active rheumatoid arthritis (RA), in combination with methotrexate (MTX). Active psoriatic arthritis (PsA), alone or with MTX. Active ankylosing spondylitis (AS).

Pharmacology:

Golimumab is a human IgG1k monoclonal antibody that is specific for human tumor necrosis factor alpha (TNFα). High levels of TNFα in the blood, synovial fluid, and joints have been linked to the pathophysiology of rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. The cytokine TNFα is a mediator in the development of inflammation in these chronic diseases. Golimumab binds to human TNFα, preventing it from interacting with its receptors and inhibiting its biological activity.

Clinical Trials:

The efficacy and safety of golimumab in treating RA were evaluated in 3 placebo-controlled trials in adults with moderately to severely active disease. One study evaluated patients who were previously treated with one or more biologic TNF-blockers without a serious reaction; the second study evaluated patients who had active RA despite a stable dose of MTX ≥15mg/week and who had not been previously treated with a TNF blocker. The third study evaluated the use of golimumab in patients who were MTX-naive and had not previously been treated with a TNF blocker. The primary efficacy variable for the first two studies was the percent of patients achieving an American College of Rheumatology (ACR) 20 response at week 14; for the third study, it was the percentage of patients achieving an ACR 50 response at week 24. A greater percentage of patients treated with golimumab + MTX achieved ACR responses at week 14 (for the 1^st and 2^nd studies) and week 24 (for the 3^rd study) compared to patients given MTX alone.

Patients with psoriatic arthritis and ankylosing spondylitis were also evaluated in clinical trials. Significant improvements in the signs and symptoms of each disease were seen amongst patients treated with golimumab.

Legal Classification:

Adults:

50mg SC once monthly. Rotate sites.

Children:

<18yrs: not recommended.

Warnings/Precautions:

Increased risk of serious or fatal infections (eg, TB, bacterial sepsis, invasive fungal). Active infections: do not initiate therapy. Chronic or history of recurring or opportunistic infections. Conditions that predispose to infection. Travel to, or residence in, areas with endemic TB or mycoses. Test for and treat latent TB prior to initiating therapy. Monitor closely if new infection, reactivation of hepatitis B virus (HBV), or blood dyscrasias develop; discontinue if serious or opportunistic infection, sepsis, HBV reactivation, new or worsening CHF, or hematological abnormality (eg, cytopenias) develops. CHF (monitor). Immunosuppression. CNS demyelinating disorders. Malignancies. Latex allergy. Elderly. Pregnancy (Cat.B). Nursing mothers: not recommended.

Interaction(s):

Concurrent abatacept, anakinra, live vaccines, or other TNF blockers: not recommended. Monitor CYP450 substrates with narrow therapeutic index.

Adverse Reaction(s):

Inj site reactions, infections (may be serious), upper respiratory tract infection, nasopharyngitis, hypertension; rare: malignancies (eg, lymphoma), blood dyscrasias, new or worsening CHF, elevated liver enzymes, antibody formation.