Last updated: October 17, 2014
Trade Names: Simponi, Simponi Aria
Drug Class: Biologic DMARD, TNF antagonist
Simponi: Subcutaneous injection 50 mg/0.5 ml and 100 mg/1 ml prefilled syringes or prefilled autoinjector
Simponi Aria: IV solution 50 mg/4ml
Dose: For RA, psoriatic arthritis, ankylosing spondylitis 50 mg subcutaneous injection once a month, or for RA 2 mg/kg IV infusion at weeks 0, 4 and then every 8 weeks. For ulcerative colitis 200 mg subcutaneous injection at week 0, followed by 100 mg at week 2 and then 100 mg every 4 weeks.
Indications: RA, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis
Mechanism of Action: A human monoclonal antibody against TNF-alpha that blocks the effects of the cytokine.
Contraindications: Hypersensitivity, untreated tuberculosis and other opportunistic infections, sepsis, active infection, chronic localized or recurrent infections, demyelinating disease, optic neuritis, moderate-to-severe heart failure.
Precautions: Increased risk of serious infections including TB and fungal. Exclude latent or active TB with a skin test or TB blood test (interferon-gamma release assays or IGRA). Caution in debilitated or high risk of infection. Exclude active hepatitis B infection or carriage. Avoid live virus vaccines and BCG. Do not use with other biologics. May exacerbate pre-existing demyelinating disease and heart failure.
Monitoring: Monitor clinically for infection. CBC periodically. After therapy started, additional TB testing may be indicated for individuals likely to have exposure to TB.
Pregnancy Risk: B
Common: Injection site reactions (subcutaneous), minor infusion reactions (IV), positive antinuclear antibody, positive antinuclear and double stranded DNA antibody.
Less common: Serious infusion reactions, allergy, infection (bacterial, but particularly opportunistic infections such as tuberculosis, listeriosis, and histoplasmosis).
Rare: Anaphylaxis, lymphoma (including fatal hepatosplenic T-cell lymphoma), hepatitis, demyelinating CNS disorders, optic neuritis, seizures, pancytopenia, drug-induced lupus, reactivation of hepatitis B, new onset psoriasis.
Drug Interactions: Concurrent use of high-dose steroids and other immunosuppressants may increase risk of infection.
Patient Instructions: Avoid live virus vaccines; avoid pregnancy; stop injections and call your doctor if an infection or fever develops that lasts more than a few days.
Comments: TNF antagonists are among the most effective treatments for RA. Patients start to respond quickly, usually within 4–6 weeks but maximum response may take 4-6 months. Combined therapy with MTX is more effective than either drug alone. TNF antagonists are being explored in a range of diseases such as sarcoidosis and inflammatory eye disease. Risk of tuberculosis may be lower with etanercept than other TNF antagonists; comparative risk of adverse effects among individual TNF antagonists is not clear and side effects likely a class effect. Patients may form antibodies to anti-TNF drugs that decrease their effect. Concurrent treatment with MTX may reduce the frequency of this.
Clinical Pharmacology: Half-life is 14 days. Biologic agents are not metabolized and thus have few drug interactions.
Bombardier C, Hazlewood GS, Akhavan P, et al. Canadian Rheumatology Association recommendations for the pharmacological management of rheumatoid arthritis with traditional and biologic disease-modifying antirheumatic drugs: part II safety. J Rheumatol 2012;39:1583-602. PMID: 22707613.
Singh JA, Furst DE, Bharat A. et al.2012 Update of the 2008 American College of Rheumatology recommendations for the use ofdisease-modifying antirheumatic drugs and biologic agents in the treatment of rheumatoid arthritis.Arthritis Care Res 2012;64(5):625-39.PMID:22473917