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Simponi (Golimumab) - Summary




Patients treated with SIMPONI™ are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions] . Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

SIMPONI should be discontinued if a patient develops a serious infection.

Reported infections include:

  • Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before SIMPONI use and during therapy. Treatment for latent infection should be initiated prior to SIMPONI use.
  • Invasive fungal infections, including histoplasmosis, coccidioidomycosis, 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 infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.
  • Bacterial, viral, and other infections due to opportunistic pathogens.

The risks and benefits of treatment with SIMPONI should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with SIMPONI, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy [see Warning and Precautions] .


Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, of which SIMPONI is a member [ see Warning and Precautions ] .



SIMPONI (golimumab) is a human IgG1k monoclonal antibody specific for human tumor necrosis factor alpha (TNF alpha) that exhibits multiple glycoforms with molecular masses of approximately 150 to 151 kilodaltons. SIMPONI was created using genetically engineered mice immunized with human TNF, resulting in an antibody with human-derived antibody variable and constant regions. SIMPONI is produced by a recombinant cell line cultured by continuous perfusion and is purified by a series of steps that includes measures to inactivate and remove viruses.

Rheumatoid Arthritis

SIMPONI, in combination with methotrexate, is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis.

Psoriatic Arthritis

SIMPONI, alone or in combination with methotrexate, is indicated for the treatment of adult patients with active psoriatic arthritis.

Ankylosing Spondylitis

SIMPONI is indicated for the treatment of adult patients with active ankylosing spondylitis.

See all Simponi indications & dosage >>


Published Studies Related to Simponi (Golimumab)

The effect of intravenous golimumab on health-related quality of life in rheumatoid arthritis: 24-week results of the phase III GO-FURTHER trial. [2014]
therapy... CONCLUSION: In active RA, IV golimumab + MTX significantly improved physical

Safety and efficacy of golimumab in Chinese patients with active ankylosing spondylitis: 1-year results of a multicentre, randomized, double-blind, placebo-controlled phase III trial. [2014]
golimumab in Chinese patients with active AS... CONCLUSION: Golimumab significantly reduced clinical symptoms/signs and improved

Golimumab reduces disease activity of rheumatoid arthritis for 1 year and strongly inhibits radiographic progression in Japanese patients: partial but detailed results of the GO-FORTH and GO-MONO studies. [2013]
The objective of this study is to evaluate the efficacy of golimumab (GLM) in Japanese patients with active rheumatoid arthritis (RA) for 1 year. Nineteen patients were enrolled; 9 were randomized to the placebo (PBO) + methotrexate (MTX), GLM 50 mg + MTX, or GLM 100 mg + MTX therapy group; and 10 were randomized to the PBO, GLM 50 mg, or GLM 100 mg therapy group...

Comparison of three enthesitis indices in a multicentre, randomized, placebo-controlled trial of golimumab in ankylosing spondylitis (GO-RAISE). [2013]
improvement in entheseal tenderness with the TNF antagonist golimumab in AS... CONCLUSION: In patients with active AS, the UCSF Index appeared most sensitive in

Tocilizumab inhibits progression of joint damage in rheumatoid arthritis irrespective of its anti-inflammatory effects: disassociation of the link between inflammation and destruction. [2012]
(TCZ) interferes with joint destruction beyond its effects on disease activity... CONCLUSIONS: IL-6 inhibition with TCZ plus MTX retards joint damage progression

more studies >>

Reports of Suspected Simponi (Golimumab) Side Effects

Pneumonia (104)Drug Dose Omission (103)Device Malfunction (71)Drug Ineffective (47)Infection (39)Hypertension (35)Headache (34)Rheumatoid Arthritis (33)Malaise (31)Device Failure (31)more >>

Page last updated: 2015-08-10

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