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Simponi (Golimumab) - Summary

 
 



WARNINGS

SERIOUS INFECTIONS

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] .

MALIGNANCY

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 SUMMARY

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 >>

NEWS HIGHLIGHTS

Published Studies Related to Simponi (Golimumab)

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

Golimumab administered subcutaneously every 4 weeks in ankylosing spondylitis: 104-week results of the GO-RAISE study. [2012]
patients with active ankylosing spondylitis... CONCLUSION: Clinical response that was achieved by patients receiving golimumab

The effects of golimumab on radiographic progression in rheumatoid arthritis: results of randomized controlled studies of golimumab before methotrexate therapy and golimumab after methotrexate therapy. [2011.05]
OBJECTIVE: To evaluate the effects of golimumab on radiographic progression in patients with rheumatoid arthritis (RA)... CONCLUSION: Golimumab in combination with MTX inhibited radiographic progression significantly better than did MTX alone in the GO-BEFORE study. Radiographic progression in the GO-FORWARD study was minimal in all treatment arms, precluding an adequate assessment of the effect of golimumab on radiographic progression in this study.

Population approach for exposure-response modeling of golimumab in patients with rheumatoid arthritis. [2011.05]
Golimumab is a human immunoglobulin G1kappa monoclonal antibody that binds with high affinity and specificity to tumor necrosis factor-alpha. The objective of this study was to establish an approach for exposure-response modeling for golimumab in patients with rheumatoid arthritis using the American College of Rheumatology index of improvement (ACRN) as a measure of change in disease severity...

Population pharmacokinetics of golimumab in patients with ankylosing spondylitis: impact of body weight and immunogenicity. [2010.09]
Aims: To develop a population pharmacokinetic (PK) model of subcutaneously administered golimumab, a human anti-tumor necrosis factor monoclonal antibody, in patients with ankylosing spondylitis (AS), estimate typical fixed and random population PK parameters, and identify significant covariates on golimumab pharmacokinetics...

more studies >>

Clinical Trials Related to Simponi (Golimumab)

Golimumab in Rheumatoid Arthritis Patients With an Inadequate Response to Etanercept (ENBREL) or Adalimumab (HUMIRA) [Recruiting]
The purpose of this study is to evaluate the efficacy and safety of switching rheumatoid arthritis (RA) patients who have an inadequate response to their current treatment with either etanercept + methotrexate or adalimumab + methotrexate to treatment with golimumab 50 mg subcutaneous injection (a needle inserted under your skin in the back of your upper arm, upper thigh or stomach area) every 4 weeks + methotrexate. This study is also designed to evaluate the benefit and safety of switching patients from treatment with golimumab 50 mg subcutaneous injection every 4 weeks + methotrexate to golimumab 2 mg/kg intravenous every 8 weeks + methotrexate, for those who do not achieve a marked improvement of their RA at Week 16.

Effect of Anti-TNF (Alpha) Treatment on Circulating Endothelial Progenitor Cells (EPCs) and Vascular Stiffness in Ankylosing Spondylitis (AS) [Recruiting]
1. To determine the effect of Golimumab treatment on the number and function of Endothelial Progenitor Cells (EPCs) in Ankylosing Spondylitis(AS) patients as a possible mechanism for the effect of this treatment on endothelial function.

2. To ascertain the effect of Golimumab treatment on , carotid intima-media thickness, vascular stiffness in Ankylosing Spondylitis(AS) patients as measured by pulse wave velocity (PWV) and Augmentation index (AIx).

3. To assess the clinical efficacy of Golimumab in Chinese Ankylosing Spondylitis(AS) patients according to ASAS response criteria at month 3, 6 and 12.

4. To perform cost-effectiveness and cost-utility analyses of the Golimumab in Ankylosing Spondylitis(AS) patients, using clinic-base data.

A Study to Assess the Safety and Effectiveness of Golimumab in Filipino Patients With Rheumatoid Arthritis, Psoriatic Arthritis and Ankylosing Spondylitis [Not yet recruiting]

The Incidence of Extra-Articular Manifestations in Participants With Ankylosing Spondylitis Treated With Golimumab (MK-8259-012) [Recruiting]
The objective of this study is to determine the difference in the annual incidence rate of uveitis attacks in participants with ankylosing spondylitis (AS) before treatment and after the start of treatment with golimumab.

A Study of the Safety and Effectiveness of CNTO 148 (Golimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (CR014176) [Recruiting]
The purpose of this study is to assess the effects (good and bad) of CNTO 148 (golimumab) therapy in patients with ulcerative colitis.

more trials >>

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: 2013-02-10

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