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Simponi (Golimumab) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Clinical Studies Experience

The safety data described below are based on 5 pooled, randomized, double-blind, controlled Phase 3 trials in patients with RA, PsA, and AS (Studies RA-1, RA-2, RA-3, PsA, and AS) [ see Clinical Studies (14.1, 14.2 and 14.3) ]. These 5 trials included 639 control-treated patients and 1659 SIMPONI-treated patients including 1089 with RA, 292 with PsA, and 278 with AS. The proportion of patients who discontinued treatment due to adverse reactions in the controlled Phase 3 trials through Week 16 in RA, PsA and AS was 2% for SIMPONI-treated patients and 3% for placebo-treated patients. The most common adverse reactions leading to discontinuation of SIMPONI in the controlled Phase 3 trials through Week 16 were sepsis (0.2%), alanine aminotransferase increased (0.2%), and aspartate aminotransferase increased (0.2%).

The most serious adverse reactions were:

  • Serious Infections [ see Warnings and Precautions ]
  • Malignancies [ see Warnings and Precautions ]

Upper respiratory tract infection and nasopharyngitis were the most common adverse reactions reported in the combined Phase 3 RA, PsA and AS trials through Week 16, occurring in 7% and 6% of SIMPONI-treated patients as compared with 6% and 5% of control-treated patients, respectively.

Infections

In controlled Phase 3 trials through Week 16 in RA, PsA, and AS, infections were observed in 28% of SIMPONI-treated patients compared to 25% of control-treated patients [for Serious Infections, see Warnings and Precautions ].

Liver Enzyme Elevations

There have been reports of severe hepatic reactions including acute liver failure in patients receiving TNF-blockers. In controlled Phase 3 trials of SIMPONI in patients with RA, PsA, and AS through Week 16, ALT elevations ≥ 5 ULN occurred in 0.2% of control-treated patients and 0.7% of SIMPONI-treated patients and ALT elevations ≥ 3 ULN occurred in 2% of control-treated patients and 2% of SIMPONI-treated patients. Since many of the patients in the Phase 3 trials were also taking medications that cause liver enzyme elevations (e.g., NSAIDS, MTX), the relationship between golimumab and liver elevation is not clear.

Autoimmune Disorders and Autoantibodies

The use of TNF-blockers has been associated with the formation of autoantibodies and, rarely, with the development of a lupus-like syndrome. In the controlled Phase 3 trials in patients with RA, PsA, and AS through Week 14, there was no association of SIMPONI treatment and the development of newly positive anti-dsDNA antibodies.

Injection Site Reactions

In controlled Phase 3 trials through Week 16 in RA, PsA and AS, 6% of SIMPONI-treated patients had injection site reactions compared with 2% of control-treated patients. The majority of the injection site reactions were mild and the most frequent manifestation was injection site erythema. In controlled Phase 2 and 3 trials in RA, PsA, and AS, no patients treated with SIMPONI developed anaphylactic reactions.

Psoriasis: New-Onset and Exacerbations

Cases of new onset psoriasis, including pustular psoriasis and palmoplantar psoriasis, have been reported with the use of TNF-blockers, including SIMPONI. Cases of exacerbation of pre-existing psoriasis have also been reported with the use of TNF-blockers. Many of these patients were taking concomitant immunosuppressants (e.g., MTX, corticosteroids). Some of these patients required hospitalization. Most patients had improvement of their psoriasis following discontinuation of their TNF-blocker. Some patients have had recurrences of the psoriasis when they were re-challenged with a different TNF-blocker. Discontinuation of SIMPONI should be considered for severe cases and those that do not improve or that worsen despite topical treatments.

Immunogenicity

Antibodies to SIMPONI were detected in 57 (4%) of SIMPONI-treated patients across the Phase 3 RA, PsA and AS trials through Week 24. Similar rates were observed in each of the three indications. Patients who received SIMPONI with concomitant MTX had a lower proportion of antibodies to SIMPONI than patients who received SIMPONI without MTX (approximately 2% versus 7%, respectively). Of the patients with a positive antibody response to SIMPONI in the Phase 2 and 3 trials, most were determined to have neutralizing antibodies to golimumab as measured by a cell-based functional assay. The small number of patients positive for antibodies to SIMPONI limits the ability to draw definitive conclusions regarding the relationship between antibodies to golimumab and clinical efficacy or safety measures.

The data above reflect the percentage of patients whose test results were considered positive for antibodies to SIMPONI in an ELISA assay, and are highly dependent on the sensitivity and specificity of the assay. Additionally, the observed incidence of antibody positivity in an assay may be influenced by several factors including sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, comparison of the incidence of antibodies to SIMPONI with the incidence of antibodies to other products may be misleading.

Other Adverse Reactions

Table 1 summarizes the adverse drug reactions that occurred at a rate of at least 1% in the combined SIMPONI groups during the controlled period of the 5 pooled Phase 3 trials through Week 16 in patients with RA, PsA, and AS.

Table 1. Adverse Drug Reactions Reported by ≥ 1% of Patients in the Phase 3 Trials of RA, PsA, and AS through Week 16Patients may have taken concomitant MTX, sulfasalazine, hydroxychloroquine, low dose corticosteroids (≤ 10 mg of prednisone/day or equivalent), and/or NSAIDs during the trials).
Placebo DMARDs SIMPONI DMARDs
Patients treated 639 1659
Adverse Reaction (Preferred Term)
Upper respiratory tract infection 37 (6%) 120 (7%)
Nasopharyngitis 31 (5%) 91 (6%)
Alanine aminotransferase increased 18 (3%) 58 (4%)
Injection site erythema 6 (1%) 56 (3%)
Hypertension 9 (1%) 48 (3%)
Aspartate aminotransferase increased 10 (2%) 44 (3%)
Bronchitis 9 (1%) 31 (2%)
Dizziness 7 (1%) 32 (2%)
Sinusitis 7 (1%) 27 (2%)
Influenza 7 (1%) 25 (2%)
Pharyngitis 8 (1%) 22 (1%)
Rhinitis 4 (< 1%) 20 (1%)
Pyrexia 4 (< 1%) 20 (1%)
Oral herpes 2 (< 1%) 16 (1%)
Paraesthesia 2 (< 1%) 16 (1%)



REPORTS OF SUSPECTED SIMPONI SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Simponi. The information is not vetted and should not be considered as verified clinical evidence.

Possible Simponi side effects / adverse reactions in 66 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 66 year old female

Reactions: Palpitations, Ill-Defined Disorder, Loss of Consciousness

Suspect drug(s):
Simponi



Possible Simponi side effects / adverse reactions in 58 year old male

Reported by a physician from Germany on 2011-10-03

Patient: 58 year old male

Reactions: Pneumonia

Adverse event resulted in: hospitalization

Suspect drug(s):
Simponi
    Indication: Rheumatoid Arthritis
    Start date: 2011-07-22

Simponi
    End date: 2011-06-26



Possible Simponi side effects / adverse reactions in 43 year old male

Reported by a pharmacist from Germany on 2011-10-03

Patient: 43 year old male

Reactions: Tooth Loss, Psoriasis

Suspect drug(s):
Simponi

Other drugs received by patient: Enbrel; ALL Other Therapeutic Drugs; Antibiotics; Arcoxia; Prednisolone; Ergocalciferol



See index of all Simponi side effect reports >>

Drug label data at the top of this Page last updated: 2009-11-30

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