SIMPONI

What it is

SIMPONI is golimumab (rmc), supplied as a solution for injection in pre-filled syringes or pre-filled pens (SmartJect) for subcutaneous injection, or as a solution for intravenous infusion in vials. SIMPONI is available in two strengths: 50 mg of golimumab in 0.5 mL and 100 mg of golimumab in 1 mL for subcutaneous administration. SIMPONI IV vials contain 50 mg golimumab per 4 mL.

Approved indications —

Moderate to severely active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drug therapy, including methotrexate, has been inadequate (in combination with methotrexate) — Active and progressive psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate (alone or in combination with methotrexate) — Active ankylosing spondylitis in adult patients — Active non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, in adults who have had an inadequate response to, or are intolerant to, nonsteroidal anti-inflammatory drugs (NSAIDs) — Moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy

Dosing overview

For rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and non-radiographic axial spondyloarthritis, SIMPONI is administered as 50 mg given by subcutaneous injection once a month, on the same date each month. For ulcerative colitis, SIMPONI is given as 200 mg by subcutaneous injection at Week 0, followed by 100 mg at Week 2 and then 100 mg every 4 weeks thereafter. For intravenous administration in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, SIMPONI IV is given as 2 mg/kg as a 30-minute intravenous infusion at Weeks 0 and 4, then every 8 weeks thereafter.

Key safety warnings

Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, protozoal, or other opportunistic pathogens have been reported in patients receiving TNF-blockers including golimumab. Among opportunistic infections, tuberculosis, histoplasmosis, aspergillosis, candidiasis, coccidioidomycosis, listeriosis, legionellosis and pneumocystosis were the most commonly reported with TNF-blockers. Treatment with SIMPONI should not be initiated in patients with an active infection, including clinically important localised infections. Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving TNF-blockers, including golimumab, and patients who have previously received treatment for latent or active tuberculosis have developed tuberculosis while receiving TNF-blockers, including golimumab. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating SIMPONI, and treatment of latent tuberculosis infection should be initiated prior to therapy with SIMPONI. The use of TNF-blockers including golimumab has been associated with reactivation of hepatitis B virus (HBV) in patients who are chronic hepatitis B carriers. Patients should be tested for hepatitis B virus infection before initiating treatment with immunosuppressants, including SIMPONI. In the controlled portions of clinical trials of all TNF-blocking agents including SIMPONI, more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with control patients. During the SIMPONI Phase 2 and Phase 3 clinical trials in RA, PsA and AS, the incidence of lymphoma in SIMPONI-treated patients was higher than expected in the general population. Cases of worsening congestive heart failure (CHF) and new onset CHF have been reported with TNF-blockers including golimumab, with some cases having a fatal outcome. SIMPONI has not been studied in patients with a history of CHF and should be used with caution in patients with CHF. Use of TNF-blocking agents has been associated with cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disorders, including multiple sclerosis and peripheral demyelinating disorders, including Guillain-Barré syndrome. Prescribers should exercise caution in considering the use of TNF-blockers, including SIMPONI, in patients with central or peripheral nervous system demyelinating disorders.

Contraindications

Active tuberculosis or other severe infections such as sepsis and opportunistic infections; concurrent administration with anakinra or abatacept; moderate or severe heart failure (NYHA class III/IV); and hypersensitivity to the active substance or to any of the excipients are contraindicated.

PBS listing

SIMPONI 50 mg in 0.5 mL single use pre-filled syringe has 9 PBS items with authority required and streamlined restrictions, at an ex-manufacturer price of A$939.99. SIMPONI 50 mg in 0.5 mL single use pre-filled pen has 9 PBS items with authority required and streamlined restrictions, at an ex-manufacturer price of A$939.99. SIMPONI 100 mg in 1 mL single use pre-filled pen has 3 PBS items with authority required restriction, at an ex-manufacturer price of A$939.99.

Regulatory history

SIMPONI 50 mg pre-filled syringe and SmartJect injector pen were first listed on the ARTG on 13 November 2009. SIMPONI 100 mg pre-filled syringe and SmartJect injector pen were first listed on 2 April 2014. SIMPONI IV 50 mg/4 mL concentrate for solution for infusion vial was first listed on 20 November 2019. The TGA approved an application on 9 July 2013, extending the indications for SIMPONI in rheumatoid arthritis and psoriatic arthritis to include the inhibition of structural damage as measured by X-ray and improvement of physical function in psoriatic arthritis. In November 2017, PBAC recommended an amendment to allow golimumab to be used as a first-line biological disease-modifying anti-rheumatic drug for rheumatoid arthritis. In November 2017, PBAC recommended a new Authority Required listing for the treatment of moderate to severe ulcerative colitis. In July 2018, PBAC recommended extending the PBS listing to include an Authority Required (written) listing for active non-radiographic axial spondyloarthritis.