How effective is SIMPONI ARIA for Rheumatoid Arthritis?
SIMPONI ARIA is a new medicine used to treat rheumatoid arthritis.
It is given into an arm vein, every two months over about thirty minutes. In a 14 week study of adults with moderately to severely active rheumatoid arthritis, when used in combination with the first line drug methotrexate, almost 60% of patients receiving SIMPONI ARIA were at least 20% better as compared with 25% of patients receiving only methotrexate and no SIMPONI ARIA.
Not only were people better using clinical measurements, there was much less joint damage; after 6 months there was a 97% reduction in the damage seen in joints. This was seen in the ‘GO-FURTHER’ study*; a global, multicenter, randomized, double-blind, placebo-controlled study in nearly 600 adult patients who had active rheumatoid arthritis despite taking methotrexate for at least 3 months and who had not been previously treated with an anti-TNF agent (such as Enbrel or Humira). Moderately to severely active RA was defined as at least 6 swollen and tender joints. They had positive tests for rheumatoid factor and/or anti-CCP antibody, and an increased level of an inflammatory marker called C-reactive protein (CRP). For an explanation of these tests click here.
How Safe is SIMPONI ARIA?
Is there more cancer in patients treated with this drug? In clinical trials, there was about 1 case of cancer (not including lymphoma and non-melanoma skin cancer) for every 200 years of patient use. More lymphomas have been seen in children and adolescent patients receiving this medicine.
Patients with a history of untreated tuberculosis, Hepatitis B, multiple sclerosis or severe congestive heart failure should not receive TNF inhibitors such as SIMPONI ARIA.
The immune system’s ability to ward off infections is diminished in patients receiving SIMPONI ARIA, or other medicines in this class of TNF blocker drugs (includes Enbrel, Cimzia and Remicade). Using patient years, if 100 patients took Simponi for a year for rheumatoid arthritis, there would be predicted 5.7 serious infections, versus 4.2 infections in patients not receiving the medication.
In all the the TNF blockers, patients at higher risk (elderly or those with diminished immune systems or a tendency for infections) are at higher risk for infections they normally would not have to worry as much about (such as tuberculosis or other tuberculosis-like bacteria, fungus, virus, parasitic, valley fever, certain molds and yeast-like diseases). These are usually less than 0.1% however, and low risk.