With the help of the American College of Rheumatology, and Robert Lahita, M.D., a New Jersey rheumatologist, MyRACentral has the answers to some basic questions about Simponi. We’ve covered everything from the science to the side effects, and we encourage you to share your experiences, questions and concerns with Simponi in the comments.
What is Simponi?
Simponi is a monoclonal antibody against tumor necrosis factor alpha. A monoclonal antibody is a protein made in the laboratory that is specific to a substance in the blood. Tumor necrosis factor is a substance that is associated with bad inflammation in the blood. We call it a cytokine, which is a chemical that allows the cells of the immune system to talk to each other.
Who should take Simponi?
Those who should take Simponi are patients with rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.
Is Simponi different from the older biological like Enbrel or Remicade?
The drug is different because it has to be given only once per month.
I have just been placed on Simponi and wondered what the clinical trial results have been?
There have been many trials with this drug for a variety of conditions. GO-BEFORE, which is Simponi sub-cutaneously every four weeks in RA patients who had not taken methotrexate before.; GO-REVEAL, which is Simponi given to psoriatic patients every four weeks; GO-RAISE, which is phase 3 drug given to those with ankylosing spondylitis. A phase 3 drug is almost ready for use in the public domain. Phase 1 and 2 are basically raw experimental data from animals and some human studies to show efficacy and safety. Phase 3 is really the true test of the drug when the study subjects are compared to people getting a placebo or fake drug. The investigators usually have no idea who is getting what, and that is called a “double blind”. In all of these trials significant efficacy has been shown.
How quickly does it work?
The median time to have serum concentrations reach efficacy was some two to six days. The drug, therefore, could have significant effects on patients and their disease processes within one to one and a half weeks.
How is it administered and how should I take it?
It is given by injection once per month sub-cutaneously. The patients can self-administer the drug.
Other Biologics, like e.g., Humira, sting when injected. Does Simponi do this, too?
What are the side-effects?
Common side effects include flu-like symptoms, dizziness and sinusitis (check Lene Andersen’s post on managing side effects). As with all biological agents of this nature (anti-TNF drugs), the major side effects are infections. Infections do not happen in everyone, and patients have to be tested for TB or fungi prior to taking the agent. The drugs have also been known to reactivate Hepatitis B, so we routinely test the patients for hepatitis antigens before they start the drug. Patients are also carefully watched for development of any severe infections during therapy. The TNF blockers have — in general — been associated with worsening of cancer, congestive heart failure, demyelination disorders and certain blood problems. These are uncommon to all of the TNF inhibitors, but have to be considered by the clinician.
Have any serious side effects been reported and if so, how frequently?
The most serious phase 2 side effects with this drug, which required discontinuation, were; infections (28 percent), liver enzyme elevations (0.2-0.7 percent), upper respiratory infections in roughly 7 percent of patients, autoimmune reactions (antibodies, lupus-like reactions, joint pains, etc.) injection site reactions, new onset psoriasis (paradoxical), and finally the development of antibodies to the drug itself.
I had my first dose of Simponi and it worked very well within three days. 19 days after my first dose, my RA started flaring again. Is this normal?
On occasion rheumatologists have seen “break through” disease in patients who achieve some remission early on. In such cases, a different TNF inhibitor or another kind of agent such as a cytokine inhibitor of another variety can and should be tried. Cytokines are like TNF. There are hundreds of cytokines or communication molecules and there are certain new class inhibitors which will be used to treat various forms of RA. Examples are anti-interleukin 10 or anti-interleukin 6.
About a month after starting Simponi I broke out in hives, rashes along with itching. Is this normal? (My doctor prescribed prednisone and Benadryl to take with my next dose)
Patients can develop autoantibodies or proteins that react with a patient’s own cells and tissues. Hives have not been seen with any of the TNF inhibitors that we have used. Local injection site erythema (redness around the injection site) is pretty common, but that is all we see. I could find nothing in the literature to suggest anaphylaxis type reactions with this drug.