Simponi treatment for psoriatic arthritis (and psoriasis?)
Simponi (golimumab) was U.S. Food and Drug Administration (FDA) approved in April 2009 for the treatment of several types of inflammatory arthritis including psoriatic arthritis, rheumatoid arthritis (RA), and ankylosing spondylitis. In the psoriatic arthritis trial, at week 24, about half of patients experienced at least 20 percent improvement in arthritis signs and symptoms (ACR 20), which is the standard measurement used by the U.S. Food and Drug Administration (FDA) in evaluating arthritis treatments. Also at week 24, about 30% of patients achieved a 50% improvement (ACR 50); and about 20% of patients achieved a 70% improvement (ACR 70).
The clinical trial that tested the effectiveness of Simponi against psoriatic arthritis also evaluated skin and nail psoriasis in trial participants. At week 24, of those with psoriasis on at least 3% of their body surface, about 60% of patients achieved a 75% improvement in skin symptoms (PASI 75); there was also significant improvement in nail symptoms. (Although Simponi has not been FDA approved for psoriasis alone, doctors are allowed to prescribe it “off-label” for this, and some will do it, especially if other psoriasis treatments have not worked for someone.)
How is it administered? Simponi is administered once a month by self-injection under the skin.
Advantages Simponi appears to be very effective against skin psoriasis and psoriatic arthritis. It also significantly improves nail psoriasis, a condition that is seldom evaluated in clinical trials. It needs to be administered only once a month, less often than Humira and Enbrel, other self-injectable biologics.
Drawbacks Like all of the TNF-inhibitors, Simpini has the potential to cause the rare but serious side effects described here. Based on the clinical trial results, Simponi appears to be as safe as the other drugs in this group. However, Simponi is very new, so it is not known whether problems might arise during long-term use.
Finally, Simponi has so far only been approved for arthritis. For other psoriasis symptoms, Simponi would need to be prescribed “off-label.” Although this is a legitimate practice, it may not be the first choice of doctors or patients, and some insurers do not reimburse patients for off-label uses (but some do, especially if a patient or physician can demonstrate that other treatments have not worked). Multi-year study results in psoriasis are also lacking, although a psoriatic arthritis study continues, and results from that are expected in 2011 or 2012.
How does it work? Like Simponi is a human antibody that binds to TNF-alpha and renders it inactive. Reducing the amount of active TNF-alpha in the body partially alleviates the inflammation that causes psoriasis symptoms.
Payment assistance
The company that markets this treatment is among those that have programs to help people afford their treatments. Learn more here: Psoriatic Arthritis Prescription Payment Assistance Programs.
[More info: Simponi website.]
[More info: Biologics for psoriasis.]
[More info: Psoriasis Treatments.]
