On April 24, the U.S. Food and Drug Administration (FDA) approved Simponi (golimumab) for the treatment of three forms of arthritis, including active psoriatic arthritis. Described in media reports as a “potential blockbuster drug,” Simponi is administered once monthly via injection under the skin. As WebMD put it: “Simponi is in a class of drugs that target and neutralize tumor necrosis factor-alpha (TNF-alpha), a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage, and tissue.” There are three other TNF blockers approved for psoriatic arthritis (and all three are also approved for psoriasis): the biologics Enbrel, Humira and Remicade. (In the United States, Remicade and Simponi are both marketed by Centocor Ortho Biotech.)
Simponi was studied in a Phase 3 trial in 405 adults with moderately to severely active psoriatic arthritis. The study found that at week 24, roughly 40% of patients achieved a significant, 20% improvement in their arthritis symptoms. In addition, roughly 30% of patients improved by 50%, and roughly 20% of patients showed a 70% improvement. Most of the improvement seen in patients had been achieved by week 14, and was sustained through continued treatment.
Like other TNF blockers, Simponi carries warnings about potentially serious side effects that can infrequently occur, including risk of tuberculosis (TB) and other serious infections. In addition, with use of TNF blockers, the risk of developing lymphoma or other cancers may increase; and heart failure and liver problems may occur more frequently in patients using TNF blockers.
“Psoriatic arthritis is a little-known, but potentially devastating disease,” said Michael Paranzino, president of Psoriasis Cure Now. “It is always exciting when patients get access to an additional, promising treatment option. Psoriasis patients who experience joint pain should mention that to their doctor and discuss their treatment options, as psoriatic arthritis can worsen over time, even causing permanent damage.”
To access the Simponi website, which includes a detailed patient guide, click here.
Category: Biologics, Treatment, psoriatic arthritis
Tags: FDA, golimumab, Simponi
