Tofacitinib oral pill for ulcerative colitis

July 16, 2018 0 By CH Unnikrishnan

The U.S. Food and Drug Administration expanded the approval of tofacitinib (Xeljanz) to include adults with moderately to severely active ulcerative colitis. Xeljanz is the first oral medication approved for chronic use in this indication.

Tofacitinib contains JAKs (Janus Kinases), which transfer signals from cytokine to regulate immune cell function. Within the signaling pathway, JAKs also activate phosphorylate and Signal Transducers and Activators of Transcription (STATs), which regulate intracellular activity.

The efficacy of tofacitinib for the treatment of this inflammatory bowel disease was demonstrated in three controlled clinical trials. This included two 8-week placebo-controlled trials that demonstrated that 10 mg of tofacitinib given twice daily induces remission in 17 to 18 percent of patients by week eight.

Tofacitinib, made by Pfizer Labs, was previously approved in 2012 for rheumatoid arthritis and in 2017 for psoriatic arthritis.