The highly-anticipated data from Pfizer‘s Phase 3 Octave Studies of tofacitinib in ulcerative colitis patients were published early last month in The New England Journal of Medicine.
The data overall demonstrated that tofacitinib was effective as both an induction therapy and a maintenance therapy in the treatment of moderate to severe ulcerative colitis.
(Even though tofacitinib (brand name XELJANZ®) is currently approved for the treatment of active rheumatoid arthritis, it is not for the treatment of ulcerative colitis.)
Ulcerative colitis is a rare inflammatory bowel disease that leads to a variety of chronic and debilitating symptoms for the people it affects. To learn more about ulcerative colitis, including current treatment options, click here.
All three Phase 3 studies in OCTAVE were successful in proving that tofacitinib was more effective than placebo in helping ulcerative colitis patients achieve remission, and study investigator, William J. Sandborn, claims that
“This robust data set provides evidence that tofacitinib, if approved, could be an important new oral treatment option [for…] ulcerative colitis.”
Tofacitinib works by inhibiting the JAK 3 inhibitor and also inhibiting an enzyme called janus kinase (JAK) 1, which is involved with a DNA transcription signaling pathway. This inhibition reduces the production of inflammatory agents in the body that contribute to immunological conditions, like rheumatoid arthritis, psoriasis, and ulcerative colitis.
In this way, tofacitinib targets the underlying biological cause of these diseases, rather than focusing merely on symptom management, thus providing a more effective treatment option for patients.
Stay tuned in the coming months for news on the next steps and the hopeful U.S. FDA approval of this exciting new medication!
