Tag: ulcerative colitis

Pharmacology News Digest, July 22nd 2018

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Arthritis Drug Tofacitinib Approved for Severe Ulcerative Colitis | FDA

The US FDA has approved tofacitinib (Xeljanz, Pfizer) for the treatment of moderate-severe ulcerative colitis (UC).

Tofacitinib

  • Janus kinase inhibitor (blocks STAT transcription factor activation and inflammatory signaling)
  • First oral agent approved for chronic use in UC
  • 10 mg tofacitinib PO BID induced remission in 17-18% of patients (vs. 8.2% placebo) after 8 weeks
  • Of patients that responded after 8 week trial, 40.6% who continued 10-mg tofacitinib for 52 weeks achieved sustained remission (versus 11.1% placebo)
  • Adverse events (common):  arthralgia, diarrhea, elevated cholesterol, headache, shingles, rash, and upper respiratory infection
  • Adverse events (severe): malignancy (e.g., lymphoma), serious opportunistic infections (FDA black-box warnings)

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