The clever title is derived from an editorial (KE Burke, AN Ananthakrishan. Clin Gastroenterol Hepatol 2019; 17: 1438-40) regarding three recent publications regarding Tofacitinib, a non-selective inhibitor of janus kinase (JAK) enzymes 1,2 and 3 which was FDA-approved in May 2018 for moderate to severe ulcerative colitis. This report was published prior to recent FDA warning regarding blood clots: FDA Warning on Tofacitinib

Two of the reports have been summarized previously on this blog:

• Tofacitinib Case Reports for Acute Severe UC and Pyoderma Gangrenosum

The third study examines the safety of tofacitinib: W Sandborn et al. Clin Gastroenterol Hepatol 2019; 17: 1541-50

Methods: This study analyzed data from phase 2 and phase 3 trials with 1157 patients who had a median treatment of 1.4 years (1613 person-years).  More than three-fourths were receiving 10 mg BID.

Findings:

• Serious infections were infrequent but there was a dose response relationship associated with herpes zoster infections.  At 10 mg BID,  the frequency was 5% whereas the rate was 1.5% in those receiving 5 mg BID and 0.5% in placebo-treated patients. This is likely related to interference of interferon production related to JAK inhibitor disruption.
• Sandborn et al conclude that the “safety profile of tofacitinib for patients with UC appeared similar to that reported for patients with rheumatoid arthritis and for patients with UC treated with biologic agents, except for the higher incidence rate of herpes zoster infection.”

The editorial recommends NOT using tofacitinib for acute severe ulcerative colitis (ASUC); it “should be encouraged only in selected patients and preferably in the context of a research study.”  “Infliximab and cyclosporine [should be used] for steroid refractory UC;” however, they suggest that “one can consider initiating tofacitinib PRIOR to patients becoming steroid refractory.  “It could be used upfront on day 1.”

Related blog posts -Tofacitinib:

• Tofacitinib: Where does it Fit in UC Treatment Algorithm?
• AGA Guidelines on the Management of Mild-to-Moderate Ulcerative Colitis
• Tofacitinib for Induction and Maintenance of Ulcerative Colitis
• Latest on Tofacitinib for Refractory Ulcerative Colitis
• Tofacitinib –a JAK Inhibitor for UC
• Tofacitinib -Risks and Benefits in Rheumatoid Arthritis

Related blog posts -ASUC:

• Management of Acute Severe Ulcerative Colitis
• Oral Antibiotics For Refractory Inflammatory Bowel Disease | gutsandgrowth
• Management of Pediatric Ulcerative Colitis -ECCO Recommendations
• Tofacitinib -Where Does it Fit in Treatment Algorithm for Ulcerative Colitis?
• An Overlooked Finding in A Recent Severe Colitis Study
• Infliximab for children with Ulcerative Colitis
• Accelerated Infliximab Dosing in Acute … – gutsandgrowth
• Predictors of colectomy in pediatric UC | gutsandgrowth

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Disclaimer: These blog posts are for educational purposes only. Specific dosing of medications/diets (along with potential adverse effects) should be confirmed by prescribing physician/nutritionist.  This content is not a substitute for medical advice, diagnosis or treatment provided by a qualified healthcare provider. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a condition.