A recent study has found that using Tofacitinib in addition to traditional IV corticosteroids could help greatly reduce risk of colectomy in hospitalized patients with severe UC. This comes as welcome news, as currently 30% of hospitalized patients with severe UC will not respond to corticosteroids, often making a colectomy the only option. If the patient is naïve to biologics, Cyclosporine or infliximab (Remicade) is often the option for care, but drug failure is common in these medications and will not be considered if previously used. Tofacitinib is also a more affordable option for patients at about $1,444 for nine 10mg doses (a full treatment) versus $3,300 for a single infusion of infliximab.Â
This is the first and largest case-study to evaluate the JAK inhibitor as therapy for ASUC (acute severe ulcerative colitis). Up until now only small case studies have been done with tofacitinib and severe UC, leaving doctors to make their own opinions about the new drug. Safety concerns have risen as of late for the JAK inhibitor after the FDA issued an alert for possible cardiovascular events. However, it was noted that none of the patients experienced this side effect while participating in the study, and the rate of contracting infections remained the same.
In this study, patients were given 10mg of Tofacitinib either two times a day or three times a day in addition to IV corticosteroids. The rest were given a placebo. Patients in this study receiving Tofacitinib had UC for an average length of ten years, versus eight years in the control group. Patients given the Tofacitinib had all also had prior experience with biologics without success. The goal of this study was to evaluate patients at 90 days to see if a colectomy was needed. After the 90-day mark, 15% of the Tofacitinib group needed a colectomy whereas the control group was at 20%. Researchers also found that the dosing of two 10mg of Tofacitinib a day in addition to corticosteroids was not enough, but the dose of three 10mg a day saw a difference.       Â
For those receiving tofacitinib the average hospital stay was nine days, while the control groups average was seven days. This is because tofacitinib is administered for nine consecutive days, where corticosteroids don’t necessarily have set time frames. It may seem like a negative to be hospitalized two days longer, but remember these patients had a 5% less chance of needing a colectomy. It may seem like a small percent, but every bit counts when major surgery is on the table. The tofacitinib group also had been taking steroids for a longer period of time (51 days vs 9) than the control, and were still able to see positive results.Â
While tofacitinib is still relatively new, after this study it will be considered not only for dual therapy treatment with corticosteroids, but for monotherapy by itself as well. This means we may see a shift in standard care for those hospitalized with ASUC. Instead of large doses of steroids, tofacitinib may take their place as the standard protocol. More research about tofacitinib’s safety and effectiveness will need to be done, as this was the first large scale study for UC treatment with it. However, the JAK inhibitor shows great promise in rapidly reducing inflammation and symptoms, as well as reducing colectomy risk. Keep your eye on this up-and-coming drug as more studies will surely be done in the next few years.   Â
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