Tofacitinib is effective for managing ulcerative colitis (UC) and is linked to sustained steroid-free remission. The product label recommends dose de-escalation after eight or 16 weeks, but is this best for patients?
To answer this question, UCSF researchers recently conducted a retrospective real-world study of adults taking tofacitinib for moderate to severe UC.
“Anecdotally in our clinic, we noticed that colitis was flaring in a lot of patients whose tofacitinib doses were dropped,” said UCSF gastroenterologist Kendall Beck, MD. “That’s why we wanted to do this study.”
10 years of data
The cohort was composed of patients with UC who took tofacitinib between June 2012 and January 2022 at an induction treatment of 10 mg twice daily. Nearly half of the patients were lowered to 5 mg twice daily within the recommended time period. Of those, more than half experienced a UC disease activity–related event, such as hospitalization or surgery, within 12 months of dose de-escalation. This was more likely in patients with an induction course of fewer than 16 weeks and active endoscopic disease at six months after induction. Notably, of the patients who re-escalated to 10 mg twice daily, only 63% were able to recapture clinical response.
“We found that there was a significant rate of patients’ ulcerative colitis flaring when the dose was dropped,” Beck said. “About a third of those patients weren’t able to recapture response, which is problematic.”
While tofacitinib dose de-escalation is recommended for long-term maintenance therapy to reduce the potential lifetime risk of medication-related adverse events, the researchers concluded that sustained remission is essential for preventing short- and long-term disease-related complications in patients with UC.
“For my patients, I no longer drop the dose unless the patient has side effects,” Beck said.
Innovative clinical research, exceptional patient care
The UCSF Colitis and Crohn’s Disease Center provides comprehensive care for people with inflammatory bowel disease (IBD), including Crohn’s disease, UC, microscopic or collagenous colitis, and related illnesses.
“Our center, led by Dr. Uma Mahadevan, has a robust group of providers with a strong track record of clinical research and patient care,” Beck said. “We have opportunities to collaborate and share our research.”
To learn more
UCSF Colitis and Crohn’s Disease Center
Phone: (415) 353-7921 | Fax: (415) 502-2249
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