Published online Apr 7, 2024. doi: 10.3748/wjg.v30.i13.1871
Peer-review started: January 9, 2024
First decision: January 17, 2024
Revised: January 30, 2024
Accepted: March 13, 2024
Article in press: March 13, 2024
Published online: April 7, 2024
Processing time: 84 Days and 16.6 Hours
Real-world data on tofacitinib (TOF) covering a period of more than 1 year for a sufficient number of Asian patients with ulcerative colitis (UC) are scarce.
To investigate the long-term efficacy and safety of TOF treatment for UC, including clinical issues.
We performed a retrospective single-center observational analysis of 111 UC patients administered TOF at Hyogo Medical University as a tertiary inflammatory bowel disease center. All consecutive UC patients who received TOF between May 2018 and February 2020 were enrolled. Patients were followed up until August 2020. The primary outcome was the clinical response rate at week 8. Secondary outcomes included clinical remission at week 8, cumulative persistence rate of TOF administration, colectomy-free survival, relapse after tapering of TOF and predictors of clinical response at week 8 and week 48.
The clinical response and remission rates were 66.3% and 50.5% at week 8, and 47.1% and 43.5% at week 48, respectively. The overall cumulative clinical remission rate was 61.7% at week 48 and history of anti-tumor necrosis factor-alpha (TNF-α) agents use had no influence (P = 0.25). The cumulative TOF persistence rate at week 48 was significantly lower in patients without clinical remission than in those with remission at week 8 (30.9% vs 88.1%; P < 0.001). Baseline partial Mayo Score was significantly lower in responders vs non-responders at week 8 (odds ratio: 0.61, 95% confidence interval: 0.45-0.82, P = 0.001). Relapse occurred in 45.7% of patients after TOF tapering, and 85.7% of patients responded within 4 wk after re-increase. All 6 patients with herpes zoster (HZ) developed the infection after achieving remission by TOF.
TOF was more effective in UC patients with mild activity at baseline and its efficacy was not affected by previous treatment with anti-TNF-α agents. Most relapsed patients responded again after re-increase of TOF and nearly half relapsed after tapering off TOF. Special attention is needed for tapering and HZ.
Core Tip: This is a retrospective single-center observational study to investigate the long-term efficacy and safety of tofacitinib (TOF) treatment for ulcerative colitis (UC), including clinical issues. TOF is more effective in low-activity UC patients and its efficacy is not affected by previous treatment with anti-tumor necrosis factor-alpha agents. Most patients in the clinical remission group at week 8 could continue TOF over a long follow-up period. Most relapsed patients responded again after re-increase of TOF and nearly half relapsed after tapering off TOF. Although most patients continue TOF without severe adverse events, careful monitoring for herpes zoster is necessary.