P093 The Comparison of Short-Term Efficacy of Treatments Between Tofacitinib and Vedolizumab in Patients With Ulcerative Colitis
Authors: Takada Yoshiaki , Naganuma Makoto , Mutaguchi Makoto , Fukuda Tomohiro , Mikami Yohei , Hagihara Yuya , Tanemoto Shun , Umeda Satoko , Nomura Ena , Yoshida Kosuke , Yoshimatsu Yusuke , Ono Keiko , Sugimoto Shinya , Nanki Kosaku , Fukuhara Kayoko , Sujino Tomohisa , Takabayashi Kaoru , Ogata Haruhiko , Iwao Yasushi , Kanai Takanori 
Published: December 2019

BACKGROUND:
The therapeutic advancements including anti-TNFα antibody has made dramatically improved the treatment of ulcerative colitis (UC), and the number of cases who can avoid surgery is increasing. However, a certain number of patients remain resistant to treatment. However, few studies have been performed to compare the real-world efficacy and safety of tofacitinib (TOF) and vedolizumab (VDZ) for UC. Here, we assessed the short-term efficacy and safety of TOF and VDZ.

METHODS:
This was a retrospective single-center observation study in UC patients who initiated TOF (n = 38) and VDZ (n = 28) from May 2018 to May 2019. The primary outcome was short-term efficacy that was evaluated by remission rate and response rate at 2 weeks and 6 weeks after the start of treatment. We defined remission as a partial Mayo score (pMayo) of 1 point or less, and response rate as a pMayo 1 point or less or a decrease of 3 points or more. Furthermore, the clinical background factors contributing to the efficacy at 6 weeks were examined, and the side effects in the mean observation period (TOF group 133.6 days and VDZ group 74.6 days) were evaluated. This study was approved by the ethics committee of Keio University School of Medicine (approval number:20150210).

RESULTS:
There was no significant difference of clinical background factors between two groups, TOF/VDZ, in terms of clinical duration (10.7 years/7.9 years), relapse-remission type (71.1%/64.3%) and all colitis type (63.2%/60.7%). However, severity of UC was higher in TOF group, average pMAYO 5.7/4.0 (P = 0.002), average endoscopic Mayo score (eMayo) 2.58/1.82 (P = 0.002) and average ulcerative colitis endoscopic index of severity (UCEIS) 4.34/2.71 (P = 0.001), and there were fewer cases of bio-naïve (23.7%/50.0% (P = 0.027)).The remission rate at 2 weeks and 6 weeks were 23.7%/28.5% (P = 0.654) and 39.4%/32.1% (P = 0.611), respectively, and the response rates at 2 weeks and 6 weeks were 50.0%/35.7% (P = 0.248) and 63.2%/35.7% (P = 0.027). The platelet count at the time of introduction and the CRP value at 2 weeks contributed to the efficacy at 6 weeks in TOF group, on the other hand, the ulcer score of eMayo and UCEIS at the time of introduction and pMayo at 2 weeks contributed in the VDZ group. Bio-naïve did not contribute to the clinical efficacy in the both groups. There were no serious side effects and no cases were discontinued due to side effects in the both groups.

CONCLUSION(S):
In the present study, TOF tended to have higher short-term efficacy regardless of the severity of the disease and the previous usage of biologics. Both groups had no serious side effects within the observation period. In the near future, further head-to-head study is required to extend these findings and determine the appropriate therapeutic options in terms of the mid-to long-term efficacy and safety.