Lower effectiveness of intravenous steroid treatment for moderate-to-severe ulcerative colitis in hospitalised patients with older onset: a multicentre cohort study
Funding information: This work was supported by a clinical research fund from the Japanese Society for Inflammatory Bowel Disease
The Handling Editor for this article was Professor Richard Gearry, and it was accepted for publication after full peer-review.
Summary
Background
The increasing incidence of older-onset ulcerative colitis (UC), which has a higher risk of surgery, is a global health issue. However, data regarding intravenous steroid treatment, one of the important treatment options to avoid surgery, for older-onset UC is lacking.
Aims
To evaluate the association between onset age and effectiveness of intravenous steroids in UC.
Methods
This retrospective multicentre (27 facilities) cohort study included moderate-to-severe hospitalised UC patients who underwent their first intravenous steroids between April 2014 and July 2019. The primary outcome was clinical remission at day 30, using two-item patient-reported outcome scoring. The key secondary outcomes were risks of surgery and adverse events (death, infection and venous thrombosis) within 90 days. A modified Poisson regression model was used for analysis.
Results
Overall, 467 UC patients (384 younger-onset and 83 older-onset) were enrolled. Clinical remission at day 30 was observed in 252 (65.6%) among younger-onset patients and 43 (51.8%) among older-onset patients (adjusted risk difference, −21.7% [95% CI, −36.1% to −7.2%]; adjusted risk ratio [ARR], 0.74 [95% CI, 0.59 to 0.93]). The risks of surgery and adverse events were higher in older-onset UC (20.5% vs. 3.1%; ARR, 8.92 [95% CI, 4.13 to 19.27], 25.3% vs. 9.1%; ARR, 2.19 [95% CI, 1.22 to 3.92], respectively). Four deaths occurred, all involving older-onset UC. The risks of infection and venous thrombosis were also higher in older-onset UC (18.1% vs. 8.6%, 7.2% vs. 0.5%, respectively).
Conclusions
Older-onset was associated with a lower effectiveness of intravenous steroids with higher risks of surgery and adverse events in UC.
CONFLICT OF INTEREST
All authors have no conflicts of interest directly associated with this study. SS has served as a speaker for AbbVie, Takeda Pharmaceutical, Zeria Pharmaceutical and an endowed chair from AbbVie, JIMRO, Zeria Pharmaceutical, Kyorin Pharmaceutical, Mochida Pharmaceutical, EA Pharma. KM has received lecture fees from Takeda Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Abbvie Inc., EA Pharma Co., Ltd., Pfizer Inc., Mochida Pharmaceutical Co., Ltd., Kyorin Pharmaceutical Co., Ltd., ZERIA Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., Alfresa Pharma Corporation, JIMRO Co., Ltd., Miyarisan Pharmaceutical Co., Ltd; has received research grants from Takeda Pharmaceutical Co., Ltd., Janssen Pharmaceutical K.K., Abbvie Inc., EA Pharma Co., Ltd., Pfizer Inc., Mochida Pharmaceutical Co., Ltd., Kyorin Pharmaceutical Co., Ltd., ZERIA Pharmaceutical Co., Ltd., Kissei Pharmaceutical Co., Ltd., Nippon Kayaku Co., Ltd., JIMRO Co., Ltd. TF has received research funding from Mitsubishi Tanabe Pharma. KY has received speaker fees from Mitsubishi Tanabe Pharma, Mochida Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd. YH has received speaker fees from Mitsubishi Tanabe Pharma, Janssen Pharmaceutical K. K., Mochida Pharmaceutical Co., Ltd., Kyorin Pharmaceutical Co., Ltd., Takeda Pharmaceutical Co., Ltd.; advisory fees from Mitsubishi Tanabe Pharma, Janssen Pharmaceutical K.K. TH has received lecture fees from Aspen Japan K.K., Abbvie GK, Ferring, Gilead Sciences, Janssen, JIMRO, Mitsubishi-Tanabe Pharma, Mochida Pharmaceutical, Pfizer, Takeda Pharmaceutical; has received advisory/consultancy fees from Apo Puls Station, Abbvie GK, Bristol-Myaers Squibb, Celltrion, EA Pharma, Eli Lilly, Gilead Sciences, Janssen, Kyorin, Mitsubishi-Tanabe Pharma, Nichi-Iko Pharmaceutical, Pfizer, Takeda Pharmaceutical, Zeria Pharmaceutical; has received research grants from Abbvie GK, EA Pharma, JIMRO, Otsuka Holdings and Zeria Pharmaceuticals. TK has received personal fees from Alfresa Pharma, Covidien, Eli Lilly, Ferring Pharmaceuticals, Janssen, Kyorin Pharmaceutical Co., Ltd, Mochida Pharmaceutical, Nippon Kayaku, Pfizer, Takeda Pharmaceutical, Thermo Scientific, Abbvie GK, Ajinomoto Pharma, Asahi Kasei Medical, Astellas, Celltrion, EA Pharma Co., Ltd, Mitsubishi Tanabe Pharma, ZERIA, Eisai Co., Ltd, Gilead Sciences, JIMRO Co., Ltd.; has received grants from Abbvie GK, EA Pharma Co., Ltd, Otsuka Holdings Co., Ltd, ZERIA, Kyorin Pharmaceutical Co., Ltd, Mochida Pharmaceutical, Thermo Fisher Scientific, Alfresa Pharma, Nippon Kayaku, Asahi Kasei medical. Under a contract between Kyoto University and Takeda Pharmaceutical Company Limited, fees for consulting with HY were paid to Kyoto University, which are not related to this work. AA has received lecture fees from Janssen Pharma, Takeda Pharmaceutical and Miyarisan Pharmaceutical. Other authors disclosed no conflicts of interest.
