Intestinal Research

Original Articles

Treatment patterns and outcomes in patients with steroid-dependent ulcerative colitis in Japan: a claims database study: Masayuki Saruta, Takumi Sugiyama, Takumi Tajima, Chisa Nagakura, Yan Zhong, Toshihiko Kaise; Received February 18, 2025 Accepted August 12, 2025 Published online November 13, 2025; DOI: https://doi.org/10.5217/ir.2025.00032 [Epub ahead of print]

Abstract PDF Supplementary Material PubReader ePub: Background/Aims
Guidelines recommend that steroid treatment for ulcerative colitis (UC) is tapered or withdrawn within 3 months of initiation, and thiopurine treatment or advanced therapy is administered for steroid-dependent UC. This study aimed to clarify real-world treatment patterns and outcomes in patients with steroid-dependent UC in Japan.
Methods
A retrospective analysis of JMDC (Japan Medical Data Center) claims data was conducted to identify patients with a new UC diagnosis between June 2010 and September 2019. Index dates were the UC treatment start date (initiation of any UC treatment), steroid dependence/resistance confirmation date (identification of steroid-dependent UC), and treatment intensification date (initiation of thiopurine treatment/advanced therapy).
Results
Of 5,602 patients with newly diagnosed UC, 986 (17.6%) initiated steroids within 12 months (85.4% [842/986] received 5-aminosalicylic acid at the UC treatment start date). Of these 986 patients, 429 (43.5%) were classified as steroid-dependent (steroid dependence/resistance confirmation date). Of these 429 patients, 128 (29.8%) initiated thiopurine treatment and 75 (17.5%) initiated advanced therapy (treatment intensification date); 226 (52.7%) continued with steroids only. Across these groups, 3-6% discontinued steroids within 3 months of initiation. Hospitalization due to UC in the 12 months after the treatment intensification date occurred in 24.2% (31/128) and 18.7% (14/75) of patients who initiated thiopurine and advanced therapy, respectively.
Conclusions
Over half of patients with steroid-dependent UC continued steroid treatment only. Steroid discontinuation within 3 months of initiation was low, irrespective of whether thiopurines or advanced therapy were initiated. Management of patients with steroid-dependent UC in Japan requires further treatment optimization toward guideline adherence.

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IBD

Efficacy and safety of the adalimumab biosimilar Exemptia as induction therapy in moderate-to-severe ulcerative colitis: Vandana Midha, Ramit Mahajan, Varun Mehta, Vikram Narang, Arshdeep Singh, Kirandeep Kaur, Ajit Sood; Intest Res 2018;16(1):83-89. Published online January 18, 2018; DOI: https://doi.org/10.5217/ir.2018.16.1.83

Abstract PDF PubReader ePub

<b>Background/Aims</b><br/>

Data on the efficacy and safety of the adalimumab biosimilar Exemptia are limited.

Methods

Patients with moderate-to-severe active steroid-refractory ulcerative colitis (UC) treated at Dayanand Medical College and Hospital, India were offered cyclosporine A, biologicals or biosimilars, or surgery. A retrospective analysis was conducted on patients who were treated with the adalimumab biosimilar, Exemptia. These patients were administered an induction dosing schedule of 160 mg Exemptia at week 0, 80 mg at week 2, and then 40 mg every other week from week 4 to 8. The clinical response and remission were assessed at week 8 using Mayo score.

Results

A total of 29 patients (62.1% male; mean age, 34.9 ± 9.7 years) with moderate-to-severe steroid-refractory active UC (mean disease duration, 6.3±5.1 years; pancolitis in 9 patients [31.1%]; left-sided colitis in 20 patients [68.9%]) were treated with the Exemptia induction dosing schedule. The mean Mayo score at presentation was 8.2±1.4. At week 8, clinical response was observed in 7 patients (24.1%), whereas clinical remission was observed only in 1 patient (3.5%). Among the non-responders (n=21), 4 patients required colectomy, 1 died, 1 was lost to follow-up, 10 were offered fecal microbiota transplant, 3 were administered infliximab, and 2 patients were administered cyclosporine and tacrolimus, respectively. Four patients (13.8%) developed extrapulmonary tuberculosis.

Conclusions

The adalimumab biosimilar Exemptia has limited efficacy for the attainment of clinical response and remission in moderate-to-severe steroid-refractory UC, with a significant risk of acquisition or reactivation of tuberculosis in developing countries such as India.

Citations

Citations to this article as recorded by

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