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Original Articles

Incidence and treatment-based risk stratification of opportunistic infections in patients with inflammatory bowel disease: an ambispective cohort study in Brazil: José Eugenio Rios Ricci Jr, Tarsila Campanha da Rocha Ribeiro, Fernando Antonio Basile Colugnati, Lívia de Almeida Costa, Pedro de Morais, Jordana AS Lopes, Hugo B Araújo, Matheus A Pacheco, Mariana V de S Paulo, João Baptista de Paula Fraga, Lucélia Paula Cabral Schmidt, Thais de Andrade Almeida, Roberta Oliveira Raimundo Borsato, Liliana Andrade Chebli, Júlio Maria Fonseca Chebli; Received September 4, 2025 Accepted February 11, 2026 Published online May 21, 2026; DOI: https://doi.org/10.5217/ir.2025.00208 [Epub ahead of print]

Abstract PDF PubReader ePub: Background/Aims
The risk of opportunistic infections (OIs) in inflammatory bowel disease (IBD) patients in Latin America is poorly known. We assessed the incidence and stratified the risk of OIs in IBD patients on immunosuppressive therapies.
Methods
In this ambispective cohort study, we retrospectively analyzed the medical charts of IBD patients between March 2014 and March 2021 and prospectively analyzed those from April 2021 to April 2024. The incidence rate of OIs was expressed as the number per 1,000 patient-years (PY) and calculated for each treatment category. The risks of OIs associated with immunosuppressants were compared with exposure to aminosalicylates or no treatment using the Cox proportional hazards model.
Results
In a total of 3,279.6 PY of follow-up, OIs occurred in 60 of 498 patients (12.0%) with an incidence rate of 18.3 per 1,000 PY. The most common OIs were herpes zoster (HZ; n=28, 5.6%) and tuberculosis (n=17, 3.4%). The incidence rates of HZ and tuberculosis were 8.5 and 5.18 per 1,000 PY, respectively. Compared with patients on aminosalicylates or no treatment, the risk of OIs was higher in those on combination therapies with anti-tumor necrosis factor (TNF) and thiopurines (hazard ratio [HR], 7.67; 95% confidence interval [CI], 2.26–26.06), followed by thiopurine monotherapy (HR, 5.35; 95% CI, 1.56–18.3), and antiTNF monotherapy (HR, 5.04; 95% CI, 1.50–16.97).
Conclusions
IBD patients on long-term anti-TNF and/or thiopurine therapy had a higher risk of OIs, especially HZ and tuberculosis, compared with non-immunosuppressed patients. In the choice of therapies for IBD, the balance of individual drug effectiveness and safety is crucial.

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IBD

Clinical outcomes and predictors of response for adalimumab in patients with moderately to severely active ulcerative colitis: a KASID prospective multicenter cohort study: Seung Yong Shin, Soo Jung Park, Young Kim, Jong Pil Im, Hyo Jong Kim, Kang-Moon Lee, Ji Won Kim, Sung-Ae Jung, Jun Lee, Sang-Bum Kang, Sung Jae Shin, Eun Sun Kim, You Sun Kim, Tae Oh Kim, Hyun-Soo Kim, Dong Il Park, Hyung Kil Kim, Eun Soo Kim, Young-Ho Kim, Do Hyun Kim, Dennis Teng, Jong-Hwa Kim, Wonyong Kim, Chang Hwan Choi, on behalf of the IBD Research Group of the Korean Association for the Study of Intestinal Diseases; Intest Res 2022;20(3):350-360. Published online July 23, 2021; DOI: https://doi.org/10.5217/ir.2021.00049

Abstract PDF Supplementary Material PubReader ePub

Background/Aims
This study assessed the efficacy and safety of adalimumab (ADA) and explored predictors of response in Korean patients with ulcerative colitis (UC).
Methods
A prospective, observational, multicenter study was conducted over 56 weeks in adult patients with moderately to severely active UC who received ADA. Clinical response, remission, and mucosal healing were assessed using the Mayo score.
Results
A total of 146 patients were enrolled from 17 academic hospitals. Clinical response rates were 52.1% and 37.7% and clinical remission rates were 24.0% and 22.0% at weeks 8 and 56, respectively. Mucosal healing rates were 39.0% and 30.1% at weeks 8 and 56, respectively. Prior use of anti-tumor necrosis factor-α (anti-TNF-α) did not affect clinical and endoscopic responses. The ADA drug level was significantly higher in patients with better outcomes at week 8 (P<0.05). In patients with lower endoscopic activity, higher body mass index, and higher serum albumin levels at baseline, the clinical response rate was higher at week 8. In patients with lower Mayo scores and C-reactive protein levels, clinical responses, and mucosal healing at week 8, the clinical response rate was higher at week 56. Serious adverse drug reactions were identified in 2.8% of patients.
Conclusions
ADA is effective and safe for induction and maintenance in Korean patients with UC, regardless of prior anti-TNF-α therapy. The ADA drug level is associated with the efficacy of induction therapy. Patients with better short-term outcomes were predictive of those with an improved long-term response.

Citations

Citations to this article as recorded by

Impact of 5‐Aminosalicylic acid discontinuation in children with ulcerative colitis on biologic therapy: A propensity score‐matched study
Giulia D'Arcangelo, Luca Scarallo, Giulia Mancuso, Mara Corpino, Claudio Romano, Lorenzo Norsa, Serena Arrigo, Matteo Bramuzzo, Maria Teresa Fioretti, Giovanna Zuin, Maria Teresa Illiceto, Paolo Lionetti, Marina Aloi
Journal of Pediatric Gastroenterology and Nutrition.2026; 83(1): 96. CrossRef
Distinct predictive factors for acute severe ulcerative colitis in East Asian and Western populations
Eun Soo Kim, Dong Hyun Kim, Seong-Jung Kim, Sang Hyoung Park, Hyun Seok Lee, Sung Kook Kim, Hyun Soo Kim, Jun Lee, Kyeong Ok Kim, Byung Ik Jang, Yoo Jin Lee, Eun Mi Song, Dae Sung Kim, Chun-Chi Lin, Joyce Wing Yan Mak, Jing Liu, Qian Cao, Shu-Chen Wei, We
Inflammatory Bowel Diseases.2026;[Epub] CrossRef
Current and novel biomarkers for predicting and assessing therapeutic response in inflammatory bowel disease: a systematic review
Shellie Radford, Anoop John, Antonina Latino-Kelly, Catherine Alexander, Owen Wilding, Jaimin Chauhan, Farhad Shokraneh, Siddhee Pradhan, Gordon W. Moran
Therapeutic Advances in Gastroenterology.2026;[Epub] CrossRef
Development and Validation of a Clinical Decision Support Tool to Predict Disease Progression in Crohn’s Disease Treated with Ustekinumab
Lingya Yao, Yushu Cao, Chenhao Bai, Rongbei Liu, Wenjing Yang, Kang Chao, Zhaopeng Huang, Yun Qiu, Xiang Gao, Minhu Chen, Qian Cao
Journal of Clinical Medicine.2025; 14(22): 7919. CrossRef
Prospective Observational Evaluation of the Time-Dependency of Adalimumab Immunogenicity and Drug Concentration in Ulcerative Colitis Patients: the POETIC II Study
Sivan Harnik, Chaya M Abitbol, Ola Haj Natour, Miri Yavzori, Ella Fudim, Orit Picard, Timna Naftali, Efrat Broide, Ayal Hirsch, Limor Selinger, Eyal Shachar, Doron Yablecovitch, Ahmad Albshesh, Daniel Coscas, Uri Kopylov, Rami Eliakim, Shomron Ben-Horin,
Journal of Crohn's and Colitis.2024; 18(3): 341. CrossRef
Rapidly achieving clinical remission in ulcerative colitis indicates better endoscopic and histological outcomes
Rirong Chen, Yizhe Tie, Yongle Huang, Xi Zhang, Zhirong Zeng, Minhu Chen, Li Li, Shenghong Zhang
United European Gastroenterology Journal.2024; 12(4): 459. CrossRef
Effectiveness of adalimumab in severe ulcerative colitis: A systematic review and a meta‐analysis
Saleh Azadbakht, Masomeh Seighali, Salehe Azadbakht, Morteza Azadbakht
Health Science Reports.2024;[Epub] CrossRef
Dynamic changes in the gut microbiota composition during adalimumab therapy in patients with ulcerative colitis: implications for treatment response prediction and therapeutic targets
Han Na Oh, Seung Yong Shin, Jong-Hwa Kim, Jihye Baek, Hyo Jong Kim, Kang-Moon Lee, Soo Jung Park, Seok-Young Kim, Hyung-Kyoon Choi, Wonyong Kim, Woo Jun Sul, Chang Hwan Choi
Gut Pathogens.2024;[Epub] CrossRef
Real-world effectiveness and safety of advanced therapies for the treatment of moderate-to-severe ulcerative colitis: Evidence from a systematic literature review
Peter M. Irving, Peter Hur, Raju Gautam, Xiang Guo, Severine Vermeire
Journal of Managed Care & Specialty Pharmacy.2024; 30(9): 1026. CrossRef
Korean clinical practice guidelines on biologics and small molecules for moderate-to-severe ulcerative colitis
Soo-Young Na, Chang Hwan Choi, Eun Mi Song, Ki Bae Bang, Sang Hyoung Park, Eun Soo Kim, Jae Jun Park, Bora Keum, Chang Kyun Lee, Bo-In Lee, Seung-Bum Ryoo, Seong-Joon Koh, Miyoung Choi, Joo Sung Kim
Intestinal Research.2023; 21(1): 61. CrossRef
Changes in fecal metabolic and lipidomic features by anti-TNF treatment and prediction of clinical remission in patients with ulcerative colitis
Seok-Young Kim, Seung Yong Shin, Soo Jung Park, Jong Pil Im, Hyo Jong Kim, Kang-Moon Lee, Ji Won Kim, Sung-Ae Jung, Jun Lee, Sang-Bum Kang, Sung Jae Shin, Eun Sun Kim, You Sun Kim, Tae Oh Kim, Hyun-Soo Kim, Dong Il Park, Hyung Kil Kim, Eun Soo Kim, Young-
Therapeutic Advances in Gastroenterology.2023;[Epub] CrossRef
Reviewing not Homer’s Iliad, but “Kai Bao Ben Cao”: indigo dye—the past, present, and future
Yusuke Yoshimatsu, Tomohisa Sujino, Takanori Kanai
Intestinal Research.2023; 21(2): 174. CrossRef
Precision medicine and drug optimization in adult inflammatory bowel disease patients
Sophie Vieujean, Edouard Louis
Therapeutic Advances in Gastroenterology.2023;[Epub] CrossRef
Real-world effectiveness and safety of adalimumab in Korean patients with intestinal Behcet’s disease: a Korean Association for the Study of Intestinal Diseases (KASID) multicenter study
Seung Bum Lee, Hee Seung Hong, Chang Kyun Lee, Bo-In Lee, Sol Kim, Seong-Joon Koh, Hosun Yu, Jung-Bin Park, Sung Wook Hwang, Byong Duk Ye, Suk-Kyun Yang, Sang Hyoung Park
The Korean Journal of Internal Medicine.2023; 38(5): 661. CrossRef
Advancements in the Management of Moderate-to-Severe Ulcerative Colitis: A Revised 2023 Korean Treatment Guidelines
Soo-Young Na
The Korean Journal of Medicine.2023; 98(5): 223. CrossRef
Prediction of Clinical Remission with Adalimumab Therapy in Patients with Ulcerative Colitis by Fourier Transform–Infrared Spectroscopy Coupled with Machine Learning Algorithms
Seok-Young Kim, Seung Yong Shin, Maham Saeed, Ji Eun Ryu, Jung-Seop Kim, Junyoung Ahn, Youngmi Jung, Jung Min Moon, Chang Hwan Choi, Hyung-Kyoon Choi
Metabolites.2023; 14(1): 2. CrossRef
Association of C-reactive Protein and Partial Mayo Score With Response to Tofacitinib Induction Therapy: Results From the Ulcerative Colitis Clinical Program
Marla C Dubinsky, Fernando Magro, Flavio Steinwurz, David P Hudesman, Jami A Kinnucan, Ryan C Ungaro, Markus F Neurath, Nicole Kulisek, Jerome Paulissen, Chinyu Su, Dario Ponce de Leon, Miguel Regueiro
Inflammatory Bowel Diseases.2022;[Epub] CrossRef
Effectiveness and Safety of Golimumab in Patients with Ulcerative Colitis: A Multicenter, Prospective, Postmarketing Surveillance Study
Jongwook Yu, Soo Jung Park, Hyung Wook Kim, Yun Jeong Lim, Jihye Park, Jae Myung Cha, Byong Duk Ye, Tae Oh Kim, Hyun-Soo Kim, Hyun Seok Lee, Su Young Jung, Youngdoe Kim, Chang Hwan Choi
Gut and Liver.2022; 16(5): 764. CrossRef
Pharmacogenetics-based personalized treatment in patients with inflammatory bowel disease: A review
Ji Young Chang, Jae Hee Cheon
Precision and Future Medicine.2021; 5(4): 151. CrossRef

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Inflammatory bowel diseases

Safety of tumor necrosis factor inhibitor use in patients with concomitant malignancy: Hiep Phan, Rick A. Weideman, Daisha J. Cipher, Linda A. Feagins; Intest Res 2020;18(3):282-288. Published online April 7, 2020; DOI: https://doi.org/10.5217/ir.2019.09140

Abstract PDF PubReader ePub

Background/Aims
Safety for tumor necrosis factor inhibitors (TNFi) in cancer has been focused on risk of incident malignancies, but studies on prognostic effects have been scarce. We determined survival and recurrence rates at 1, 2, and 5 years after cancer diagnosis in patients with and without concurrent TNFi use.
Methods
Chart reviews were performed between 1996 and 2015 at the VA North Texas Healthcare System. Cases were patients with inflammatory disease, concomitant malignancy, and TNFi use while controls were patients with inflammatory disease, concomitant malignancy but no TNFi use. Cases and controls were matched for type of malignancy. Analysis was performed with log-rank tests on Kaplan-Meier curves.
Results
Thirty-six cases and 72 controls were identified. For cases, survival at 1, 2, and 5 years were 32 (89%), 31 (86%), and 29 (81%) compared to 63 (90%), 61 (87%), and 51 (73%) for the control group (P=0.985). For cases, recurrence rates at 1, 2, and 5 years were 3 (8%), 5 (14%), and 6 (17%) compared to 2 (3%), 5 (7%), and 7 (10%) for the control group (P=0.158).
Conclusions
Our findings suggest TNFi may be safely used in select inflammatory disease patients with concurrent cancer if therapy is needed for proper disease control. However, case-by-case consideration in conjunction with an oncologist is recommended while considering the apparent safety of TNFi for patients suffering from active inflammatory diseases despite having a concomitant malignancy.

Citations

Citations to this article as recorded by

Effect of TNF inhibitors on the risk of cancer recurrence in patients with AS: a nested case-control study
Oh Chan Kwon, Hye Sun Lee, So Young Jeon, Min-Chan Park
Rheumatology.2025; 64(10): 5413. CrossRef
Risk of Cancer Recurrence in Patients With Immune-Mediated Diseases With Use of Immunosuppressive Therapies: An Updated Systematic Review and Meta-Analysis
Akshita Gupta, Laurent Peyrin-Biroulet, Ashwin N. Ananthakrishnan
Clinical Gastroenterology and Hepatology.2024; 22(3): 499. CrossRef
Survival in patients with rheumatoid arthritis and early breast cancer treated with tumor necrosis factor inhibitors
Juan I. Ruiz, Xiudong Lei, Wu Chi-Fang, Sharon H. Giordano, Hui Zhao, Suja S. Rajan, Heather Lin, Maria E. Suarez-Almazor
Breast Cancer.2024; 31(6): 1059. CrossRef
Anti-tumor necrosis factor-alpha monoclonal antibody suppresses colorectal cancer growth in an orthotopic transplant mouse model
Takeshi Takasago, Ryohei Hayashi, Yoshitaka Ueno, Misa Ariyoshi, Kana Onishi, Ken Yamashita, Yuichi Hiyama, Hidehiko Takigawa, Ryo Yuge, Yuji Urabe, Shiro Oka, Yasuhiko Kitadai, Shinji Tanaka, Kenji Fujiwara
PLOS ONE.2023; 18(3): e0283822. CrossRef
Dermatofibrosarcoma Protuberans (DFSP) with Fibrosarcomatous Changes in a Patient with Crohn’s Disease Treated with Anti-TNF (Adalimumab)
Ivo Klarin, Yoshihiro Moriwaki
Case Reports in Gastrointestinal Medicine.2023; 2023: 1. CrossRef
Use of Disease-modifying Antirheumatic Drugs After Cancer Diagnosis in Rheumatoid Arthritis Patients
Young Bin Joo, Seung Min Jung, Yune-Jung Park, Ki-Jo Kim, Kyung-Su Park
Journal of Rheumatic Diseases.2022; 29(3): 162. CrossRef
Updates on conventional therapies for inflammatory bowel diseases: 5-aminosalicylates, corticosteroids, immunomodulators, and anti-TNF-α
Jihye Park, Jae Hee Cheon
The Korean Journal of Internal Medicine.2022; 37(5): 895. CrossRef
Twenty Years of Targeted and Biologic Immunomodulatory Drugs
Julia Berman, Yarden Yavne, Yonatan Edel, Ori Elkayam, Victoria Furer, Daniel Shepshelovich
Mayo Clinic Proceedings.2022; 97(8): 1512. CrossRef
Impact of rheumatoid arthritis and biologic and targeted synthetic disease modifying antirheumatic agents on cancer risk and recurrence
Namrata Singh, Christopher I. Li
Current Opinion in Rheumatology.2021; 33(3): 292. CrossRef
Can Anti-Tumor Necrosis Factor Agents Be Discontinued in Patients with Inflammatory Bowel Disease?
Jihye Park, Jae Hee Cheon
Gut and Liver.2021; 15(5): 641. CrossRef

9,409 View
164 Download
11 Web of Science
10 Crossref

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