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Sakamoto K, Okabayashi K, Seishima R, Shigeta K, Kiyohara H, Mikami Y, Kanai T, Kitagawa Y. Radiomics prediction of surgery in ulcerative colitis refractory to medical treatment. Tech Coloproctol 2025; 29:113. [PMID: 40347388 PMCID: PMC12065716 DOI: 10.1007/s10151-025-03139-x] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Download PDF] [Figures] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 07/12/2024] [Accepted: 03/08/2025] [Indexed: 05/12/2025]
Abstract
BACKGROUND The surgeries in drug-resistant ulcerative colitis are determined by complex factors. This study evaluated the predictive performance of radiomics analysis on the basis of whether patients with ulcerative colitis in hospital were in the surgical or medical treatment group by discharge from hospital. METHODS This single-center retrospective cohort study used CT at admission of patients with US admitted from 2015 to 2022. The target of prediction was whether the patient would undergo surgery by the time of discharge. Radiomics features were extracted using the rectal wall at the level of the tailbone tip of the CT as the region of interest. CT data were randomly classified into a training cohort and a validation cohort, and LASSO regression was performed using the training cohort to create a formula for calculating the radiomics score. RESULTS A total of 147 patients were selected, and data from 184 CT scans were collected. Data from 157 CT scans matched the selection criteria and were included. Five features were used for the radiomics score. Univariate logistic regression analysis of clinical information detected a significant influence of severity (p < 0.001), number of drugs used until surgery (p < 0.001), Lichtiger score (p = 0.024), and hemoglobin (p = 0.010). Using a nomogram combining these items, we found that the discriminatory power in the surgery and medical treatment groups was AUC 0.822 (95% confidence interval (CI) 0.841-0.951) for the training cohort and AUC 0.868 (95% CI 0.729-1.000) for the validation cohort, indicating a good ability to discriminate the outcomes. CONCLUSIONS Radiomics analysis of CT images of patients with US at the time of admission, combined with clinical data, showed high predictive ability regarding a treatment strategy of surgery or medical treatment.
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Affiliation(s)
- K Sakamoto
- Department of Surgery, Keio University School of Medicine, 35 Shinano-Machi Shinjuku-Ku, Tokyo, 1608582, Japan
| | - K Okabayashi
- Department of Surgery, Keio University School of Medicine, 35 Shinano-Machi Shinjuku-Ku, Tokyo, 1608582, Japan.
| | - R Seishima
- Department of Surgery, Keio University School of Medicine, 35 Shinano-Machi Shinjuku-Ku, Tokyo, 1608582, Japan
| | - K Shigeta
- Department of Surgery, Keio University School of Medicine, 35 Shinano-Machi Shinjuku-Ku, Tokyo, 1608582, Japan
| | - H Kiyohara
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Y Mikami
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
| | - T Kanai
- Division of Gastroenterology and Hepatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan
| | - Y Kitagawa
- Department of Surgery, Keio University School of Medicine, 35 Shinano-Machi Shinjuku-Ku, Tokyo, 1608582, Japan
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Savio MC, Ceconello Coelho J, Oliveira E, Oliveira Magro D, Valverde DA, Quaresma AB, Molteni RDA, Gimenez Villamil MP, Kotze PG. Nationwide trends in colectomy rates for ulcerative colitis in Brazil: An analysis of the unified public healthcare system. GASTROENTEROLOGIA Y HEPATOLOGIA 2025:502434. [PMID: 40120855 DOI: 10.1016/j.gastrohep.2025.502434] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Subscribe] [Scholar Register] [Received: 12/18/2024] [Revised: 02/11/2025] [Accepted: 03/17/2025] [Indexed: 03/25/2025]
Abstract
INTRODUCTION Ulcerative colitis (UC) is a chronic inflammatory bowel disease with significant global prevalence. Despite advancements in medical management, including the widespread use of biologic agents and small molecules, approximately 15-20% of patients eventually require surgery. This study aimed to analyze colectomy and hospitalization rates for UC in Brazil from 2012 to 2022 and assess their temporal trends. METHODS This was a retrospective, observational, population-based study using public database records from January 1, 2012, to December 31, 2022. The study included all patients with one or more diagnostic codes associated with UC (ICD-10) who underwent a UC-related surgical procedure during the study period. RESULTS A total of 178,552 unique UC patients were identified. UC prevalence increased significantly, from 17.31 per 100,000 in 2012 to 84.23 per 100,000 in 2022, with an annual average percentage change (AAPC) of 15% (95% CI 14.97-15.11, p<0.001). The Southeastern and Southern regions accounted for the highest number of cases. Among the 1374 surgical procedures identified, 69.4% were total colectomies, and 10.6% were pouch procedures. By the end of 2022, the proportion of surgeries relative to the total number of UC patients was 0.7%, with a declining trend (AAPC -11.8%; 95% CI -13.38 to -10.33, p<0.001). Hospitalization rates also showed a significant decline over time (AAPC -14.3%; 95% CI -14.75 to -14.03, p<0.001). CONCLUSIONS UC prevalence in Brazil has increased substantially over the past decade. However, colectomy rates remain low and have shown a declining trend over the same period. Additionally, there has been a notable reduction in hospitalization rates, reflecting potential improvements in UC management and disease control.
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Affiliation(s)
| | | | - Emilia Oliveira
- State University of Campinas (UNICAMP), Campinas, São Paulo, Brazil
| | | | | | - Abel Botelho Quaresma
- Pontifical Catholic Univeristy of Paraná (PUC-PR), Curitiba, Paraná, Brazil; Universidade do Oeste de Santa Catarina (UNOESC), Joaçaba, Santa Catarina, Brazil
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Totaro A, Gavi F, Fettucciari D, Bizzarri FP, Sanesi D, Cosenza L, Marino F, Cretì A, Russo P, Sacco E. Efficacy of the Rezūm System for lower urinary tract symptoms in patients with benign prostatic hyperplasia: Long term results from a single centre prospective study. Urologia 2025; 92:141-147. [PMID: 39513572 DOI: 10.1177/03915603241297137] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Subscribe] [Scholar Register] [Indexed: 11/15/2024]
Abstract
INTRODUCTION Benign prostatic hyperplasia (BPH) is a prevalent urological condition leading to lower urinary tract symptoms. Minimal invasive surgical treatment (MISTs) such as Rezūm System are emerging aiming to relieve symptoms. We present results from a single centre prospective study. METHODS We prospectively followed patients undergoing Rezūm between 2021 and 2023 from a single centre. International Prostate Symptom Score (IPSS), functional outcomes (maximum urinary flow rate (Qmax) and post-void urinary residual (PVR) and International Index of Erectile Function-5 (IIEF-5) were assessed at 3, 6, 12 and 24 months. Anterograde ejaculation was assessed at 12 months follow up. Linear mixed-effects models (LMMs) for repeated measures were applied to assess differences in the IPSS, maximum flow rate (Qmax), PVR, and International Index of Erectile Function-5 (IIEF-5) from baseline (t0) to 3, 6, 12 and 24 months. Results: After adjusting for prostate volume and symptoms severity, significant differences were observed at 3, 6, 12 and 24 months for IPSS (p < 0.001), Qmax (p < 0.001), PVR (p < 0.001) and IPSS-QoL (p < 0.001) from baseline. No statistically significant changes were found in the IIEF-5 scores at 3, 6, 12 and 24 months from baseline. Anterograde ejaculation remained in 98% of patients after treatment. CONCLUSIONS In conclusion, the study's findings indicate that patients undergoing Rezūm treatment experience sustained improvements in IPSS, Qmax, PVR and IPSS-related quality of life up to 24 months following the intervention. Anterograde ejaculation remained in 98% of patients after treatment.
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Affiliation(s)
- Angelo Totaro
- Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
| | - Filippo Gavi
- Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
- Postgraduate School of Urology, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Daniele Fettucciari
- Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
- Postgraduate School of Urology, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Francesco Pio Bizzarri
- Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
- Postgraduate School of Urology, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Domenico Sanesi
- Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
- Postgraduate School of Urology, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Luigi Cosenza
- Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
- Postgraduate School of Urology, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Filippo Marino
- Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
- Postgraduate School of Urology, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Antonio Cretì
- Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
- Postgraduate School of Urology, Università Cattolica del Sacro Cuore, Rome, Italy
| | - Pierluigi Russo
- Department of Urology, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
| | - Emilio Sacco
- Postgraduate School of Urology, Università Cattolica del Sacro Cuore, Rome, Italy
- Urology Department, Isola Tiberina-Gemelli Isola Hospital, Catholic University Medical School, Rome, Italy
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Lee Y, Anvari S, Padoan A, McKechnie T, Park L, Doumouras AG, Eskicioglu C, Hong D. Financial toxicity among patients undergoing resectional surgery for inflammatory bowel disease in the United States. Colorectal Dis 2024; 26:692-701. [PMID: 38353528 DOI: 10.1111/codi.16903] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/02/2023] [Revised: 07/11/2023] [Accepted: 01/21/2024] [Indexed: 05/02/2024]
Abstract
AIM Financial toxicity describes the financial burden and distress that patients experience due to medical treatment. Financial toxicity has yet to be characterized among patients with inflammatory bowel disease (IBD) undergoing surgical management of their disease. This study investigated the risk of financial toxicity associated with undergoing surgery for IBD. METHODS This study used a retrospective analysis using the National Inpatient Sample from 2015 to 2019. Adult patients who underwent IBD-related surgery were identified using the International Classification of Diseases (10th Revision) diagnostic and procedure codes and stratified into privately insured and uninsured groups. The primary outcome was risk of financial toxicity, defined as hospital admission charges that constituted 40% or more of patient's post-subsistence income. Secondary outcomes included total hospital admission cost and predictors of financial toxicity. RESULTS The analytical cohort consisted of 6412 privately insured and 3694 uninsured patients. Overall median hospital charges were $21 628 (interquartile range $14 758-$35 386). Risk of financial toxicity was 86.5% among uninsured patients and 0% among insured patients. Predictors of financial toxicity included emergency admission, being in the lowest residential income quartile and having ulcerative colitis (compared to Crohn's disease). Additional predictors were being of Black race or male sex. CONCLUSION Financial toxicity is a serious consequence of IBD-related surgery among uninsured patients. Given the pervasive nature of this consequence, future steps to support uninsured patients receiving surgery, in particular emergency surgery, related to their IBD are needed to protect this group from financial risk.
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Affiliation(s)
- Yung Lee
- Division of General Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada
- Department of Epidemiology, Harvard T.H. Chan School of Public Health, Harvard University, Boston, Massachusetts, USA
| | - Sama Anvari
- Division of Gastroenterology, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
| | - Adelia Padoan
- Division of General Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada
| | - Tyler McKechnie
- Division of General Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada
- Division of Gastroenterology, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
| | - Lily Park
- Division of General Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada
- Division of Gastroenterology, Department of Medicine, McMaster University, Hamilton, Ontario, Canada
| | - Aristithes G Doumouras
- Division of General Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada
| | - Cagla Eskicioglu
- Division of General Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada
| | - Dennis Hong
- Division of General Surgery, Department of Surgery, McMaster University, Hamilton, Ontario, Canada
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Ng AP, Chervu N, Porter G, Mallick S, Le N, Benharash P, Lee H. Cost variation of nonelective surgery for ulcerative colitis across the United States. J Gastrointest Surg 2024; 28:488-493. [PMID: 38583900 DOI: 10.1016/j.gassur.2024.01.036] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/13/2023] [Revised: 01/07/2024] [Accepted: 01/27/2024] [Indexed: 04/09/2024]
Abstract
BACKGROUND Although clinical outcomes of surgery for ulcerative colitis (UC) have improved in the modern biologic era, expenditures continue to increase. A contemporary cost analysis of UC operative care is lacking. The present study aimed to characterize risk factors and center-level variation in hospitalization costs after nonelective resection for UC. METHODS All adults with UC in the 2016-2020 Nationwide Readmissions Database undergoing nonelective colectomy or rectal resection were identified. Mixed-effects models were developed to evaluate patient and hospital factors associated with costs. Random effects were estimated and used to rank hospitals by increasing risk-adjusted center-level costs. High-cost hospitals (HCHs) in the top decile of expenditure were identified, and their association with select outcomes was subsequently assessed. RESULTS An estimated 10,280 patients met study criteria with median index hospitalization costs of $40,300 (IQR, $26,400-$65,000). Increased time to surgery was significantly associated with a +$2500 increment in costs per day. Compared with low-volume hospitals, medium- and high-volume centers demonstrated a -$5900 and -$8200 reduction in costs, respectively. Approximately 19.2% of variability in costs was attributable to interhospital differences rather than patient factors. Although mortality and readmission rates were similar, HCH status was significantly associated with increased complications (adjusted odds ratio [AOR], 1.39), length of stay (+10.1 days), and nonhome discharge (AOR, 1.78). CONCLUSION The present work identified significant hospital-level variation in the costs of nonelective operations for UC. Further efforts to optimize time to surgery and regionalize care to higher-volume centers may improve the value of UC surgical care in the United States.
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Affiliation(s)
- Ayesha P Ng
- Cardiovascular Outcomes Research Laboratories, David Geffen School of Medicine at UCLA, Los Angeles, California, United States
| | - Nikhil Chervu
- Cardiovascular Outcomes Research Laboratories, David Geffen School of Medicine at UCLA, Los Angeles, California, United States
| | - Giselle Porter
- Cardiovascular Outcomes Research Laboratories, David Geffen School of Medicine at UCLA, Los Angeles, California, United States
| | - Saad Mallick
- Cardiovascular Outcomes Research Laboratories, David Geffen School of Medicine at UCLA, Los Angeles, California, United States
| | - Nguyen Le
- Cardiovascular Outcomes Research Laboratories, David Geffen School of Medicine at UCLA, Los Angeles, California, United States
| | - Peyman Benharash
- Cardiovascular Outcomes Research Laboratories, David Geffen School of Medicine at UCLA, Los Angeles, California, United States; Division of Cardiac Surgery, Department of Surgery, David Geffen School of Medicine at UCLA, Los Angeles, California, United States
| | - Hanjoo Lee
- Division of Colon and Rectal Surgery, Department of Surgery, Harbor-UCLA Medical Center, Torrance, California, United States.
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Park EY, Baek DH, Kim GH, Kim C, Kim H, Lee JW, Song GA. Longitudinal trends in direct costs and healthcare utilization ascribable to inflammatory bowel disease in the biologic era: a nationwide, population-based study. J Gastroenterol Hepatol 2023; 38:1485-1495. [PMID: 37129098 DOI: 10.1111/jgh.16202] [Citation(s) in RCA: 0] [Impact Index Per Article: 0] [Reference Citation Analysis] [Abstract] [Key Words] [MESH Headings] [Grants] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 12/13/2022] [Revised: 03/17/2023] [Accepted: 04/14/2023] [Indexed: 05/03/2023]
Abstract
BACKGROUND AND AIM Biologic-era data regarding the direct cost and healthcare utilization of inflammatory bowel disease at the population level are limited, especially in Asia. Thus, we aimed to investigate the nationwide prevalence, direct cost, and healthcare utilization of inflammatory bowel disease in Korea in a recent 10-year period. METHODS Using the Korean National Health Insurance claim data from 2008 to 2017, we investigated all prescription medications and their associated direct costs, hospitalizations, and outpatient visits. We also estimated the nationwide prevalence of inflammatory bowel disease using population census data. RESULTS The estimated inflammatory bowel disease prevalence significantly increased from 108.8/100 000 in 2008 to 140.4/100 000 in 2017. The overall annual costs for inflammatory bowel disease and the healthcare cost per capita increased from $24.5 million (in US dollars) to $105.1 million and from $458.4 to $1456.6 million, respectively (both P < 0.001). Whereas the ratio of outpatient costs increased from 35.3% to 69.4%, that of outpatient days remained steady. The total annual medication cost and proportion rose from $13.3 million to $76.8 million and from 54.2% to 73.3%, respectively, mainly due to the increasing antitumor necrosis factor cost, from $1.5 million to $49.3 million (from 11.1% to 64.1% of the total annual drug cost and from 6.3% to 46.9% of the total annual cost). CONCLUSIONS We observed increasing trends in the prevalence, direct costs, and healthcare utilization of inflammatory bowel disease in Korea in recent years. The attributable cost was mainly driven by rising expenditures on antitumor necrosis factor medications.
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Affiliation(s)
- Eun Young Park
- Department of Internal Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea
- Department of Internal Medicine, Dong-Eui Medical Center, Busan, South Korea
| | - Dong Hoon Baek
- Department of Internal Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea
| | - Gwang Ha Kim
- Department of Internal Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea
| | - Choongrak Kim
- Department of Statistics, Pusan National University, Busan, South Korea
| | - Hasung Kim
- Data Science Team, Hanmi Pharm. Co., Ltd, Seoul, South Korea
| | - Jeong Woo Lee
- Data Science Team, Hanmi Pharm. Co., Ltd, Seoul, South Korea
| | - Geun Am Song
- Department of Internal Medicine, Pusan National University School of Medicine and Biomedical Research Institute, Pusan National University Hospital, Busan, South Korea
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Soriano CR, Powell CR, Chiorean MV, Simianu VV. Role of hospitalization for inflammatory bowel disease in the post-biologic era. World J Clin Cases 2021; 9:7632-7642. [PMID: 34621815 PMCID: PMC8462259 DOI: 10.12998/wjcc.v9.i26.7632] [Citation(s) in RCA: 2] [Impact Index Per Article: 0.5] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Download PDF] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 03/19/2021] [Revised: 05/17/2021] [Accepted: 08/12/2021] [Indexed: 02/06/2023] Open
Abstract
Treatment for inflammatory bowel disease (IBD) often requires specialized care. While much of IBD care has shifted to the outpatient setting, hospitalizations remain a major site of healthcare utilization and a sizable proportion of patients with inflammatory bowel disease require hospitalization or surgery during their lifetime. In this review, we approach IBD care from the population-level with a specific focus on hospitalization for IBD, including the shifts from inpatient to outpatient care, the balance of emergency and elective hospitalizations, regionalization of specialty IBD care, and contribution of surgery and endoscopy to hospitalized care.
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Affiliation(s)
- Celine R Soriano
- Department of Surgery, Virginia Mason Franciscan Health, Seattle, WA 98101, United States
| | - Charleston R Powell
- Department of Internal Medicine, Madigan Army Medical Center, Tacoma, WA 98431, United States
| | - Michael V Chiorean
- Department of Gastroenterology, Swedish Medical Center, Seattle, WA 98109, United States
| | - Vlad V Simianu
- Department of Surgery, Virginia Mason Franciscan Health, Seattle, WA 98101, United States
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Fiorino G, Danese S, Giacobazzi G, Spinelli A. Medical therapy versus surgery in moderate-to-severe ulcerative colitis. Dig Liver Dis 2021; 53:403-408. [PMID: 33051163 DOI: 10.1016/j.dld.2020.09.022] [Citation(s) in RCA: 8] [Impact Index Per Article: 2.0] [Reference Citation Analysis] [Abstract] [Key Words] [Track Full Text] [Journal Information] [Submit a Manuscript] [Subscribe] [Scholar Register] [Received: 06/08/2020] [Revised: 08/25/2020] [Accepted: 09/11/2020] [Indexed: 12/11/2022]
Abstract
Ulcerative colitis, a chronic inflammatory condition that affects the colon from rectum to caecum, is characterized by periods of increased bowel movements, blood in feces, rectal urgency, tenesmus, and abdominal pain, with periods of remission and flares of disease, which negatively impact quality of life. A number of therapeutic options are available for patients with moderate-to-severe ulcerative colitis, however, no clear treatment algorithm exists. Therapeutic goals include short-term benefits for patients (i.e., the reduction/absence of symptoms, essentially stool frequency and rectal bleeding) and long-term benefits (i.e., sustained clinical remission, steroid-free remission, and mucosal healing). Therapies currently approved and available for the treatment of moderate-to-severe ulcerative colitis include monoclonal antibodies such as those targeting anti-tumor necrosis factor α (i.e., infliximab, adalimumab, golimumab), anti-adhesion molecules (i.e., vedolizumab), anti-interleukin 12/23 agents (i.e., ustekinumab), and Janus Kinase inhibitors (i.e., tofacitinib). Surgical approaches should also be considered in patients refractory to medical therapy or with complications (including toxic megacolon or colonic dysplasia/cancer). This review provides an overview of currently available treatment options for patients with moderate-to-severe ulcerative colitis and summarizes factors that should be considered during the therapeutic decision.
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Affiliation(s)
- Gionata Fiorino
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; IBD Center, Humanitas Clinical and Research Hospital IRCCS, Rozzano, Milan, Italy
| | - Silvio Danese
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; IBD Center, Humanitas Clinical and Research Hospital IRCCS, Rozzano, Milan, Italy
| | | | - Antonino Spinelli
- Department of Biomedical Sciences, Humanitas University, Pieve Emanuele, Milan, Italy; Division of Colon and Rectal Surgery, Humanitas Clinical and Research Hospital IRCCS, Rozzano, Milan, Italy.
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