Introduction: The comprehensive complication index (CCI), which weights all postoperative complications according to severity and integrates them into a single formula, has been reported as a new evaluation system. We aimed to compare the CCI with the Clavien-Dindo Classification (CDC) to patients with ulcerative colitis (UC).
Methods: Patients who underwent initial surgery for UC from April 2012 to March 2020 were included. The patients were classified into a length of stay (LOS) >30 days group or an LOS ≤30 days group. We performed a multivariate analysis of risk factors for LOS >30 days in the model with the factors identified in the univariate analysis plus the CCI (the CCI model) and plus CDC (the CDC model). An ROC curve was used to test the difference in the area under the curve (AUC) between the CCI model and the CDC model.
Results: The median LOS was 21 days (IQR: 16-29 days), and the rate of LOS >30 days was 119/588 (20.2%). In the CCI model, age at the time of surgery (odds ratio [OR] = 1.24, 95% confidence interval [CI] 1.07-1.45, p = 0.01), ASA score ≥3 (OR = 1.94, 95% CI:1.00-3.76, p = 0.04), and CCI (OR = 1.07, 95% CI: 1.05-1.09; p < 0.01) were identified as independent risk factors for LOS >30 days. The AUC value of the CCI model (0.86) was significantly better in relation to LOS >30 days than that of the CDC model (0.82) (p = 0.02).
Conclusion: The CCI was a better measure of LOS than was the CDC and was found to be a useful indicator in UC.
{"title":"The Comprehensive Complication Index in Ulcerative Colitis: A Comparison with the Clavien-Dindo Classification.","authors":"Yuki Horio, Motoi Uchino, Masataka Igeta, Kentaro Nagano, Kurando Kusunoki, Ryuichi Kuwahara, Toshiyuki Sato, Shinichiro Shinzaki, Hiroki Ikeuchi","doi":"10.1159/000538180","DOIUrl":"https://doi.org/10.1159/000538180","url":null,"abstract":"<p><strong>Introduction: </strong>The comprehensive complication index (CCI), which weights all postoperative complications according to severity and integrates them into a single formula, has been reported as a new evaluation system. We aimed to compare the CCI with the Clavien-Dindo Classification (CDC) to patients with ulcerative colitis (UC).</p><p><strong>Methods: </strong>Patients who underwent initial surgery for UC from April 2012 to March 2020 were included. The patients were classified into a length of stay (LOS) >30 days group or an LOS ≤30 days group. We performed a multivariate analysis of risk factors for LOS >30 days in the model with the factors identified in the univariate analysis plus the CCI (the CCI model) and plus CDC (the CDC model). An ROC curve was used to test the difference in the area under the curve (AUC) between the CCI model and the CDC model.</p><p><strong>Results: </strong>The median LOS was 21 days (IQR: 16-29 days), and the rate of LOS >30 days was 119/588 (20.2%). In the CCI model, age at the time of surgery (odds ratio [OR] = 1.24, 95% confidence interval [CI] 1.07-1.45, <i>p</i> = 0.01), ASA score ≥3 (OR = 1.94, 95% CI:1.00-3.76, <i>p</i> = 0.04), and CCI (OR = 1.07, 95% CI: 1.05-1.09; <i>p</i> < 0.01) were identified as independent risk factors for LOS >30 days. The AUC value of the CCI model (0.86) was significantly better in relation to LOS >30 days than that of the CDC model (0.82) (<i>p</i> = 0.02).</p><p><strong>Conclusion: </strong>The CCI was a better measure of LOS than was the CDC and was found to be a useful indicator in UC.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"9 1","pages":"85-95"},"PeriodicalIF":0.0,"publicationDate":"2024-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11001287/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140849349","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Laparoscopic surgery (LAP) is now recognized as the standard procedure for colorectal surgery. However, the standard surgery for ulcerative colitis (UC) is total proctocolectomy with ileal pouch anal anastomosis (IPAA), which may be an overly complex procedure to complete laparoscopically. We conducted this systematic review and meta-analysis to evaluate the efficacy as well as the advantages and disadvantages of LAP-IPAA in patients with UC stratified by the outcome of interest.
Method: We performed a systematic literature review by searching the PubMed/MEDLINE, the Cochrane Library, and the Japan Centra Reuvo Medicina databases from inception until January 2023. Meta-analyses were performed for surgical outcomes, including morbidity and surgical course, to evaluate the efficacy of LAP-IPAA.
Results: A total of 707 participants, including 341 LAP and 366 open surgery (OPEN) patients in 9 observational studies and one randomized controlled study, were included. From the results of the meta-analyses, the odds ratio (OR) of total complications in LAP was 1.12 (95% CI: 0.58-2.17, p = 0.74). The OR of mortality for LAP was 0.38 (95% CI: 0.08-1.92, p = 0.24). Although the duration of surgery was extended in LAP (mean difference (MD) 118.74 min (95% CI: 91.67-145.81), p < 0.01) and hospital stay were not shortened, the duration until oral intake after surgery was shortened in LAP (MD -2.10 days (95% CI: -3.52-0.68), p = 0.004).
Conclusions: During IPAA for UC, a similar morbidity rate was seen for LAP and OPEN. Although LAP necessitates extended surgery, there may be certain advantages to this procedure, including easy visibility during the surgical procedure or a shortened time to oral intake after surgery.
{"title":"The Impacts of Laparoscopic Restorative Proctocolectomy for Ulcerative Colitis: Systematic Review and Meta-Analysis.","authors":"Motoi Uchino, Hiroki Ikeuchi, Yuki Horio, Ryuichi Kuwahara, Kurando Kusunoki, Kentaro Nagano, Kei Kimura, Kozo Kataoka, Naohito Beppu, Masataka Ikeda","doi":"10.1159/000535832","DOIUrl":"10.1159/000535832","url":null,"abstract":"<p><strong>Introduction: </strong>Laparoscopic surgery (LAP) is now recognized as the standard procedure for colorectal surgery. However, the standard surgery for ulcerative colitis (UC) is total proctocolectomy with ileal pouch anal anastomosis (IPAA), which may be an overly complex procedure to complete laparoscopically. We conducted this systematic review and meta-analysis to evaluate the efficacy as well as the advantages and disadvantages of LAP-IPAA in patients with UC stratified by the outcome of interest.</p><p><strong>Method: </strong>We performed a systematic literature review by searching the PubMed/MEDLINE, the Cochrane Library, and the Japan Centra Reuvo Medicina databases from inception until January 2023. Meta-analyses were performed for surgical outcomes, including morbidity and surgical course, to evaluate the efficacy of LAP-IPAA.</p><p><strong>Results: </strong>A total of 707 participants, including 341 LAP and 366 open surgery (OPEN) patients in 9 observational studies and one randomized controlled study, were included. From the results of the meta-analyses, the odds ratio (OR) of total complications in LAP was 1.12 (95% CI: 0.58-2.17, <i>p</i> = 0.74). The OR of mortality for LAP was 0.38 (95% CI: 0.08-1.92, <i>p</i> = 0.24). Although the duration of surgery was extended in LAP (mean difference (MD) 118.74 min (95% CI: 91.67-145.81), <i>p</i> < 0.01) and hospital stay were not shortened, the duration until oral intake after surgery was shortened in LAP (MD -2.10 days (95% CI: -3.52-0.68), <i>p</i> = 0.004).</p><p><strong>Conclusions: </strong>During IPAA for UC, a similar morbidity rate was seen for LAP and OPEN. Although LAP necessitates extended surgery, there may be certain advantages to this procedure, including easy visibility during the surgical procedure or a shortened time to oral intake after surgery.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"9 1","pages":"62-70"},"PeriodicalIF":0.0,"publicationDate":"2024-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10972575/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140305521","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the surgical procedure for ulcerative colitis (UC). Intestinal ischemia may occur if the main blood vessels are ligated at an early stage of this surgery. Considering that the blood flow in the large intestine can be maintained by preserving the middle colic artery, we have used a new IPAA method: ligating the middle colic artery immediately before removal of the specimens ("M-method"). Here, we evaluated the M-method's clinical outcomes.
Methods: Between April 2009 and December 2021, 13 patients underwent a laparoscopy-assisted IPAA procedure at our institution. The conventional method was used for 6 patients, and the M-method was used for the other 7 patients. We retrospectively analyzed the cases' clinical notes.
Results: The M-method's rate of postoperative complications (Clavien-Dindo classification grade II or more) was significantly lower than that of the conventional method (14.2% vs. 83.3%). The M-method group's postoperative stay period was also significantly shorter (average 16.4 days vs. 55.5). There were significant differences in the albumin value and the ratio of the modified GPS score 1 or 2 on the 7th postoperative day between the M- and conventional methods (average 3.15 vs. 2.5, average 4/7 vs. 6/6). However, it is necessary to consider the small number of cases and the uncontrolled historical comparison.
Conclusion: Late ligation of the middle colic artery may be beneficial for patients' post-surgery recovery and can be recommended for IPAAs in UC patients.
{"title":"Laparoscopy-Assisted Restorative Proctocolectomy with Ileal Pouch-Anal Anastomosis in Middle Colic Artery Ligation Immediately before Specimen Removal.","authors":"Keiji Matsuda, Yojiro Hashiguchi, Tamuro Hayama, Kurara Hayashi, Toshiya Miyata, Kentaro Asako, Yoshihisa Fukushima, Ryu Shimada, Kensuke Kaneko, Keijiro Nozawa, Hiroki Ochiai, Takatsugu Yamamoto","doi":"10.1159/000538025","DOIUrl":"10.1159/000538025","url":null,"abstract":"<p><strong>Introduction: </strong>Restorative proctocolectomy with ileal pouch-anal anastomosis (IPAA) is the surgical procedure for ulcerative colitis (UC). Intestinal ischemia may occur if the main blood vessels are ligated at an early stage of this surgery. Considering that the blood flow in the large intestine can be maintained by preserving the middle colic artery, we have used a new IPAA method: ligating the middle colic artery immediately before removal of the specimens (\"M-method\"). Here, we evaluated the M-method's clinical outcomes.</p><p><strong>Methods: </strong>Between April 2009 and December 2021, 13 patients underwent a laparoscopy-assisted IPAA procedure at our institution. The conventional method was used for 6 patients, and the M-method was used for the other 7 patients. We retrospectively analyzed the cases' clinical notes.</p><p><strong>Results: </strong>The M-method's rate of postoperative complications (Clavien-Dindo classification grade II or more) was significantly lower than that of the conventional method (14.2% vs. 83.3%). The M-method group's postoperative stay period was also significantly shorter (average 16.4 days vs. 55.5). There were significant differences in the albumin value and the ratio of the modified GPS score 1 or 2 on the 7th postoperative day between the M- and conventional methods (average 3.15 vs. 2.5, average 4/7 vs. 6/6). However, it is necessary to consider the small number of cases and the uncontrolled historical comparison.</p><p><strong>Conclusion: </strong>Late ligation of the middle colic artery may be beneficial for patients' post-surgery recovery and can be recommended for IPAAs in UC patients.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"9 1","pages":"55-61"},"PeriodicalIF":0.0,"publicationDate":"2024-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10963053/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140287348","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2024-02-18eCollection Date: 2024-01-01DOI: 10.1159/000536281
Makoto Tanaka, Aki Kawakami, Kayoko Sakagami, Hiroaki Ito
Introduction: Dietary temperance significantly affects the quality of life of patients with Crohn's disease (CD) and remains a major concern. However, perceptions of diet in remission may have changed from the era when treatment options were limited. Therefore, we compared the dietary perceptions and treatment of patients with CD in remission with previously published data from the time biologic therapy was not introduced.
Methods: We compared the data of 254 patients with CD in remission who completed a questionnaire survey in 2022 with those of 76 patients with CD in remission collected in 2003, when biologics were not used for maintenance therapy in Japan. Remission was defined as a CD activity index of 150 or less in both studies. Perceptions of diet (degree of eating whatever one likes) were assessed using single-item nominal scale responses.
Results: The percentage of patients receiving enteral nutrition therapy had decreased (past vs. present: 43.4 vs. 12.6%), while the proportion of patients receiving biologic therapy increased (0 vs. 88.6%, respectively). The percentages of patients who responded "not at all," "sometimes," and "mostly" when asked if they could eat whatever they liked had changed, respectively, from 9.2%, 46.1%, and 44.7% in the past to 4.3%, 25.2%, and 70.5% in the present.
Conclusion: The proportion of those who ate whatever they liked and the mean body mass index increased in comparison with the corresponding values 20 years ago. With the advent of biologic therapies, the number of patients with CD who can enjoy eating has increased.
导言：饮食节制严重影响克罗恩病（CD）患者的生活质量，仍然是一个主要问题。然而，与治疗方案有限的时代相比，缓解期患者的饮食观念可能已经发生了变化。因此，我们将处于缓解期的克罗恩病患者的饮食观念和治疗方法与之前公布的未引入生物疗法时的数据进行了比较：我们将 2022 年完成问卷调查的 254 名 CD 缓解期患者的数据与 2003 年收集的 76 名 CD 缓解期患者的数据进行了比较，当时日本尚未使用生物制剂进行维持治疗。在这两项研究中，缓解的定义都是 CD 活动指数达到或低于 150。对饮食的看法（喜欢吃什么就吃什么的程度）采用单项名义量表进行评估：结果：接受肠内营养治疗的患者比例有所下降（过去与现在：43.4% 与 12.6%），而接受生物治疗的患者比例有所上升（分别为 0 与 88.6%）。当被问及是否可以随意进食时，回答 "完全不能"、"有时 "和 "大部分 "的患者比例分别从过去的 9.2%、46.1% 和 44.7% 变为现在的 4.3%、25.2% 和 70.5%：结论：与 20 年前的相应数值相比，爱吃什么就吃什么的人群比例和平均体重指数都有所上升。随着生物疗法的出现，能够享受饮食的 CD 患者人数有所增加。
{"title":"Dietary Perceptions among Patients with Crohn's Disease in Clinical Remission: Comparison with an Era Preceding the Availability of Biologic Therapy.","authors":"Makoto Tanaka, Aki Kawakami, Kayoko Sakagami, Hiroaki Ito","doi":"10.1159/000536281","DOIUrl":"10.1159/000536281","url":null,"abstract":"<p><strong>Introduction: </strong>Dietary temperance significantly affects the quality of life of patients with Crohn's disease (CD) and remains a major concern. However, perceptions of diet in remission may have changed from the era when treatment options were limited. Therefore, we compared the dietary perceptions and treatment of patients with CD in remission with previously published data from the time biologic therapy was not introduced.</p><p><strong>Methods: </strong>We compared the data of 254 patients with CD in remission who completed a questionnaire survey in 2022 with those of 76 patients with CD in remission collected in 2003, when biologics were not used for maintenance therapy in Japan. Remission was defined as a CD activity index of 150 or less in both studies. Perceptions of diet (degree of eating whatever one likes) were assessed using single-item nominal scale responses.</p><p><strong>Results: </strong>The percentage of patients receiving enteral nutrition therapy had decreased (past vs. present: 43.4 vs. 12.6%), while the proportion of patients receiving biologic therapy increased (0 vs. 88.6%, respectively). The percentages of patients who responded \"not at all,\" \"sometimes,\" and \"mostly\" when asked if they could eat whatever they liked had changed, respectively, from 9.2%, 46.1%, and 44.7% in the past to 4.3%, 25.2%, and 70.5% in the present.</p><p><strong>Conclusion: </strong>The proportion of those who ate whatever they liked and the mean body mass index increased in comparison with the corresponding values 20 years ago. With the advent of biologic therapies, the number of patients with CD who can enjoy eating has increased.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"9 1","pages":"47-54"},"PeriodicalIF":0.0,"publicationDate":"2024-02-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10942792/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140143342","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Collagenous colitis (CC) is a disabling disease primarily affecting elderly women. Sparse, well-documented treatment modalities exist, except for budesonide. Long term and repetitive treatment with budesonide is often necessary. Rifaximin is a poorly absorbed antibiotic with a positive modulatory effect on gut microbiota. In this randomised, double-blind, placebo-controlled single center trial, we test the effect of adding rifaximin in continuation to budesonide on relapse rates in collagenous colitis. Methods: Eligible patients with active, biopsy verified CC received oral budesonide during a 6-week open-label induction phase. Patients in clinical remission after four weeks of treatment were randomised to receive either rifaximin or placebo for four weeks. Results: Fifteen patients were randomised to receive either rifaximin (n=7) or placebo (n=8). At 12-week follow-up, two patients in the rifaximin group were still in remission and none in the placebo group (p = 0.2). The median number of days in remission in the rifaximin group was 42 (IQR 33-126) compared to 18.5 (IQR 10.5-51.5) in the placebo group (P = 0.189). At 12-week follow-up the relapse rate per 100 person-days in the placebo group was higher (3.25 (1.40-6.41)) than in the rifaximin group (1.33 (0.43-3.10)). Conclusion: Although not statistically significant (p = 0.0996), the study suggests a potential improvement in relapse rates within the rifaximin group compared to the placebo group. A major limitation in the study is the small sample size.
{"title":"Rifaximin-treatment for collagenous colitis: A randomised, double-blind, placebo-controlled trial","authors":"Sabine Becker, Louise B. Grode, O. Bonderup","doi":"10.1159/000536124","DOIUrl":"https://doi.org/10.1159/000536124","url":null,"abstract":"Introduction: Collagenous colitis (CC) is a disabling disease primarily affecting elderly women. Sparse, well-documented treatment modalities exist, except for budesonide. Long term and repetitive treatment with budesonide is often necessary. Rifaximin is a poorly absorbed antibiotic with a positive modulatory effect on gut microbiota. In this randomised, double-blind, placebo-controlled single center trial, we test the effect of adding rifaximin in continuation to budesonide on relapse rates in collagenous colitis.\u0000Methods: Eligible patients with active, biopsy verified CC received oral budesonide during a 6-week open-label induction phase. Patients in clinical remission after four weeks of treatment were randomised to receive either rifaximin or placebo for four weeks. \u0000Results: Fifteen patients were randomised to receive either rifaximin (n=7) or placebo (n=8). At 12-week follow-up, two patients in the rifaximin group were still in remission and none in the placebo group (p = 0.2). The median number of days in remission in the rifaximin group was 42 (IQR 33-126) compared to 18.5 (IQR 10.5-51.5) in the placebo group (P = 0.189). At 12-week follow-up the relapse rate per 100 person-days in the placebo group was higher (3.25 (1.40-6.41)) than in the rifaximin group (1.33 (0.43-3.10)).\u0000Conclusion: Although not statistically significant (p = 0.0996), the study suggests a potential improvement in relapse rates within the rifaximin group compared to the placebo group. A major limitation in the study is the small sample size.","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"56 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139602041","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
F. Pelizzaro, R. Cardin, Giulia Sarasini, M. Minotto, Chiara Carlotto, Matteo Fassan, Michela Palo, Fabio Farinati, Fabiana Zingone
MicroRNAs (miRNAs) are small, non-coding RNA molecules involved in regulating gene expression. Many studies, mostly conducted on pediatric patients, suggested that oxidative stress and several miRNAs may play an important role in coeliac disease (CeD) pathogenesis. However, the interplay between oxidative stress and miRNA regulatory functions in CeD remains to be clarified. In this review, we aimed to perform a literature review on the role of miRNAs and oxidative stress in adult CeD patients and to analyze their potential interactions. In this direction, we also reported the preliminary results of a pilot study we recently performed.
{"title":"Crosstalk between microRNAs and Oxidative stress in coeliac disease.","authors":"F. Pelizzaro, R. Cardin, Giulia Sarasini, M. Minotto, Chiara Carlotto, Matteo Fassan, Michela Palo, Fabio Farinati, Fabiana Zingone","doi":"10.1159/000536107","DOIUrl":"https://doi.org/10.1159/000536107","url":null,"abstract":"MicroRNAs (miRNAs) are small, non-coding RNA molecules involved in regulating gene expression. Many studies, mostly conducted on pediatric patients, suggested that oxidative stress and several miRNAs may play an important role in coeliac disease (CeD) pathogenesis. However, the interplay between oxidative stress and miRNA regulatory functions in CeD remains to be clarified. In this review, we aimed to perform a literature review on the role of miRNAs and oxidative stress in adult CeD patients and to analyze their potential interactions. In this direction, we also reported the preliminary results of a pilot study we recently performed.\u0000\u0000","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"96 8","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139601979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Rintaro Moroi, Y. Kakuta, Hiroshi Nagai, Yusuke Shimoyama, Takeo Naito, H. Shiga, Y. Kinouchi, Atsushi Masamune
Introduction: Limited data exist regarding the prevalence and clinical practice involving generic drugs and biosimilars for treating ulcerative colitis (UC) in Japan. We aimed to clarify the clinical usage of these generic drugs and biosimilars for UC treatment in Japan using a nationwide database. Methods: We collected data from 30,675 UC cases, along with their prescriptions for both generic drugs or biosimilars and their original counterparts, using a medical claims database provided by DeSC Healthcare, Inc. We calculated the prescription and penetration rates of generic drugs and biosimilars and demonstrated the transition of these rates. Additionally, the cumulative retention rates between infliximab originator and biosimilar were compared using the Kaplan–Meier method. Results: The prescription rate of generic mesalazine increased from approximately 10% in 2015 to over 30% in 2021. Although the prescription rate of generic molecular targeting drugs (MTDs) also increased from approximately 0.15% in 2014 to 2.5% in 2021, the increment was lower than that of generic mesalazine. The penetration rates of generic 5-aminosalicylic acid and tacrolimus ranged from over 30% to approximately 50%. Infliximab biosimilar achieved an approximate 20% penetration rate, whereas adalimumab achieved< 5%. The cumulative retention rates did not differ between infliximab originator and biosimilar. Conclusions: The penetration rates of generics and biosimilars for UC treatment are relatively low compared with those for treatment in other fields and the goal of Ministry of Health, Labor, and Welfare. Several countermeasures are necessary for the widespread use of generics and biosimilars, ultimately contributing to cost-effective and sustainable healthcare delivery.
{"title":"Clinical utilization of generic drugs and biosimilars for ulcerative colitis treatment: Insights from a nationwide database study in Japan","authors":"Rintaro Moroi, Y. Kakuta, Hiroshi Nagai, Yusuke Shimoyama, Takeo Naito, H. Shiga, Y. Kinouchi, Atsushi Masamune","doi":"10.1159/000536146","DOIUrl":"https://doi.org/10.1159/000536146","url":null,"abstract":"Introduction: Limited data exist regarding the prevalence and clinical practice involving generic drugs and biosimilars for treating ulcerative colitis (UC) in Japan. We aimed to clarify the clinical usage of these generic drugs and biosimilars for UC treatment in Japan using a nationwide database.\u0000Methods: We collected data from 30,675 UC cases, along with their prescriptions for both generic drugs or biosimilars and their original counterparts, using a medical claims database provided by DeSC Healthcare, Inc. We calculated the prescription and penetration rates of generic drugs and biosimilars and demonstrated the transition of these rates. Additionally, the cumulative retention rates between infliximab originator and biosimilar were compared using the Kaplan–Meier method.\u0000Results: The prescription rate of generic mesalazine increased from approximately 10% in 2015 to over 30% in 2021. Although the prescription rate of generic molecular targeting drugs (MTDs) also increased from approximately 0.15% in 2014 to 2.5% in 2021, the increment was lower than that of generic mesalazine. The penetration rates of generic 5-aminosalicylic acid and tacrolimus ranged from over 30% to approximately 50%. Infliximab biosimilar achieved an approximate 20% penetration rate, whereas adalimumab achieved< 5%. The cumulative retention rates did not differ between infliximab originator and biosimilar.\u0000Conclusions: The penetration rates of generics and biosimilars for UC treatment are relatively low compared with those for treatment in other fields and the goal of Ministry of Health, Labor, and Welfare. Several countermeasures are necessary for the widespread use of generics and biosimilars, ultimately contributing to cost-effective and sustainable healthcare delivery. \u0000","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-01-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139445108","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
H. Kiyohara, H. Yamazaki, Kei Moriya, Naohiko Akimoto, S. Kawai, Kento Takenaka, Tomohiro Fukuda, Keiichi Tominaga, Junji Umeno, S. Shinzaki, Yusuke Honzawa, Tomohisa Takagi, Hitoshi Ichikawa, Toshiyuki Endo, R. Ozaki, Akira Andoh, K. Matsuoka, Toshifumi Hibi, Taku Kobayashi
Introduction Whether white blood cell (WBC) counts are predictors for the effectiveness of thiopurine treatment in ulcerative colitis (UC) has been inconclusive in previous studies with small sample sizes. We investigated the association between WBC counts and future relapses in UC patients in a large-scale multi-center study. Methods This retrospective cohort study enrolled a total of 723 UC patients in remission from 33 hospitals and followed up for three years. Relapse was defined as a need for treatment intensification. The risk of relapse was compared among patients with the baseline WBC counts<3000/µL (N=31), 3000–4000/µL (N=167), 4000–5000/µL (N=241), and ≥5000/µL (N=284) using a Cox regression model analysis. Moreover, exploratory analyses were conducted to identify other factors predicting relapse. Results During a median follow-up period of 1095 (interquartile range, 1032–1119) days, relapse occurred in 17.2% (125/723). In a crude analysis, WBC counts were not associated with relapse; hazard ratios (HRs) [95% confidence interval (CI)] were 1.50 [0.74–3.06], 1.02 [0.66–1.59] and 0.67 [0.43–1.05] in WBC<3000/µL, 3000–4000/µL, and 4000–5000/µL groups, respectively (WBC≥5000/µL group, as reference). Multivariable-adjusted analyses showed similar results; HRs [95% CI] were 1.21 [0.59–2.49], 1.08 [0.69–1.69], and 0.69 [0.44–1.07], in <3000/µL, 3000–4000/µL, and 4000–5000/µL group, respectively. In the exploratory analyses, thiopurine use <1 year and a mean corpuscular volume <90 fL were predictors for relapse. Discussion/Conclusion WBC counts were not predictors for future relapses in patients with UC treated with thiopurine as a maintenance therapy.
{"title":"White blood cell counts and future relapse in ulcerative colitis under low-dose thiopurine treatment in real-world practice: a three year Japanese multi-center retrospective cohort study.","authors":"H. Kiyohara, H. Yamazaki, Kei Moriya, Naohiko Akimoto, S. Kawai, Kento Takenaka, Tomohiro Fukuda, Keiichi Tominaga, Junji Umeno, S. Shinzaki, Yusuke Honzawa, Tomohisa Takagi, Hitoshi Ichikawa, Toshiyuki Endo, R. Ozaki, Akira Andoh, K. Matsuoka, Toshifumi Hibi, Taku Kobayashi","doi":"10.1159/000535889","DOIUrl":"https://doi.org/10.1159/000535889","url":null,"abstract":"Introduction Whether white blood cell (WBC) counts are predictors for the effectiveness of thiopurine treatment in ulcerative colitis (UC) has been inconclusive in previous studies with small sample sizes. We investigated the association between WBC counts and future relapses in UC patients in a large-scale multi-center study. Methods This retrospective cohort study enrolled a total of 723 UC patients in remission from 33 hospitals and followed up for three years. Relapse was defined as a need for treatment intensification. The risk of relapse was compared among patients with the baseline WBC counts<3000/µL (N=31), 3000–4000/µL (N=167), 4000–5000/µL (N=241), and ≥5000/µL (N=284) using a Cox regression model analysis. Moreover, exploratory analyses were conducted to identify other factors predicting relapse. Results During a median follow-up period of 1095 (interquartile range, 1032–1119) days, relapse occurred in 17.2% (125/723). In a crude analysis, WBC counts were not associated with relapse; hazard ratios (HRs) [95% confidence interval (CI)] were 1.50 [0.74–3.06], 1.02 [0.66–1.59] and 0.67 [0.43–1.05] in WBC<3000/µL, 3000–4000/µL, and 4000–5000/µL groups, respectively (WBC≥5000/µL group, as reference). Multivariable-adjusted analyses showed similar results; HRs [95% CI] were 1.21 [0.59–2.49], 1.08 [0.69–1.69], and 0.69 [0.44–1.07], in <3000/µL, 3000–4000/µL, and 4000–5000/µL group, respectively. In the exploratory analyses, thiopurine use <1 year and a mean corpuscular volume <90 fL were predictors for relapse. Discussion/Conclusion WBC counts were not predictors for future relapses in patients with UC treated with thiopurine as a maintenance therapy.","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"27 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-12-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139150052","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Introduction: Limited data exist on the efficacy of combination therapy with ustekinumab and budesonide in patients with Crohn’s disease. Our objective was to compare the clinical outcomes of ustekinumab and budesonide combination therapy with those of ustekinumab monotherapy. Methods: In this Phase 2 single-center, double-blind, randomized controlled trial, we assigned 19 patients with Crohn’s disease with a Crohn’s disease activity index (CDAI) equal to or greater than 220 and less than 450 in a 1:1 ratio to receive ustekinumab and budesonide or ustekinumab for 32 weeks. The primary endpoint was the clinical remission rate at 8 weeks. The secondary endpoints were the clinical remission rate at 32 weeks and mucosal healing rates at 8 and 32 weeks. Results: Of 19 patients, the mean age was 37.8 years, and 42.1% were women (CDAI ≥220 and <450). There was no difference between combination therapy and ustekinumab monotherapy in terms of clinical remission rates (50.0% vs. 30.0%, P=0.39 at 8 weeks and 37.5% vs. 20.0%, P=0.41) and mucosal healing rates (75.0% vs. 90.0%, P= 0.40 and 37.5% vs. 60.0%, P=0.34 at 8 and 32 weeks, respectively). The most common adverse event was an exacerbation of Crohn’s. There were no differences in safety profiles between the two groups. Conclusions: Our study showed no difference between ustekinumab monotherapy and ustekinumab and budesonide combination therapy in terms of the induction and maintenance of remission (trial registration number: jRCTs021200013).
关于ustekinumab和布地奈德联合治疗克罗恩病患者的疗效的数据有限。我们的目的是比较ustekinumab和布地奈德联合治疗与ustekinumab单药治疗的临床结果。方法:在这项2期单中心、双盲、随机对照试验中，我们将19例克罗恩病活动性指数(CDAI)等于或大于220且小于450的克罗恩病患者按1:1的比例分配给ustekinumab和布地奈德或ustekinumab治疗32周。主要终点是8周时的临床缓解率。次要终点是32周的临床缓解率和8周和32周的粘膜愈合率。结果:19例患者平均年龄37.8岁，女性占42.1% (CDAI≥220，<450)。联合治疗和ustekinumab单药治疗在临床缓解率(50.0% vs. 30.0%， 8周时P=0.39; 37.5% vs. 20.0%， P=0.41)和粘膜愈合率(75.0% vs. 90.0%， P= 0.40; 37.5% vs. 60.0%， 8周和32周时P=0.34)方面没有差异。最常见的不良事件是克罗恩病的恶化。两组之间在安全性方面没有差异。结论:我们的研究显示，在诱导和维持缓解方面，ustekinumab单药治疗与ustekinumab和布地奈德联合治疗没有差异(试验注册号:jRCTs021200013)。
{"title":"The Efficacy of Combination Therapy with Ustekinumab and Budesonide for Crohn's Disease: A Randomized Controlled Trial","authors":"Rintaro Moroi, Kasumi Hishinuma, Yumi Sugawara, Kotaro Nochioka, Yusuke Shimoyama, Takeo Naito, Hisashi Shiga, Yoichi Kakuta, Yoshitaka Kinouchi, Ichiro Tsuji, Atsushi Masamune","doi":"10.1159/000535070","DOIUrl":"https://doi.org/10.1159/000535070","url":null,"abstract":"Introduction: Limited data exist on the efficacy of combination therapy with ustekinumab and budesonide in patients with Crohn’s disease. Our objective was to compare the clinical outcomes of ustekinumab and budesonide combination therapy with those of ustekinumab monotherapy. Methods: In this Phase 2 single-center, double-blind, randomized controlled trial, we assigned 19 patients with Crohn’s disease with a Crohn’s disease activity index (CDAI) equal to or greater than 220 and less than 450 in a 1:1 ratio to receive ustekinumab and budesonide or ustekinumab for 32 weeks. The primary endpoint was the clinical remission rate at 8 weeks. The secondary endpoints were the clinical remission rate at 32 weeks and mucosal healing rates at 8 and 32 weeks. Results: Of 19 patients, the mean age was 37.8 years, and 42.1% were women (CDAI ≥220 and <450). There was no difference between combination therapy and ustekinumab monotherapy in terms of clinical remission rates (50.0% vs. 30.0%, P=0.39 at 8 weeks and 37.5% vs. 20.0%, P=0.41) and mucosal healing rates (75.0% vs. 90.0%, P= 0.40 and 37.5% vs. 60.0%, P=0.34 at 8 and 32 weeks, respectively). The most common adverse event was an exacerbation of Crohn’s. There were no differences in safety profiles between the two groups. Conclusions: Our study showed no difference between ustekinumab monotherapy and ustekinumab and budesonide combination therapy in terms of the induction and maintenance of remission (trial registration number: jRCTs021200013).","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"76 23","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-11-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135092977","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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