Inflammatory Intestinal Diseases最新文献

{"title":"Usefulness of Serum Leucine-Rich Alpha-2 Glycoprotein as a Surrogate Marker of Small Bowel Mucosal Injury in Crohn's Disease.","authors":"Takuto Saiki,&nbsp;Takehiro Torisu,&nbsp;Akira Harada,&nbsp;Yu Kajiya,&nbsp;Yoshiaki Taniguchi,&nbsp;Shinji Morisaki,&nbsp;Junji Umeno,&nbsp;Hiroshi Suekane,&nbsp;Takanari Kitazono","doi":"10.1159/000531622","DOIUrl":"https://doi.org/10.1159/000531622","url":null,"abstract":"<p><strong>Introduction: </strong>Although the importance of mucosal healing has been suggested in Crohn's disease, it is difficult to repeat endoscopy, especially for the entire small bowel. Recently, serum leucine-rich alpha-2 glycoprotein (LRG) has been used as a surrogate marker of endoscopy. However, few studies have investigated a correlation between LRG and mucosal injury of the entire small bowel.</p><p><strong>Methods: </strong>We retrospectively analyzed the clinical data of 30 patients with Crohn's disease from June 2020 to August 2022 at Yamaguchi Red Cross Hospital. All the patients were surveyed through the gastrointestinal tract by esophagogastroduodenoscopy, total colonoscopy, and capsule endoscopy (CE). Subjects with mucosal injury only in the small bowel were selected. Then, we assessed the relationship between serum biomarkers (LRG, C-reactive protein [CRP], hemoglobin, albumin) and small bowel mucosal injury scores (Lewis score [LS], Capsule Endoscopy Crohn's Disease Activity Index [CECDAI], and Crohn's Disease Activity in Capsule Endoscopy [CDACE]) calculated by CE.</p><p><strong>Results: </strong>LRG and CRP were significantly correlated with small bowel mucosal injury scores (LS, CECDAI, CDACE) (<i>p <</i> 0.05<i>,</i> Spearman's rank correlation coefficient). The degree of correlation was greater for LRG than for CRP.</p><p><strong>Conclusions: </strong>LRG is a useful surrogate marker that closely reflects small bowel mucosal injury in the entire small bowel.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"8 2","pages":"69-76"},"PeriodicalIF":0.0,"publicationDate":"2023-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10601960/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71412067","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}

{"title":"Assessing the Clinical and Endoscopic Efficacy of Extended Treatment Duration with Different Doses of Mesalazine for Mild-to-Moderate Ulcerative Colitis beyond 8 Weeks of Induction.","authors":"Geert D'Haens,&nbsp;Ekaterina Safroneeva,&nbsp;Helen Thorne,&nbsp;Raphaël Laoun","doi":"10.1159/000531372","DOIUrl":"https://doi.org/10.1159/000531372","url":null,"abstract":"<p><strong>Introduction: </strong>High-strength mesalazine formulations play an important role in providing a convenient option to increase the dose in ulcerative colitis (UC) patients and therefore avoiding the switch to another therapeutic class. Higher doses of mesalazine may be required during periods of remission in order to prevent relapse.</p><p><strong>Aim: </strong>The aim of the study was to investigate clinical outcomes of three mesalazine maintenance doses adapted for post induction response.</p><p><strong>Methods: </strong>In this post hoc analysis, 675 UC patients entered an open-label extension study for a total of 38 weeks (including 8-12 week induction period with 3.2 g/day mesalazine). After the induction period, they were separated into three groups: remitters (in clinical and endoscopic remission), responders (decrease in Partial Mayo Clinic Score of ≥2 points and ≥30% from week 0), and nonresponders (failed to achieve endoscopic or clinical response at week 8) and received 1.6 g/day, 3.2 g/day, or 4.8 g/day of mesalazine (using a new 1,600 mg mesalazine tablet), respectively.</p><p><strong>Results: </strong>133/202 (65.8%), 108/274 (39.4%), and 59/199 (29.6%) patients achieved clinical and endoscopic remission at week 38 with 1.6 g/day, 3.2 g/day, and 4.8 g/day, respectively. At week 38, 142/202 (70.3%), 93/274 (33.9%), and 61/199 (30.7%) patients achieved clinical remission (stool score of 0 and rectal bleeding score of 0) with 1.6 g/day, 3.2 g/day, and 4.8 g/day, respectively.</p><p><strong>Conclusions: </strong>Patients partially responding or not responding to an initial induction dose of 3.2 g/day mesalazine could benefit from an extended treatment period at the same dose, or an increase to 4.8 g/day in an attempt to achieve combined clinical and endoscopic remission.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"8 2","pages":"51-59"},"PeriodicalIF":0.0,"publicationDate":"2023-06-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10601940/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71412162","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}

{"title":"Real-World Effectiveness and Risk Factors for Discontinuation of Ustekinumab in Ulcerative Colitis.","authors":"Genta Uchida,&nbsp;Masanao Nakamura,&nbsp;Takeshi Yamamura,&nbsp;Keiko Maeda,&nbsp;Tsunaki Sawada,&nbsp;Eri Ishikawa,&nbsp;Kazuhiro Furukawa,&nbsp;Tadashi Iida,&nbsp;Yasuyuki Mizutani,&nbsp;Kentaro Yamao,&nbsp;Takuya Ishikawa,&nbsp;Yoji Ishizu,&nbsp;Takashi Honda,&nbsp;Masatoshi Ishigami,&nbsp;Hiroki Kawashima","doi":"10.1159/000531497","DOIUrl":"https://doi.org/10.1159/000531497","url":null,"abstract":"<p><strong>Introduction: </strong>Ustekinumab (UST) has been approved for the treatment of moderate-to-severe ulcerative colitis (UC). Real-world data showing the effectiveness and safety of UST are necessary to confirm the results of clinical trials for applicability in daily clinical practice. Although some studies have reported real-world evidence of UST, only few studies have confirmed its effectiveness in the real world. The aim of this study was to assess the short- and long-term effectiveness, durability, safety, and risk factors for discontinuation of UST in UC in clinical practice.</p><p><strong>Methods: </strong>This was a retrospective, single-center, observational study. From March 2020 to January 2023, all consecutive patients with active UC who were treated with UST at Nagoya University Hospital were included. The primary outcome was the clinical remission rate at weeks 2-8 and weeks 24-48. The secondary outcomes included clinical response, persistence of UST therapy, endoscopic changes during follow-up, risk factors for UST discontinuation, and occurrence of any adverse events. The clinical effectiveness was evaluated using the Lichtiger score.</p><p><strong>Results: </strong>A total of 31 patients were included in this study. The clinical remission rates were 9.7%, 29.0%, 54.8%, and 64.5% at weeks 2, 8, 24, and 48, respectively. Twelve (38.7%) patients discontinued UST during the follow-up period. The probability of continuing UST was 93.5%, 80.6%, 77%, and 70% at weeks 2, 8, 24, and 48, respectively. The major reason for discontinuation of UST was primary failure (75.0%). A high baseline C-reactive protein (CRP) level was a significant risk factor for the discontinuation of UST. No adverse events were observed in this study.</p><p><strong>Conclusion: </strong>UST is effective for patients with UC. High CRP levels were identified as a risk factor for UST discontinuation. The findings of this study would help clinicians to select appropriate treatment options for patients with UC by identifying the risk factors for treatment discontinuation.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"8 2","pages":"60-68"},"PeriodicalIF":0.0,"publicationDate":"2023-06-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10601947/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71412066","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}

{"title":"Medication Formulation Preference of Mild and Moderate Ulcerative Colitis Patients: a European Survey.","authors":"Xavier Hébuterne, Stephan R Vavricka, Helen C Thorne, Lara MacKenzie-Smith, Raphaël Laoun, Johan Burisch","doi":"10.1159/000530139","DOIUrl":"10.1159/000530139","url":null,"abstract":"<p><strong>Introduction: </strong>Patient adherence is a major challenge for the successful management of any chronic disease, and ulcerative colitis (UC) is no exception. Patient adherence is closely related to patient preference of medication and formulation used.</p><p><strong>Aim: </strong>The aim of this study was to investigate patient and physician perspectives around UC treatment preference.</p><p><strong>Methods: </strong>This study was conducted in France, Germany, Spain, and the UK. Physicians and UK inflammatory bowel disease (IBD) nurses answered an online questionnaire. In addition, adult mild-to-moderate UC patients, treated with oral mesalazine, were invited to answer a 30-min online survey which included a conjoint exercise.</p><p><strong>Results: </strong>400 patients, 160 physicians, and 20 IBD nurses participated in the survey. 68% of patients were taking tablets and 32% granules. Physicians stated that from their perspective patients are more adherent to tablets than granules (76% vs. 24%), patients tended to have better relief of symptoms with tablets (69% vs. 31%), and patients found tablets to be the most convenient formulation (61% vs. 39%). From the patients' perspective, when questioned which formulation they prefer, 58% answered tablets, 37% granules, and 5% none of these. When patients were asked about some negative attributes of tablets, the highest agreement was for \"I would like to take fewer each day\" (6.1/10) and \"I wish I could take fewer at a time\" (5.4/10).</p><p><strong>Conclusions: </strong>The majority of UC patients in this survey prefer the tablet formulation. A high strength tablet overcoming the high pill burden could be a good solution to address patient expectations.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"8 1","pages":"41-49"},"PeriodicalIF":0.0,"publicationDate":"2023-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10498945/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10272910","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}

{"title":"Optimal Use of Serum Leucine-Rich Alpha-2 Glycoprotein as a Biomarker for Small Bowel Lesions of Crohn's Disease.","authors":"Kunio Asonuma, Taku Kobayashi, Nao Kikkawa, Masaru Nakano, Shintaro Sagami, Hiromu Morikubo, Yusuke Miyatani, Aya Hojo, Tomohiro Fukuda, Toshifumi Hibi","doi":"10.1159/000530825","DOIUrl":"10.1159/000530825","url":null,"abstract":"<p><strong>Introduction: </strong>A large proportion of small bowel lesions in Crohn's disease (CD) may exist beyond the reach of ileocolonoscopy and there is no gold standard imaging modality to screen them, suggesting the need for optimal biomarkers. We aimed to compare the usefulness of C-reactive protein (CRP), faecal calprotectin (FC), and leucine-rich alpha-2 glycoprotein (LRG) in determining small bowel lesions of CD.</p><p><strong>Methods: </strong>This was a cross-sectional observational study. CRP, FC, and LRG were prospectively measured in patients with quiescent CD who underwent imaging examinations (capsule or balloon-assisted endoscopy, magnetic resonance enterography, or intestinal ultrasound) selected by the physician in clinical practice. Mucosal healing (MH) of the small bowel was defined as a lack of ulcers. Patients with a CD activity index >150 and active colonic lesions were excluded.</p><p><strong>Results: </strong>A total of 65 patients (27, MH; 38, small bowel inflammation) were analysed. The area under the curve (AUC) of CRP, FC, and LRG was 0.74 (95% confidence interval: 0.61-0.87), 0.69 (0.52-0.81), and 0.77 (0.59-0.85), respectively. The AUC of FC and LRG in a subgroup of 61 patients with CRP <3 mg/L (26, MH; 32, small bowel inflammation) was 0.68 (0.50-0.81) and 0.74 (0.54-0.84), respectively. The cut-off of 16 μg/mL of LRG showed the highest positive predictive value of 1.00 with specificity of 1.00, while negative predictive value was highest (0.71) with sensitivity of 0.89 at the cut-off of 9 μg/mL.</p><p><strong>Conclusion: </strong>LRG can accurately detect and/or exclude the small bowel lesions with two cut-off values.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"8 1","pages":"13-22"},"PeriodicalIF":0.0,"publicationDate":"2023-05-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10315012/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10234880","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}

{"title":"Construction of an Explanatory Model for Quality of Life in Outpatients with Ulcerative Colitis.","authors":"Miho Takahashi, Maya Nunotani, Nobuo Aoyama","doi":"10.1159/000530455","DOIUrl":"10.1159/000530455","url":null,"abstract":"<p><strong>Introduction: </strong>To date, no studies have reported explanatory models of health-related quality of life (HRQoL) in patients with ulcerative colitis. Therefore, this study aimed to examine HRQoL and its related factors in outpatients with ulcerative colitis to construct an explanatory model.</p><p><strong>Methods: </strong>We conducted a cross-sectional survey at a clinic in Japan. The HRQoL was evaluated using the 32-item Inflammatory Bowel Disease Questionnaire. We extracted explanatory variables of HRQoL from demographic, physical, psychological, and social factors reported in previous studies and created a predictive explanatory model. The relationship between explanatory variables and the questionnaire total score was examined using Spearman's rank correlation coefficient, the Mann-Whitney test, or the Kruskal-Wallis test. We conducted multiple regression and path analyses to examine the effect of explanatory variables on the total score.</p><p><strong>Results: </strong>We included 203 patients. Variables that were associated with the total score were the partial Mayo score (<i>r</i> = -0.451), treatment side effects (<i>p</i> = 0.004), the Hospital Anxiety and Depression Scale-Anxiety score (<i>r</i> = -0.678), the Hospital Anxiety and Depression Scale-Depression score (<i>r</i> = -0.528), and the availability of an advisor during difficult times (<i>p</i> = 0.001). The model included the partial Mayo score, treatment side effects, the Hospital Anxiety and Depression Scale-Anxiety score, and the availability of an advisor during difficult times as explanatory variables of the total score that showed the best goodness-of-fit (adjusted <i>R</i>^<i>2</i> = 0.597). The anxiety score exerted the greatest negative effect on the questionnaire total score (β = -0.586), followed by the partial Mayo score (β = -0.373), treatment side effects (β = 0.121), and availability of an advisor during difficult times (β = -0.101).</p><p><strong>Conclusion: </strong>Psychological symptoms exerted the strongest direct effect on HRQoL in outpatients with ulcerative colitis and mediated the relationship between social support and HRQoL. Nurses should listen carefully to the concerns and anxieties of patients to ensure that a social support system is provided by leveraging multidisciplinary collaborations.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"8 1","pages":"23-33"},"PeriodicalIF":0.0,"publicationDate":"2023-04-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10315687/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10234879","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}

{"title":"Front & Back Matter","authors":"","doi":"10.1159/000530324","DOIUrl":"https://doi.org/10.1159/000530324","url":null,"abstract":"","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"56 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73501048","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}

{"title":"The Impact of Concomitant Ulcerative Colitis on the Clinical Course in Patients with Primary Sclerosing Cholangitis: An Investigation Using a Nationwide Database in Japan.","authors":"Rintaro Moroi,&nbsp;Kota Yano,&nbsp;Kunio Tarasawa,&nbsp;Yusuke Shimoyama,&nbsp;Takeo Naito,&nbsp;Hisashi Shiga,&nbsp;Shin Hamada,&nbsp;Yoichi Kakuta,&nbsp;Kiyohide Fushimi,&nbsp;Kenji Fujimori,&nbsp;Yoshitaka Kinouchi,&nbsp;Atsushi Masamune","doi":"10.1159/000529338","DOIUrl":"https://doi.org/10.1159/000529338","url":null,"abstract":"<p><strong>Introoduction: </strong>Primary sclerosing cholangitis (PSC) is a rare disease, especially in Asian countries. PSC often develops during ulcerative colitis (UC). Little is known about the severity of PSC in patients with UC. Thus, this study aimed to investigate the impact of concomitant UC on the clinical course of patients with PSC using a nationwide database in Japan.</p><p><strong>Methods: </strong>We collected data on patients who were admitted for PSC using a nationwide database and divided eligible admissions according to concomitant UC (PSC-UC group vs. PSC-alone group). We conducted propensity score matching and compared the rates of liver transplantation, biliary drainage, and other clinical events between the two groups. We also conducted a multivariate analysis to identify the clinical factors that affect biliary drainage, cholangiocarcinoma, and liver transplantation.</p><p><strong>Results: </strong>We enrolled 672 patients after propensity score matching. The rate of liver transplantation in the PSC-UC group was lower than that in the PSC-alone group (2.2 vs. 5.4%, <i>p</i> = 0.002), whereas the rate of biliary drainage did not differ between the two groups (38.1 vs. 33.8%, <i>p</i> = 0.10). On multivariate analysis, concomitant UC was identified as a clinical factor that decreased the risk of liver transplantation (odds ratio = 0.40, 95% confidence interval: 0.23-0.68, <i>p</i> = 0.0007).</p><p><strong>Discussion: </strong>Concomitant UC in patients with PSC may decrease the risk of liver transplantation. The milder disease activity of PSC with UC is more likely compared to that of PSC without UC.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"7 3-4","pages":"147-154"},"PeriodicalIF":0.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/5d/64/iid-0007-0147.PMC10091018.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9321856","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}

{"title":"A Regional Survey of Awareness of Inflammatory Bowel Disease among the Saudi Population.","authors":"Yaser Khalid Meeralam,&nbsp;Adnan Al Zanabgi,&nbsp;Mahmoud Mosli,&nbsp;Yosif Qari,&nbsp;Mona Al Saedi,&nbsp;Abdulaziz Tashkhandi,&nbsp;Mohmoud Eliouny,&nbsp;Abdulwahab Neyazi,&nbsp;Ghadeer Al Hazmi,&nbsp;Mohammed Kareem Shariff","doi":"10.1159/000529318","DOIUrl":"https://doi.org/10.1159/000529318","url":null,"abstract":"<p><strong>Introduction: </strong>Inflammatory bowel disease (IBD) is common worldwide, including the gulf region. Early diagnosis of IBD can improve patients' outcomes. However, early diagnosis is dependent on patients' awareness of the disease to seek medical advice. This study aimed to survey the awareness of IBD in the general population of the western region of Saudi Arabia.</p><p><strong>Methods: </strong>A questionnaire about Crohn's disease (CD) and ulcerative colitis (UC) was distributed to the general public. A score of 1 was given for the right response and 0 for an incorrect response, giving a maximum of 3 and a minimum of 0 for the three questions in the questionnaire.</p><p><strong>Results: </strong>1,304 participants responded. Twenty nine percentage had not heard or read about CD, while 19% had not heard or read about UC. The mean awareness level score was 1.72 ± 1.19. Females showed a significantly higher score compared to males (<i>p</i> < 0.001). The age-group 31 to 40 had the highest score (<i>p</i> = 0.002). Moreover, responders who had a PhD. showed significantly higher scores than those with other educational degrees (<i>p</i> < 0.001). Responders who dealt with CD or UC patients showed significantly higher scores than their peers (<i>p</i> < 0.001) for both.</p><p><strong>Conclusion: </strong>The general population in Saudi Arabia has an unacceptable level of awareness of IBD. Females, young adults (age-group: 31-40 years), educated individuals (with a PhD), and those who had dealt with IBD patients previously had better awareness compared to the rest of the population. National acts are essential to improve public awareness toward the disease.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"7 3-4","pages":"139-146"},"PeriodicalIF":0.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/89/80/iid-0007-0139.PMC10091000.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9321859","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}

{"title":"Effectiveness and Safety of Golimumab in the Treatment of Ulcerative Colitis: 52-Week Results from Post-Marketing Surveillance in Japan.","authors":"Shiro Nakamura,&nbsp;Teita Asano,&nbsp;Yoshihito Tanaka,&nbsp;Kanami Sugimoto,&nbsp;Shinichi Yoshigoe,&nbsp;Yasuo Suzuki","doi":"10.1159/000528185","DOIUrl":"https://doi.org/10.1159/000528185","url":null,"abstract":"<p><strong>Introduction: </strong>Real-world evidence for the effectiveness and safety of golimumab (GLM) in patients with ulcerative colitis (UC) is limited. The aim of this study was to investigate the 52-week effectiveness and safety of GLM treatment for UC.</p><p><strong>Methods: </strong>This prospective, multicentre, post-marketing surveillance study is conducted in 393 patients with UC in Japan (UMIN000027542). Clinical remission (partial Mayo score ≤2), adverse drug reactions (ADRs) and their predictors, and treatment persistence were analysed.</p><p><strong>Results: </strong>The safety analysis sets comprised 391 patients. Patients in clinical remission at baseline were excluded, and 336 were used for effectiveness analysis. Clinical remission was 47.9%, 48.5%, 44.6%, and 39.6% at weeks 6, 22, 36, and 52, respectively, in the intent-to-treat analysis. In biologic-naive patients, clinical remission was slightly higher than that in biologic-experienced patients. At week 52, patients who concomitantly used corticosteroids at baseline showed numerically lower clinical remission rates than non-users of corticosteroids (34.9% vs. 44.5%). Multivariate analysis showed that smoking history (<i>p</i> = 0.040, odds ratio [OR] = 1.911, 95% confidence interval [CI] 1.030-3.546) was an independent factor associated with clinical remission at week 52. ADRs occurred in 71 patients (18.2%) and included 9 cases of rash. Serious ADRs occurred in 40 patients (10.2%), including 8 cases of UC exacerbation. Additionally, the presence of comorbidities was associated with ADR incidence (<i>p</i> = 0.010, OR = 2.000, 95% CI: 1.183-3.380).</p><p><strong>Conclusion: </strong>The real-world effectiveness of GLM treatment was confirmed in biologic-naive and experienced populations. The safety profile of GLM treatment was consistent with previous findings.</p>","PeriodicalId":13605,"journal":{"name":"Inflammatory Intestinal Diseases","volume":"7 3-4","pages":"128-138"},"PeriodicalIF":0.0,"publicationDate":"2023-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://ftp.ncbi.nlm.nih.gov/pub/pmc/oa_pdf/58/eb/iid-0007-0128.PMC10090977.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9321857","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}