Crohn's & Colitis 360最新文献

{"title":"Comparative effectiveness and safety of risankizumab vs ustekinumab in patients with Crohn's disease: a propensity score-matched multicenter retrospective cohort study.","authors":"Bisher Sawaf, Umberto Battistin, Mohammed Abu-Rumaileh, Kyrillos Mahrous Gerges, Yusuf Hallak, Shahem Abbarh, Elias Batikh, Nwal Hadaki, Muhammed Elhadi, Miguel Regueiro, Mohammad Al-Haddad","doi":"10.1093/crocol/otag096","DOIUrl":"10.1093/crocol/otag096","url":null,"abstract":"<p><strong>Background: </strong>In the SEQUENCE trial, risankizumab was non-inferior for clinical remission and superior for endoscopic remission compared to ustekinumab in anti-TNF-exposed Crohn's disease (CD) patients. Given unclear results in real-world settings, we aimed to evaluate whether these findings translate to real-world advanced therapy-exposed and naïve CD cohorts.</p><p><strong>Methods: </strong>A retrospective cohort study using the TriNetX database with 1:1 propensity-score matching (PSM) analyzed 2 CD cohorts (advanced therapy-exposed and naïve) from inception to March 29, 2026. Primary outcomes were corticosteroid use, hospitalization, emergency department (ED) visits, intestinal surgery, intestinal complications, C-reactive protein (CRP) ≥ 10 mg/L, and therapy switching. Secondary outcomes included venous thromboembolism (VTE), major adverse cardiovascular events (MACE), and opportunistic infections. Odds ratios (ORs) with 95% confidence intervals (CIs) were calculated, with outcomes assessed at 12 and 24 months.</p><p><strong>Results: </strong>After PSM, each group in the advanced therapy-exposed cohort comprised 1799 patients, and each group in the advanced therapy-naïve cohort comprised 1776 patients. In the advanced therapy-exposed cohort, compared with ustekinumab, the risankizumab group had a statistically significant lower odds of ED visits, intestinal fistula, CRP ≥10 mg/L, MACE, and opportunistic infections at 12 months, while hospitalization (OR = 0.67, 95% CI, 0.50-0.91), ED visits (OR = 0.49, 95% CI, 0.35-0.68), overall intestinal surgery (OR = 0.68, 95% CI, 0.52-0.90), small intestine surgery (OR = 0.71, 95% CI, 0.52-0.99), large intestine surgery (OR = 0.72, 95% CI, 0.53-0.97), intestinal obstruction (OR = 0.69, 95% CI, 0.51-0.93), intestinal fistula (OR = 0.53, 95% CI, 0.36-0.78), CRP ≥10 mg/L (OR: 0.62, 95% CI, 0.46-0.85), MACE, and opportunistic infections at 24 months. Similarly, in the naïve cohort, compared with ustekinumab, risankizumab had a statistically significant lower odds of only CRP ≥10 mg/L at 12 months, while hospitalization, ED visits, overall intestinal surgery, small intestine surgery, large intestine surgery, anal surgery, overall complication of intestines, intestinal obstruction, switching to another advanced therapy, CRP ≥10 mg/L, and opportunistic infections at 24 months.</p><p><strong>Conclusions: </strong>In real-world practice, risankizumab was associated with modestly more favorable outcomes in patients with prior advanced therapy exposure, whereas differences became more apparent at 24 months in advanced therapy-naïve patients. Prospective studies are needed to confirm these findings.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"8 3","pages":"otag096"},"PeriodicalIF":1.8,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13568817/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148955190","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":"Long-term safety and efficacy of darvadstrocel for complex perianal fistulas in Japanese adults with Crohn's disease: 3-year follow-up results.","authors":"Tsunekazu Mizushima, Satomi Furukawa, Rikisaburo Sahara, Akihiko Ohta, Yoshiki Okita, Takahiro Ito, Hiroki Ikeuchi, Daijiro Higashi, Akira Sugita, Kenichi Takahashi, Takayuki Ogino, Shigeru Kiryu, Ryo Nakaya, Nobuhiro Narii, Takayoshi Yamaguchi, Kenji Watanabe, Kitaro Futami","doi":"10.1093/crocol/otag090","DOIUrl":"10.1093/crocol/otag090","url":null,"abstract":"<p><strong>Background/aims: </strong>Darvadstrocel is a 1-time local injection for treatment-refractory complex perianal fistulas in patients with Crohn's disease. Here we present 3-year (week 156) follow-up results from a Japanese phase 3, multicenter, open-label study of darvadstrocel.</p><p><strong>Methods: </strong>Adult Japanese patients with Crohn's disease and complex perianal fistulas refractory to previous treatment were treated with darvadstrocel after fistula curettage and seton placement. In this long-term follow-up extension, treatment-emergent adverse events, including serious treatment-emergent adverse events, were recorded through week 156. The proportions of patients with combined remission (clinical remission plus magnetic resonance imaging confirmation of fistula closure) and clinical remission were recorded at week 104 and week 156.</p><p><strong>Results: </strong>In total, 22 patients were treated with darvadstrocel; 19 patients completed assessment at week 156. Through week 156, treatment-emergent adverse events were experienced by 21/22 patients (95.5%); most treatment-emergent adverse events were moderate (40.9%) or mild (31.8%). Serious treatment-emergent adverse events were reported in 11 patients (50.0%). At week 104 and week 156, 77.3% of patients (17/22) and 68.2% of patients (15/22), respectively, achieved both combined and clinical remission. Mean maximum short axis diameter of the fistula tract at the time of remission was shortest in patients who maintained combined remission until week 156.</p><p><strong>Conclusions: </strong>No new safety signals for darvadstrocel were identified during the 3-year follow-up period. Combined and clinical remission of complex perianal fistulas was sustained up to 156 weeks.</p><p><strong>Clinicaltrialsgov registration: </strong>NCT03706456.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"8 3","pages":"otag090"},"PeriodicalIF":1.8,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13622351/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149079947","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":"Serum leucine-rich α-2-glycoprotein and monocyte chemoattractant protein-1 as novel biomarkers for predicting vedolizumab response in patients with ulcerative colitis.","authors":"Takeo Yoshihara, Shinichiro Shinzaki, Tetsuji Naka, Hideki Iijima, Yoshito Hayashi, Kaori Ishiguro, Yuji Baba, Tetsuo Takehara","doi":"10.1093/crocol/otag084","DOIUrl":"10.1093/crocol/otag084","url":null,"abstract":"<p><strong>Background and aims: </strong>Effective, minimally invasive biomarkers are needed to predict treatment outcomes in ulcerative colitis (UC). This multicenter observational study investigated predictive serum and genetic biomarkers for vedolizumab (VDZ) therapy in UC, including serum leucine-rich α-2-glycoprotein (LRG), cytokines, and differentially expressed genes (DEGs) in intestinal tissue.</p><p><strong>Methods: </strong>Eligible patients (18-80 years; moderately to severely active UC) received intravenous VDZ (300 mg; Weeks 0, 2, 6, then every 8 weeks through Week 54). Serum biomarkers were compared between those who did/did not achieve clinical remission (CR; full Mayo score ≤2, all subscores ≤1) or mucosal healing (MH; Mayo endoscopic subscore ≤1) at Week 14. Week 0 inflammatory tissue data were stratified by Week 14 VDZ effect (CR and complete-MH [Mayo endoscopic subscore = 0]) for DEGs.</p><p><strong>Results: </strong>Overall, 21 patients were included. Mean serum LRG was significantly lower in the CR (<i>n</i> = 11) versus non-CR (<i>n</i> = 10) group at Week 0 (19.0 vs 29.0 µg/mL; <i>P</i> = .0267) and Week 6 (13.4 vs 19.6 µg/mL; <i>P</i> = .0340), and in the MH (<i>n</i> = 14) versus non-MH (<i>n</i> = 7) group at Week 6 (13.7 vs 21.6 µg/mL; <i>P</i> = .0326). Mean monocyte chemoattractant protein-1 (MCP-1) was significantly different between CR and non-CR groups at Week 0 (609.0 vs 403.4 pg/mL; <i>P</i> = .0018) and MH versus non-MH at Week 0 (587.2 vs 358.9 pg/mL; <i>P</i> < .001) and Week 6 (606.9 vs 451.6 pg/mL; <i>P</i> = .037). No significant differences in C-reactive protein and fecal calprotectin levels were observed. DEGs included <i>LRG1</i>, LRG-related cytokines, and <i>MCP1</i>.</p><p><strong>Conclusions: </strong>Serum LRG and MCP-1 may be candidate biomarkers of VDZ treatment response in UC.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"8 3","pages":"otag084"},"PeriodicalIF":1.8,"publicationDate":"2026-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13495107/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148789254","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":"Correction to: The Dedicated Inflammatory Bowel Disease Nurse, If You Know Them, You Love Them: Survey of the Italian IBD Patients' Association.","authors":"","doi":"10.1093/crocol/otag089","DOIUrl":"https://doi.org/10.1093/crocol/otag089","url":null,"abstract":"<p><p>[This corrects the article DOI: 10.1093/crocol/otaf063.].</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"8 3","pages":"otag089"},"PeriodicalIF":1.8,"publicationDate":"2026-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13457914/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148711476","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":"Inflammatory burden index (CRP×NLR) is associated with moderate-to-severe endoscopic activity in hospitalized patients with ulcerative colitis: a single-center retrospective study.","authors":"Zihan Xu, Shiqing Yuan, Zhen Hu, Jiarun Qian, Lihong Gu, Xiaoyun Wang","doi":"10.1093/crocol/otag073","DOIUrl":"10.1093/crocol/otag073","url":null,"abstract":"<p><strong>Background: </strong>In hospitalized patients with ulcerative colitis (UC), timely endoscopy may be constrained. We evaluated whether the inflammatory burden index (IBI; C-reactive protein × neutrophil-to-lymphocyte ratio [CRP×NLR]) is associated with endoscopic activity.</p><p><strong>Methods: </strong>We retrospectively studied adults hospitalized with UC between 2023 and 2025 who underwent index lower endoscopy during the same admission, with blood sampling within 24 hours of admission and endoscopy within 72 hours of admission. Endoscopic activity was graded by Mayo Endoscopic Subscore (MES) and dichotomized as MES 0-1 versus ≥2. Associations with MES ≥2 were examined using logistic regression with adjustment for age, sex, and body mass index, with IBI modeled as log(IBI + 1). Discrimination was assessed by receiver operating characteristic analysis with same-sample DeLong testing. Sensitivity analyses were restricted to endoscopy within 48 hours after blood sampling.</p><p><strong>Results: </strong>Among 107 patients, 83 (77.6%) had MES ≥2. IBI correlated with MES (ρ  =  0.58; <i>P</i> < .001) and remained independently associated with MES ≥2 (adjusted OR, 5.28; 95% CI, 2.12-13.14; <i>P</i> < .001). Discrimination was reasonable (AUC, 0.83; 95% CI, 0.76-0.90). CRP alone performed similarly (AUC, 0.80; 95% CI, 0.71-0.88; <i>P</i> = .227 vs IBI), as did a CRP+NLR model (AUC, 0.84; 95% CI, 0.77-0.91; <i>P</i> = .40 vs IBI). Findings were directionally consistent in the ≤48-hour sensitivity analysis. The Youden-derived IBI cutoff was 3.65 (sensitivity, 72.3%; specificity, 91.7%) and should be considered exploratory.</p><p><strong>Conclusions: </strong>In this cohort, IBI was associated with moderate-to-severe endoscopic activity. Performance was comparable to CRP alone, and findings should be interpreted as exploratory rather than as evidence for a standalone clinical decision tool.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"8 3","pages":"otag073"},"PeriodicalIF":1.8,"publicationDate":"2026-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13459971/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148711619","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":"Outcomes of tofacitinib dose reduction in patients with ulcerative colitis in stable remission: a long-term follow-up of the randomized RIVETING trial.","authors":"David T Rubin, Julian Panés, Joana Torres, Taku Kobayashi, Chinyu Su, Nervin Lawendy, Irene Modesto, Michelle Segovia, Sean Gardiner, Wenjin Wang, Séverine Vermeire","doi":"10.1093/crocol/otag093","DOIUrl":"10.1093/crocol/otag093","url":null,"abstract":"<p><strong>Background: </strong>Tofacitinib is an oral Janus kinase inhibitor used for the treatment of ulcerative colitis. This study evaluated efficacy/safety of dose reduction to tofacitinib 5 mg twice daily (BID) versus remaining on 10 mg BID in patients in stable remission on 10 mg BID.</p><p><strong>Methods: </strong>RIVETING, a phase 3b/4, double-blind, randomized, parallel-group trial, enrolled patients in stable remission (≥6 months) and corticosteroid-free (≥4 weeks) who received tofacitinib 10 mg BID for ≥2 years. Efficacy was reported to month (M)30 and safety was reported throughout.</p><p><strong>Results: </strong>One hundred and forty patients were randomized (1:1) to tofacitinib 5 or 10 mg BID; 50.0% and 62.9%, respectively, maintained modified Mayo score remission at M30. Remission rate differences at M30 between doses were generally greater in patients with a baseline endoscopic subscore of 1 versus 0, and with versus without tumor necrosis factor inhibitor (TNFi) failure. 11/14 patients who dose-escalated from 5 to 10 mg BID following relapse recaptured remission (median 4.8 months). Serious infection and herpes zoster incidence rates were numerically higher with tofacitinib 10 versus 5 mg BID; overall, adverse event rates were generally similar between doses.</p><p><strong>Conclusions: </strong>Patients on tofacitinib 10 mg BID generally maintained modified Mayo score remission through M30 after reduction to 5 mg BID; most patients who relapsed recaptured remission after dose-escalating back to 10 mg BID. Efficacy was more likely to be maintained following dose reduction in patients with baseline endoscopic subscore 0 versus 1, without versus with prior TNFi failure. Serious infection and herpes zoster incidence was higher with tofacitinib 10 versus 5 mg BID, consistent with known safety profile.</p><p><strong>Clinicaltrialsgov: </strong>NCT03281304.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"8 3","pages":"otag093"},"PeriodicalIF":1.8,"publicationDate":"2026-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13525840/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148857143","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":"FUT2 non-secretor status is not associated with disease phenotype or outcomes in patients with Crohn's disease.","authors":"Rachel Lombard, Wenfei Wang, Alexander Chervonsky, Sushila Dalal, Russell D Cohen, Atsushi Sakuraba, David T Rubin, Christopher R Weber, Joel Pekow","doi":"10.1093/crocol/otag094","DOIUrl":"10.1093/crocol/otag094","url":null,"abstract":"<p><strong>Purpose: </strong>The fucosyltransferase 2 gene (FUT2) is responsible for the regulation of mucosal blood type antigens which can act as receptors for bacterial adhesion and regulate intestinal flora. A homozygous nonsense mutation in this gene leads to the absence of these antigens, termed FUT2 non-secretor status, and is associated with the development of Crohn's disease (CD). The mechanism of this association is likely via changes in homeostatic symbiosis, thus promoting development of inflammation. However, the impact of FUT2 genotype on CD phenotype and outcomes is not known.</p><p><strong>Methods: </strong>Subjects were prospectively enrolled into a single-center translational IBD registry. All patients with CD who had available DNA extracted from peripheral blood for genotyping were included. Genotyping was performed using the rs601338-AA SNP, which represents the nonsense mutation (428GA) shown to be causing non-secretor status. Baseline demographics, disease phenotype, CD-related surgeries, and hospitalizations were also assessed retrospectively and statistically compared based on FUT2 genotype.</p><p><strong>Results: </strong>635 patients with CD were included in the analysis, including 178 FUT2 wild-type (WT), 314 heterozygous (HET) and 143 homozygous (O) patients. The mean duration of follow-up was 8 years and 2 months. There were no statistically significant differences detected between genotypes when comparing sex, race, smoking status, body-mass index, and age of onset. Presence of extra-intestinal manifestations including arthritis, uveitis, erythema nodosum, pyoderma gangrenosum and primary sclerosing cholangitis, as well as disease location and behavior were also found to be similar when compared between O and WT, O and HET, and O and HET plus WT populations. The mean number of biologics used between groups was 1.50 (O), 1.39 (HET)and 1.42 (WT) (<i>P </i>= .55), with no difference in total duration of biologic therapy between groups. 60.8% of O patients used immunomodulators compared to 54.8% of HET and 59.6% of WT patients. In addition, there were no differences between groups in the number of patients who required more than one CD-related hospitalization (O = 30.1%, HET = 34.1%, WT = 30.3%) or surgery (O = 32.2%, HET = 39.5%, WT = 32%).</p><p><strong>Conclusion: </strong>In this single-center analysis of 635 patients with CD, the FUT2 genotype was not associated with disease phenotype, disease severity, or clinical outcomes. These data suggest that while lack of fucosylation is associated with developing CD, it does not play a major role in driving disease progression.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"8 3","pages":"otag094"},"PeriodicalIF":1.8,"publicationDate":"2026-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13521598/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148839387","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":"Most of moderate to severe ulcerative colitis patients in academic clinical practice still do not qualify for randomized controlled trials.","authors":"Sandra Elmasry, Shabana Pasha, Manreet Kaur, Jonathan A Leighton, Suryakanth R Gurudu, Christina Ha","doi":"10.1093/crocol/otag092","DOIUrl":"10.1093/crocol/otag092","url":null,"abstract":"<p><strong>Background: </strong>While biologic and small molecule therapies have expanded treatment options for moderate to severe ulcerative colitis (UC), prior research revealed that only 26% of patients in routine practice would have qualified for pivotal randomized controlled trials (RCTs) due to stringent eligibility criteria. This study aimed to evaluate contemporary clinical trial eligibility for UC patients in a tertiary care setting based on more recently approved therapies.</p><p><strong>Methods: </strong>We performed a retrospective cohort study of adult patients with moderate to severe UC (total Mayo score ≥6) seen between January 2022 and February 2023. Inclusion and exclusion criteria from seven phase III RCTs conducted between 2012 and 2022 (eg, VARSITY, UNIFI, OCTAVE, LUCENT) were applied to determine patient eligibility and identify reasons for ineligibility.</p><p><strong>Results: </strong>Of 150 patients (mean age 44.9 years; 55.7% male), only 42.7% were eligible for at least one RCT. The most common exclusion factor was current or prior medication use, followed by anemia, dysplasia, and disease extent. Trial eligibility did not significantly differ by age, gender, or disease duration.</p><p><strong>Conclusions: </strong>Despite modest improvements since 2012, over half of real-world UC patients remain ineligible for current RCTs. Expanding inclusion criteria, especially regarding prior medication exposure, and adopting more inclusive trial designs may enhance external validity. Addressing disparities in trial access and participation remains essential to ensuring equitable representation and improving clinical applicability of RCT findings.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"8 3","pages":"otag092"},"PeriodicalIF":1.8,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13499232/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148788930","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":"Continued concomitant antibiotic or immunosuppression therapies reduce the risk of pouchitis among patients with ileal pouch-anal anastomosis and primary sclerosing cholangitis.","authors":"John P Haydek, Priscila Santiago, Joseph Carter Powers, Latchmin Ruplall, Hoang Anh Richardson, Erin Causey, Mohamed Elhawary, Taylor Karl, Rami Tfayli, Jana G Hashash, Taha Qazi, Shannon Chang, Sara Horst, Frank I Scott, Millie D Long, Laura Raffals, Edward L Barnes","doi":"10.1093/crocol/otag091","DOIUrl":"https://doi.org/10.1093/crocol/otag091","url":null,"abstract":"<p><strong>Background: </strong>Complications such as intermittent pouchitis (IP) and chronic inflammatory disorders of the pouch (CP) are common after ileal pouch-anal anastomosis (IPAA), particularly among patients with both ulcerative colitis and primary sclerosing cholangitis (PSC). There are no standardized approaches for prophylaxis against these complications for patients with PSC undergoing IPAA. We compared outcomes among patients with PSC and IPAA who received antibiotic or immunosuppressive therapies to those who did not.</p><p><strong>Methods: </strong>We designed a retrospective cohort study that included patients with ulcerative colitis and PSC from 7 tertiary care centers that underwent IPAA between 1994 and 2023. Patients were categorized on whether they received medications following IPAA that may provide primary prophylactic benefit, such as antibiotics, probiotics, immunomodulators, or biologic medications; and the proportion of patients developing IP and CP was evaluated.</p><p><strong>Results: </strong>A total of 172 patients were included in the cohort, and 13 (7.6%) patients received antibiotics or immunosuppressant medications. Antibiotics and probiotics were the most common therapy (5 patients, 2.9%), followed by biologics, small-molecule inhibitors, immunomodulators, or mesalamine (all 1 patient, 0.6%). Compared to patients not receiving antibiotics or immunosuppression, patients receiving antibiotics or immunosuppression were significantly less likely to develop IP (69.2% vs 91.2%; <i>P</i> = .03; odds ratio 0.22; 95% CI, 0.06-0.80) and CP (23.1% vs 56.0%, <i>P</i> = 0.04; OR 0.24, 95% CI, 0.06-0.89).</p><p><strong>Conclusions: </strong>In this retrospective cohort of patients with ulcerative colitis and PSC undergoing IPAA, usage of concomitant antibiotics or immunosuppression was low. However, use of concomitant antibiotics or immunosuppression may decrease the burden of inflammatory conditions of the pouch in these high-risk patients.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"8 3","pages":"otag091"},"PeriodicalIF":1.8,"publicationDate":"2026-08-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13472676/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148759092","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":"Evaluating the access process for patients transitioning from intravenous to subcutaneous biologic administration for inflammatory bowel disease.","authors":"Taylor Kissel, Miranda Murray, Josh DeClercq, Autumn Zuckerman","doi":"10.1093/crocol/otag087","DOIUrl":"10.1093/crocol/otag087","url":null,"abstract":"<p><strong>Background: </strong>Research is needed to evaluate challenges associated with payers' and patients' uptake of vedolizumab and infliximab subcutaneous (SC) formulations, which were recently approved by the U.S. Food and Drug Administration.</p><p><strong>Methods: </strong>A single center, ambispective study evaluated patients with inflammatory bowel disease with a referral to start or transition to SC vedolizumab or infliximab between September 2023 and December 2024. The primary outcome was time to SC formulation access. Secondary outcomes included whether patients were approved for SC therapy, method of approval, and number of patients not starting SC maintenance therapy after referral.</p><p><strong>Results: </strong>Of the 248 patients included in the regression analyses, most patients (72%) referred to SC were approved, with over half of those approvals occurring via prior authorization (56%). Of the 179 patients approved to start therapy, 21% of patients did not start therapy, largely due to patient decision (45%). The median time to access was 11 days (interquartile range 1-43) with a range of 0-457 days. Patients with commercial pharmacy insurance were 3 times more likely to have a longer time to medication access (odds ratios [OR]: 3.40, 95% confidence interval [CI]: 1.5-6.1, <i>P</i> = .003). Patients not in remission at baseline were 90% more likely to have a longer time to medication access than patients in remission (OR: 1.9, 95% CI 0.8-4.2, <i>P</i> = .127).</p><p><strong>Conclusions: </strong>Over a quarter of patients prescribed SC vedolizumab or infliximab do not start due to payer restrictions or patient preference. Patients with commercial insurance may be less likely to access SC therapy.</p>","PeriodicalId":10847,"journal":{"name":"Crohn's & Colitis 360","volume":"8 3","pages":"otag087"},"PeriodicalIF":1.8,"publicationDate":"2026-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13455085/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148705435","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}