bluuebunny/crossref_metadata_2025_split huggingface dataset:
P554 Extended induction response in patients treated with mirikizumab with moderately to severely active ulcerative colitis in the LUCENT trials
Authors: D'Haens G , Higgins P D R , Peyrin-Biroulet L , Sands B E , Lee S , Moses R E , Redondo I , Escobar R , Morris N , Kobayashi T 
Published: January 2023

Abstract

Background
The efficacy and safety of mirikizumab (miri) for moderately to severely active ulcerative colitis (UC) was demonstrated in the Phase 3 LUCENT trials (LUCENT-1 and -2; NCT03518086, NCT03524092).1,2 Some patients may improve more slowly and require a prolonged course of induction before achieving clinical response. Therefore, we evaluated clinical response in patients who had not responded by the end of the 12-week(W) induction period and who received extended induction treatment for an additional 12W.

Methods
Patients not responding to intravenous (IV) administration of 300 mg miri every 4 weeks (Q4W) (n=272) at W12 (LUCENT-1), received extended 12-W induction treatment of open label 300 mg miri IV Q4W for 3 additional doses (LUCENT-2). Patients responding at W24 (n=144) of continuous IV treatment, entered open label maintenance and received 200 mg miri Q4W subcutaneously (SC) until W52. Key outcomes through 52W are reported (Definitions in Table).

Results
Among the 272 patients who failed to achieve a clinical response after 12W of induction treatment, 72.4% had a Mayo endoscopic subscore of 3, indicating severe disease. Of these patients, 146 (53.7%) achieved a clinical response and 31 (11.4%) achieved clinical remission at W24.
Of the 144 responders at 24W entering the open label maintenance study, 52 (36.1%) patients achieved clinical remission, 104 (72.2%) achieved clinical response, 62 (43.1%) achieved endoscopic remission and 60 (41.7%) patients achieved histologic improvement at W52. Furthermore, for these patients, there was a 3.8 (±2.7) point reduction from baseline in bowel urgency (BU) severity and 58.8% achieved clinically meaningful improvement in BU (Table). Among these patients, 38.3% demonstrated treatment-emergent adverse events (TEAEs). Most TEAEs were mild (21.4%), while only 5.4% were serious. Overall, there was a 3.2% of discontinuation due to TEAEs. No new safety signals or deaths were reported.

Conclusion
Among patients who did not initially respond to induction treatment with miri at 12W, 3 additional miri induction doses induced clinical response and remission in patients, highlighting the potential benefit of extended induction treatment with miri in those patients with more severe inflammation at baseline.
1.D’Haens et al., OP26: Efficacy and safety of mirikizumab as induction therapy in patients with moderately to severely active Ulcerative Colitis: Results from the Phase 3 LUCENT-1 study, Crohn's and Colitis, Vol. 16, Iss. Supplement_1, Jan. 2022, i028–i029
2.Dubinsky et al., 867e: Efficacy and safety of mirikizumab as maintenance therapy in patients with moderately to severely active Ulcerative Colitis: Results from the Phase 3 Lucent-2 study, Gastroenterology, Vol. 162, Iss. 7, S-1393-94
P559 SARS-CoV-2 vaccination does not increase the risk for flares in Inflammatory Bowel Disease patients
Authors: Rossier L , Seibold F 
Published: January 2023

Abstract

Background
Vaccination hesitancy is an important barrier to vaccination among inflammatory bowel disease (IBD) patients. The development of adverse events is the main concern reported. With this study we wanted to assess the SARS-CoV-2 vaccination safety by evaluating the post-vaccination flare risk and incidence of overall adverse events.

Methods
Surveys were distributed three consecutive months to each IBD patient coming in for a consultation in the Intesto Crohn & Colitis centre (Bern, Switzerland). Information about their vaccination-status and the occurrence of subsequent side effects was recorded. Their electronic medical record was then reviewed. Their baseline- and IBD- characteristics were transcribed as well as the dates of any flare occurring in 2021. These characteristics and the flare incidence were compared between the vaccinated and unvaccinated patients. Among the vaccinated population, the flare-risk was analysed at three different points in time: pre-vaccination, 1 month after any vaccination and over 1 month after any vaccination. Effect measurements according to Poisson models were applied. The characteristics of patients developing side effects were compared to those who did not.

Results
396 IBD patients were enrolled, of which 91% were vaccinated, predominantly with mRNA vaccines. Throughout 2021, 85 flares were recorded with no difference between the vaccinated and unvaccinated groups. Among the vaccinated group, there was no statistically significant difference between the flare-incidence in the pre-vaccination, 1 month after any vaccination and over 1 month after any vaccination subgroups as well as the Moderna- and Pfizer-subgroups. Overall, 37% patients reported side effects following any vaccination, mostly mild flu-like symptoms. More side effects were reported in the patients who were vaccinated with the mRNA-1273/ Spikevax (NIH-Moderna) vaccine in comparison with BNT162b2/Cominarty (Pfizer-BioNTech).

Conclusion
In this mono-centric study SARS-CoV-2 vaccination with mRNA vaccines seems safe with the occurrence of mostly mild side effects. The flare risk is not increased in the month following any vaccination.
P568 Patients with ulcerative colitis after pouch surgery are at risk for low spinal bone mineral density: a cross sectional study
Authors: Pfeffer-Gik T , Godny L , Ollech J , Wasserberg N , White I , Barkan R , Cohen S , Avni-Biron I , Banai H , Snir Y , Yanai H , Yackobovich Gavan M , Shimon I , Tsvetov G , Broitman Y , Dotan I 
Published: January 2023

Abstract

Background
Low bone mineral density (BMD) is prevalent in patients with inflammatory bowel diseases (IBD), specifically Crohn’s disease (CD) due to multiple factors including active inflammation, use of corticosteroids, surgeries and nutritional deficiencies. Patients with ulcerative colitis (UC) who undergo total proctocolectomy and pouch surgery may develop small bowel inflammation (pouchitis) resembling CD. Data regarding their BMD are scarce. We assessed low BMD rates and risk factors in these patientsץ

Methods
Patients with UC-pouch ages 18-50 without BMD assessment in the past 5 years were recruited. BMD was assessed by dual-energy x-ray absorptiometry (DEXA). Clinical data, biochemical and inflammatory markers were detected and dietary patterns were assessed using validated questionnaires.

Results
Patients recruited-30: male/female 14/16; Median age 45 (IQR 31-51.7) years; median BMI 23.2 (IQR 21-26.5); median IBD duration 23 (IQR 15-30) years; median pouch age 17 (IQR 10-25) years. Low BMD detected in 16/30 (53.3%): 6/30 (20%) osteoporosis,10/30 (33.3%) osteopenia. Low L1-L4 T-scores correlated with younger age, lower BMI and shorter disease duration (p= 0.001; p= 0.001; p= 0.023, respectively). In univariate analysis patients with low and normal BMD were comparable in age, gender, BMI, smoking, past and current medical treatment. In multivariate analysis younger age and lower BMI remained significant (age SE= 0.22, β 0.422 p=0.043, BMI SE=0.06, β=0.531 p=0.006)
independently of sex, years since IBD diagnosis, and smoking. Dietary patterns were comparable (p=0.715).

Conclusion
Abnormally low BMD was prevalent in over half of patients with UC-Pouch. Interestingly younger age and lower BMI were risk factors for low spinal BMD. Dietary patterns did not account for the findings. BMD should be routinely assessed in patients with UC-pouch and intervention to correct abnormally low BMD should be planned.
P592 Clinical evaluation of leukocytapheresis compared to vedolizumab in patients with Ulcerative Colitis with contraindications to anti-TNF-alpha: a single-centre experience
Authors: Ferronato A , Rigno M , Rodriguez-Castro K I , Brozzi L , Errigo G , Castelli M , Baldassarre G 
Published: January 2023

Abstract

Background
Various therapeutic advances have led to a paradigm shift in the clinical management of patients with Inflammatory Bowel Diseases (IBD). Recently vedolizumab and other biologic agents have been introduced as a second choice to anti-TNF-alpha and in whom an anti-TNF-alpha cannot be used. Moreover, leukocytapheresis (LA) is a recognized potential option for the treatment for these IBD patients. The aim of this study is to assess if leukocytapheresis can still have a use in selected Ulcerative Colitis (UC) patients comparing it with vedolizumab.

Methods
From February 2019 to November 2021, 15 patients with UC were evaluated: 8 patients treated with leukocytapheresis (5 weekly apheresis session) (group 1) and 7 with vedolizumab (group 2). All patients had contraindications to anti-TNF-alpha use. The choice of treatment was driven by disease severity, presence of recognized optimal indications for leukocytapheresis and patient’s choice. We evaluated patients by clinical disease activity indexes and blood parameters levels at the beginning of therapy, then after 3 and 12 months.

Results
In group 1 after 12 months of follow up (FU) 5 patients achieved clinical remission with 3 patients receiving monthly maintenance therapy. During the FU 3 patients lost response and started biological therapy (vedolizumab). In group 2 after 12 months 3 patients achieved clinical remission with no treatment failure. In table 1 is shown the clinical disease activity for each patient according to Mayo partial score (MPS). The development of the blood parameters is similar in the two groups, with a general reduction of inflammatory parameters after 12 months. In group 1: leukocyte from 6,1 to 5,8 103/mm3; erythrocyte sedimentation rate (ESR) from 21,1 to 15,6 mm/h; platelets (PLT) from 286,6 to 269,5 103/mm3, faecal calprotectin (FC) from 579,1 to 208,5 mg/kg. In group 2: leukocyte from 8,7 to 7,7; ESR from 42,2 to 45,5; PLT from 320,8 to 266,3; FC from 586,2 to 257,2.

Conclusion
There is an indication overlap between leukocytapheresis and vedolizumab, with a trend in research favouring new biologics. From this clinical experience apheresis appears to be effective as second-choice biological drugs. This type of therapy should not be abandoned but should be investigated further with other comparative study to select patients for the best therapy in terms of efficacy, security and compliance. Moreover, a synergistic approach between these therapies could also be evaluated in the future.
P594 Bowel ultrasound is useful in predicting relapse in patients with Ulcerative Colitis in remission
Authors: Maeda M , Sagami S , Tashima M , Yamana Y , Karashima R , Miyatani Y , Hojo A , Nakano M , Hibi T , Kobayashi T 
Published: January 2023

Abstract

Background
Endoscopic remission is associated with better long-term outcomes of ulcerative colitis (UC), and therefore, it is considered a treatment target. However, endoscopy is invasive and frequent monitoring is not feasible. We have reported that bowel ultrasound (BUS) is useful in predicting endoscopic and histologic severity and in determining response to treatment (Sagami S et al, APT 2020 & 2022). However, it is unclear whether BUS can predict the relapse of UC in remission.

Methods
We conducted a retrospective cohort study enrolling UC patients who underwent BUS from Jul 2018 to Jul 2021 during clinical remission (Patient Reported Outcome-2 ≦ 1 and no rectal bleeding) for at least 3 months and followed for 1 year. Spearman rank correlation coefficient was used to analyse the correlation between BUS and Mayo endoscopic subscore (MES) (evaluation of the most severe part of the colon). The association between BUS findings (bowel wall thickness (BWT), bowel wall flow (BWF), bowel wall stratification (BWS), enlarged lymph nodes), Milan Ultrasound Criteria (MUC = 1.4 × colonic BWT + 2 × colonic BWF (0 = absence, 1 = presence of colour Doppler signal)) (Allocca M et al, UEGJ 2021), MES, CRP and faecal calprotectin (FC) and subsequent clinical relapse was evaluated. Relapse was defined as rectal bleeding score ≧ 1, stool frequency score ≧ 2, or treatment intensification for symptoms.

Results
A total of 58 patients were included in the study. The median age was 46 years, 37 (63.8%) were male, 39 (67.2%) were pancolitis, and the median disease duration was 116 months. BWT and BWF were moderately correlated with MES but MUC showed a numerically highest coefficiency (0.61) when evaluated for the colon. Overall, 18 patients (31.0%) relapsed within 1 year. Neither BWT, BWF, BWS, enlarged lymph nodes, nor CRP was predictive for relapse. The log-rank test showed MUC &gt; 6.2 (p = 0.019), MES ≥ 1 (p = 0.013), and FC ≥ 250 μg/g (p = 0.040) were associated with a shorter time to relapse. Cox proportional hazards model showed MUC &gt; 6.2 (HR 3.22: 95%CI 1.14-9.08, p = 0.027), MES ≥1 (HR 8.70: 95%CI 1.11-68.1, p = 0.040) had a higher risk of relapse in 1 year. Sensitivity, specificity, PPV, and NPV of MUC &gt; 6.2 for relapses of different time points (3, 6, and 12 months) showed high specificity of 0.90-0.91 and NPV of 0.74-0.90. Interestingly, 4 out of 9 patients with MUC &gt; 6.2 relapsed within 3 months, suggesting MUC &gt; 6.2 is a risk of short-term relapse.

Conclusion
BUS in UC patients in remission can predict relapse using MUC. In particular, the MUC score ≤ 6.2 is associated with a lower risk of relapse and could be a treatment-target alternative to endoscopic healing.
P597 Usefulness of histological monitoring in predicting relapse after de-escalation of thiopurines in Ulcerative Colitis
Authors: Yamana Y , Sagami S , Maeda M , Karashima R , Miyatani Y , Hojo A , Nakano M , Maeda I , Hibi T , Kobayashi T 
Published: January 2023

Abstract

Background
Thiopurines are useful to maintain remission for ulcerative colitis (UC) and to inhibit immunogenicity in combination with biologics while their long-term use may increase risks of infections and malignancies. Therefore, the risk-benefit balance should be evaluated, and de-escalation needs to be discussed. However, optimal de-escalation strategy such as dosing and monitoring has not been well studied.

Methods
UC patients in clinical remission (partial Mayo score ≤ 2 and rectal bleeding subscore of 0) who de-escalated thiopurines (dose-reduction or discontinuation) were enrolled. The risk of relapse and changes in Mayo endoscopic subscore (MES) and histological findings after thiopurine de-escalation were retrospectively investigated. The correlation with relapse (treatment escalation (including topical therapy) with the exacerbation of symptoms or rectal bleeding score ≥ 1) was analyzed by logistic regression analysis.

Results
A total of 69 de-escalation steps (51 dose-reductions and 18 discontinuations) were conducted in 39 patients. The mean duration and dose of thiopurine use were 3.5 years and 66.6mg (converted to azathioprine). Thiopurines were used in combination with biologics in 16 (41.0%). Relapse occurred in 17/69 (24.6%) de-escalation steps (10/17 discontinuations). In 36 de-escalations remaining in remission with available data before and after de-escalations, worsening of MES occurred in 13%, whereas exacerbations of any histopathological finding occurred in 44% (crypt architectural irregularities 25%, chronic inflammatory cell infiltrate 19％, acute inflammatory cell infiltrate 16％, basal plasmacytosis 13%, mucin depletion 13%, crypt abscess 8%). Chronic inflammatory cellular infiltrate (p=0.002), basal plasmacytosis (p=0.008), and acute inflammatory cell infiltrate (p=0.039) at de-escalation were significantly associated with relapse after de-escalation. Nancy Index was also associated with relapse (p=0.011), while MES was not.

Conclusion
Histological worsening may precede clinical relapse thus may be useful to predict relapse after thiopurine withdrawal.
P601 Pneumococcal vaccination in patients with immunomediated inflammatory diseases (IMIDs) using a real-world multidisciplinary project
Authors: Martins A , Silva F , Canelas G , Ribeiro L , Pinto S , Sarmento A , Magro F , Ferreira de Abreu C M 
Published: January 2023

Abstract

Background
Vaccination is a crucial element in managing patients with IMIDs, however rates of vaccination remains suboptimal. This study assessed the adherence to pneumococcal vaccination.

Methods
A prospective cohort study was conducted between January 2020 and December 2021. Vaccine prescription and adherence were assessed during an Infectious Diseases (ID) consultation. Were considered pneumococcal conjugate (PCV13) and polysaccharide (PPS23) vaccines.

Results
There were 262 patients included (215 with inflammatory bowel disease and 47 with rheumatological diseases), 136 (52%) were male, median age was 41±15 years and 167 (64%) were on immunossuppresive therapy. At baseline, 26 (10%) patients were fully vaccinated against pneumococcal disease and for 236 (90%) vaccination was prescribed as such: PCV13 followed by PPSV23 in 86 (36%) patients, PCV13 in 126 (54%) and PPSV23 in 24 (10%). Adherence to PCV13 occurred in 185 (87%) patients and to PPSV23 in 76 (69%). In patients with both vaccines prescribed (n=86), 57 (66%) had complete adherence and the remaining had at least one of them. In this group (n=86), patients with complete adherence were older than the remaining (45±17 vs. 38±12 years, p=0.03) but no difference was found concerning the baseline disease. After the ID consultation, 175 patients from 236 (74%) became fully vaccinated against pneumococcal disease.

Conclusion
A multidisciplinary approach and adequate local interventions shall be considered to improve vaccine adherence. ID physicians can play a role in the process of increasing vaccine prescription and adherence.
P606 Significant regional differences in referral patterns for bowel resection in Crohn’s disease patients
Authors: Iesalnieks I , Adamou A , Bercher M , Streetz K 
Published: January 2023

Abstract

Background
Preoperative factors - mainly patients’ condition and disease phenotype – are main determinants of postoperative outcome. However, those factors might be strongly dictated by regional traditions and treatment patterns of referring gastroenterologists. The present prospective observational study compared two German IBD-referral centers located in two different geographical regions regarding patients’ characteristics and postoperative outcome.

Methods
Consecutive patients referred to undergo intestinal resections at two different regional centers of IBD-surgery were included in present prospective observational study. Both surgical departments were headed by same surgeon, thus, decisions to perform surgery, preoperative routine and the postoperative management did not differ between hospitals. One hospital (Hospital 1) was located in Bavaria. Patients underwent intestinal surgery at this hospital between 2019 and 2021. The second hospital (Hospital 2) was located in North Rhine-Westphalia. All surgeries at Hospital 2 were performed 2022. The distance between both hospitals was about 600km.

Results
181 patients underwent bowel resections – 102 at Hospital 1 and 79 at Hospital 2. There were significant differences between both hospitals regarding preoperative variables: Azathioprine intake (8% vs. 23%, p=0.005), Steroid intake (13% vs. 29%, p=0.008) and presence of colonic disease (27% vs. 46%, p=0.013). Also, the frequency of some intraoperative procedures differed significantly: ostomy formation at surgery (16% vs. 29%, p=0.044), ileocolic resections (78% vs. 58%, p=0.001), colonic resections (15% vs. 34%, p=0.003). Postoperatively, there was difference in incidence of postoperative ileus (8% vs. 18%, p=0.041). Also, overall complication rate was lower in Hospital 1 (21% vs. 31%), however, the difference was not statistically significant (p=0.12).

Conclusion
Different referral patterns might exist between various hospitals and regions leading to different perioperative outcomes. This should be taken in consideration when results of studies are compared.
P611 COMPARATIVE EFFECTIVENESS AND SAFETY OF VEDOLIZUMAB VS. ANTI-TNFs IN CROHN’S DISEASE BIO-NAÏVE PATIENTS AND PATIENTS WITH FAILURE OF ONE PREVIOUS ANTI-TNFα (EVOLVE-IBERIA STUDY)
Authors: Muñoz Nuñez J F , Rodríguez C , Gisbert J P , Bernardo S , Aparicio J , Tagarro I , Casellas F 
Published: January 2023

Abstract

Background
Vedolizumab (VDZ) is a gut-selective, anti- lymphocyte trafficking drug inhibiting α4β7-integrin approved for treatment of moderately to severely Crohn’s disease (CD) and ulcerative colitis (UC).

Methods
Medical charts from CD patients were retrospectively reviewed in sites from Spain and Portugal. The primary objectives are to compare real-world clinical effectiveness and treatment patterns data on the use VDZ vs. anti-TNFα in CD patients, either as the first biologic or after failure to a single anti-TNFα. Inverse probability of treatment weights (IPTW) were used to balance both study cohorts for the baseline demographic and clinical patient characteristics.

Results
210 CD patients were included with a median follow-up of 26.0 months. Eighty-three (40%) patients started treatment with VDZ, being 57% of them bio-naïve. In the anti-TNFα cohort, 76% of patients were bio-naïve. Clinical response rates at week 14 were higher for anti-TNFα group (88%) vs. VDZ group (68%) (p=0.007). However, at week 52, clinical response rates were comparable with 75% in the VDZ group and 70% in the anti-TNFα group (p=0.48). Clinical remission rates at week 14 were higher for anti-TNFα group (79%) vs. VDZ group (56%) (p=0.005). However, at week 52, clinical remission rates were comparable among VDZ and anti-TNFα cohorts, 51% vs. 67%, respectively (p=0.07). The rate of treatment intensification was 31% in VDZ vs. 42% in the anti-TNFα group (p=0.13). Median time (months) to first treatment intensification was 8.8 in the VDZ group vs. 6.3 in the anti-TNFα group (p=0.83). The overall discontinuation rates were 39% with VDZ vs 49% with anti-TNFα (p=0.16) (Fig.1). Among patients with endoscopic assessments available, endoscopic remission occurred in 47% of patients in the VDZ group (n=7/15), and in 42% of patients in the anti-TNFα arm (n=10/24) (p=0.86) at week 52. And among those patients with biochemical assessment available, biochemical remission (CRP&lt;5mg/L) was achieved by 70% of patients in VDZ cohort (n=49/70) vs. 75% patients in anti-TNFα cohort (n=88/118) (p=0.45) at week 14, and by 74% of patients in both arms (n=45/61 and 78/106, respectively) at week 52. VDZ treated patients showed a significant lower rate of treatment related adverse events vs. anti-TNFα cohort: 1.15 vs. 2.7 per 100 patients-year, respectively (p=0.024). Infections, serious infections, and malignancies were also less frequent in the VDZ than in the anti-TNFα cohort: 0.48 vs. 1.75 per 100 patients-year, respectively (p=0.015) (Fig.2).

Conclusion
This real-world study supports the long-term use of VDZ as the first or second biologic for CD patients, showing similar effectiveness than anti-TNFα after 1 year, but better safety outcomes.