bluuebunny/crossref_metadata_2025_split huggingface dataset:
P709 Endoscopic healing and clinical remission after administration of adalimumab to patients with Crohn’s disease of the small intestine
Authors: Viazis N , Koustenis K , Veretanos C , Mountaki A , Almpani F , Tsatsa A , Trikola A , Beka H , Arvanitis K , Georgiadi T , Nousias G , Mylonas I , Kozompoli D , Paparizou N , Karaouzas L , Papastergiou V , Archavlis E , Mela M , Christidou A , Varytimiadis K , Hatzievangelinou C , Katopodi K , Vienna E , Mantzaris G 
Published: January 2023

Abstract

Background
In patients with Crohn’s disease (CD) localized in the small intestine, endoscopic healing can be assessed by small bowel capsule endoscopy (SBCE). We aimed to investigate the rate of achieving deep remission, i.e. endoscopic healing and clinical remission in patients with CD of the small intestine, after treatment with adalimumab.

Methods
Retrospective analysis of prospectively collected data from all patients who were subjected to SBCE in our department from 1/3/2003 to 30/9/2022. Out of the patients who were subjected to the test for the investigation of suspected or confirmed CD of the small intestine we sought those who were treated with adalimumab (originator or biosimilar) and underwent repetitive SBCE at least 24 weeks after the start of treatment. Endoscopic healing was defined as a Lewis score &lt; 350, while clinical remission was defined as Harvey Bradshaw index ≤ 4.

Results
During the study period, 102 patients (men/women: 54/48, mean age ± SD: 31.2±14.1 years) were subjected to SBCE before and after administration of adalimumab for the treatment of small intestinal CD. Of these patients, 11 (10.7%) also had extra-intestinal manifestations (arthritis: n=9, erythema nodosum: n=1, uveitis: n=1). After a mean period of 104 weeks (range 24-416 weeks), endoscopic healing was observed in 49 patients (48.0%). All patients who experienced endoscopic healing were also in clinical remission. There was no statistically significant difference in patients with endoscopic healing between those receiving adalimumab originator or biosimilar (36 out of 73, 49.3% vs 13 out of 29, 44.8%, p=NS).

Conclusion
Small bowel capsule endoscopy can help us to identify endoscopic healing, which is observed in about half of patients with CD of the small intestine treated with adalimumab.
P712 Real-World Efficacy And Safety Of Ustekinumab And Adalimumab In Patients With Crohn’s Disease: Propensity Matched Analysis
Authors: Shin Y , Hong S N , Kim E R , Chang D K , Kim Y H 
Published: January 2023

Abstract

Background
Ustekinumab (UST), an anti-IL-12/23 p40 monoclonal antibody, was shown to be as effective and safe as the anti-TNF-alpha monoclonal antibody adalimumab (ADL) in the treatment of Crohn's disease (CD). Most studies on UST in patients with CD have been conducted in the Western patients and lack in Asian patients with CD. This study aimed to compare real-world clinical efficacy and safety of UST with ADL in Korean CD patients with anti-TNF naïve and failure group.

Methods
The retrospective single-center cohort study was conducted on the adult patients with moderated to severe active Crohn’s disease, from 2010 to July 2022. Medical records was extracted from the Clinical Data Werehouse of Samsung Medical Center, Seoul, Korea. Propensity-matched analysis was performed to evaluate patient-reported outcome (PRO)-based clinical remission (PRO3&lt;13) at week 52 and 96 in patient treated with UST and ADL. Subgroup analysis was performed on the biologics-naïve and anti-TNF-failure patients.

Results
A total of 188 CD patients treated with UST and and 299 received with ADL were enrolled. In a propensity -matched cohort adjusted with age, sex, initial CDAI score, and Montreal classification, the clinical remission rate was higher in UST group than ADL at week 52 (Odds ratio [OR] 2.7, 95% confidence interval [CI] 1.31-5.58, P = 0.007) and at week 96 (OR 12.0, 95% CI 1.56-92.29, p = 0.017). In subgroup analysis, there was no significant difference in both group in biologics-naïve group, whereas UST group showed higher clinical remission compared with ADL group in anti-TNF failure group (OR 4.67, 95% CI 1.34-16.23, p = 0.016). Biochemical remission (CRP &lt; 0.05) showed no significant difference between both groups at week 52 and 96. Severe adverse effects leading to biologics discontinuation was numerically high in UST group and ADL group (1, 0.53% vs. 7, 2.34%, p = 0.160).

Conclusion
Compared with ADL, UST showed comparable efficacy in biologic-naïve patients and superior efficacy in anti-TNF failure patients with CD in Korean patients with CD.
P717 Use of tramadol versus traditional opioids and adverse outcomes of Inflammatory Bowel Diseases: a Danish nationwide cohort study
Authors: Dalal R , Lund K , Zegers F , Friedman S , Allegretti J , Norgard B 
Published: January 2023

Abstract

Background
Patients with inflammatory bowel diseases (IBD) commonly suffer from pain that requires analgesic therapies such as tramadol and opioids. However, use of traditional opioids (TOs) has been associated with severe infections and mortality in this population. Tramadol, a partial agonist of opioid receptors, has been considered to have less abuse potential compared to TOs. It is unknown if tramadol is associated with fewer IBD-related complications compared to TOs.

Methods
This was a Danish nationwide cohort study examining adverse outcomes associated with use of tramadol vs TOs in the IBD population. Patients with IBD (ICD-10 codes K50 and K51) diagnosed 1995-2021 in Denmark with subsequent prescriptions for tramadol or TOs were included. For each drug exposure, two populations were defined: initial users (“IUs”; first prescription after IBD diagnosis) and persistent users (“PUs”; first 3 consecutive prescriptions within 365 days after IBD diagnosis). Outcomes included severe (hospital-diagnosed) infection, bowel obstruction or ileus, IBD surgery, and mortality within 90 days after the IU index date (i.e. date of first prescription) and within 365 days after the PU index date (i.e. date of third prescription) (Figure 1). Multivariable logistic regression was performed to determine associations of tramadol vs TOs with outcomes while adjusting for age, sex, Charlson comorbidity index, year of IBD diagnosis, IBD type, IBD duration, and prior immunomodulator use, corticosteroid use, IBD hospitalization, severe infection, bowel obstruction or ileus, and IBD surgery within 6 months before the index date. A sensitivity analysis was performed in which patients with any diagnosis of a malignant neoplasm (ICD-10 codes C00-99) &lt;1 year prior to the first tramadol or TO prescription were excluded.

Results
We identified 37,377 IUs and 15,237 PUs of tramadol or TOs. Baseline characteristics are presented in Table 1. IUs of tramadol had lower odds of severe infection (adjusted odds ratio [aOR] 0.80, 95% CI 0.65-0.99), bowel obstruction or ileus (aOR 0.74, 95% CI 0.53-1.03), and mortality (aOR 0.43, 95% CI 0.35-0.55), and higher odds of IBD surgery (aOR 1.27, 95% CI 1.02-1.60) vs TOs. PUs of tramadol had lower odds of severe infection (aOR 0.69, 95% CI 0.55-0.86), bowel obstruction or ileus (aOR 0.58, 95% CI 0.39-0.85), and mortality (aOR 0.35, 95% CI 0.28-0.44) but no difference in IBD surgery (aOR 1.13, 95% CI 0.86-1.47) vs TOs (Table 2). Results were unchanged after excluding patients with malignancy (Table 3).

Conclusion
Use of tramadol was associated with lower odds of severe infection, bowel obstruction or ileus, and mortality vs use of TOs among patients with IBD. Safety comparisons of tramadol to other analgesics are needed.
P723 Comparison of the Persistence Rates of Biologic Agents in Paediatric Crohn's Disease Patients (Japanese Paediatric IBD Registry Study)
Authors: Nishida D , Ishige T , Arai K , Shimizu H , Iwama I , Nambu R , Kunisaki R , Yaguchi K , Mizuochi T , Murakoshi T , Saito T , Kato S , Kudo T , Iwata N , Inoue M , Yodoshi T , Hagiwara S I , Toita N , Tajiri H , Mochizuki T , Kakuta F , Kumagai H , Noguchi A , Sasaki M , Nishimata S , Aomatsu T , Hirano Y , Shimizu T 
Published: January 2023

Abstract

Background
Biologics are widely used for paediatric Crohn's disease (CD) and are highly effective; however, primary inefficacy and the emergence of secondary inefficacy during long-term use remain challenges. Although it is desirable for biologics used in paediatric patients to be safe and usable long-term, there are few detailed reports on the comparison of persistence rates of biologics in paediatric patients.

Methods
This was a multicentre prospective cohort study using a web-based registry system in Japan that was performed between October 2012 and March 2020. New paediatric inflammatory bowel disease patients diagnosed at less than 18 years of age were enrolled from 23 Japanese hospitals. The persistence rates of the first biologics (Infliximab: IFX and Adalimumab: ADA), and the second biologics (IFX, ADA, and Ustekinumab: UST) were analysed. Patients with unknown outcomes were excluded.

Results
We enrolled 185 patients with CD as the final diagnosis, and 109 (59%) received biologics during the observation period. As the first biologic, IFX was used in 52 (45%) patients, ADA in 52 (45%), UST and Vedolizumab (VED) in one, respectively, and the biologic in one patient was unidentified. The 1-, 3- and 5-year persistence rates of IFX and ADA as the first biologic were 90%, 70% and 61% for IFX, and 80%, 71% and 49% for ADA, respectively (Fig.1), with no statistically significant difference (P=0.31). There was also no statistically significant difference after propensity score matching (P=0.27). Multivariate analysis showed that Paris classification L4a and b were independent risk factors for lower retention of biologics in IFX and ADA. Of the 104 patients whose first biologic was IFX or ADA, 31 patients were treated with a second biologic (IFX: 7, ADA: 6, UST: 15, VED: 2 and unknown: 1). The 1- and 3-year persistence rates of the second biologic were 86% and 51% for IFX; 80% and 80% for ADA and 100% and 100% for UST, respectively (Fig.2).

Conclusion
The persistence rates of IFX and ADA as first biologics were similar in paediatric patients with CD, and the persistence rates of UST tended to be higher than IFX or ADA as second biologics, although the differences were not statistically significant.
P724 Upadacitinib is Effective and Safe in Tofacitinib-Experienced Patients with Ulcerative Colitis: A Prospective Real-World Experience
Authors: Krugliak Cleveland N , Friedberg S , Choi D , Hunold T , Choi N K , Garcia N M , Picker E A , Cohen N A , Cohen R D , Dalal S R , Pekow J , Sakuraba A , Rubin D T 
Published: January 2023

Abstract

Background
The development and availability of Janus kinus inhibitors (JAKinibs) for moderately to severely active ulcerative colitis (UC) provides new therapeutic options with both novel mechanisms and unique pharmacodynamic benefits. Tofacitinib (tofa) is a non-selective pan-JAKinib that received FDA approval for UC in 2018 and upadacitinib (upa) is a JAK-1 selective inhibitor, that received FDA approval for UC in 2022. It is unknown whether patients who do not respond to tofa will subsequently respond to upa. We report our real-world experience with upa in UC patients with primary or secondary non-response to tofa.

Methods
We performed a prospective analysis of clinical outcomes on upa in patients with UC and Crohn’s disease (CD) using pre-determined intervals at weeks 0, 2, 4, and 8 as part of a formalized treatment protocol at our institution. We used the SCCAI and HBI, as well as CRP and fecal calprotectin (FCP) to assess efficacy and recorded treatment-related adverse events and serious adverse events (AEs). Here we report our experience in patients treated with upa who have been previously treated with tofa.

Results
26 patients (18=UC, 8=CD) with primary or secondary non-response to tofa received upa. (Table 1) In addition to tofa, all of these patients failed at least two biologics prior to upa treatment. In UC: by week 2 60% (6/10) achieved clinical response, and 40% (4/10) achieved clinical remission. By week 4 87.5% (7/8) achieved clinical remission, and 87.5% (6/8) achieved steroid-free remission; FCP decreased by a mean of 649.2 μg/g from baseline (+/- 772.7). At week 8: 100% (8/8) of patients achieved clinical response, 87.5% (7/8) achieved clinical remission, and of all of these (7/7) achieved steroid-free remission; FCP decreased by a mean of 180 μg/g (+/- 721.8) from baseline. One patient had follow-up to week 12 and continued to be in steroid-free remission. (Table 2) In CD: by week 2 2 of 2 patients achieved clinical remission, by week 4 3 of 3 were in clinical remission, 2 of 3 achieved steroid-free remission, and one patient had follow-up to week 8 and he remained in steroid-free remission. (Table 2). 6 patients experienced AEs, with the most common being acne (19.2%). No infections, MACE, or VTE occurred.

Conclusion
In this prospective real-world experience in medically-resistant patients with UC and CD who previously failed treatment with tofa and at least two biologics, we describe that upa is rapidly effective, inducing both clinical, steroid-free, and biochemical remission with no serious AEs.
P725 Patients with Immune Mediated Inflammatory Diseases are insufficiently protected against vaccine-preventable influenza and pneumococcal infections due to low vaccination rates
Authors: Van De Pol N , van der Woude C J , Vis M , van Doorn M B A , Derikx L A A P , Molendijk I , de Vries A C 
Published: January 2023

Abstract

Background
Patients with Immune Mediated Inflammatory Diseases (IMIDs) treated with immunosuppressive drugs are at an increased risk of infections and a more complicated course of the infection, including vaccine-preventable infections. National and international guidelines have specified vaccination strategies in patients with IMIDs. However, the adherence to these guidelines in clinical practice is uncertain. Therefore, we evaluated the current vaccination status of patients with IMIDs at the outpatient clinic of the Erasmus MC Rotterdam.

Methods
Between August 2022 and October 2022, a survey was sent out to patients with various IMIDs at the rheumatology, dermatology and gastroenterology outpatient clinics. Only patients on immunosuppressive treatment were included. The survey contained questions on patient demographics, disease characteristics and current vaccination status.

Results
The survey was sent out to 3,345 patients with IMIDs, of whom 1,094 patients filled in the questionnaire (response rate 32.7%). Mean age was 51 ± 16 years and 40.8% were male (Table 1). Patients were treated by a dermatologist (n=306), gastroenterologist (n=414) and/or rheumatologist (n=527). Overall, 55.1% of patients received a yearly influenza vaccination and 9.2% occasionally (Table 2). Furthermore, 8.7% of patients received the pneumococcal vaccination five-yearly and 1.4% occasionally. Both the influenza and pneumococcal vaccination rates were highest in patients with rheumatoid arthritis (64.1%, and 14.7%, respectively). On the contrary, patients with hidradenitis suppurativa had the lowest rates for both the influenza vaccination (32.3%) and pneumococcal vaccination (n=0). Overall, 91.7% of patients (n=1,003) received one or more COVID-19 vaccinations.

Conclusion
Patients with Immune Mediated Inflammatory Diseases are insufficiently protected against vaccine-preventable infections due to low vaccination rates. Better implementation strategies of current guidelines on seasonal influenza vaccination and pneumococcal vaccination are required. A high rate of COVID-19 vaccination was observed, possibly indicating the willingness of patients to receive vaccinations. Further research into facilitators and barriers to vaccination in these specific patient populations is required.
P726 Fecal calprotectin and quality of life questionnaires are responsive to change in pouch disease activity following antibiotic therapy—results from a prospective clinical trial
Authors: Ollech J , Yanai H , Avni Biron I , Dotan I 
Published: January 2023

Abstract

Background
Whether fecal calprotectin (FC) and quality of life (QoL) questionnaires reflect change in disease activity in patients with a J-pouch is unknown.

Methods
Patients with UC following ileal pouch-anal anastomosis developing acute pouchitis were prospectively recruited to a clinical trial at the Rabin Medical Center in Israel, a major referral center for patients with a J-pouch. Consecutive patients with acute pouchitis were diagnosed clinically by the treating physician in a patient with compatible clinical symptoms. Patients were treated with a 2-week course of antibiotics – either metronidazole and ciprofloxacin or metronidazole and doxycycline. Full PDAI, including clinical, endoscopic, and histologic evaluation, was performed at baseline and following 2 weeks of antibiotic therapy. Patients had comprehensive laboratory tests, including fecal calprotectin (FC) measurements at both time points. Patients also filled out QoL questionnaires (short inflammatory bowel disease questionnaire - SIBDQ, inflammatory bowel disease [IBD] disk) at both time points. Outcomes of interest included the responsiveness of FC and QoL questionnaires to change in pouch disease activity according to the PDAI. Paired analyses were performed to compare results between the 2-time points.

Results
Twenty patients were enrolled in a prospective clinical trial. At enrollment, the median age was 36 years IQR [27-56], females 12 (60%). The median interval from the ileostomy closure was 7 years IQR [2-17]. Median PDAI score: 9 IQR [8-11.5], median FC: 661 ug/g IQR [425-1261], median C-reactive protein: 1.1 mg/dl IQR [0.5-1.8] and median hemoglobin: 13.2 g/dl IQR [12.1-14.1].
Following 14 days of antibiotic treatment, there was a significant decrease in the total PDAI, which decreased from a median of 9 IQR[8-11.5] to 6 IQR[2.5-7],(p=0.007). This difference was mainly related to a significant reduction in both the clinical (p=0.01) and endoscopic subscores (p=0.001) but not the histologic subscore (p=0.1). FC was responsive to this change in PDAI and correlated with the change in endoscopic findings; it decreased significantly between the 2-time points from a median of 661 ug/g IQR[425-1261] to 294 ug/g IQR[113-418] (p=0.02).
Both quality of life questionnaires (SIBDQ, IBD disk) improved significantly following antibiotic therapy: The median SIBDQ increased from 44 to 50 (p=0.02), and the median IBD disk score decreased from 59 to 31 (p=0.01) Figure 2 Panel B and C respectively.

Conclusion
FC is a sensitive and rapidly responsive biomarker of pouch disease activity, and we encourage its use when managing patients with pouchitis. Likewise, the SIBDQ and IBD disk accurately reflect change in QoL associated with change in disease state in patients with a pouch
P732 Impact of different types of physical activity in inflammatory bowel disease
Authors: Gofflot A , Monin L , Seidel L , Reenaers C , Kropp S , Van Kemseke C , Latour P , Forthomme B , Croisier J L , Louis E , Vieujean S 
Published: January 2023

Abstract

Background
Moderate physical activity (PA) appears to be beneficial for inflammatory bowel disease (IBD), improving the symptoms of the disease and promoting the maintenance of remission. However, little is known about the impact of different types of PA on IBD activity.

Methods
IBD patients with stable treatment without steroids for 4 months were prospectively included and randomized into 3 groups: muscle strengthening exercises, aerobic exercises, and a control group. The impact of a 10-week training period with 2 sessions per week was evaluated. Following parameters were collected: clinical activity of the disease (Mayo score for ulcerative colitis or UC, Harvey-Bradshaw index or HBI for Crohn’s disease or CD, patient reported outcome or PRO for both), Godin Leisure Time Exercise Questionnaire or GLTEQ (assessing PA level), Metabolic Equivalent Task or MET (assessing sedentarity level), barriers to PA, quality of life assessment (by EuroQol 5 dimensions or EQ5D and Short health scale or SHS), Inflammatory Bowel Disease Fatigue (IBD-F), physical abilities according to exercise stress test and maximum strength test.

Results
Between January 2021 and September 2022, a total 33 patients were enrolled in the program. Of these, 24 patients (13 women, 17 CD, median age of 31.6 [IQR, 29.4- 46.4]) completed the program and were included in the analysis (dropout rate of 18.2%). Table 1 shows the characteristics of these patients at inclusion. Eight, six and ten patients were respectively randomized in the muscle strengthening, aerobic exercise and control groups. After the training period, 50% of patients in the muscle strengthening group and 66.7% of patients in the aerobic exercise group showed a clinical improvement (according Mayo score and HBI). Strengthening was associated with significant reduction in PRO rectal bleeding in UC patients (p&lt;0.0001) and aerobic exercise was associated with a significant lowering of HBI (p=0.039). Among the 24 patients, 2 CD patients relapsed in the muscle strengthening group during the training period. Aerobic exercise significantly reduced the barriers to PA (p=0.037). In neither group did we find any positive or negative impact of PA on quality of life or fatigue. Strengthening exercise and aerobic exercise significantly improved VO2max (maximal oxygen consumption) and Pmax in the exercise stress test, respectively. Most of the maximum strength tests were improved in the muscle strengthening group.

Conclusion
PA was well tolerated and associated with an improvement of disease activity in the majority of the IBD patients. There may be a variable impact of different types of PA in CD and UC, which should be explored further in larger cohorts.