bluuebunny/crossref_metadata_2025_split huggingface dataset:
P801 Maintenance phase effectiveness and persistence after two years in biologic-naïve ulcerative colitis patients treated with vedolizumab or anti-TNF (VEDO-IBD-study)
Authors: Plachta-Danielzik S , Bokemeyer B , Efken P , Mohl W , Krause T , Hoffstadt M , Ehehalt R , Trentmann L , Schweitzer A , Jessen P , Franzenburg S , Hartmann P , di Giuseppe R , Schreiber S 
Published: January 2023

Abstract

Background
In this two-arm prospective real-world-evidence (RWE) study with propensity score adjustment, we aimed to analyse the persistence of biologic therapy in biologic-naïve ulcerative colitis (UC) patients and to compare the 2-year effectiveness of vedolizumab (VEDO) and anti-TNF.

Methods
Between 2017 and 2020, 1200 consecutively enrolled biologic-naïve and biologic-experienced patients with UC and CD (Crohn’s disease) were prospectively included in the VEDOIBD study from 45 IBD-experienced centres across Germany. After the exclusion of biologic-experienced patients, CD, and missing outcomes, the final sample consisted of 314 biologic-naïve UC patients with 2-year follow-up data. In this mITT analysis switching was considered as outcome failure, and clinical remission and (steroid-free) remission rates (pMayo ≤1 plus a bleeding subscore=0 - and no systemic use of steroids or oral budesonide at two years) at two years were predefined as outcomes. To reduce the effect of confounders, propensity score (PS) adjustment with inverse probability of treatment weighting (IPTW) was implemented. A weighted logistic regression was used, and the results were reported as odds ratio (OR) and 95% confidence interval (CI).

Results
The two-year maintenance phase effectiveness of 182 VEDO and 132 anti-TNF (ADA: 25.8%; IFX: 58.3%; GOL 15.9%) biologic-naïve UC patients were analysed in this prospective RWE-comparison of VEDO vs anti-TNF. Significantly more patients switched to another biologic in the anti-TNF group when compared to the VEDO group up to 2 years (54% vs 29%; p&lt;0.0001) (Fig. 1). In the mITT analysis after 2 years a statistically significant higher clinical remission rate of 43.2% was found for VEDO vs 25.8% for anti-TNF (OR 95% 2.18 (1.19-3.99), p=0.011) (Fig. 2). Considering the two-year effectiveness of ADA and IFX the response rates of VEDO were numerically higher than those of ADA (45.2% vs 37.9%) but not statistically significant. In contrast, for VEDO versus IFX, there was a clear difference in favour of VEDO that resulted in a clinical remission rate of 43.1% versus 16.5% for IFX (p=0.0003).

Conclusion
As shown previously, in the induction phase, there is comparable effectiveness for VEDO and anti-TNF, although the remission rates are relatively low and similar to the range reported in RCTs. Over one year, the effectiveness tends to improve in favour of VEDO, potentially due to better treatment persistence. After two years, the clinical remission rate in the VEDO group is statistically significantly higher than in the anti-TNF group. The higher treatment persistence of VEDO vs anti-TNF and the higher effectiveness may suggest VEDO as a first-line biologics therapy option in UC patients.
P802 Relationships between validated clinical, endoscopic and histological indices in ulcerative colitis
Authors: Walsh A , Kormilitzin A , Friedrich M , Pakpoor J , Hosack T , Matini L , Kantschuster R , Sharda A , Dunbar G , Cheung V T F , Ambrose T , Brain A O , Palmer R , Satsangi J , Travis S P L 
Published: January 2023

Abstract

Background
The simple clinical colitis activity index (SCCAI) is increasingly used in practice for monitoring symptoms, because it documents urgency and nocturnal stool frequency, which are excluded from other indices. The question is how the SCCAI relates to validated endoscopic and histological indices, so that SCCAI thresholds for remission and active disease can be defined.

Methods
The SCCAI (range 0-19) was collected in real time from patients with ulcerative colitis (UC) using web-based TrueColours-IBD monitoring and collated with endoscopic activity (UCEIS, 0-8) and Nancy histological index (NHI, 0-4) for patients who had recorded SCCAI data up to 14d before endoscopy.

Results
482 SCCAI/endoscopy/biopsy trios were analysed from 323 unique patients (162 male) aged 18 to 86 years (male: mean = 43.8, SD = 15.9; female: mean = 44, SD = 14.9). Disease extent for male: Normal=48, E1=23, E2=116, E3=43, female: Normal=45, E1=42, E2=110, E3=27. Spearman's rank correlation coefficient between UCEIS and NHI scores was r=0.77 (95% confidence interval [CI] 0.72 - 0.82, p &lt;0.001). When the UCEIS was ≤ 1, or NHI ≤ 1, which is consistent with remission, the median (IQR) SCCAI was 2 (1 to 4) (Fig 1A, 1B). When the SCCAI was ≥5, the median (IQR) UCEIS was 4 (3 to 5) and the median (IQR) NHI was 3 (2 to 4). For patients with both histologic and endoscopic mucosal remission (HEMR), defined as NHI ≤ 1 and UCEIS ≤ 1, the median (IQR) SCCAI was 2 (0.25 to 4) (Fig 1C). Patients with SCCAI scores outside the IQR (n=8 for UCEIS, n=5 for NHI) had symptoms primarily driven by bowel urgency or poor general wellbeing. Four groups of patients could be identified using linear regression analysis modelling of relationships between bowel urgency and UCEIS score: ‘no urgency without active disease’; ‘urgency without active disease’; ‘urgency with active disease’; and ‘no urgency with active disease’ (Fig 2).

Conclusion
There is a ‘grey zone’ at low scores of symptom-based indices that cannot discriminate endoscopic or histologic remission from mildly active disease. The SCCAI threshold for active UC is &gt;5, but with wide confidence intervals. Mechanisms behind symptoms in the absence of active inflammation need investigating.
P811 Combination biological or small molecule therapy in patients with refractory inflammatory bowel disease: a multicenter Brazilian experience
Authors: Feitosa F , Parra R , Queiroz N , Flores C , Schiavetti B , Azevedo M , Porto Alegre Rosa C , Chebli L , Chebli J 
Published: January 2023

Abstract

Background
This preliminary study describes the Brazilian experience on dual biologic therapy or small molecule combined with a biologic therapy in patients with inflammatory bowel disease (IBD) refractory to multiple biologics.

Methods
We identified patients from 6 IBD centers in Brazil between April 2020 and November 2022 who received treatment with a combination of two biologics or a biologic and a small molecule drug due to refractory disease or concomitant immunomediated condition. The primary endpoint was clinical remission at week 16, defined as a total Mayo score of ≤2 for UC and Harvey-Bradshaw Index (HBI) &lt;4 for CD. Secondary endpoints were improvement in disease activity scores and biomarkers. Adverse events were monitored and summarized descriptively.

Results
Twenty-nine patients were identified (69% CD, n=20), 51.8% female, mean age 38.8 years old [SD= ± 14.8 years]). Seventy per cent (n=14) had penetrating behavior among CD patients. Twenty-seven had failed to, at least, one anti-TNF; 79.9% had failed to ustekinumab (UST), and 34.5% to vedolizumab (VEDO). Twenty-six patients were treated with combination advanced therapy due to loss of response to biologics and three patients had concomitant ankylosing spondylitis. The most common combination used was UST+ADA (n=12, 41.4%), followed by UST+VEDO (n=6, 21.7%). Mean treatment time was 53.8 weeks (SD= 40.4 weeks, CI 95% [37.5 – 70]). At week 16, clinical remission rates were 80% and 66% for CD and UC, respectively. All patients under VEDO + UST combination achieved clinical remission at 16w, in both diseases. Baseline HBI mean was 10.8 (SD= ± 3.6 points; CI 95% [9.1- 12.5]), decreasing to a mean of 5.5 at week 16 (SD= ± 3.5 points; CI 95% [3.8 - 7.2]) and plateauing at 7 by week 24 (SD= ±5.4 CI 95% [3.4- 10.6]). There was a notable decrease in HBI at week 16 (p&lt; 0.001) and a significant decrease at week 24 (p= 0.02) compared to baseline. Mean CRP at week 16 was significantly lower than baseline in CD (17.4mg/dL vs 5.5 mg/dL, p=0.001) and numerically lower in UC (from 14.3mg/dL to 9.9mg/dL, p= 0.5). Fecal calprotectin decreased from 2509mcg/g to 1472mcg/g in both groups (p=0,2). In addition, all patients with ankylosing spondylitis showed symptomatic remission. No new safety signals were identified during follow-up

Conclusion
Despite combination of advanced therapies in IBD is not yet recommended by treatment guidelines, this strategy seems to be a promising option for patients with refractory IBD or concomitant autoimmune disease. Our data indicate that further investigation in this direction is worthwhile.
P819 Histologic activity and clinical outcomes in Ulcerative Colitis
Authors: Liang R , Lin H , Lim W C 
Published: January 2023

Abstract

Background
Microscopic inflammation persisting in ulcerative colitis (UC) patients with endoscopic remission (ER) may be associated with a higher risk of clinical relapse (CRL). Growing evidence suggests histologic remission (HR) improves clinical outcomes. Data from Asian UC patients is lacking. We hypothesize that achieving HR is associated with better clinical outcomes in Asian UC patients.

Methods
We performed a single-centre retrospective cohort study of UC patients in clinical remission (CR) who had a follow-up (‘index’) colonoscopy and minimum one-year follow-up post-colonoscopy. CR was defined as Simple Clinical Colitis Activity Index (SCCAI) ≤2. ER was defined as Mayo Endoscopic Sub-Score (MES) ≤1 at index colonoscopy. HR was defined as Nancy Index ≤1 at index colonoscopy.
CRL was defined as either SCCAI&gt;2 (sub-score &gt;1 for stool frequency or rectal bleeding), medication escalation for active disease, hospitalisation for UC relapse or colectomy for refractory UC.
Kaplan-Meier survival analysis was performed to evaluate clinical relapse-free survival post-colonoscopy. Univariate and multivariate regression analyses were performed to assess predictors of CRL.

Results
169 consecutive UC patients who had undergone colonoscopy from 1 Jan 2000 to 30 Jul 2019 were assessed for eligibility. 100 patients were included with a median follow-up of 22 months. At index colonoscopy, 80 patients (80%) were in ER, with 20 patients having persistent endoscopic activity (Table 1). On follow-up, 41 patients (41%) experienced CRL, with 59 remaining in CR.

Of 80 patients in ER, 34 (42.5%) had persistent histologic activity (Nancy Index ≥2) and 29 (36.3%) relapsed during the follow-up period (Table 2). Amongst patients in CR and ER, those with HR had lower CRL rate (26.1% vs 50%, p=.028) and longer clinical relapse-free survival (mean 46.1 vs 31.5 months, p=.015) than those with persistent histologic activity (Figure 1).

On univariate and multivariate analysis of 100 patients in CR, HR was significantly associated with lower risk of CRL (Table 3).

Conclusion
Above and beyond CR and ER, achieving HR improves clinical outcomes in Asian UC patients. Further prospective studies evaluating the benefit of histologically guided therapeutic decisions are needed.
P831 Clinical factors associated with severity in patients with Inflammatory Bowel Disease in Brazil (On Behalf of GEDIIB)
Authors: Froes R , Andrade A R , Faria M A G , Parra R S , Zaltman C , Souza H S P , Santos C H M D S , Bafutto M , Quaresma A B , Santana G O , Rafael Luís Luporini R L , Lima Junior S F D , Miszputen S J , Souza M M D , Herrerias G S P , Kaiser Junior R L , Nascimento C R D , Féres O , Barros J R D , Guimarães C D S , Sassaki L Y , Saad-Hossne R 
Published: January 2023

Abstract

Background
Brazil has shown an increase in Inflammatory Bowel Disease (IBD) cases. GEDIIB (Brazilian Organization of Crohn’s Disease and Colitis) established a data platform to create a national registry of IBD patients. The study aimed to characterize the profile of IBD patients and identify clinical factors associated with IBD severity.

Methods
A cohort study was conducted between Jul/20 and Aug/22. Data obtained from medical records and/or directly from patients were registered via REDCap. Local institutional review boards approved the study protocol. We designed a population-based risk model aimed at stratifying severe disease based on one or more outcome variables: previous hospitalization, surgery, and biologics. Univariate and bivariate analyses and Poisson modeling were used.

Results
A total of 1,179 patients were included: 600 (51%) with ulcerative colitis (UC), 568 (48%) with Crohn’s Disease (CD), and 11 (0.9%) with indeterminate colitis. The mean age was 34.4±14.7y, 59% female, 73% Caucasian, and 85.3% non-smoker. Regarding the initial symptoms, 42% presented diarrhea, 38% abdominal pain, and 20% weight loss. The age of IBD symptom onset ranged from 1-87 years (32.3±14.4). According to the Montreal classification of CD, A1: 5%, A2: 63%, A3: 32%; L1: 29.7%, L2: 14.3%, L3: 41.2%, B1: 32%, B2: 26.7%, B3: 11.3%; perianal 15.5%. In UC, 46.3% presented pancolitis and 30% left-sided colitis. Only 3.9% were malnourished, 30.9% were overweight, and 18% were obese. The main extraintestinal manifestations were rheumatologic (21%). Regarding medical treatment, 68.1% of the patients received biologics (45% Infliximab, 29% Adalimumab, 9.7% Vedolizumab, and 8.8% Ustekinumab), 67% salicylates, 47.6% immunosuppressors, and 0.8% Tofacitinib. Of those submitted to surgery (34.1%, n=439), 54% were elective versus 46% urgent; most procedures (80%) were open/laparotomy, while 20% were laparoscopic. Of those, 8.5% were colectomy. The presence of CD, pancolitis, the absence of (isolated) proctitis, younger age (&lt;20 years), rheumatologic manifestations, and no history of smoking were found to be independent risk factors.

Conclusion
This is the first epidemiological study using the national patient registry organized by GEDIIB. The profile of patients with severe disease is consistent with the data in the literature, characterized by younger age, greater extent of disease, and extraintestinal manifestations. Further epidemiological studies should be encouraged to guide national policies aimed at the early diagnosis and treatment of IBD.
P838 Increased Risk of Avascular Necrosis in Patients With Inflammatory Bowel Disease: a nationwide population based cohort study
Authors: Moon J M , Kwon K E , Jung S Y , Choi C H , Lee J W , Shin S Y , Joo H J 
Published: January 2023

Abstract

Background
Avascular necrosis (AVN) is bone death due to disruption of blood supply causing disability and significant morbidity. Although considered multi-factorial, corticosteroid use is a well-known risk factor. Not only is AVN more prevalent in Inflammatory bowel disease (IBD), but IBD patients are often exposed to higher corticosteroids usage. Therefore, we aimed to investigate epidemiology and risk factors of avascular necrosis in Asian IBD patients.

Methods
We conducted a nationwide population-based cohort using Korean National Health Insurance Service (NHIS) database from January 2007 to December 2020. Newly diagnosed IBD patients were defined according to the International Classification of Diseases, 10th revision (ICD-10), and at least one prescription of IBD-specific medications. 1:3 sex-, age- matched subjects from the general population were selected. We investigated newly diagnosed AVN using the ICD-10 code and the incidence rates and risk of AVN were assessed with multivariate cox regression models.

Results
A total of 62,417 IBD population was identified, where ulcerative colitis (UC) comprised of 44,106. Age at diagnosis was younger in Crohn's disease (CD) than in UC (30±15 years and 43±16.3 years). UC population revealed greater number of comorbidities such as hypertension (16.7% and 7.1% for UC and CD, respectively), diabetes mellitus (12.4% and 9.5%), dyslipidemia (27.6% and 25.2%), and cerebrovascular diseases (4.5% and 2.5%). During the mean follow-up period of 6.75 years, 54,591 (87.5%) of the total IBD patients were exposed to systemic steroids (86.4% and 90.1% for UC and CD, respectively). Approximately 76.8% in the IBD group were prescribed with ≥10 mg/day of corticosteroids with mean duration of 16.3±35.1 days. A total of 100 (0.16%) newly diagnosed AVN cases were observed in the IBD population. Time from the index date to AVN diagnosis was 4.47±3.29 years. Compared to the non-IBD controls, the incidence of AVN was significantly increased in IBD subjects (adjusted hazard ratio [aHR] with 95% confidence interval [CI], 1.28 [1.01-1.63]). UC patients in particular were at an elevated risk for developing AVN (aHR with 95% CI, 1.39 [1.07-1.80]), whereas risk analysis for CD patients demonstrated results that were statistically not significant (aHR with 95% CI, 1.00 [0.63-1.57]).
Table 1 Incidence rates and risk ratios of AVN in patients with IBD

Conclusion
Risk of AVN was elevated in Korean IBD patients compared to non-IBD population, especially for UC. Physicians dealing with IBD patients should be aware of etiological factors of AVN along with corticosteroid use. Future study is needed to investigate on the mechanisms associated with AVN in IBD.
P844 Frequency of Extraintestinal Manifestations in vedolizumab versus anti-TNF Treated Patients with Inflammatory Bowel Diseases
Authors: Liava C , Sinakos E , Dimitroulas T , Navrozidou C , Akriviadis E 
Published: January 2023

Abstract

Background
Patients with moderate to severe inflammatory bowel diseases (IBD) treated with gut-selective vedolizumab (VDZ) may be more likely to develop de novo extraintestinal manifestations (EIMs) or exacerbate pre-existing EIMs, compared to those treated with systemic anti-tumor necrosis factors (anti-TNF), as has been demonstrated mainly in retrospective studies. We aimed to compare the frequency of EIMs in IBD patients treated with VDZ vs those receiving anti-TNF therapies, based on prospectively-retrospectively collected data from a cohort of IBD patients followed in daily clinical practice.

Methods
300 patients with biopsy-confirmed IBD aged 10–90 years old were included in the study. A comprehensive questionnaire was used to collect data on each site visit from July 2018 until March 2022. Logistic regression analysis and chi-squared test were used to compare the frequency of EIMs between IBD patients treated with VDZ vs anti-TNF.

Results
Of the 300 patients with IBD, 111 received biologic therapy [82 with Crohn’s disease (CD), 28 with ulcerative colitis (UC), and 1 with indeterminate colitis (IC)]. The median age of these IBD patients was 39 years. The majority (80%) were treated with anti-TNF agents (88 received anti-TNF and 23VDZ). CD patients received more frequent anti-TNF therapy (69 of 88 patients treated with anti-TNF, OR 2.95; 95% CI: 1.11-7.81; P&lt;.05); patients with UC received more frequently VDZ [10 of 23 patients treated with VDZ (44%) vs 18 of 88 patients treated with anti-TNF (21%), P&lt;.05]. IBD patients diagnosed with perianal disease had an increased trend of receiving anti-TNF therapy than those without (OR 2.34; 95% CI: 0.87-6.31; P=.094). EIMs were observed in 55% of patients included in the cohort (52% were treated with anti-TNF vs 70% treated with VDZ, P=.144), as summarized in table 1. IBD patients treated with VDZ had a 3-fold increased risk of developing de novo or exacerbating pre-existing peripheral arthropathy, compared to those treated with anti-TNF agents (OR 3.03; 95% CI:1.12–8.21; P&lt;.05).

Conclusion
In this cohort study, IBD patients treated with VDZ had a 3-fold increased risk of developing de novo or exacerbating pre-existing peripheral arthropathy, compared to those treated with anti-TNF agents. This result may be explained by the gut-selective anti-inflammatory effect of VDZ, which appears to limit its clinical effect on EIM prevention.
P859 Accuracy of self-reporting of immune-mediated inflammatory diseases by patients with inflammatory bowel disease. Results from a hospital-based cohort.
Authors: De Francisco Garcia R M , Pérez-Martínez I , Castaño-García A , Celada-Sendino M , Fernández-González E , García-Pérez C , Martínez-Gozález S , Rolle V , Queiro R , Alonso-Castro S , Santos-Juanes J , Gueimonde M , Riestra S 
Published: January 2023

Abstract

Background
The association of several immune-mediated inflammatory diseases (IMIDs) in the same patient is well known. IMID, especially joint and cutaneous diseases, are frequently diagnosed in patients with inflammatory bowel disease (IBD). However, the degree of knowledge that patients with IBD have about the coexistence of other IMIDs is little studied. Our aim was to evaluate the accuracy of self-reporting of IMID by patients with IBD.

Methods
Prospective, unicentric study that included patients attended in person at the IBD Unit of the Central University Hospital of Asturias (Spain) between August 2020 and December 2021. Patients were invited to participate in the study, and, after signing the informed consent, they answered a questionnaire about the presence or not of 50 IMIDs (self-reported diagnosis). The diagnosis of an IMID was confirmed in the medical records of each patient (reference diagnosis). Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy (proportion of subjects correctly classified) of self-reporting was calculated. Statistical analyses were performed with R software version 4.0.2.

Results
A total of 1,621 patients were included. Forty-four percent of patients had ulcerative colitis, 53% had Crohn’s disease and 3% had an IBD-unclassified, 50% were men, and the age at diagnosis of IBD was 38±15.2 years. Seven hundred and twelve patients were receiving mesalazine, 67 corticosteroids, 394 immunomodulators and 532 biologics. Six hundred and twenty-seven (39%) patients were diagnosed with at least one IMID, 177 (10.9%) with two, 49 (3%) with three, and 17 (1%) with more than three. Sixteen percent of patients had a joint IMID and 15% a cutaneous IMID. Self-reporting of IMID by IBD patients has a sensitivity, specificity, PPV, NPV and accuracy of 0.75 (95% CI 0.73-0,78), 0.89 (95% CI 0.86-0.91), 0.92 (95% CI 0.89-0.93), 0.69 (95% CI 0.66-0.73) and 0.81 (95% CI 0.79-0.83), respectively. Table 1 shows the results by IMID groups (joint, cutaneous, digestive, endocrinological, ocular, others), and Table 2 shows the results of the most frequent IMIDs.

Conclusion
Eighty-one percent of patients with IBD are able to correctly identify the coexistence or not of IMIDs. It was observed that in the case of joint IMIDs there is a significant percentage of patients who do not know whether or not they suffer from one of these diseases.