bluuebunny/crossref_metadata_2025_split huggingface dataset:
P145 Inflammatory Bowel Disease patients requiring surgery can be treated in referral centres regardless of the COVID-19 status of the hospital: results of a multicentric European study during the first COVID-19 outbreak (COVIBD-Surg)
Authors: Rottoli M , Pellino G , Tanzanu M , Baldi C , Frontali A , Carvello M , Foppa C , Kontovounisios C , Tekkis P , Colombo F , Sancho-Muriel J , Matteo F , Danelli P , Celentano V , Spinelli A , Panis Y , Sampietro G , Poggioli G 
Published: May 2021

Abstract

Background
Little is known regarding the outcomes of inflammatory bowel disease (IBD) patients who required surgery during the outbreak of Coronavirus disease 19 (COVID-19). This study aimed to compare outcomes of IBD patients undergoing surgery in COVID-19-treatment and COVID-19-free hospitals.

Methods
Retrospective study involving patients undergoing IBD surgery in seven centres (six COVID-19-treatment hubs and one COVID-free hospital) across 5 European countries during the period of highest reduction of elective activity due to the first peak of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections. Predictive variables of the risk of moderate-to-severe postoperative complications were analysed using logistic regression analysis. Considering the large number of regressors and the risk of over-fitting due to the small number of events, the least absolute shrinkage and selection operator (LASSO) method was used.

Results
Of the 91 patients (59 males, 64.8%) with Crohn’s disease (54, 59.3%) or ulcerative colitis (37, 40.7%), 66 (72.5%) had surgery in a COVID-19-treatment hospital, while 25 (27.5%) were treated in the COVID-19-free centre. A higher proportion of COVID-19-treatment patients required urgent surgery (48.4% vs 24%, p=0.035), did not discontinue the biologic therapy (15.1% vs. 0%, p=0.039), underwent surgery without a SARS-CoV-2 test (19.7% vs. 0%, p=0.0033), and were admitted to intensive care postoperatively (10.6% vs. 0%, p=0.032). Three patients (4.6%) of the COVID-19-treatment group had a SARS-CoV-2 infection during the hospital course.
Use of steroids at surgery (Odds ratio [OR]=4.10, 95% CI 1.14–15.3, p=0.03), presence of comorbidities (OR=3.33, 95% CI 1.08–11, p=0.035), and Crohn’s disease (vs. ulcerative colitis, OR=3.82, 95% CI 1.14–15.4, p=0.028) were associated with risk of moderate-to-severe postoperative complications. The admission to a COVID-19-treatment hospital was not associated with higher risks of complications (OR 2.06, 95% CI 0.54–10.4, p=0.30)

Conclusion
Although a SARS-CoV-2 infection in the postoperative period represented a concrete risk in IBD patients undergoing surgery in COVID-19-treatment hospitals, the study showed that IBD patients can undergo surgery regardless of the COVID-19-status of the referral centre. The study also showed the lack of standardized practice for IBD patients requiring surgery during the COVID-19 outbreak.
P154 Faecal calprotectin and patient reported disease control of IBD: results from the baseline dataset of the PREdiCCt study
Authors: Siakavellas S , Derikx L , Derr L , Williams L , Plevris N , Jenkinson P , Lucaciu L , Constantine-Cooke N , Covil K , Murdoch L , Jones G R , Lees C 
Published: May 2021

Abstract

Background
There is an established disconnect between intestinal inflammation and symptoms in patients with IBD. Faecal calprotectin (FCAL) is an excellent surrogate for mucosal healing and we have good data to support treat to target approaches based on FCAL. However, there is relatively little data analysing how well FCAL correlates with a fuller breakdown of a patient’s symptoms. We were interested to explore the impact of ongoing intestinal inflammation as measured by FCAL in patients reported to be in clinical remission.

Methods
The PREdiCCt study (https://www.predicct.co.uk) is the largest prospective study of the causes of IBD flare. 2629 patients in clinical remission were recruited from 48 UK sites and followed for 2 years. 1946 (74%) patients completed the baseline questionnaires. We present here the results of the baseline questionnaire analysis of IBD symptoms (IBD Control questionnaire). Eight of the question items generate a summary score (IBDControl-8) ranging from 0 (worst control) to 16 (best control). This questionnaire also includes a visual analogue scale (VAS) for disease control ranging from 0 (worst control) to 100 (best control). These data were matched to a contemporaneous FCAL measurements, taken at study entry.

Results
IBD Control-8 results are available in 1,919 patients [male=840, CD=985 UC/IBDU=934, age 45.8±15.5 (mean±SD in years)]). Median FCAL values were 46 mcg/g (IQR 20–150) for the overall cohort, 50 mcg/g (IQR 20–156) for CD and 39 mcg/g (IQR 20–143) for UC. UC patients reported better disease control compared to CD patients (p&lt;0.001, for both IBDControl-8 and VAS). CD patients with previous surgery (p=0.031 for IBDControl-8) and perianal disease (p=0.015 and p=0.035, for IBDControl-8 and VAS respectively) reported worse disease control than the rest of the CD patients. Better disease control was reported in males versus female patients (p&lt;0.001 and p=0.003 for IBDControl-8 and VAS respectively).
There was a negative correlation between baseline FCAL values and (p&lt;0.001). Patients who reported waking up at night due to their disease had higher FCAL values at baseline [median 60 mcg/g (IQR 20–162) vs 43 mcg/g (IQR 20–144), p=0.013] with the correlation being more prominent in UC (p=0.002). Patients who reported the need to change their treatment had higher FCAL values at baseline [85 mcg/g (IQR 24–336) vs 43 mcg/g (IQR 20–139), mcg/g, median (IQR), p=0.032].

Conclusion
This is the first detailed symptom examination of clinical versus deep remission. We show how residual gut inflammation in patients in clinical remission affects meaningful patient reported outcomes measures including waking at night. UC and male patients reported better disease control compared to CD and female patients.
P305 Effectiveness and Safety of Vedolizumab in Biologic-Naïve Patients: Real-World Data from the Sicilian Network for Inflammatory Bowel Diseases (SN-IBD)
Authors: Macaluso F , Fries W , Renna S , Viola A , Muscianisi M , Cappello M , Guida L , Siringo S , Camilleri S , Garufi S , Privitera A C , Belluardo N , Giangreco E , Bertolami C , Vassallo R , Rizzuto G , Orlando R , Ventimiglia M , Orlando A 
Published: May 2021

Abstract

Background
Biologic-naïve patients treated with Vedolizumab (VDZ) are largely underrepresented in real-world cohorts. We performed a multicentre, observational, cohort study on the effectiveness and safety of VDZ as treatment for Crohn’s disease (CD) and ulcerative colitis (UC) among biologic-naïve subjects.

Methods
Data of consecutive biologic-naïve patients with CD and UC treated with VDZ from July 2016 to December 2019 were extracted from the cohort of the Sicilian Network for Inflammatory Bowel Disease (SN-IBD). The primary outcome was the clinical response at 14 and 52 weeks evaluated with Harvey Bradshaw Index in CD and partial Mayo score in UC.

Results
172 consecutive patients (CD: n=88; UC: n=84; median age 66.0 years) were included, with a median follow-up of 58.8 weeks. After 14 weeks, a clinical response was reported in 68.2% of patients with CD and 67.9% of patients with UC treated with VDZ, including 45.5% patients in the CD group and 46.4% patients in the UC group who achieved steroid-free remission. After 52 weeks, a clinical response was reported in 77.4% of CD and in 73.8% of UC patients treated with VDZ, including 59.7% patients in the CD group and 60.7% patients in the UC group who achieved steroid-free remission. All differences between CD and UC were not statistically significant. Cox survival analysis showed no significant difference in the probability of treatment discontinuation between CD and UC patients (log-rank p=0.73).

Conclusion
This large, real-world, multicenter study demonstrated the effectiveness and safety of VDZ as a first-line biologic, showing high rates of clinical response and steroid-free remission at both induction and maintenance.
P322 Hepatitis B reactivation under biologic therapy in patients with HBsAg negative phase of chronic HBV infection
Authors: Ergenç I , Kani H T , Karabacak M , Cömert Özer E , Mehdiyev S , Jafarov F , Abacar K Y , Kutluğ Ağaçkıran S , Seven Sevik G , Alibaz Öner F , İnanç N , Atagündüz M P , Gençosmanoğlu D S , Özen Alahdab Y , Ergun T , Direskeneli R H , Atuğ Ö 
Published: May 2021

Abstract

Background
Biologic agents are widely used in immune mediated inflammatory diseases (IMID). The risk and consequences of hepatitis B reactivation in hepatitis B surface antigen (HBsAg) negative phase of hepatitis B virus (HBV) exposed patients is not clear. We aim to investigate the reactivation rate in biologic exposed patients within surface antigen negative phase of HBV infection.

Methods
We identified patients followed up at gastroenterology, rheumatology and dermatology out-patient clinics with a diagnosis of IMID from clinical charts. Patients exposed to biologic agents with a negative HBsAg and positive Anti-HBc IgG were included. Primary outcome was HBV reactivation, which was defined as reverse seroconversion of HBsAg.

Results
We screened 8266 IMID patients and 2484 of them were exposed to biologic agents. A total of 221 patients were included in the study. The mean age was 54.08 ± 11.69 years and 115 (52.0%) patients were female. The median number of different biologic subtype use was 1 (range: 1 – 6). The mean biologic agent exposure time was 55 (range: 2 – 179) months. One hundred and fifty-two (68.8%) patients were using concomitant immunomodulatory agents and 84 (38.0%) patients were exposed to corticosteroids during biologic use. No hepatitis B reactivation with a reverse seroconversion of HBsAg positivity was observed in the whole cohort. Antiviral prophylaxis for hepatitis B was given to 48 (21.7%) patients with entecavir, tenofovir or lamivudine. HBV-DNA was screened in 56 (25.3%) patients prior to the biologic exposure. Two patients had HBV-DNA reactivation with a negative HBsAg during exposure to the biologic agent.

Conclusion
Though only 21.7% of our patients used prophylaxis, we found only two reactivations (1%) and no HBsAg seroconversion in our cohort. Our results suggest a re-assessment of antiviral prophylaxis for anti-HBc Ag (+) patients exposed to biologic agents. Current guidelines would be updated in the light of future studies.
P323 Efficacy and safety of tofacitinib treatment for one year in Japanese patients with Ulcerative Colitis in a specialized Inflammatory Bowel Disease center
Authors: Kojima K , Yokoyama K , Kaku K , Takashima Y , Sato T , Kawai M , Kamikozuru K , Takagawa T , Yokoyama Y , Watanabe K 
Published: May 2021

Abstract

Background
Few reports of the real-world efficacy and safety of tofacitinib (TFB) in Asians are available, and potential predictors of the response to therapy are unclear. We investigated the efficacy and safety profiles of TFB treatment for one year in patients with active Ulcerative Colitis (UC) in our specialized Inflammatory Bowel Disease center.

Methods
This study included 111 patients who received TFB between May 2018 and February 2020. We assessed disease activity using the partial Mayo Score (pMS). Clinical remission was defined as pMS ≤2, with no subscore &gt;1 and a rectal bleeding subscore of 0. Clinical response was defined as a decrease in pMS of ≥2 points from baseline with an accompanying decrease in the rectal bleeding subscore of ≥1 point or an absolute rectal bleeding subscore of ≤1 point.

Results
Mean patient age was 35 years (interquartile range [IQR]: 28-47), 60 (59.4%) were men, and mean disease duration was 4.8 years (IQR:1.5-10). The pMS was 6 (IQR:4-7) and C-reactive protein was 0.30 mg/dl (IQR: 0.1-1.0). At baseline, 63 (62.4%) patients received an anti-TNFα agent, 11 (10.9%) received vedolizumab, and 7 (6.9%) received both. Clinical response and clinical remission were, respectively, 66.3% (67/101) and 50.5% (51/101) at week 8, and 47.1% (40/85) and 43.5% (37/85) at week 48. The cumulative remission rate was 61.7% at 1 year and 51.7% at 2 years, and tended to be better in the ≥2 anti-TNFα agents failure group than in the 1 anti-TNFα agent failure and bio-naïve groups (P=0.10). Cumulative colectomy-free survival was 91.9% at 1 year and 89.1% at 2 years. Cumulative drug-free survival in the non-remission group at week 8 was 30.9% at 1 year and 30.9% at 2 years, significantly lower than in the remission-achieving group at week 8 (P&lt;0.01). Baseline pMS was significantly lower in responders vs non-responders at week 8 (odds ratio, 0.61; 95% confidence interval, 0.45-0.82). Relapse occurred in 45.7% of patients after tapering TFB, and 85.7% of patients with re-increased TFB responded by week 4. Herpes zoster occurred in 6 unvaccinated patients (46±16 years old). There were no specific features regarding age, TFB dosage, duration of administration, or lymphocyte count in these patients. No thrombotic adverse events occurred, even though 54.1% patients continued treatment with 10 mg twice daily at week 48.

Conclusion
TFB was more effective in low-activity UC patients and its efficacy was not affected by previous treatment with anti-TNF agents. Most patients in the remission groups at week 8 could continue TFB for one year without severe adverse events, although careful monitoring for herpes zoster is necessary. The risk of thrombotic adverse events might be lower in Japanese UC patients.
P335 Real-life effectiveness and safety of tofacitinib treatment in patients with ulcerative colitis: A KASID multicenter cohort study
Authors: Oh K , Hong S N , Kim E S , Na S Y , Kang S B , Koh S J , Bang K B , Jung S A , Kim K O , Choi C H , Ye B D 
Published: May 2021

Abstract

Background
Tofacitinib is a small molecule which inhibits janus kinase and has been shown to be effective for patients with active ulcerative colitis (UC). We investigated the real-life therapeutic effectiveness and safety of tofacitinib treatment for Korean patient with UC.

Methods
We retrospectively analyzed the data of patients with UC who received tofacitinib treatment at 10 hospitals in Korea. The primary outcome was clinical remission at week 16 which was defined as a partial Mayo score ≤2 with a combined rectal bleeding subscore and stool frequency subscore ≤1. The secondary outcome was endoscopic remission (Mayo endoscopic subscore ≤1) at week 16. Adverse events including herpes zoster and deep vein thrombosis were also evaluated.

Results
Between January 2018 and November 2020, a total of 123 patients with UC received tofacitinib treatment (Table 1). Clinical effectiveness was evaluated for those who had completed or stopped the tofacitinib therapy by week 16, week 24 and week 52, respectively (Figure 1). Clinical remission and response rates at week 16 were 65.3% and 73.7%, respectively (Figure 2A). Ninety-one out of 123 patients (74.0%) were followed up to week 52. Their clinical remission and response rates at week 52 were 49.5% and 58.2%, respectively (Figure 2A). Among 117 patients with baseline Mayo endoscopic subscore ≥2, endoscopic remission rate at week 16 was 55.6% (Figure 2C). Any adverse events occurred in 15 patients (12.2%) and serious adverse events occurred in 9 patients (7.3%). Herpes zoster occurred in 4 patients (3.3%) and one patient (0.8%) suffered from deep vein thrombosis (Table 2).

Conclusion
Tofacitinib was effective with an acceptable safety profile for Korean patients with UC in the real world.
P342 Correlation of the first lateral flow-based Point of Care test to quantify infliximab and anti-infliximab antibodies in a finger prick sample with the reference ELISA technique
Authors: Ruiz-Argüello M B , Pascual J , Del Río L , Urigoitia A , Balo Farto C , Fernández C , Mera A , De Toro J , Nagore D , Ametzazurra A 
Published: May 2021

Abstract

Background
The goal of this study was to validate the use of capillary blood in a real point-of-care (POC) setting for patients under infliximab treatment by using Promonitor Quick lateral flow (LF) tests. Results were compared to the Promonitor ELISA reference technique in serum samples used by centralised laboratories.

Methods
A prospective, observational study was designed to evaluate the performance of a rapid LF test (Promonitor Quick IFX, Progenika, Spain). 160 infliximab treated rheumatology consecutive patients (400 samples) were recruited in two hospitals in Galicia, Spain. Prior to the infusion, a finger prick sample was obtained and analysed. Anti-infliximab antibodies were also determined with Promonitor Quick ANTI-IFX1-4. Results were read with the automated portable PQreader instrument. Additionally, a serum sample was collected for subsequent comparative analysis with either LF or ELISA tests.
Qualitative (positive (PPA) and negative (NPA) agreements) and quantitative (Pearson correlation and bias) performance of the LF test was compared to ELISA, as well as between different specimens following CLSI EP09-A3.

Results
Overall agreement between Promonitor Quick IFX finger prick and ELISA test was 91% (88% PPA; 100% NPA). The quantitative comparison showed a good correlation (Pearson correlation coefficient: 0.85 and observed bias: 25%) (Table 1).
Similar results were also observed when serum was used with either the LF or the ELISA tests (98% overall agreement, 0.91 correlation coefficient; 6% bias) (Table 1).
Overall agreements for visual and automated (PQreader) interpretations with Promonitor Quick ANTI-IFX were 99% and 100% for finger prick and serum specimens, respectively (Table 2).

Conclusion
Promonitor Quick can be used to reliably quantify infliximab in capillary blood samples and results are comparable to those obtained with the reference ELISA technique. The use of the rapid POC test with finger prick will allow clinicians to monitor their patients in a fully decentralized mode to aid in the decision making process. PQreader is a sensitive portable equipment to report drug as well as antibody levels in the patient samples.

References
P343 Maintenance of deep remission in Crohn’s disease after switching from anti–TNF to ustekinumab
Authors: Mantzaris G , Vraka M , Beka H , Georgiadi T , Albani F , Veretanos C , Mountaki K , Trikola A , Archavlis E , Christidou A , Manolakis A , Viazis N , Karampekos G , Philippidis G , Hatzievangelinou C , Tsatsa A , Georgiadou A , Panagopoulou S 
Published: May 2021

Abstract

Background
Anti-TNF agents, infliximab (IFX) and adalimumab (ADL) are first line treatment for moderate-to-severe Crohn’s disease (CD) and for preventing post-operative recurrence of CD (CD-POR) following right hemicolectomy (RH). However, a considerable proportion of patients develop allergic reactions and/or paradoxical inflammation to anti-TNFs necessitating switching to out of class biologic despite deep remission. We aimed to assess whether ustekinumab (UST), an IL12/IL23 inhibitor, can maintain deep remission in these patients.

Methods
This prospective, single centre study enrolled CD patients with B1 phenotype or on POR preventive therapy who were in prolonged deep remission when became intolerable of anti-TNFs. Deep remission was defined as clinical (HBI&lt;4), biomarker (normal CRP and faecal calprotectin [FC&lt;150μg/dl]), and endoscopic remission (SES-CD≤2 or Rutgeerts’ score [RS]≤1). Patients received UST (6mg/kg iv followed by 90mg sc q8 weeks) and were followed every 2 months with HBI score calculation and routine laboratory tests. Ileocolonoscopy was performed at 1y after UST initiation and the SES-CD or the RS were calculated. Absence of deep remission was defined as clinical (HBI&gt;5), or biomarker relapse or endoscopic recurrence (SES-CD&gt;2 or RS≥2, respectively).

Results
Twenty five patients (15 males), median age(range) 42(20-65)y were included. Seven patients had undergone RH, 6 had colitis and 12 had ileitis or ileocolitis; 13 patients had received ADL, 8 IFX and 4 both. Patients were in deep remission for 3.8 (2-10)y [median (range)]. Reasons for switching were severe psoriasis/proriasiform lesions (11), persistent arthralgias (10), infusion/injection reactions (2), anti-TNF-induced lupus erythematosus (2), sweet syndrome (1), and vasculitis (1). Two patients had more than one paradoxical inflammation. At baseline the median (range) CRP was 0.21mg/dl (0.10-0.40), FC 52μg/g (20-114). Trough levels for anti-TNFs in 15/25 patients were normal without antibodies. At 1-year post-switching endoscopic CD-POR was seen in 3/7 patients (RS≥2b) associated with biomarker relapse in 2 and clinical relapse in 1 patient. Of 18 patients with B1 phenotype deep remission was maintained in 15: two patients with infusion reactions to IFX relapsed and 1 patient developed endoscopic lesions in view of normal CRP but abnormal FC (SES-CD 6, 5 and 3, respectively). Paradoxical inflammation resolved in all 23 patients but de novo arthralgias developed in 2 patients. Thus, one year after switching to UST, 19/25 CD patients maintained deep remission.

Conclusion
UST seems to be a reliable therapeutic alternative for anti-TNF-dependent patients who have who cannot tolerate anti-TNFs.
P347 Vedolizumab as first line biologic therapy in elderly patients with contraindications against anti-TNF therapy - A real-world nationwide cohort of patients with inflammatory bowel diseases
Authors: Attauabi M , Höglund C , Fassov J , Pedersen K B , Bansholm Hansen H , Wildt S , Dam Jensen M , Neumann A , Lind C , Albæk Jacobsen H , Popa A M , Kjeldsen J , Pedersen N , Molazahi A , Haderselv K , Aalykke C , Knudsen T , Cebula W , Munkholm P , Bendtsen F , Seidelin J B , Johan B 
Published: May 2021

Abstract

Background
Data regarding the efficacy and safety of vedolizumab as the first line of biologic therapy for elderly patients with ulcerative colitis (UC) and Crohn’s disease (CD) or patients with contraindications against anti-tumor necrosis factor antagonists (anti-TNFs) are scarce. Therefore, we aimed to investigate the short and long-term efficacy and safety of vedolizumab in patients with bio-naïve UC and CD stratified according to age.

Methods
A Danish nationwide cohort study was conducted between November 2014 and November 2019, including all bio-naïve patients receiving vedolizumab. The primary outcomes were clinical remission, steroid-free clinical remission, and sustained clinical remission defined as clinical remission at week 14 through week 52. Elderly patients were defined as patients aged 60 years or older at initiation of vedolizumab.

Results
The study included 56 patients (UC: 31 (55.4%), CD: 25 (44.6%)) with 15 (60.0%) and nine (47.4%) elderly patients with UC and CD, respectively. Elderly patients with UC and CD experienced higher rates of early response, remission, and steroid-free clinical remission, which, however, did not reach statistical significance (Figures 1 and 2). However, elderly patients with CD had similar long-term response as compared with younger patients.
In the overall study population, lack of remission at week 52 was associated with female gender (p=0.01) in UC and ileal CD (p=0.03). Discontinuation due to primary non-response occurred in 20.0% and 5.3%, while rates of secondary loss of response were 12.0% and 5.3% after 26 weeks and 52 weeks, respectively.
Only one UC patient, who developed a serious infection, experienced a serious adverse event during treatment with vedolizumab. However, mild adverse events were experienced by 35.5% and 8.0% of patients with UC and CD, respectively. As shown in Table 1, elderly patients experienced adverse events similar to the corresponding younger patients.

Conclusion
Vedolizumab is effective for induction of short and long-term sustained clinical remission in bio-naïve elderly and younger UC and CD patients with contraindications to anti-TNFs.