bluuebunny/crossref_metadata_2025 huggingface dataset:
P702 Treatment decisions in older inflammatory bowel disease patients: Applying gut feeling in an evidence-based era? A qualitative study
Authors: Waars S , Asscher V , Pieterse A , van der Meulen-de Jong A , Mooijaart S , Maljaars J
Published: January 2020

Background

The population of older patients with inflammatory bowel diseases (IBD) is increasing. Treating older patients is challenging as they are characterised by heterogeneity in geriatric domains, such as functional, social or mental status. Although treatment guidelines do not distinguish between older and adult patients with IBD, several studies have found a difference in applied treatment strategies. It is unknown which considerations contribute to this. Therefore, we performed semi-structured interviews with IBD gastroenterologists and IBD nurses to assess a) which patient characteristics they consider and b) which treatment goals they pursue in older IBD patients, compared with adult IBD patients and c) what view they have on prescribing IBD medications in older IBD patients.

Methods

IBD gastroenterologists and IBD nurses practicing throughout The Netherlands were asked to participate. Purposive sampling ensured a heterogenous population. Interviews took place in May or July 2019 were audio recorded and conducted face to face. Two researchers coded the verbatim transcripts independently. Codes and themes were obtained inductively and were finalised in consensus. Recruitment was stopped when no new information came out of three consecutive interviews.

Results

Ten gastroenterologists and five IBD nurses were included: eight females, median age 43 years (34–61), median years of experience in IBD care, eight years (1–20), three working in an academic centre. Comorbidity and polypharmacy were most frequently mentioned as important patient characteristics in the choice of treatment of IBD in older patients. Only when asked specifically, participants mentioned characteristics of frailty, of which self-dependence, mobility, and cognitive impairment most often. However, applying ‘a clinical view’ or ‘gut feeling’ were frequently mentioned and none of the participants assessed frailty systematically. Therapy goals in older patients differed from those in adult patients: participants indicated to pursue clinical remission more often than endoscopic remission. Most participants stated to be reluctant to prescribe thiopurines. Other opinions about preferred medication differed remarkably, especially regarding low dose prednisone maintenance therapy.

Conclusion

In the treatment of older IBD patients, attention is paid to comorbidity and polypharmacy, but geriatric characteristics, such as functional or cognitive impairment or frailty are barely taken into consideration. Clinicians put lower priority on pursuing endoscopic remission in older compared with younger patients. The large variation in clinicians’ treatment preferences reflects a lack of evidence regarding treatment of older patients with IBD.
P704 The biennial direct pharmaceutical costs per treatment with biologics for the inflammatory bowel disease in Greece: A comparative calculation study
Authors: Liatsos C , Papaefthymiou A , Kyriakos N , Giakoumis M , Tzouvala M , Doulberis M , Mavrogiannis C , Kountouras J
Published: January 2020

Background

Inflammatory bowel disease (IBD), as a chronic disease with relatively high prevalence worldwide, has undoubtedly resulted in a notable economic burden on health care systems globally. The IBD treatment with biologics (IBD-BT) seems quite complex with various strategies to induce and maintain remission and balance against long-term complications. IBD-BT costs have never been estimated in detail so far in Greece, especially during such a severe 10-years financial crisis experience.

Methods

Direct pharmaceutical costs for one and two years, both for induction and maintenance, adult treatment diagnosed with Crohn’s disease (CD-BT) or Ulcerative colitis (UC-BT) were estimated. For intravenous agents, the hospital drug prices and one day admission costs were calculated, whereas for subcutaneous biologics the retail ones. It was taken for granted that all patients were fully responders and after the approved induction scheme continued with the standard maintenance strategy. Prototype and biosimilar drug prices were also assessed where available. More specifically, when considering biosimilars, the most affordable one was included to our analysis. Each drug price was estimated based on the data collected from the 2019 Greek official electronic national publication on drug therapy of the Greek national organisation for medicines.

Results

Table shows the costs in euros of each IBD-BT scheme. The biosimilar adalimumab was proved as the most affordable choice both for CD- and UC-BT. The second most affordable choice for CD revealed to be the prototype Adalimumab and respectively for UC the recently introduced tofacitinib, in the maintenance dose of 5 mg bid after week 8 (with a slight burden when the more intensive scheme with Tofacitinib 10 mg bid for 16 weeks is necessary). The most expensive strategies include Ustekinumab 90 mg (per 8 weeks for body weight—BW > 55 to ≤85 kg and >85 kg) and the prototype Infliximab 5 mg/kg (per 8 weeks for BW>81 kg), whereas Vedolizumab remains expensive regardless BW. It is worthwhile to mention that the hospitalisation expenditures (563€) raise the costs of intravenous agents when compared with the subcutaneous ones.

Conclusion

The biennial direct pharmaceutical costs for the approved IBD-BT schemes both for induction and maintenance phases in fully responders were estimated thoroughly for the first time in Greece. These results should motivate Governments and European Union policymakers in order to promote cost-benefit and cost-utility studies to offer the best patients’ benefit by evaluating and deciding the most suitable regimen with respect to biologic prices, adverse effects, hospitalisation expenditures, IBD complications and recurrences.
P707 Anti-TNFα therapy has no effect on bone mineral density in younger patients with inflammatory bowel disease: A single-centre observational study
Authors: Filip R , Jarmakiewicz - Czaja S , Piątek D , Sztembis J , Pękala A , Guz W
Published: January 2020

Background

Active inflammation negatively affects bone mineral density. Biological treatment, among others silences the excessive reaction of the immune system, which can also reduce the risk of osteoporosis. The aim of the study is to determine whether bone mineral density is higher in patients with biological therapy.

Methods

In total, 112 patients over 18 years of age with CD (Crohn’s Disease) or UC (Ulcerative colitis) were included in the study. The mean value age was 35 years. Patients who had received anti-TNFα therapy (biosimilar infliximab CT-P13 or adalimumab), and who underwent densitometric evaluation after two year treatment, were selected. Those who had never received anti-TNFα therapy were selected as controls. Information regarding age, sex, weight, duration of CD, use of glucocorticoids and bisphosphonates, and signs of disease activity at the time of densitometric measurement were collected. Bone mineral density was measured by dual-energy X-ray absorptiometry (DEXA) within femoral neck and lumbar spine. Results are reported as g/cm2 and presented either as Z-score or as a T-score.

Results

The study group has characterised a mean value BMI (Body Mass Index)—24. The group of patients with anti-TNFαα therapy showed an average T-score left femur −0.7744 (CD) and −0.4382 (UC), but without anti-TNFα therapy −0.6636 (CD) and −0.2208 (UC). The entire study group showed a mean value t-score left femur of −0.54286. There were no significant statistical differences between the examined groups and the effect of anti-TNFα therapy on BMI, T-score left femur, T-score L2–L4

Conclusion

The results of the preliminary study assessing the effect of anti-TNFα therapy on bone mineral density among the two treatment groups (CD and UC) do not indicate significant differences after the introduction of such therapy
P717 Ustekinumab in Crohn’s disease: Real-world outcomes from the Sicilian Network for inflammatory bowel diseases (SN-IBD):–Preliminary results
Authors: Viola A , Fiocco G , Alibrandi A , Macaluso F S , Cappello M , Privitera A C , Magrì G , Garufi S , Centritto A , Ventimiglia M , Giuffrida E , Ferracane C , Costantino G , Renna S , Orlando A , Fries W
Published: January 2020

Background

Ustekinumab is approved in Europe for the treatment of moderate-to-severe Crohn’s disease (CD) since 2016. Italian real-life data on efficacy and safety are scarce. The aim of this study was to assess effectiveness, safety and usage of Ustekinumab in an Italian cohort of patients.

Methods

Data of patients with moderate-to-severe CD who started Ustekinumab in Sicily were extracted from the database of the SN-IBD. Demographic data, disease-related data (disease duration, location, clinical activity) and previous therapies with biologics were collected. The primary study endpoints were steroid-free clinical remission and steroid-free clinical response at week 12, 24 and 52 on Ustekinumab therapy. Secondary study endpoints were: treatment persistence at 24 weeks, safety, and biochemical response (reduction of CRP).

Results

One hundred thirteen patients started Ustekinumab in Sicily. We performed a preliminary analysis only on patients who reached at least 24 weeks of follow-up. Ninety-three patients (M = 53%; mean age 45 ± 14.9 years) were included. At week 24, 38 patients (41%) achieved steroid-free clinical remission, 56 patients (60%) clinical response. From baseline to the end of follow-up there was a significant reduction of steroid use (41% vs. 21%, p = 0.038) and of mean HBI score (6.5 ± 4.4 vs. 4.8 ± 4.1; p < 0.001). No significant CRP changes were recorded during follow-up. Twelve patients (11%) discontinued therapy due to primary failure (3 patients), secondary failure (5 patients), adverse events (3 patients) and 1 patient was lost to follow-up. Kaplan–Meier survival analysis showed a persistence on therapy with Ustekinumab of 89% of patients after 24 weeks (Figure 1).

Conclusion

Preliminary data from our real-life cohort of treatment-refractory CD patients suggest a satisfactory effectiveness and a good safety profile of Ustekinumab.
P722 Upadacitinib was not associated with anaemia in patients with moderately to severely active ulcerative colitis: Results from the U-ACHIEVE study
Authors: D’Haens G , Hebuterne X , Higgins P D R , Loftus- E V , Zhou W , Lacerda A P , Xie W , Liu J , Danese S
Published: January 2020

Background

Anaemia is a frequent complication in patients with Crohn’s disease and ulcerative colitis (UC), and patients who respond to treatment generally show improvement in anaemia. Decrease in haemoglobin (Hgb) levels and anaemia may be associated with Janus kinase (JAK) inhibitors. Upadacitinib (UPA), an oral JAK1 selective inhibitor, has demonstrated favourable dose-dependent efficacy in patients with moderately to severely active UC.1 This analysis of data from the U-ACHIEVE study addressed effects of UPA treatment on Hgb levels in patients with UC.

Methods

U-ACHIEVE (NCT02819635) was a randomised, double-blind, placebo (PBO)-controlled phase 2b clinical trial. Adults with moderately to severely active UC were randomised to receive 7.5, 15, 30, or 45 mg UPA or PBO once daily (QD) for 8 weeks. Hgb levels were measured for all groups at baseline (BL) and weeks 2, 4, 6, and 8. Mean change from BL was calculated for each group. p-values for comparison between UPA and PBO groups were calculated using one-way ANOVA; no multiplicity adjustment was applied. Percentage of patients with Hgb values grade 2 (15–20 g/l Hgb decrease from BL), grade 3 (<80 g/l Hgb level or 21–29 g/l Hgb decrease from BL), and grade 4 (<70 g/l Hgb level or >29 g/l Hgb decrease BL) anaemia were determined for all treatment groups using the Common Terminology Criteria for Adverse Events version 5. Adverse events (AE) were reported by investigators.

Results

Included in the analysis were 250 patients (mean age ± SD, 42.3 ± 14.2 years; disease duration, 8.2 ± 2.5 years). At BL, most treatment groups had similar mean Hgb levels, except for the 15 mg UPA group, which had significantly lower Hgb levels vs. PBO group (Table). Increased or stable mean levels of Hgb at week 8 vs. BL were observed in most UPA treatment groups. The PBO group had the greatest decrease in Hgb vs. BL at week 8 compared with UPA treatment groups (Figure). Grade ≥2 anaemia was reported in 17.4% of patients receiving PBO and 14.4% of all patients receiving UPA (14.9%, 12.2%, 12.0%, and 17.9% of patients receiving 7.5, 15, 30, and 45 mg UPA, respectively). Grade ≥3 anaemia was reported in 8.7% of patients receiving PBO and 5% of all patients receiving UPA (6.4%, 6.1%, 6.0%, and 1.8% of patients receiving 7.5, 15, 30, and 45 mg UPA, respectively). One subject receiving 7.5 mg QD UPA had grade 4 anaemia. AE of anaemia was reported in 6.5% of patients receiving PBO and in 2.1%, 8.2%, and 3.8% of patients receiving 7.5, 15, and 30 mg UPA, respectively, but not in the 45 mg UPA group.

Conclusion

Decreased Hgb levels over time were observed more frequently in the PBO group. The maintenance of Hgb levels in patients receiving UPA was likely because of improvement of underlying UC.

Reference
P727 Small bowel capsule endoscopy impact on therapeutic decisions in established Crohn’s disease: Analysis of a real-world data
Authors: Gómez E J , Gonzalez R A , Pereyra L , Mella J M , Panigadi G N , Fischer C , Roel M , Cimmino D G , Pedreira S , Boerr L A
Published: January 2020

Background

Small bowel (SB) evaluation in established Crohn’s disease (eCD) is of paramount importance for planning therapy strategies. However, the utility of CE in helping physicians to make decisions in eCD is not currently well established. To investigate clinical impact of CE to assess activity and extension of eCD and to evaluate whether the results of CE modify therapeutic decisions.

Methods

We conducted a single centre retrospective cohort study. All consecutive adult’s patients submitted to CE for eCD were included from November 2012 to November 2018. Data on demography, previous research, medications for IBD and follow-up were analysed. Univariate analysis was carried out to identify CE features associated with changes in therapeutic management.

Results

A total of 329 CE protocols in adult′s patients were performed, of which 90 were in IBD. We included in the analysis 27 CEs submitted for eCD. The mean age was 35 years (range 15–75), 17 (63%) were males and median disease duration was 8 years. The CE reached the cecum in 26 cases (96%) and retention was observed in only one patient (4%) without necessity of surgical removal. At the time of CE, 5 patients (18%) had abnormal inflammatory biomarkers, anaemia in 4 (15%), abdominal pain in 18 (67%) and diarrhoea in 16 (59%). Thirteen of 27 patients (48%) had CE findings consistent with mucosal activity of CD. The lesions identified by CE included ulcers 11 (41%), erythema and villous enema 10 (37%), erosions 2 (7%), stenosis 2 (7%) and were distributed mainly in the distal part of the SB (3rd tertile) in 12 (44%), but in 4 (15%) the proximal SB (1st and 2nd tertile) was also affected. The mean Lewis Score (LS) was 784 (8–5392). Significant inflammatory activity (LS ≥ 135) was detected in 9 (33%) and was moderate or severe (LS > 790) in 2 (7%). CE has changed Montreal classification in 4 (15%) of patients and in 14 (52%) SB mucosal activity was ruled out. Indeed, CE has changed therapeutic management in 14 (52%) of patients within 3 months after the CE, as follows: 8 patients were started new biological therapy, 3 were optimised biological therapy, 2 were started on budesonide and 1 suspended azathioprine. Proximal SB affected, as compared with only distal SB affected, were more frequently associate with changes in therapeutic management (100% vs. 43%, p: 0.04). Significant inflammatory activity (LS ≥ 135), as compared with LS < 135, were also more frequently associate with changes in therapeutic management (82% vs. 25%, p: 0.004).

Conclusion

In our study, CE in patients with eCD added valuable clinical information and had a great impact on therapeutic decisions. Whether this approach will improve outcomes in eCD will require further investigation.
P728 Comparative assessment of faecal microbiota transplantation and current therapies as induction treatment for active refractory ulcerative colitis: A systematic review and network meta-analysis
Authors: Malandris K , Paschos P , Koukoufiki A , Katsoula A , Manolopoulos A , Tsapas A , Bekiari E
Published: January 2020

Background

Emerging evidence suggests that faecal microbiota transplantation (FMT) can induce remission in patients with refractory to standard treatment ulcerative colitis (UC).

Methods

We performed a systematic review and network meta-analysis to assess the comparative efficacy and safety of FMT and current therapies as induction treatments in UC. We searched Medline, Embase, CENTRAL and grey literature sources up to October 2019. We included randomised controlled trials of patients with active UC that compared FMT, infliximab, adalimumab, golimumab, vedolizumab and tofacitinib to each other or placebo. Efficacy outcomes were clinical remission and response. Safety outcomes were incidence of any adverse event (AE), serious AEs and infections. We conducted random-effects network meta-analysis and ranked treatments based on the surface under the cumulative ranking (SUCRA) probabilities.

Results

Twenty trials (5177 patients) were included in the analysis. There was only one head to head RCT (vedolizumab vs. adalimumab). FMT was superior to placebo for induction of clinical remission (OR 2.80; 95% CI 1.50–5.23) and response (OR 2.53; 95% CI 1.53–4.20). No indirect comparisons between FMT and licensed treatments reached statistical significance for efficacy outcomes. On SUCRA analysis, FMT (SUCRA 0.57, 0.58) had comparable SUCRA values with golimumab (SUCRA 0.53, 0.39) and vedolizumab (SUCRA 0.58, 0.61) in terms of clinical remission and response respectively. Infliximab (SUCRA 0.71, 0.93) and tofacitinib (SUCRA 0.85, 0.75) were ranked highest while adalimumab (SUCRA 0.23, 0.21) was ranked lowest. There was no increase in the rates of any AEs for FMT and licensed therapies and no differences in indirect comparisons. Vedolizumab (SUCRA 0.81) was the safest option, followed by tofacitinib (SUCRA 0.55). FMT (SUCRA 0.38) had comparable SUCRA values with adalimumab (SUCRA 0.37) and golimumab (SUCRA 0.47). Only tofacitinib increased the incidence of infections compared with placebo (OR 1.51; 95%CI 1.05–2.19). Based on SUCRAs, FMT (SUCRA 0.83) was the safest in terms of infections. Vedolizumab had lower incidence of serious AEs compared with FMT and placebo, while FMT was ranked as the least safe treatment. In subgroup analysis, FMT through the lower gastrointestinal (GI) tract was superior to placebo (OR 3.92; 95%CI 1.94–7.92) and performed numerically better than FMT through the upper GI tract (OR 0.29; 95%CI 0.08–1.13).

Conclusion

Evidence suggests that FMT could be an efficacious and safe alternative induction therapy for refractory UC. Lower GI delivery of FMT might be more effective. Due to the absence of head-to-head trials and the limited size of FMT trials, conclusions must be interpreted with caution.
P734 Should we have a higher threshold for anti-TNF serum levels in Crohn’s disease patients with perianal disease?
Authors: Arieira C , Dias de Castro F , Cúrdia Gonçalves T , Moreira M J , Cotter J
Published: January 2020

Background

Tumour necrosis factor (TNF) inhibitors are potent drugs effective for the treatment of both luminal disease and perianal fistulas in Crohn’s disease (CD). Recently, there is some evidence that patients with perianal disease might need higher concentrations of anti-TNF levels compared with patients without perianal disease. The aim of this study was to compare anti-TNF serum concentrations: IFX (infliximab) or ADA (adalimumab) between patients with active and closed perianal fistulas with CD.

Methods

Retrospective study including that was on anti-TNF for at least 6 months. Fistula closure was defined as absence of active drainage at gentle finger compression and/or fistula healing on magnetic resonance imaging/ultrasound.

Results

We included 55 patients with CD and perianal disease, 54.5% males, median age of 31 (interquartile range: 18–71) years. Forty-two were on IFX and 13 on ADA. Median IFX serum concentrations [IQR] were higher in patients with closed fistulas (n = 19) compared with patients with actively draining fistulas (n = 23): 7.7 mg/ml [0–32.6] vs. 1.5 mg/ml [0–9.5], respectively (p < 0.001). A similar difference was seen in patients treated with ADA: median serum concentrations were 9.6 mg/ml [6–21.9] in 10 patients with closed fistulas vs. 4 mg/ml [4–4.3] in 3 patients with producing fistulas, p = 0.007. Serum concentrations superior or equal to 4.68 mg/ml for IFX (AUC of 0.87; 95% CI: 0.73–0.96) were associated with fistula closure.

Conclusion

Higher serum levels of anti-TNF drugs were associated with perianal fistula closure. Patients with CD and perianal disease may benefit from intensification of biological therapy.
P737 Ustekinumab induction effectiveness in Crohn’s disease in a real-life cohort
Authors: Sánchez Rodríguez E , Mesonero Gismero F , López sanroman A
Published: January 2020

Background

Evaluation of Ustekinumab induction therapy is generally performed at week 16. Our aim was to evaluate if a delayed response may be expected beyond that time.

Methods

Retrospective study including patients with CD who received Ustekinumab since 1 June 2017 to 1 May 2019. Iv induction dose was based on weight while maintenance was conducted with 90 mg subcutaneous every 8 weeks.

Results

Twenty-five patients (52% male) were enrolled, of whom 28% (7/25) had ileal, 28(7/25) colonic, 44% (11/25) ileocolonic and 8% (2/25) upper tract involvement. Sixty-eight per cent (17/25) presented an inflammatory, 16% (4/25) a stricturing and 16% (4/25) a penetrating behaviour. Perianal disease was diagnosed in 20% of patients (5/25). All patients 100% (25/25) had previously taken immunosuppressants and 96% (24/25) biological therapy (mean 1.8 ± 0.87 (0–3) per patient): 36% (9/25) one, 36% (9/25) two and 24% (6/25) three agents. Ustekinumab was prescribed for achieving remission in 92% (23/25) of the patients, fistulising disease in 4% (1/25) and for maintenance of remission in the same percentage. Follow-up was 373.16 ± 182.53(59–683) days. Discontinuation rate was 24% (6/25), due to primary failure in 100% (6/6). For those who stopped the drug, average treatment time was 137.17 ± 95.11(61–1320) days whereas that of those who continued was 346.84 ± 192.10(32–669) days. Clinical response was evaluated at week 8, week 14–16, week 22–24 and during long-term maintenance (Table 1). All comparisons were statistically significant (p < 0.05). We recorded Harvey-Bradshaw index(H-B), CRP and faecal calprotectin (FC) before induction with ustekinumab, at weeks 14–16, at weeks 22–24 and during maintenance. Results are presented in Table 2.

Conclusion

Evaluation of induction effectiveness at week 22–24 may allow to rescue those patients who present a delayed response to UST. During a 373.16 days follow-up, loss of response to Ustekinumab is low.
P738 Real world outcomes on the efficacy and safety of combination of biologic and immunosuppressive therapy in liver transplant recipients with inflammatory bowel disease
Authors: Chatzinikolaou M L , O’Shea N , Erian G , Koutsoumpas A , Ryan J , Hamilton M , Murray C
Published: January 2020

Background

Following liver transplantation (LT), more than a third of patients with inflammatory bowel disease (IBD) will have an aggressive disease course, requiring treatment with biologics. Data on efficacy and safety of biologics in this setting are limited. We report our experience in IBD patients on biologics following LT.

Methods

Data were collected retrospectively from medical files of patients who underwent LT from 1989 to 2019 in a tertiary referral centre and required IBD treatment with biologics post-LT. Clinical and endoscopic responses, and concomitant corticosteroid requirement were used as a measure of efficacy. Adverse events and infections were recorded.

Results

We identified 10 patients who received treatment with biologics post-LT. The majority were males (n = 7), had a diagnosis of ulcerative colitis (UC) prior to LT (n = 9) and the primary liver disease leading to LT was primary sclerosing cholangitis (PSC). Median time from LT to biologic initiation was 6 years (range 2–17). All patients received tacrolimus as part of anti-rejection therapy, 8 patients were on azathioprine and 2 on mycophenolate mofetil. Two patients had a proctocolectomy prior to LT. The majority (n = 9) were biologic naïve. As a 1st line treatment 7 patients received infliximab (IFX), 1 adalimumab (ADA) and 2 vedolizumab (VDZ). Following allergic reaction to IFX, 2 patients were switched to VDZ. One patient with chronic pouchitis received ADA following IFX failure. Mean duration on IFX in patients on maintenance therapy was 23 months (range 8–33), for ADA 34 months (range 17–50) and for VDZ 12 months (range 6–24). Three patients on IFX (1 with chronic pouchitis) responded to treatment, with one achieving endoscopic remission and another improvement of pouchitis. One patient, despite initial response, treatment escalation and rescue corticosteroids, required colectomy, and so did another after failing both IFX and VDZ. The 2 patients on maintenance ADA showed clinical and endoscopic improvement. Responses to VDZ were mixed; 2 patients improved, but 3 did not respond to VDZ therapy. The infections recorded for patients on IFX (n = 4/7) were cholangitis, Clostridium difficile, TB-related erythema induratum, EBV and CMV colitis, liver and perianal abscesses and Bell’s palsy secondary to CMV/EBV. One patient (n = 1/2) on ADA had a bacterial upper respiratory tract infection, while another on VDZ (n = 1/5) developed pericarditis, corneal ulceration and viral eye infection. No cancers have been detected to date (median follow-up 107 months, range 26–253).

Conclusion

Anti-TNF and VDZ therapy may be effective in the post-LT IBD setting. Caution is warranted regarding infections, particularly for patients on concomitant anti-rejection therapy and IFX.
P743 Time trends of Crohn’s disease in Catalonia from 2011 to 2017. Increasing use of biologics correlates with a reduced need for surgery. A population-based study in Catalonia
Authors: Brunet E , Melcarne L , Vela E , Clèries M , Pontes C , García-Iglesias P , Gallach M , Hernández L , Soria A , Jordi V , Pedregal P , Grau G , Garcia-Sagué B , Frisancho L E , Villòria A , Vergara M , Calvet X
Published: January 2020

Background

Data from clinical trials suggest that biological drugs may improve the outcomes in Crohn’s disease (CD) by reducing the need for surgery or hospitalisation. However, data on the trends in biological drug use and outcomes in CD patients are scarce. The aim of this study is to evaluate the time-trends of the use of biological drugs and other treatments for CD, and its relationship with outcomes such as surgery and hospitalisation in Catalonia.

Methods

All patients with CD included in the Catalan Health Surveillance System (containing data on a population of more than 7.5 million) from 2011 to 2017 were identified. The exposures to different treatments for inflammatory bowel disease were retrieved from electronic invoicing records. Time trends for surgery and hospitalisation were described and tested for correlation with treatment using the statistical package R, version 3.4.3.

Results

Between 2011 and 2017, the use of salicylates, corticosteroids and immunosuppressive treatment fell from 28.8% to 17.1%, 15.8% to 13.7%, and 32.9% to 29.6%, respectively. Biological treatment use rose from 15.0% to 18.7%. Adalimumab was the most frequently prescribed biologic (1604 patients; 52% of all biologics in 2017). Ostomy rates per 1000 patients/year fell from 13.2 in 2011 to 9.8 in 2017, and surgical resection rates from 24.1 to 18.0. The rate of CD-related hospitalisations per 1000 patients/year also fell, from 92.7 to 72.2.

Conclusion

Biological drug use rose from 15.0% to 18.7% between 2011 and 2017. During the same period, we observed an improvement in the outcomes of CD patients.
P751 Prevalence and risk factors of non-alcoholic fatty liver disease in inflammatory bowel diseases
Authors: Hoffmann P , Jung V , Behnisch R , Gauss A
Published: January 2020

Background

Non-alcohol fatty liver disease (NAFLD) is a widespread disease in Europe with a prevalence of 20–30% in the German population. Some studies have revealed even higher prevalence in patients with inflammatory bowel diseases (IBD). The majority of prior studies on this subject are cross-sectional analyses. Longitudinal data for the identification of prognostic parameters are missing.

Methods

This is a monocentric retrospective study encompassing both a cross-sectional and a longitudinal part. The study included 440 patients with Crohn’s disease (CD) and 254 patients with ulcerative colitis (UC). Inclusion criteria were diagnosis of IBD, age >17 years, and having received at least one abdominal ultrasound of the liver at the IBD outpatient clinic of the Heidelberg University Hospital. Exclusion criteria were presence of any infectious liver disease, alcoholic fatty liver disease, or documented abuse of alcohol. NAFLD was defined by echogenicity via ultrasoud and assigned in degrees of severity (no, mild, moderate or severe steatosis). As potential risk factors for the development of NAFLD, demographic characteristics, IBD activity (clinical scores, laboratory results, endoscopic or ultrasound findings), and IBD medications were investigated.

Results

The prevalence of NAFLD was 48% in CD patients and 44% in UC patients. Higher age and body mass index (BMI) were significantly associated with the occurrence of NAFLD. NAFLD was associated with higher Harvey Bradshaw Index in CD patients, while laboratory results, endoscopic or ultrasound findings proving inflammation were not associated with NAFLD. In UC patients, there was no association between disease activity and NAFLD.

The use of steroids, immunomodulators or biologics was not associated with NAFLD, while the use of sulfasalazine was associated with NAFLD only in CD patients.

In the longitudinal part of this study, 2467 hepatic ultrasound results were included. Age and BMI in CD patients and BMI in UC patients were significant risk factors in the mixed logistic regression model. Also, in CD patients, higher HBI, former bowel resections, endoscopic disease activity and use of azathioprine–not of steroids–were risk factors of NAFLD. In UC patients, endoscopic disease activity was significantly associated with NAFLD in the mixed logistic regression model.

Conclusion

There is a high prevalence of NAFLD in German IBD patients. The risk to develop NAFLD increases in older patients and patients with higher BMI. Disease activity and azathioprine use in CD may increase the prevalence of NAFLD. Our study provides a rationale for regular ultrasound screening of the liver in IBD patients.
P754 Inflammatory bowel disease-like disease in patients with primary immunodeficiencies with chronic digestive symptoms: Diagnostic yield of colonoscopy
Authors: SANCHEZ M B , Cepeda J , Etchevers M J , Sobrero M J , Gonzalez Sueyro R , Arguero M J , De Paula J A , Marcolongo M M
Published: January 2020

Background

Primary immunodeficiencies (PIDs) are a heterogeneous group of diseases characterised by genetic defects in the immune system. The respiratory and gastrointestinal tracts are the most affected. Digestive involvement may be due to infections, immune-mediation or malignancy. Immune-mediated involvement is expressed clinically and endoscopically like an inflammatory bowel disease (IBD-like disease). The objective of this study was to describe the endoscopic and histological findings in patients with PID and chronic digestive symptoms studied by colonoscopy with a final diagnosis of IBD-like disease.

Methods

Between 2004 and 2017 we included 30 patients with PID, chronic digestive manifestations and at least one colonoscopy with negative stool microbiological studies.

Results

Of the patients included, 19 (63%) were women. The median age was 62 years (IQR 49–74). Seven (23%) presented selective IgA deficiency, 11 (37%) common variable immunodeficiency (CVID) and 12 (40%) hypogammaglobulinemia. The digestive symptoms reported were chronic diarrhea (73%), abdominal pain (73%) and weight loss (36%). Ten patients (33.3%) had IBD associated, 5 had a pattern of ulcerative colitis (UC), 3 of Crohn’s disease (CD) and 2 of non-classifiable IBD (NCIBD). Diarrhoea was the most common manifestation in those with IBD-like disease (100%). The most frequent-related PID was CVID (54%). Of the 5 UC-like patients, 4 were extensive and 1 proctitis; the 3 CD-like patients presented ileocolic location. Of the 10 patients with IBD-like disease colonoscopy showed: oedema (40%), loss of vascular pattern (40%), erosions (30%), ulcers (40%), pseudopolyps (10%) and 50% did not present endoscopic findings at the time of the study. Histological features were chronic inflammation (100%), cryptitis-pericryptitis-microabscesses (60%) and granulomas (10%). Additionally, we found the presence of apoptotic cells (40%) and absence of plasmocytes in the lamina propria (40%). Upper endoscopy was performed concomitantly in 24 patients, in 17% we found at duodenum nodularity and scalloping. Duodenal biopsies were taken in 15 patients and the histological features were: increased intraepithelial lymphocytes (40%), crypt hyperplasia (20%), atrophic mucosa (6.6%).

Conclusion

One third of patients with PID and chronic digestive symptoms who performed a colonoscopy presented IBD-like disease. CVID was the most associated PID with IBD-like disease. Half of the patients had no colonoscopic findings, so taking random biopsies is suggested. Histological findings were typical of IBD, being the presence of apoptotic bodies and the absence of plasma cells distinctive of the associated PID.
P757 Focusing on the future: Reducing barriers and improving access to inflammatory bowel disease specialty care across Canada
Authors: Heisler C G , Mirza R , Kits O , Zelinsky S , Veldhuyzen van Zanten S , Nguyen G , McCurdy J , MacMillan M , Lakatos P L , Targownik L , Fowler S , Rioux K , Jones J
Published: January 2020

Background

Inflammatory Bowel Disease (IBD) is a chronic immune-mediated disease which affects nearly two million North Americans, with Canada demonstrating the highest age-adjusted incidence and prevalence rates globally. Resulting from compounding prevalence and limited resources, timely access to IBD care continues to be a widespread issue for patients and healthcare providers. Despite this pervasive issue, there has been no published research to date elucidating the patient perspective using qualitative approaches to compare and contrast the patient experience across Canada. The aim of the study was to elicit a qualitative stream of data to better understand phenomena related to access to IBD care from a patient-centered perspective.

Methods

Patients diagnosed with IBD (≥18 years of age) were recruited from gastroenterology clinics and communities through IBD specialists and Crohn’s & Colitis Canada. To ensure geographic diversity and representation, patients were recruited from both urban and rural regions. In order to acquire multiple access perspectives, patients were invited to bring a family member involved in their care to the focus groups. Co-facilitated by a researcher and patient-research partner, all focus groups were audio recorded, transcribed verbatim, and coded for themes. Themes were distilled through qualitative thematic analysis using Atlas.ti software to ascertain congruence or discordance of patient experiences in relation to IBD care access.

Results

Sixty-three participants were recruited in 14 focus groups across seven provinces. The majority of participants were female (41/63, 65%) and from urban/suburban regions (34/63, 54%). The mean age of participants was 48 years (SD=16 years, range=16 to 77 years). Thematic analyses identified four main barrier themes, each with multiple sub-themes: (1) structure/system issues (i.e. system stagnation), (2) processes (i.e. information management), (3) experiences (i.e. psychosocial support), and (4) patient as partner (i.e. autonomy, power dynamics). In response, four solution themes were proposed: (1) integration of holistic care into the clinical practice, (2) readily accessible psychosocial and nutritional support, (3) increased patient advocacy, and (4) continuity and liaison through provision of a healthcare navigator resource.

Conclusion

The complexity of IBD specialty care access cannot be underestimated. It is vital to possess a robust understanding of healthcare system structures, processes, and the significant impact these factors have on patients and the care received. Through the use of patient-centered exploration of barriers and facilitators, access to IBD specialty care in can be better understood and improved on both a national and international scale.
P761 Illness cognition of Saudi patients with Crohn’s disease
Authors: Mosli M H A , Saeedi A , ALNEFAIE M , Bawahab N , Abdu L , Shobai S
Published: January 2020

Background

The prevalence of Crohn’s disease (CD) has markedly increased in Saudi Arabia over the past 3 decades.Patients’ awareness of the chronic recurrent course and potential risk of disease complications can lead to a wide range of psychological and interpersonal concerns. Patients’ cognition about the disease and treatment are important mediators as they explain the occurrence of individual differences in the individuals’ adjustment to chronic diseases. The aim of this study is to assess illness cognition of Saudi patients diagnosed with CD and to identify clinical predictors.

Methods

Consecutive patients with confirmed CD seen in the adult outpatient gastroenterology clinic at King Abdulaziz university hospital were recruited between January and December of 2019. Data was collected from interviews conducted with the patients and from the hospitals’ electronic medical records.The primary endpoint of the study was patients’ illness cognition according to the illness cognition questionnaire (ICQ), which can be used to assess three cognitive functions that patients attribute to disease: helplessness (6 items), acceptance (6 items), and perceived benefits (6 items). Each item is scored from 1 to 4, with 1 corresponding to ‘Not’, and 4 corresponding to ‘Totally. Descriptive statistics were used to summarise patient characteristics and linear regression analysis was used to identify predictors of the ICQ score.

Results

A total of 88 patients were surveyed, of which 55.8% were females, 18% were smokers and 11.5% had undergone CD-related surgery. The mean age was 26.9 ± 7.7 years and the mean duration of disease was 54.7 ± 60.5 months. Perianal disease was reported by 16.1% of the cohort. Twenty eight percent of patients reported that they ‘completely’ missed things that they like to do the most because of their illness and 35% responded by ‘not at all’ when asked if they had learned to live with their disease. Forty one percent of patients reported that the illness ‘completely’ controls their life and 30% responded by ‘not at all’ when asked if they can accept their illness. Mean ICQ score was 44.3 ( ± 6.6). On linear regression analysis, duration of the disease in months (coef = −0.04, p = 0.008) and fatigue (coef = −1.40, p = 0.04) were predictive of the ICQ score.

Conclusion

A considerable proportion of Saudi patients diagnosed with CD report negative perception of their disease. Duration of illness and presence of fatigue appear to be predictive of the ICQ score.
P764 Phenotypic analysis of patients with inflammatory bowel disease: 23 year data of a centre in a South American country
Authors: Páez Cancelado C C , García Duperly R , Park J , López Panqueva R , Londoño Schimmer E E , Rey Rubiano A M , Padrón Mercado J E , Mejía Arango M , Gómez Aldana A , Vallejo Madroñero R J , Mendoza De Molano B
Published: January 2020

Background

Inflammatory Bowel Disease (IBD) includes Ulcerative Colitis (UC) and Crohn Disease (CD). In the last decade, there have been introduced therapeutic changes that have revolutionised the pharmacologic and surgical management of patients with IBD. The incidence of UC and CD has been increasing in Latin America but the exact prevalence is unknown. Our objective is to describe the demographic characteristics, clinical and therapeutic aspects of the IBD in patients that have presented in the University Hospital Fundación Santa Fe de Bogotá (UH-FSFB), Colombia.

Methods

Retrospective Descriptive Cohort Study. Clinical histories, pathology reports, and endoscopic results from data base HI-ISIS of the UH-FSFB and medical data between January 1996 and February 2019 were recollected, stored in Excel and analysed using IBM SPSS Statistics Visor. Patients with diagnosis of IBD were included. Patients with incomplete clinical histories were excluded.

Results

From 398 patients included in this study, 72.1% had UC, 25.6% CD and 2.3% Indeterminate Colitis. The average age of diagnosis was 43.54 years (range: 12–91). In both patients with UC and CD there were smaller proportions of men than women (0.9:1 for UC and 0.7:1 for CD).

Of the patients with UC, 46.3% had been hospitalised. 37.2% presented with proctitis, 23.8% left colitis and 39% with pancolitis. 13.5% had an asymptomatic clinical disease, 22.4% mild, 15.3% moderate, and 48.8% severe. 12.9% received biological therapy (BT). 24.3% of patients received a second line BT. Fifteen per cent required surgical interventions (SI), of which there were no mortalities. 27% who were receiving BT required SI.

Of the patients with CD, 82.4% required hospitalisation. 43.1% had an ileal, 9.8% colonic, 39.2% ileal- colonic, 0% isolated upper digestive and 21.6% perianal compromise. 34.3% had non-stenosing behaviour, 49% stenosing and 16.7% penetrating. 44.1% of patients with CD received BT of which 40% required a second line BT. 55.9% required SI, of which 1 mortality was reported. 71.1% who were receiving BT required a SI.

Conclusion

Our study contributes to the epidemiology and integral management required by patients with IBD in our environment. More studies are recommended that replicate our methodology in the population with IBD in both Colombia and Latin America.
P772 Trends and risk factors of elderly-onset Crohn’s disease: A nationwide cohort study in South Korea
Authors: Moon J M , Kang E A , Han K , Hong S W , Soh H , Park S , Lee J , Lee H J , Im J P , Kim J S
Published: January 2020

Background

The incidence of inflammatory bowel disease (IBD) is increasing in Asia. Numerous risk factors associated with IBD development have been investigated. This study aimed to demonstrate the risk factors of Crohn’s disease (CD) diagnosed in persons aged >40 years in South Korea and to specify any differences between age groups by using the National Health Insurance Service (NHIS) database.

Methods

Using the National Health Insurance Service (NHIS) database, a total of 14,060,821 persons aged >40 years who underwent national health screening in 2009 were followed up until December 2017. Patients with newly diagnosed CD were enrolled and compared with non-CD cohort. CD was identified according to the International Classification of Diseases 10th revision and the rare/intractable disease registration programme codes from the NHIS database. The mean follow-up periods were 7.39 years. Age and sex were adjusted for in the multivariate analysis model.

Results

During the follow-up, 1337 (1.33/100,000) patients developed CD. Men in the middle-aged group (40–64 years) had a higher risk than women (adjusted HR [aHR] 1.46, 95% CI 1.29–1.66); however, this difference tended to disappear as the age of onset increases. In the middle-aged group, patients with a history of smoking (adjusted hazard ratio [aHR] 1.29, 95% confidence interval [CI] 1.06–1.58) and anemia (aHR 1.99, 95% CI 1.67–2.36) had a significantly higher CD risk. In the elderly group (age, ³65 years), ex-smoking and anemia also increased the CD risk (aHR 1.58 [95% CI 1.16–2.18] and 1.91 [95% CI 1.53–2.38], respectively). Especially in the middle-aged group, those with chronic kidney disease (CKD) had a statistically elevated CD risk (aHR 1.38, 95% CI 1.06–1.79). Alcohol consumption and higher body mass index showed negative association trend with CD incidence in both of the age groups. (Middle-aged: aHR 0.76 [95%CI 0.65–0.87] and aHR 0.38 [95%CI 0.27–0.53], respectively) (elderly-group: aHR 0.57 [95%CI 0.42–0.77] and aHR 0.52 [95%CI 0.32-.83], respectively) For regular physical activity and dyslipidemia, negative correlation between CD incidences was proved only in the middle-aged group (aHR 0.85 [95%CI 0.74–0.96] and aHR 0. [95%CI 0.75 [95% CI 0.63–0.89], respectively).

Conclusion

This study demonstrated four risk factors (ex-smoking, anemia, CKD, and lower BMI) and three possible protective factors (alcohol consumption, physical activity, and dyslipidemia) for CD in Asians age >40 years. Individuals with potential risk factors need more cautious monitoring for CD.
P775 Evolution of inflammatory bowel disease research from a bird’s eye perspective: A text-mining analysis of publication trends and topics
Authors: Barash Y , Klan E , Tau N , Ben-Horin S , Levartovsky A , Arebi N , Soffer S , Kopylov U
Published: January 2020

Background

There is an extensive and growing research effort in the field of inflammatory bowel diseases (IBD), with varying topics over the years. A comprehensive analysis of the trends in research and publications in IBD may help us grasp the gaps in knowledge and map out potential future areas of interest. Text-mining is the extraction of information from free text using computational methods. It can be applied to identify trends in a research field. The aim of our study was to create a map of IBD research of the last 25 years using text-mining techniques

Methods

We retrieved all available MEDLINE/PubMed annual datasets from 1992 to the end of 2017. We selected a set of relevant keywords from MeSH to include all papers relating to inflammatory bowel disease, Crohn’s disease and Ulcerative colitis. For each article we extracted the following data: article ID, title, journal, date of publication, abstract text, article type, keywords, citation frequency, and first author name and affiliation (from which we extracted the country of origin). We categorised the articles screening topics by using word combination and title match technique. We also scanned the topics in list of 100 papers (grouped by 5-year periods starting with 1992–1997) with the highest citation factor, i.e., the articles with the most citations from publish up to 2018.

Results

Between the years 1992 and 2017, 20,014 IBD-related publications appeared on PubMed. The annual number of publications increased almost 4-fold (from 354 in 1992 to 1361 in 2017). The USA had the highest number of papers (n = 3427/20,014, 17%) while Denmark and Israel had the highest rate of publications per population (for 2012–2017, 12 publications per 1 million in Israel and 17 in Denmark). The countries that achieved the most significant growth in publication rates were China, Egypt, Romania with growth rates of 0.0069, 0.0068 and 0.0062 respectively defined as the increase in articles per year normalised by the total amount of articles from that country. Out of 20014 papers, 5590 were successfully classified into 14 major topics. The topics that attracted the most publications over the years were medical therapeutics 1808/20014 (9% of articles from 1992 to 2017), followed by surgical treatment 1111/20014 (5.5%), endoscopy 637/20014 (3.2%) and genetics 552/20014 (2.7%), remaining stable through the study period.

Conclusion

There is a steady growth in the number of IBD-related publications. Although US is a world leader in the number of IBD publications overall, Denmark and Israel publish the most in relation to population size, while China, Romania and Egypt display the highest growth rate in the number of publications. Medical therapeutics is the most popular and best-cited topic.