bluuebunny/crossref_metadata_2025_split huggingface dataset:
DOP44 Cancer risk in a high-incidence inflammatory bowel disease population: a Faroese IBD cohort study
Authors: Midjord J M M , Vang A G , Hammer T , Burisch J , Nielsen K R 
Published: January 2020

Abstract

Background
The association between inflammatory bowel disease and malignancy is still controversial despite many observational studies. The Faroese population exhibits the highest occurrence of inflammatory bowel disease (IBD) in the world. The aim of this study was to investigate the risk of cancer in Faroese IBD patients within the nationwide Faroese IBD cohort.

Methods
This was a nationwide cohort study of all IBD patients diagnosed in the Faroe Islands from 1960 to 2014. Clinical demographics and cancer diagnosis were retrieved from patient files and from the Faroese cancer registry. Patients were followed until the event of cancer, death or emigration. Patients diagnosed with cancer prior to the IBD diagnosis were excluded. Observed numbers of cancer were compared with expected numbers based on ASR(N) (Nordic age- and sex-specific incidence rates) from Nordcan, by multiplying ASR(N) with person-years and follow-up in the study cohort and presented as standardised incidence ratios (SIRs) with 95 % intervals (CIs).

Results
The cohort consisted of 664 incidence IBD patients. After excluding 12 patients with cancer prior to IBD diagnosis, 652 patients with a total follow-up length of 11 476 person-years were included (414 UC with 7.494 patient-years, 128 IBDU with 2.038 patient-years and 110 CD with 1.944 patient-years). A total of 56 patients developed cancer during the follow-up period compared with 39.2 expected cases in the background population. We observed no gender difference. In UC, 33 observed compared with 25.7 expected patients developed cancer (SIR 1.28; 95% CI, 0.88–1.80). In IBDU, 13 observed compared with 6.9 expected patients developed cancer (SIR 1.88; 95% CI 1.00–0.22). In CD, 10 cases were observed compared with 6.6 expected (SIR 1.51; 95% CI 0.73–2.79). The most common types of cancers observed are shown in Table 1.

Conclusion
In this nationwide cohort study, we found no overall risk of cancer in IBD patients in the geographic isolated Faroe Island. However, skin cancer occurred more than expected in IBDU patients. This finding needs to be investigated further including the influence of treatment on cancer risk.
DOP47 The changing pattern of inflammatory bowel disease incidence in Northern France: A continuing increase in the young women (1988–2014)
Authors: CRETIN T , Sarter H , Savoye G , Fumery M , Leroyer A , Dauchet L , Pariente B , Gower-Rousseau C 
Published: January 2020

Abstract

Background
In industrialised countries, inflammatory bowel disease (IBD) incidence rates appear to have stabilised in adults but not in children. The objective was to describe changes in the incidence and phenotype of adult-onset IBD in northern France over a 27-year period.

Methods
We included all patients aged 17 or over at IBD diagnosis, recorded in the EPIMAD population-based registry between 1988 and 2014. Standardised incidence rates for Crohn’s disease (CD) and for ulcerative colitis (UC) were calculated in the population as a whole and by age and sex. Patients were divided into three age groups: 17–39, 40–59, and 60 and over. Disease locations were defined according to the Montreal classification.

Results
17,686 incident adult-onset IBD cases were recorded, including 10,206 cases of CD (58%), 6,839 cases of UC (38%) and 641 cases of IBD unclassified (IBDU; 4%). The mean [95% CI] annual incidences of adult-onset IBD, CD, UC, and IBDU were 13.5 per 105 [13.3–13.7], 7.5 per 105 [7.4–7.7], 5.4 per 105 [5.3–5.6] and 0.51 per 105 [0.47–0.55] respectively. The median [IQR] age at diagnosis was lower in CD (28 [22–40]) than in UC (36 [27–49]) (p &lt; 0.0001). The median [IQR] age at diagnosis was lower in women than in men: 28 [21–39] vs. 29 [22–40] in CD (p &lt; 0.0001), and 33 [26–45] vs. 39 [28–51] (p &lt; 0.0001) in UC. The incidence of IBD rose from 11.5 per 105 in 1988–1990 to 12.9 per 105 in 2012–2014 (p = 0.053). The incidence of CD steadily increased from 5.5 to 7.9 per 105 (average percent change per year [APC] +1%; [0.5;1.4]; p &lt; 0.0001), whilst that of UC was stable at 5.0 per 105. The largest increase was seen in young women: APC of +2.0% per year for CD (p &lt; 0.0001) and +1.7% per year for UC (p &lt; 0.0001) in the 17–39 age group, and APC of +1.1% per year for both disease (p = 0.019 for CD and p = 0.024 for UC) in the 40–59 age group. The sex ratio did not vary for CD but changed from 0.70 in 1988–1990 to 1.10 in 2012–2014 for UC (p = 0.001). Among CD patients having undergone a full assessment of the ileum and colon, ileal locations increased from 19% to 26% for L1 (p &lt; 0.0001) and from 50% to 58% for L3 (p &lt; 0.0001), while L2 locations decreased from 31% to 16% (p &lt; 0.0001). In the UC group, the proportion of patients with E1 location decreased from 42% to 34%, whereas the proportion with E3 location increased from 19% to 28% (p &lt; 0.0001).

Conclusion
In a large, population-based study over a period of 27 years, we found that the incidences of CD and UC in the young women in northern France are still rising quickly. Our present results suggest that one or more environmental factors may significantly predispose women to IBD in our region. Among patients with CD, we observed an increase in ileal involvement and a concomitant decrease in colonic involvement.
DOP56 Ustekinumab maintained clinically meaningful improvement in health-related quality of life in patients with moderate to severe ulcerative colitis: Results from the UNIFI long-term extension
Authors: Sandborn W J , Rowbotham D S , Leong R W L , Han C , Zhou Y , Zhang H , Johanns J , Marano C , Danese S 
Published: January 2020

Abstract

Background
The UNIFI maintenance study evaluated the safety and efficacy of subcutaneous (SC) ustekinumab (UST) in patients with moderately–severely active UC who had responded to IV UST induction. Previously, we reported that health-related quality of life (HRQoL) improvements achieved after UST induction were maintained through Week 44 with UST maintenance. Here, we evaluated HRQoL through Week 92 in patients who continued UST maintenance in the long-term extension (LTE).

Methods
Patients who completed the maintenance study were eligible to continue their maintenance treatment regimen (placebo [PBO], UST90mg q12w, or UST90mg q8w) in the LTE if the investigator thought they could benefit from continued treatment. PBO patients discontinued from the LTE after the maintenance study was unblinded. Per investigator discretion, patients could receive a single dose adjustment (UST q12w to q8w or UST q8w to q8w [sham dose adjustment]) starting at Week 56. The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item questionnaire with a total score ranging from 32 to 224. Higher scores indicate better HRQoL, a score ≥170 indicates remission, and a change ≥16 was defined as clinically meaningful. General health was assessed using SF-36. A change ≥5 points in physical and mental component scores was defined as clinically meaningful. In this analysis, patients who dose adjusted were considered treatment failures.

Results
Most patients who received UST in the LTE maintained the improvements in IBDQ and SF-36 that were achieved after induction (Tables 1 and 2) through Week 92. Overall, 158 of 284 patients (55.6%) who received UST were in IBDQ remission at Week 92, and 114 of 169 patients (67.5%) who were in IBDQ remission at maintenance baseline were in IBDQ remission at Week 92. Of the 284 patients, 179 (63.0%) achieved a ≥16-point improvement in IBDQ score from induction baseline to Week 92. Of 250 patients who achieved a ≥16-point improvement from induction baseline to maintenance baseline, 154(61.6%) maintained a ≥16-point improvement at both Weeks 44 and 92. For SF-36, 142 of 284 patients (50.0%) had a ≥5-point improvement from induction baseline to Week 92 in the physical component score, while 128 of 284 (45.1%) had a ≥5-point improvement in the mental component score.

Conclusion
The majority of patients who were treated with UST in the LTE generally maintained improvements in IBDQ and SF-36 scores that were achieved after IV induction.
DOP58 Tofacitinib for ulcerative colitis: Results of the ICC Registry, a nationwide prospective observational cohort study
Authors: Biemans V B , Sleutjes J A M , de Vries A C , Bodelier A G , Dijkstra G , Oldenburg B , Löwenberg M , van Bodegraven A A , van der Meulen-de Jong A E , de Boer N K , Srivastava N , West R L , Römkens T , Horjus Talabur Horje C S , Jansen J M , Hoekstra J , Weersma R K , van Schaik F D , Hoentjen F , Pierik M J 
Published: January 2020

Abstract

Background
Tofacitinib is a janus kinase 1 and 3 inhibitor approved for the treatment of ulcerative colitis (UC). Real-world evidence is needed to evaluate the effectiveness, usage and safety in daily practice.

Methods
UC patients in whom tofacitinib was started in 15 hospitals (8 academic, 7 non-academic) participated in the ICC Registry: a Dutch prospective, observational registry. Visits were planned at baseline, Week 12, and 24. Patients with both clinical (Short Clinical Colitis Activity Index (SCCAI) &gt;2) and objective disease activity (endoscopy (Mayo &gt;0), C-reactive protein (CRP) &gt;5 mg/l or faecal calprotectin (FCP) &gt;250 µg/g) were included. In this study, corticosteroid-free clinical remission (SCCAI ≤2), biochemical remission (FCP ≤250 µg/g), combined corticosteroid-free clinical and biochemical remission, predictors of remission, safety outcomes, dose optimisation, and effect on lipids were determined at Week 24. Only patients from centres with routine endoscopic follow-up (regardless of symptoms) were analysed to determine endoscopic remission (Mayo = 0) at Week 12. All analyses were done on an intention-to-treat basis.

Results
In total, 111 UC patients (95% anti-TNF, 60% vedolizumab, 4% ustekinumab exposed) were followed for a median of 24 weeks (IQR 12–26). All patients had both active clinical and objective disease (SCCAI 8 (IQR 5–11), FCP 1800µg/g (IQR 633–2682)). Corticosteroid-free clinical, biochemical, and combined corticosteroid-free clinical and biochemical remission rate at week 24 was 29%, 25%, and 19%, respectively. Endoscopic remission was achieved in 21% of patients (n = 33) at Week 12. Prior vedolizumab exposure was associated with a lower remission rate at week 24 (OR 0.33, 95% CI 0.11–0.94) in multivariable analysis. In total, 36 patients (88 per 100 patient-years) experienced tofacitinib-related adverse events (most common: cutaneous lesions and headache) of which 6 patients (18 per 100 patient-years) discontinued treatment. No thromboembolic events were reported. We observed 4 cases of herpes zoster re-activation but no severe infections (requiring hospitalisation). During follow-up 14 hospitalisations and 5 (4.5%) colectomies were performed. Cholesterol, HDL, and LDL increased between baseline and week 12 (18% (95% CI 9–26, n = 35), 18% (95% CI 8–28, n = 35) and 27% (95% CI 14–39, n = 35), respectively). At week 24, 33% of patients used 10 mg twice daily.

Conclusion
Tofacitinib is an effective treatment for UC after anti-TNF and/or vedolizumab failure. We did observe a relatively high rate of adverse events in this refractory UC cohort.
DOP59 Maintenance of remission with tofacitinib in patients with ulcerative colitis: Updated results of a subpopulation analysis from an open-label, long-term extension study, OCTAVE Open
Authors: Colombel J F , Osterman M T , Ibanez P , Thorpe A J , Zhang H , Lawendy N , Su C , Reinisch W 
Published: January 2020

Abstract

Background
Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Efficacy and safety were demonstrated in 3 Phase 3, randomised, placebo-controlled studies in patients with moderate to severe UC.1 An ongoing, Phase 3, open-label, long-term extension (OLE) study (OCTAVE Open, NCT01470612) included patients from OCTAVE Induction 1 and 2 and OCTAVE Sustain.

Methods
We present data (as of May 2019) from the ‘maintenance remission’ subpopulation in the OLE study who were in remission (total Mayo score ≤2, no individual subscore &gt;1, rectal bleeding subscore of 0) at Week 52 of OCTAVE Sustain (having received tofacitinib 5 or 10 mg twice daily [BID]). These patients received tofacitinib 5 mg BID as per protocol in the OLE study. Efficacy data up to Month 36 of the OLE study (as observed and with non-responder and last observation carried forward imputation [NRI-LOCF]) are presented for this subpopulation. Safety data are reported for all patients who received tofacitinib 5 mg BID in the OLE study.

Results
Of 944 patients receiving ≥1 dose of tofacitinib in the OLE study, 163 were in remission at Week 52 of OCTAVE Sustain (mean age 45 years; 46.0% female). Of these, 66 (40.5%) and 76 (46.6%) received tofacitinib 5 and 10 mg BID, respectively, in OCTAVE Sustain, and 21 (12.9%) received a placebo. In total, 67/163 (41.1%) patients discontinued the OLE study, 16 (9.8%) due to adverse events (AEs) excl. worsening UC and 15 (9.2%) due to insufficient clinical response. Among patients that continued, efficacy (Table) was maintained over 36 months and was similar irrespective of the dose received in OCTAVE Sustain. Of 175 patients who received tofacitinib 5 mg BID (incl. 163 from the maintenance remission subpopulation), 152 (86.9%), 33 (18.9%) and 20 (11.4%) had AEs, serious AEs and severe AEs, respectively. The most frequent treatment-emergent AEs (TEAEs) were worsening UC (41 patients, 23.4%) and nasopharyngitis (38 patients, 21.7%). Six (3.4%) patients receiving tofacitinib 5 mg BID had serious infections, 11 (6.3%) had herpes zoster (non-serious and serious), 4 (2.3%) had opportunistic infections, 2 (1.1%) had major adverse cardiovascular events and 5 (2.9%) had malignancy (excl. non-melanoma skin cancer). No deep vein thrombosis, pulmonary embolism or deaths were reported in patients receiving tofacitinib 5 mg BID.

Conclusion
Most patients in remission at Week 52 of OCTAVE Sustain maintained efficacy with tofacitinib 5 mg BID over 36 months in the OLE study. Similar efficacy was observed for patients whose dose was reduced from tofacitinib 10 mg BID in OCTAVE Sustain to 5 mg BID in the OLE study, vs. those who received 5 mg BID throughout both OCTAVE Sustain and the OLE study. No new safety risks were identified.

Reference
N23 Concerns of patients with inflammatory bowel disease in the process of disease management
Authors: Mohsenizadeh S M , Manzari Z S , vosoghinia H , Ebrahimipour H 
Published: January 2020

Abstract

Background
Inflammatory bowel diseases (IBD) are among the most common disorders that cause poor quality of life and impose a lot of social and economic burden on patients and their family. Therefore, identifying the main concerns of these patients in the management of the disease is very important for designing a specific care plan. The aim of this study was to explaining the concerns of patients with IBD in the process of disease management.

Methods
This research was carried out using thematic analysis method. Sixteen patients with at least one year of IBD were interviewed individually by semi-structural questions. Their main concerns in the management of the disease were analysed.

Results
The main concerns of patients with IBD were categorised into four main groups as follows: mental (negative attitude toward disease, encounter with disease, tolerance of tough condition, maladaptation, acceptance and denial of disease), behavioural (avoidance of situations, out-of-home planning, physical activity, diet, seeking information, seeking the best treatment), socioeconomic (weak support, high cost of treatment, confidentiality of the disease), and biomedical (supplying medicine and experiencing surgery). These concerns have a substantial impact on patients’ ability regarding the reconciliation of their living with disease.

Conclusion
By identifying the concerns of patients with IBD in their disease management process, nurses can develop care programmes and interventions to meet the essential needs of these patients.
N27 What people want! Exploring inflammatory bowel disease patients’ perspectives on healthcare professionals addressing sexual well-being
Authors: Fourie S , Czuber-Dochan W , Norton C 
Published: January 2020

Abstract

Background
Inflammatory bowel disease (IBD) affects every aspect of one’s life, yet no routine assessment for the impact on sexuality is made. Our aim was to explore patients’ perspective on healthcare professionals (HCPs) addressing sexuality/sexual well-being concerns.

Methods
This was a qualitative narrative study. Inclusion criteria were any sexual orientation and with known IBD for longer than 18 months. Data were collected via semi structured interviews and anonymous narrative accounts submitted via Google Forms. Thematic analysis was used to analyse the data.

Results
Fourteen adults, 4 male and 10 female, took part. Eleven participants were from the UK, one from the USA of America and one for South Africa. The following main themes and subthemes were identified: I cannot imagine talking about my sex life (a difficult topic; there is not enough time), Those who talked about sex, talked badly (nobody volunteered information; badly handled conversations), Still living whilst unwell (sex is an important part of my life; sex issues break down relationships, medicalised body), IBD ruined my sex life (feeling unattractive; feelings of shame and embarrassment), I feel unheard (HCPs don’t open the discussion; sex not taken seriously), I’m a person, not my IBD (holistic approach to care; time, space and ways to talk about sex). The findings reflect the importance of sexual well-being to those living with IBD, the experiences of such conversations, barriers to conversations with HCPs on sexual well-being, and suggestions on how HCPs should address their unmet needs. The importance of discussing intimacy and sexuality was emphasised, as participants felt their sexual well-being was considerably affected by IBD. The majority reported that HCPs did not initiate discussions on sexual well-being, nor did they understand the impact of IBD on sexual well-being, with a distinct accent on the perceived lack of a holistic approach to their care. Therefore, participants made suggestions for practice, such as provision of information related to sexual well-being in the form of leaflets, additionally to HCPs raising the issue.

Conclusion
Our findings indicate that communicating on sexuality/sexual well-being is a problematic area of IBD care. HCPs must be cognisant of the sexual well-being concerns and needs of those living with IBD, who want this topic discussed routinely, as part of a holistic approach to their clinical care.
DOP71 Efficacy, safety, and tolerability of ustekinumab in paediatric patients with moderately to severely active Crohn’s disease: Results from, UniStar, a phase 1 study
Authors: Rosh J , Turner D , Griffiths A , Jacobstein D , Adedokun O , Padgett L , Terry N , O’Brien C , Hyams J 
Published: January 2020

Abstract

Background
Ustekinumab (UST) is approved for the treatment of adults with moderate to severe Crohn’s disease (CD). The objective of this study was to evaluate the pharmacokinetics (PK), safety, and efficacy of UST in paediatric patients with moderately to severely active CD who had failed treatment with corticosteroids (CS) and/or immunomodulators (IM) and/or anti-tumour necrosis factor (TNF) therapies. Here, we report the safety and efficacy results through Week 16; PK results are reported separately.

Methods
This was a Phase 1, multicentre, 16-week, double-blind induction dose-ranging study (NCT02968108) in patients aged 2 to &lt;18 years (body weight [BW] ≥10 kg) with a Paediatric CD Activity Index (PCDAI) score &gt;30 and at least an abnormal C-reactive protein &gt;3.0 mg/l or faecal calprotectin &gt;250 µg/g), or ulcerations in the ileum or colon upon ileocolonoscopy despite adequate treatment with CS ± IM ± anti-TNF therapy. Patients were randomised (1:1) and stratified by weight and prior anti-TNF use for induction to one of 2 weight range-based intravenous (IV) doses: 130mg vs. 390 mg if BW ≥40 kg and 3 mg/kg vs. 9 mg/kg if BW &lt;40 kg. At week 8, all patients received a single subcutaneous (SC) UST maintenance dose of 90mg if BW ≥40 kg or 2 mg/kg if BW &lt;40 kg.

Results
Forty-four patients (59% ≥40kg BW; &gt;90% anti-TNF exposed) were randomised (n = 23 lower dose; n = 21 higher dose) and treated with UST. Baseline characteristics are summarised in Table 1. At week 16, in the lower dose and higher dose groups, 52%/52% achieved clinical response (reduction in PCDAI ≥15) and 22%/29% had clinical remission (PCDAI ≤10), respectively (Table 2). In addition, 32% and 28% of patients showed endoscopic response (reduction in Simple Endoscopic Score for CD of ≥50%), respectively. Through week 16, 73% of patients reported ≥1 adverse event (AE; 82.6% lower dose vs. 62% higher dose); 2 discontinued due to AEs (1 in each group). Serious AEs occurred in 16% of patients (26% lower dose and 5% higher dose, with CD exacerbation being the most frequent (13%/5%, respectively). Infections occurred in 41% of patients (1 was serious, which was intestinal abscess that spontaneously resolved with sequelae). No injection site reactions, opportunistic infections, malignancies, or deaths were reported. No antibodies to UST were observed.

Conclusion
As early as 3 weeks and through 16 weeks, both the lower and higher doses of UST (IV week 0 and SC at week 8) improved clinical and endoscopic disease activity in this previously treatment-refractory group of children with CD. The safety profile was consistent with that for UST in adults with CD.