bluuebunny/crossref_metadata_2025_split huggingface dataset:
DOP61 Tofacitinib, an oral, small-molecule Janus kinase inhibitor, in the treatment of ulcerative colitis: Analysis of an open-label, long-term extension study with up to 5.9 years of treatment
Authors: Lichtenstein G R , Loftus E V , Wei S C , Damião A O , Judd D , Lawendy N , Chan G , Zhang H , Wang W , Thorpe A J , Bloom S 
Published: January 2020

Abstract

Background
Tofacitinib is an oral, small-molecule JAK inhibitor for the treatment of ulcerative colitis (UC). Efficacy and safety of tofacitinib were demonstrated in patients with moderate to severe UC in 3 Phase 3 studies.1 Here, we present data from an ongoing, open-label, long-term extension (OLE) study.2

Methods
We present updated safety and efficacy data from the OLE study (OCTAVE Open, NCT01470612; as of May 2019, database not locked). Eligible patients included non-responders (Week 8 data) in OCTAVE Induction 1 and 2 (NCT01465763; NCT01458951) and completers (Week 52 data) or treatment failures (early-termination data) in OCTAVE Sustain (NCT01458574). Patients in remission (total Mayo score ≤2, no individual subscore &gt;1, rectal bleeding [RB] subscore 0) at Week 52 of OCTAVE Sustain (central read) received tofacitinib 5 mg twice daily (BID); all others received 10 mg BID. Induction non-responders without clinical response (≥3-point and ≥30% decrease from induction study baseline total Mayo score, plus ≥1-point RB subscore decrease or absolute RB subscore ≤1) at Month 2 of the OLE study were withdrawn. Incidence rates (IRs) for adverse events (AEs) of special interest were calculated (no. of unique patients with events per 100 patient-years). Efficacy endpoints were derived from Mayo score (local read) with non-responder and last observation carried forward imputation (NRI-LOCF) [a].

Results
Of 944 patients who received ≥1 dose of tofacitinib, 769 (81.5%) received 10 mg BID (median duration [range]: 5 mg BID 1170 [36–2066]; 10 mg BID 668 [1–2159] days). In total, 338 (35.8%) and 93 (9.9%) patients discontinued due to insufficient clinical response and AEs (excl. worsening UC), respectively. IRs (95% confidence interval) in the Tofacitinib. All group were: deaths 0.18 (0.05, 0.47); serious infections 1.57 (1.08, 2.19); herpes zoster (non-serious and serious) 3.27 (2.54, 4.14); major adverse cardiovascular events 0.14 (0.03, 0.40); malignancies excl. non-melanoma skin cancer (NMSC) 0.92 (0.56, 1.42); NMSC 0.74 (0.43, 1.21); deep vein thrombosis 0.05 (0.00, 0.25); pulmonary embolism 0.18 (0.05, 0.47) (Table). At Month 36 (NRI-LOCF), 58.9% (n = 103) and 33.5% (n = 257) were in remission, 64.6% (n = 113) and 37.0% (n = 284) had mucosal healing (Mayo endoscopic subscore of 0 or 1) [b] and 66.9% (n = 117) and 40.2% (n = 309) showed clinical response, in the 5 and 10 mg BID groups, respectively.

Conclusion
Incidence of AEs remained generally consistent in patients with moderate to severe UC in the OLE study compared with a previous analysis.2 Data continue to support long-term efficacy with tofacitinib up to 36 months beyond Week 52 of OCTAVE Sustain.

References
N17 Profile of ostomy patients treated at a referral hospital for inflammatory bowel disease
Authors: Barros J , Herrerias G , Oliveira L , Baima J , Alencar R , Saad-Hossne R , Sassaki L 
Published: January 2020

Abstract

Background
As part of the surgical treatment of inflammatory bowel disease (IBD), sometimes is necessary the intestinal stoma. The aim of this study is to identify the profile of ostomy patients treated at a referral public hospital in IBD in Brazil.

Methods
This is a descriptive study with a quantitative approach. The sample consisted of all patients who underwent stoma surgery at a referral public hospital in IBD in Brazil. The inclusion criteria were: to have a medical diagnosis of Crohn’s Disease (CD) or Ulcerative Colitis (UC) and to have or have had intestinal stoma. Data collection was performed through the analysis of patient records.

Results
The number of patients attending the outpatient clinic is approximately 200 with UC and 150 with DC. The sample consisted of 33 patients, the majority of male gender (51.52%), age between 22 to 77 years (44.55 ± 15.10), literate (93.94%), self-declared white (84.85%), coming from the state of São Paulo (96.97%), smokers (6.06%), alcoholics (3.03%), married (63.64%) and the number of children ranged from 01 to 10. Regarding the characteristics related to IBD, 15 (45.45%) were diagnosed with CD, 6 (40%) were fistulising ileocolonic type and 18 (54.55%) were diagnosed with UC and most with pancolitis (88.89%). The average time of illness was 14.2 years. Among the causes of the stoma, the most frequent were perforating acute abdomen (n = 5, 15.15%), severe acute colitis (n = 4, 12.12%), obstructive acute abdomen (n = 4, 12.12%), toxic megacolon. (n = 3, 9.09%) and neoplasia (n = 2, 6.06%). Regarding the character of the surgery, 10 (30.30%) were urgency and emergency and 11 (33.33%) elective. Only 5 (15.15%) surgeries performed the previous demarcation of the stoma. Regarding the types of stoma, 4 (12.12%) had temporary colostomy and 3 (9.09%) permanent, 16 (48.48%) had temporary ileostomy and 3 (9.09%) permanent. The average time of stoma was 3.19 years. 2 (6.06%) colostomised and 9 (27.27%) ileostomised reversed the stoma. 2 (6.06%) patients refused intestinal reconstruction.

Conclusion
The study results showed us that IBD with more severe extension and behaviour can result in intestinal ostomy, either temporary or permanent. The characterisation of ostomised patients is necessary for the identification of nursing needs to be highlighted, such as the previous demarcation of the stoma.
N21 Self-management and healthcare utilisation of 16–21 year olds with inflammatory bowel disease (IBD) attending one Irish hospital
Authors: Forry M , Milewska M , Lardner C , Lukose T , Godwin N , Boland K , Patchett S , O’Toole A 
Published: January 2020

Abstract

Background
IBD is an umbrella term used to describe Crohn’s disease and ulcerative colitis, both characterised as lifelong relapsing remitting diseases (O’Connor et al., 2013). Hope et al (2012) reported a significant increase in the incidence of childhood IBD in Ireland over a relatively short period of time.
The aim of this research study was to assess the self-management and healthcare utilisation skills of adolescents and young adults (AYA) (aged 16–21 years) with (IBD).

Methods
Service users aged from 16 to 21 attending the IBD service were asked to complete the Transition Readiness Assessment Questionnaire (TRAQ). Divided into five domains, 20 questions related to: managing medications, appointment keeping, tracking health issues, talking with providers and managing daily activities.

Results
31 completed questionnaires were returned via stamped addressed envelope provided. Seventeen patients were diagnosed in a paediatric hospital and 14 were diagnosed in adult hospital services. Seventy-five per cent of respondents manage their own medications, 50% take responsibility for appointment keeping and 51% keep track of their health issues. Eighty-nine per cent talk to health care providers independently and 81% manage daily activities independently. Further analysis showed that females had significantly higher health tracking scores compared with males p = 0.04. Overall, 65% of all female users provided positive feedback regarding this domain. In male group this score reached only 40%. The biggest discrepancy was noted in relation to query concerning the list of questions before doctor`s visit. Almost 70% of females replied positively to this question, while only 28% of male patients provided positive answer. There was no significant difference in scores from those diagnosed in paediatric setting vs. those diagnosed in adult hospital services.

Conclusion
Some aspects of the appointment keeping as well as health tracking issues (especially in male group) were identified as domains that need further improvement. Ongoing education will be provided to patients attending the service with training focused on increasing awareness of the users in the most lacking domains.
N22 Nurse led therapeutic drug monitoring (TDM) of Infliximab in IBD
Authors: Gleeson S , Sugrue K , Buckley M , McCarthy J 
Published: January 2020

Abstract

Background
Therapeutic drug monitoring (TDM) is the clinical practice of measuring serum drug concentrations to guide clinical decision making. Achieving therapeutic drug concentrations has been associated with clinical, endoscopic and histological outcomes in IBD. The use of TDM offers a more personalised treatment approach and is associated with sustained clinical remission. Proactive TDM was introduced to the Mercy University Hospital in 2014 for all patients on biologics.

Methods
One hundred patients receiving biologic infusion (Infliximab) were evaluated post induction (week 12) for therapeutic drug trough concentration and for clinical response. Serum samples were taken from all IBD patients at week 12. Biologic response assessment forms were complete for all patients to assess symptom improvement.

Results
Thirty-five per cent of patients had sub therapeutic trough levels at week 12. They subsequently received 3 increased doses of 10mgs/kg and levels were rechecked. Of these 90% achieved therapeutic levels after the dose escalation. 65% of patients had therapeutic levels at week 12. There was a correlation between therapeutic trough levels and patient reported improvement of clinical symptoms in 85% of respondents.

Conclusion
TDM in our unit facilitates appropriate dose 100 patients receiving biologic infusion (Infliximab) were evaluated post induction (week 12) for therapeutic drug trough concentration and for clinical response. Serum samples were taken from all IBD patients at week 12. Biologic response assessment forms were complete for all patients to assess symptom improvement.
N24 Prioritised adolescent healthcare transition readiness factors by Canadian inflammatory bowel disease nurses
Authors: Rohatinsky N , Risling T , Kumaran M , Hellsten L A 
Published: January 2020

Abstract

Background
Canada has over 270,000 individuals living with inflammatory bowel disease (IBD). Over 7000 children and adolescents have been diagnosed and these numbers are continuing to increase. Due to the chronic, life long nature of IBD, more adolescents are transitioning from paediatric to adult healthcare environments than ever before. There is great need to ensure that adolescents are properly supported through this transitional period to ensure that their health outcomes are maximised. IBD nurses are integral members of the transition team; however, their perspectives on priority transition readiness factors are limited. Therefore, the purpose of this study was for Canadian IBD nurses to prioritise healthcare transition readiness assessment factors.

Methods
An anonymous survey was created and distributed to IBD nurses across Canada. Nine transition topic categories with several transition statements within each category were identified based on a previous scoping review and expert opinion. Nurses were asked to rank the top three statements under each category.

Results
Fifty-six Canadian IBD nurses participated in the survey. The highest priority statement that was most frequently identified as the top selection under each transition topic category is listed below.

Conclusion
IBD nurses identified key transition readiness factors that will ultimately allow young adults to self-manage their IBD; promote successful transition into adult care; and allow for positive health outcomes.
N29 Application of the AREA model to a standard care plan for patients with inflammatory bowel disease
Authors: Mateos Hernandez M I 
Published: January 2020

Abstract

Background
The clinical characteristics of the inflammatory bowel disease (IBD), its psychosocial/occupational impact and the increase in its incidence and prevalence, justify the proliferation of Multidisciplinary Care Units (with reference nurses for patients). The standardisation of care and the recording of the performance of the professionals that integrate them are necessary to give continuity to the care, to value the role of each of them in these, to reduce the variability in clinical practice and the collection of data that allow decision-making at the management and research assistance level. All of the above plus the existence in our country of legal regulations that define and regulate the records of mandatory existence and completion in the medical records, of our patients has made us set ourselves as a general objective: Develop a standard nursing care plan for the care of patients with IBD.

Methods
A literature review of the literature published in the last 10 years in the Medline, Cocharane, Cinahl and Cuiden databases is carried out. The search criteria establish the existence of the words ‘Care plan’ ‘nursing care’ and ‘nursing diagnoses’, all of them combined with IBD. Natural words bounded by the limits determined in the inclusion criteria. The needs model of Virginia Henderson (Institutional model) is used for the assessment and for the diagnosis, objectives and planning of nursing interventions the taxonomies NANDA, NOC, and NIC (NNN). Finally, in order to achieve a realistic and applicable plan of care taking into account, criteria of average hospital stay per process, and average time of outpatient care, we apply the AREA model (Analysis of Current State Outcomes) of Pesut1.

Results
The assessment highlights the altered needs: food, disposal, safety mobility, self-realisation, values and communication beliefs. In relation to the diagnoses, we classify them into clinical, psychosocial and secondary to the treatment, discriminating those written as diagnosed by nurses and therefore resolved or minimised autonomously by the nurses from whom they should be considered as collaborative problems.
Normality characteristics are defined by protocol.

Conclusion
The model favours a broad and comprehensive view of the situation, leading to the selection of the diagnosis (or more than three) that allows the holistic approach to be effective and efficient. It would allow us to know the prevalence and incidence of diagnoses and agree on objectives and activities to establish comparison patterns.
N30 Experience of living with intestinal failure: a systematic review of qualitative studies
Authors: Czuber-Dochan W , Liu Q , Roberts D , Smith P , Norton C 
Published: January 2020

Abstract

Background
Intestinal failure (IF) affects about 2000 people with Crohn’s disease (CD) in the UK. It is a result of the most severe phenotype of CD where an individual can no longer obtain sufficient nutrients from their gut to sustain life without supplementation in the form of parenteral nutrition (PN) or fluids intravenously and most have a stoma. Many cannot tolerate any food and very little drink by mouth. Such individuals usually need a permanent central venous catheter and must have an infusion of PN overnight, all or most nights in the week, often for 10–12 h at the time. Complications such as infection or thrombosis of the central line are a constant risk. This treatment must often continue for life. This systematic review aimed to explore the experience of people living with IF and the impact of the condition on their daily lives.

Methods
The following databases were searched in July 2019: MEDLINE, PubMed, PsychINFO, Web of Science and Global Health Scopus. Search terms included ‘intestinal failure’, ‘short bowel syndrome’, ‘quality of life’ (QoL) and terms relating to psychosocial functioning. English language articles were retrieved and screened by one reviewer at title and abstract, ratified by a second reviewer. The resulting articles selected at abstract were screened at full text by 3 reviewers.

Results
Eight papers, based on 7 studies, were included with a total of 97 participants: 36 male, 61 female. The age range of adults was 28–83. One study was conducted in children, with age range of 7–17. In 5 studies, all participants were on HPN. In 2 studies, 4/6 and 7/10 participants were on HPN respectively. There was one overarching theme: ‘Complications and challenges of living with IF’, with three specific themes that reflect the patients’ experience: (1) ‘Eating for survival’ encompasses the perpetual need to eat in order to make up for the large quantities of nutrients lost due to malabsorption (2) ‘Life with HPN: nutritional safety net at a price’ describes relief from the pressure to eat for survival but with drawbacks such as restrictions on social activities and risk of catheter line infections. (3) ‘Benefits and pitfalls of having a stoma’ relates to benefits of having a stoma, such as reduced frequency of toilet visits, and the accompanying inconvenience of leaks, high output and negative body image.

Conclusion
Living with IF has many challenges. Patients struggle with retaining enough nutrients and the physical and technical difficulties with having HPN and/or a stoma. The psychosocial well-being in these patients is affected by these challenges, as a result. Overall, QoL is poor and currently very little is being done to improve this.
DOP65 Mirikizumab regulates genes involved in anti-TNF resistance and ulcerative colitis disease activity
Authors: Steere B , Schmitz J , Powell N , Higgs R , Gottlieb K , Liu Y , Jia B , Tuttle J L , Sandborn W J , Sands B E , Krishnan V 
Published: January 2020

Abstract

Background
Mirikizumab (miri), a p19-directed IL-23 antibody, demonstrated efficacy and was well-tolerated in a phase 2 randomised clinical trial in patients with moderate-to-severe UC (NCT02589665). This abstract explores gene expression changes in colonic tissue from study patients and their association with clinical outcomes.

Methods
Patients were randomised 1:1:1:1 to receive intravenous placebo (PBO, N = 63), miri 50 mg (N = 63) or 200 mg (N = 62) with the possibility of exposure-based dose increases, or fixed miri 600 mg (N = 61) every 4 weeks for 12 weeks. Patient biopsies were collected at baseline (BL) and Week 12, and differential gene expression was measured using an Affymetrix HTA2.0 exon-format microarray workflow. Genes were represented by their largest groups of highly correlated exons. Weeks 0 and 12 data were compared in all treatment groups to produce differential expression values (DEVs). Mean fold changes in DEVs between PBO and each dose group were calculated in a mixed-effect model. A threshold of false discovery rate-adjusted p-value ≤ 0.05 was applied to the significance of the fold change values, and a filter of an absolute value for the fold changes of ≥0.5 log2 units was applied.

Results
The greatest improvement in clinical outcomes at Week 12 was observed in the 200 mg miri group1; likewise, the greatest PBO-adjusted change from BL in transcripts was observed in this group. Transcripts correlating with key UC disease activity indices at BL, including modified Mayo score (MMS), ulcerative colitis Endoscopic Index of Severity (UCEIS), Geboes score, and Robarts Histopathology Index (RHI), included MMP1, MMP3, S100A8, IL1B, and UGT2A3, with the highest correlations occurring with the histopathologic indices (Figure 1). Miri treatment modulated the expression of transcriptional modules predicted to be enriched in cell profiles identified as key drivers of UC2 (Table 1, columns 1–2) as well as genes determined to be associated with UC by genome-wide association studies (GWAS; Table 1, column 3). Moreover, miri treatment affected transcripts involved in resistance to anti-TNF treatments (Table 1, column 4). A number of the genes in these categories were among those most affected by miri treatment (Table 1, columns 5–6).

Conclusion
This is the first large-scale gene expression study of diseased tissue from UC patients treated with anti-IL23p19 therapy. It is the first study to show how anti-IL23p19 therapy modulates biological pathways involved in resistance to anti-TNFs. These results are consistent with the demonstrated efficacy of miri in patients in whom TNF antagonists have failed.
References
DOP70 High-dimensional analysis reveals a novel signature for IL-17 producing CD8 T cells in inflammatory bowel disease
Authors: Globig A M , Otto-Mora P , Hipp A , Heeg M , Schwacha H , Tomov V , Thimme R , Hasselblatt P , Bengsch B 
Published: January 2020

Abstract

Background
The pathogenesis of IBD has previously mainly been associated with a dysregulation of CD4 T-cell responses, and active disease is linked to induction of pathogenic IL-17 producing T helper cells. Importantly, CD8 T cells can also produce IL-17 and demonstrate a significant increase in active IBD. However, it remains unclear whether this is due to conventional or unconventional T-cell responses and whether these CD8 responses could play a role as novel biomarkers or therapeutic targets of active IBD.

Methods
We isolated lymphocytes from the peripheral blood and intestinal tissue of IBD patients (n = 56) and performed a detailed analysis of CD8 T-cell phenotype and function using high-parametric flow cytometry and mass cytometry in combination with algorithm-aided bioinformatic analysis.

Results
We observe a significant increase in IL-17 production by CD8 T cells in active IBD, primarily produced by conventional CD8 T cells. Unconventional T-cell subsets (e.g. MAIT cells, γδ T cells and NKT cells) represented only ~30% (peripheral blood) or ~25% (intestinal tissue) of IL-17 producing CD8 T cells (Tc17). The mass cytometric analysis identified Tc17 cells as a distinct cell population within the intestinal CD8 T-cell compartment that can be further subdivided into 3 subsets which share expression of phenotypic markers such as CD6, CD39, CD69 and PD1 and a low expression of CD27. This novel signature was validated in a separate cohort of IBD patients. Moreover, at initial IBD diagnosis, the IL-17 signature is associated with flare-free survival in a retrospective cohort analysis based on published transcriptome data.

Conclusion
Our data indicate that conventional IL-17 producing CD8 T cells are a very distinct cell population that is linked to IBD activity. The identification of a novel IL-17 CD8 signature may help guide treatment decisions as a biomarker and for immunotherapeutic approaches.