bluuebunny/crossref_metadata_2025_split huggingface dataset:
P234 Association between anti-TNFα drug levels and drug-induced lupus in patients with Inflammatory Bowel Disease
Authors: Muñoz-Villafranca C , Irabien M , Hernandez-Aretxabaleta N , Arreba P , Ortiz de Zárate J , Garcia-Gomez C , Aresti U , Bilbao A , Irigoyen M , Garcia-Vivar M L 
Published: May 2021

Abstract

Background
Drug-induced lupus (DIL) has been described as an adverse event of an immunological nature, in relation to treatment with anti-TNFα drugs. It is considered as a manifestation uncommon in patients with inflammatory bowel disease (IBD).
The main objective of the study was to know the prevalence of DIL, the main characteristics and the management of IBD patients. The secondary objetive was to identify predictive factors related to the pathology.

Methods
We conducted a retrospective study, between January 2017- March 2020, in patients with IBD treated with anti-TNFα drugs during this time, in a single center. The information was obtained from the clinical history of the hospital. Patients with different degrees of data incompleteness were dismissed.
Although there are no accepted diagnostic criteria, diagnosis was based on the criteria proposed by De Bandt: (i) the presence of immunologic abnormalities: ANA+ and/or anti-dsDNA+; (ii) at least two clinical features; (iii) clear temporal association with exposure to the anti-TNFα.
The serum concentration of Infliximab (IFX) was considered optimal within the interval 3–7 μg/mL2. For Adalimumab (ADA) the optimal interval was 5–8 μg/mL3.

Results
We identified 248 patients with anti-TNFα therapy. 15 of them were dismissed due to incomplete data.
We found 8 patients with a DIL diagnosis (3.34%). The manifestations of DIL occurred after a mean of treatment duration of 29.63 months. The clinical features of DIL included arthritis (87.5%), fatigue (75%), fever (25%), vasculitis, cutaneous manifestations, and nephropaty (12.5%) each. All patients required specific treatment and in 7 of them (87.5%) the anti-TNFα drug was discontinued followed by complete clinical resolution in all of them.
Patients with DIL had a higher prevalence of suboptimal serum concentration of anti-TNFα drug than the rest of the patients (83.33% versus 29.89%, p = 0.012). In addition, the combination therapy with immunomodulators (IMM) was less frequent in the DIL group (0% versus 64.37%, p = 0.003). Antinuclear antibodies (ANA) had a higher prevalence in DIL cases (100% versus 25.36%, p&gt;0.001).
No differences were found regarding the type of disease (CD versus UC), duration of anti-TNFα treatment, previous treatment with another anti-TNFα or with the type of anti-TNFα (IFX versus ADA).

Conclusion
The prevalence of DIL in IBD patients undergoing anti-TNFα treatment could be even higher than described due to the lack of knowledge of the disease and the absence of clearly reported diagnostic criteria. The DIL does not seem to be related to the type of disease, or the type of anti-TNFα. Suboptimal serum concentrations of anti-TNFα, as well as monotherapy treatment (without IMM) could be related to the development of DIL.
P271 Evolving Targets in Ulcerative colitis: Defining Disease Clearance in the VARSITY Study
Authors: Danese S , Schreiber S , Loftus E , Colombel J F , Peyrin-Biroulet L , Agboton C , Lindner D , Lirio R , Sands B 
Published: May 2021

Abstract

Background
In VARSITY, the first head-to-head randomized controlled trial of biologics, vedolizumab (VDZ) was superior vs adalimumab (ADA) in achieving clinical remission (CR) at Week 52 in patients (pts) with moderate to severe ulcerative colitis (UC).1 Current treatment goals in UC are based on clinical symptoms and endoscopy, with histologic improvement considered an aspirational goal.2-4 In pts with CR in VARSITY, greater treatment differences between VDZ and ADA at Week 52 were seen in endoscopic improvement and histologic response. Here, data from VARSITY were used to define disease clearance: a novel composite outcome in UC comprising clinical and endoscopic remission plus minimal histologic disease activity.

Methods
VARSITY was a phase 3b, randomized, double-blind, double-dummy, active-control trial of treatment with VDZ (300mg IV Q8W) vs ADA (40mg SC Q2W) maintenance after induction. Pts were randomized in a treat through design, and no dose escalation was allowed. For these analyses, based on pts who completed the study until Week 52, disease clearance was defined as a composite outcome based on 1) CR: partial Mayo score ≤2 and no individual subscore &gt;1 (excluding sigmoidoscopy subscore); 2) endoscopic improvement: endoscopic subscore ≤1; and 3) absence of active histologic disease (minimum histological disease activity [MHDA]): Robarts Histology Index (RHI) &lt;5. Treatment failure was defined as discontinuation from treatment or completion of treatment but failure to achieve any of CR, endoscopic improvement, or MHDA. The rates of disease clearance and failures were compared between treatment groups and stratified by presence of inflammatory burden at baseline: C-reactive protein ≥5 mg/L and fecal calprotectin &gt;100 µg/g.

Results
More pts in the VDZ treatment group than the ADA group achieved disease clearance at Week 52 (VDZ: 112/383, 29.2%, 95% CI 24.7-34.1 vs ADA: 63/386, 16.3%, 95% CI 12.8-20.4). Compared with treatment failures (VDZ: 92/383, 24.0% vs ADA: 134/386, 34.7%, Table 1), disease clearers had lower C-reactive protein (CRP) baseline mean values (7.4mg/L and 6.4mg/L vs 13.6mg/L and 9.4mg/L for disease clearers vs treatment failures, for VDZ and ADA, respectively). Fewer pts with inflammatory burden at baseline (CRP ≥5 mg/L and fecal calprotectin &gt;100 µg/g) achieved disease clearance (Fig 1). Baseline corticosteroid use was more frequent in ADA disease clearers (42.9%) compared with VDZ disease clearers (32.1%).

Conclusion
Disease clearance is a novel and achievable composite outcome that is achieved by almost one third of pts in the VDZ treatment group in VARSITY. Analyses are ongoing to further characterize the trajectory leading to disease clearance as well as the role of baseline characteristics.
P376 Improving stress and fatigue in a real-world setting among patients with Inflammatory Bowel Disease through a digital platform
Authors: Oddsson S , Gunnarsdottir T , Johannsdottir L , Amundadottir M , Frimannsdottir A , Ylanne K , Molander P , Islind A , Oskarsdottir M , Thorgeirsson T 
Published: May 2021

Abstract

Background
Fatigue is one of the most prominent and disabling symptoms reported by adult patients with inflammatory bowel disease (IBD). Also, stress is perceived by these patients as one of the main causes of IBD flare-ups. Therapeutic guidelines call for effective disease assessment, early intervention, and personalized care using a treat-to-target approach which may be hard to achieve through standard care. Providing patients with effective self-management strategies and patient support programs (PSPs) via a digital platform to complement standard care, may be optimal for improving fatigue and reducing stress.
The objective of this study was to perform a preliminary test of engagement and effectiveness of a newly developed 16-week PSP delivered via the digital platform Sidekick Health.

Methods
Participants were recruited via Finnish IBD patient association websites and social media (advertisements through Facebook and Instagram). Participants entered baseline characteristics upon program signup. Platform engagement was automatically tracked, and participants reported stress, energy levels (fatigue), and quality of sleep through the platform.

Results
An intention to treat (ITT) sample included 205 participants. Eighty people completed the required outcome measures during weeks 12-16 (completers). More women than men took part (61.5%) with the average age of 40.3 years (mean, SD=11.5) and average BMI of 27.9 (mean, SD=6.0). ITT analyses showed significant improvements in ratings of stress (t(204)=3.488; p&lt;0.01, percentage change=-9.52%), and energy levels (t(204)=-2.381; p&lt;0.05, percentage change=4.60%). No significant difference was observed in quality of sleep (t(204)=-1.368; p=0.173). For completers (n=80), significant improvements were observed for stress (t(79)=4.574; p&lt;0.01, percentage change=-23.26%) and energy levels (t(79)=-2.440; p&lt;0.05, percentage change=9.48%) but not for quality of sleep (t(79)=-1.319; p=0.191).

Conclusion
These results indicate that participation in the Sidekick Health PSP for IBD has significant positive effects on patient-reported stress and energy levels. These findings are promising and provide initial support for using this digital platform for supplementing standard care for IBD patients.
P394 Serological biomarkers of type III and IV collagen remodeling predict and monitor infliximab treatment response in patients with Inflammatory Bowel Disease
Authors: Sorokina Alexdóttir M , Bourgonje A R , Asser Karsdal M , Bay-Jensen A C , Faber K N , Loveikyte R , van Dullemen H M , Visschedijk M C , Festen E A M , Weersma R K , Dijkstra G , Mortensen J H 
Published: May 2021

Abstract

Background
Immunotherapeutic drugs such as anti-TNFα antibodies have greatly improved the treatment of inflammatory bowel disease (IBD). However, up to 20-40% of patients still fail to respond to therapy as the pattern of disease is variable. Better patient profiling could increase treatment response and improve quality of life. The aim of this study was to assess whether serological biomarkers reflecting tissue formation and different forms of basement membrane (BM) degradation could monitor or predict treatment response to anti-TNFα in patients with Crohn’s disease (CD) and Ulcerative Colitis (UC).

Methods
Using competitive ELISA, serum biomarkers of matrix metalloproteinase (MMP)-mediated type IV collagen degradation (C4M), T-cell related collagen degradation (C4G) and type III and IV collagen formation (PRO-C3, PRO-C4) were measured in 89 patients (CD=63, UC=26) receiving infliximab (IFX) induction therapy. Disease activity was defined by composite assessment of the Harvey-Bradshaw Index (HBI) for CD and Simple Clinical Colitis Activity Index (SCCAI) for UC together with physician’s global assessments (PGA). Clinical remission (HBI &lt;5, SCCAI &lt;2.5) was assessed at week 14. Logistic regression models adjusted for confounding factors (CD: age of diagnosis and ileoceacal surgery, UC: steroid use at week 14) were used to examine prediction value for treatment response.

Results
In patients with CD, baseline ratios of C4M/C4G (P&lt;0.001, AUC=0.95) and PRO-C4/C4G (P&lt; 0.05, AUC=0.92) were significantly lower at baseline in responders (n=57) compared to non-responders (n=6). PRO-C3 levels were increased at week 14 in CD patients responding to therapy compared to those not responding (P&lt;0.01, AUC=0.93). Finally, UC patients responding to treatment (n=19) showed decreased levels of C4M/C4G (P&lt;0.01, AUC=0.96) at week 14 compared to non-responders (n=7).

Figure 1: A) Serum levels at baseline or week 14 between non-responders and responders for CD and UC. B) ROC curves showing discriminative capacity of the biomarkers (ratios) between responders and non-responders.

Conclusion
Increased baseline ratios of type IV collagen remodeling (C4M/C4G, PRO-C4/C4G) in serum predict treatment response to IFX in patients with CD, whereas PRO-C3 may serve as a monitoring tool reflecting tissue restoration. The ratio between MMP- and granzyme B-mediated degradation of type IV collagen (C4M/C4G) in serum was elevated in non-responders compared to responders and may serve as non-invasive tool to monitor treatment response in patients with UC. Together, these biomarkers may help reveal different profiles of ECM turnover and inflammation and thus aid in better prediction and monitoring of response to anti-TNFα treatment.
P396 Acceptance of switch, patient satisfaction and adverse events after switch from adalimumab originator to biosimilar SB5 in patients with Inflammatory Bowel Disease in a real-life setting
Authors: De Somer T , Deprez N , Baert D , Deceuninck M , Huys I , Mattens V , Sterckx A , Vanden Branden S , Vanderstraeten E , Vandervoort J , Van Heddegem N , Dewint P 
Published: May 2021

Abstract

Background
SB5 is approved as a biosimilar of the adalimumab originator. However, data on patient acceptance of switch from originator to biosimilar, patient satisfaction, adverse events and nocebo effects are lacking, especially in the inflammatory bowel disease (IBD) population. We sought to elucidate these issues in a real-life switch IBD population.

Methods
IBD patients, in clinical remission or stable response, treated with adalimumab originator in 2 Belgian centers were offered to participate in this phase IV, interventional trial. Switch was voluntary and was offered after being informed about biosimilars. Satisfaction with the switch and local discomfort after injection (within and after 30 minutes) was semi-quantitatively (visual analogue scales (VAS)) assessed at baseline and 8 weeks, 6 months and 12 months after switch. Reasons for non-switch, discontinuation and adverse events were documented.

Results
An acceptance of switch rate of 79.3% was observed. Fifteen patients reported 22 reasons for refusal; the most common were fear for a flare (n = 8), ease to stay on the originator (n = 4) and absence of trust in biosimilars (n = 3). No patient-related demographic factors associated with refusal of switch could be defined. By month 12, 28 patients discontinued SB5 for several reasons; the most frequent being high anti-adalimumab antibodies at baseline (n = 5), secondary loss of response (n = 3), injection site pain (ISP) (n = 8) and other adverse events (n = 10) not causally related to SB5. At month 12 after switch, 74.5% of the study population was still treated with SB5 (table 1). The median VAS for local discomfort up to 30 minutes after injection of the originator was 1/10 and increased significantly to values between 2 and 3/10 at the different time points on SB5 (p &lt; 0.001 for all) (table 2). However, the median VAS for local discomfort after 30 minutes was between 0 and 1/10 at all time points, which was not significantly different compared to the originator. Nevertheless, satisfaction with the decision to switch was high and remained stable over the different time points with a median VAS between 7 and 8/10, which was not significantly different compared to baseline.

Conclusion
After being well informed, the great majority of patients treated with adalimumab originator is willing to switch to biosimilar SB5. The rate of satisfaction under treatment with SB5 is high and remains stable over time. The most important reasons for discontinuation were adverse events, which could be mostly attributed to the nocebo effect and to ISP. Of note, patients in general report a higher, temporary, local discomfort within 30 minutes after injection with SB5.
P419 Psychological acceptability of surgery in patients with ulcerative colitis after total colectomy
Authors: Itabashi M , Hirano Y , Saito T , Inoue M , Uchida K , Arai K , Minakuchi E , Ishihara H , Onizawa R , Hirayama A , Araki K , Kimura H , Kunisaki R 
Published: May 2021

Abstract

Background
The purpose of surgery for patients with ulcerative colitis (UC) is to save their lives and improve their quality of life (QOL). However, deciding whether to undergo surgical intestinal resection is among the most difficult decision that patients with UC may be required to make during the disease course. Although clinical outcomes and changes in QOL after total colectomy have been reported, few studies have investigated the psychological acceptability or subjective feelings among patients after surgery. This study aimed to evaluate the psychological acceptability of surgery among patients with UC who underwent total colectomy.

Methods
A cross-sectional single questionnaire survey for patients with UC who underwent colectomy was conducted from October 2019 to February 2020 at five Japanese IBD centres in Japan. According to the opinions of seven physicians specialising in IBD and a clinical psychologist, we created a questionnaire using a 10-point visual analog scale (VAS) consisting of 20 questions related to surgical acceptance and concerns related to UC. We asked patients to answer the questionnaire by recollection of the pre- and postoperative periods. The VAS scores before surgery were described by the patients looking back on their recollections. Pre- and post-surgical VAS scores were compared using Wilcoxon’s rank sum test. Cases under 6 years old at colectomy and patients followed for more than 10 years after surgery were excluded.

Results
There were 71 cases, and the median age at surgery was 31.0 [range 9–75] years. The median time since surgery was 4.0 [range 0–10] years, and the valid response rate was 93 percent. Compared with pre-operatively, psychological acceptability of surgery significantly improved significantly after total colectomy (p &lt; .001). The median scores for psychological acceptability of surgery were 5.1 (0–10) and 8.6 (0.3–10) before and after surgery, respectively. Scores improved in more than 90% of the patients. Subscores for a sense of loss of the colon, shame related to excretion, and dietary satisfaction improved significantly after surgery (p &lt; .0001).

Conclusion
We examined for the first time the psychological acceptance of surgery among patients with UC who underwent total colectomy. We found that many of the emotional, physical, and social questions associated with UC improved after surgery.
P426 Health-Related Quality of Life and Work Productivity in patients with moderate-to-severe Inflammatory Bowel Disease in Argentina: Data from the RISE AR study
Authors: Correa G J , Yantorno M , Olivera Sendra P , Lasa J S , Lubrano P , Balderramo D C , Zubiaurre I , Ruffinengo O , Brion L , Leonardi D B , El-Hakeh J , Guimaraens P N , Sambuelli A 
Published: May 2021

Abstract

Background
Patient-reported outcomes (PROs) are increasingly recognized as complementary to objective markers of disease activity, yet evidence on PROs in inflammatory bowel disease (IBD) in the real-world setting in Latin America is limited. Herein, we describe health-related quality of life (HRQoL) and work productivity and activity impairment (WPAI) of IBD patients (pts) in Argentina.

Methods
RISE-AR (NCT03488030) was a non-interventional study with a cross-sectional evaluation and a 3-year retrospective chart review conducted in 7 centres in Argentina (12/2018-05/2019) to assess healthcare resource utilisation, HRQoL and WPAI. Adult pts (≥18 yr old) with a previous diagnosis of moderate-to-severe (Mod/Sev) ulcerative colitis (UC) or Crohn′s disease (CD) based on clinical, endoscopic or imaging criteria ≥6 months prior to enrolment, were included. HRQoL (IBD Questionnaire [IBDQ], 5-dimensional EuroQoL measure [EQ5D]) and WPAI instruments were administered at screening. Disease activity at enrolment was classified as Mod/Sev (Harvey Bradshaw Index ≥8 or partial Mayo Score ≥5) vs. “no-or-mild” (No/Mild). A p-value ≤0.05 was considered statistically significant (Mann-Whitney U test).

Results
Overall, 246 pts were included (41.1% CD; 58.9% UC). At enrolment, median (range) age (years) was 39.5 (18.2-74.0) for CD (51.2% female) and 41.9 (18.0-80.4) for UC (55.2% female) pts; 20 pts (9.3% CD; 7.7% UC; excluding 4 ostomized pts) had Mod/Sev disease activity. During the previous 3 years, 17.8% (CD) and 1.4% (UC) of pts required ≥1 surgery, and 33.7% (CD) and 21.4% (UC) were hospitalized. No/Mild pts showed significantly higher overall HRQoL scores (mean±SD) vs. Mod/Sev pts in CD (IBDQ: 178.1±35.4 vs. 140.0±43.5, p&lt;0.05; EQ5D [visual analogue scale]: 75.7±1.8 vs. 64.4±5.5, p&lt;0.05) and UC (180.2±32.9 vs. 132.9±43.8, p&lt;0.001; 77.1±1.3 vs. 57.7±5.3, p&lt;0.001), respectively. Activity impairment was reported by 55.4% and 58.6% of CD and UC pts, respectively, while 37.9% and 43.9% of CD and UC employed pts (67 CD, 92 UC; Mod/Sev: 5 CD, 6 UC) reported work impairment. Mod/Sev IBD pts had higher absenteeism (30.8% vs. 6.3%, p&lt;0.05) and presenteeism (20.0% vs. 7.5%, p=0.149) vs. No/Mild pts. Female gender, surgeries and hospitalizations were associated with lower QoL in the overall IBD population.

Conclusion
This is the first study to evaluate QoL and WPAI in IBD pts in Argentina. Pts with Mod/Sev activity showed impaired QoL and WPAI compared to No/Mild pts. Whilst, less than 10% of IBD pts had Mod/Sev disease activity at enrolment, nearly 60% of the overall IBD population reported either work or activity impairment. Thus, disease activity scores alone may fail to assess the real burden of IBD, suggesting a relevant role for PROs in disease management.
P435 The impact of perianal fistula in Crohn’s disease on quality of life: results of a patient survey conducted in Europe
Authors: Spinelli A , Yanai H , Lönnfors S , Girardi P , Milicevic S , Carvello M , Maroli A , Avedano L 
Published: May 2021

Abstract

Background
Perianal fistulas (PAF) in Crohn’s disease (CD) may impair social performance, sexual function, life activities and overall patients’ quality of life (QoL). Patient experience is important in the treatment decision making and in providing adequate support. Despite the clinical relevance, few studies have addressed the patient perspective on the impact of PAF and complex PAF (CPAF) in CD on QoL.

Methods
A questionnaire assessing the impact of PAF on QoL was developed by patient representatives and medical experts addressing diagnosis, symptoms and QoL including close relationships, social life, sexual activity and working life. CD patients with and without PAF were invited to participate. The self-selective anonymous survey was available in 11 languages and accessible on the European Federation of Crohn’s & Ulcerative Colitis Associations’ (EFCCA) website and national inflammatory bowel disease patient association websites from 15 July to 31 December 2019.

Results
Of 820 respondents with CD (67.2% women; mean age 40.8 years), 532 (64.9%) reported PAF in CD of which 272 (51.1%) reported CPAF. PAF/CPAF patients had experienced and were currently experiencing more anal pain and perianal leaking than CD patients (Figure). On a 10-point scale, PAF/CPAF patients reported a greater impact on overall QoL (6.91 vs 6.18, p&lt;0.001), relationships with family and friends (5.54 vs 4.78, p&lt;0.001), relationship with partner (5.24 vs 4.11, p&lt;0.001), social life (5.65 vs 4.97, p=0.001) and working life (5.54 vs 5.12, p=0.02) than CD patients. PAF/CPAF patients reported feeling more unhygienic, uncomfortable, and guilty about their condition toward family and friends than CD patients. They also found it more difficult to talk with family and close friends about their condition. PAF/CPAF patients avoided having sex, ended relationships, had arguments with partner, felt inadequate to partner, avoided dating and had their partner refuse having sex more often than CD patients. Furthermore, these patients were unable to play sports, carried a personal hygiene kit, were aware of access to clean toilets, and had changed profession/career due to their condition more often (Figure).

Conclusion
From the patients’ perspective, PAF/CPAF in CD severely impacts patients’ overall QoL, social and sexual relationships and work life. These results are important to consider when tailoring treatment strategy and patient services in a multidisciplinary way to address individual patient needs.