bluuebunny/crossref_metadata_2025_split huggingface dataset:
P403 Therapeutic compliance in patients with chronic inflammatory bowel disease.
Authors: Hajlaoui A , Sabbah M , Bibani N , Jlassi H , Bellil N , Lassoued K , Trad D , Gargouri D 
Published: January 2023

Abstract

Background
The World Health Organization estimates that half of all patients do not take their treatment as agreedwith the prescriber. Thus, the evaluation of compliance is essential in the management of patients withchronic diseases, particularly chronic inflammatory bowel diseases (IBD). This evaluation cansometimes be variable. Hence, it is of clinical significance to develop objective scales unifying compliance assessment methods.
The aim of our study was to assess therapeutic compliance in IBD patients and to identify predictivefactors of non compliance.

Methods
A cross-sectional study over a period of six months (from June to November 2022) including all IBD patients from our department was conducted.The data collection was carried out by one investigator. We used an analytical chart containingdemographic and clinical questions, the Perceived Stress Scale (PSS) questionnaire in its French version to evaluate the degree of stress and the "Morisky medication adherence scale -8 MMAS" and the "Girerd" questionnaires to evaluate compliance to treatment.

Results
Forty-seven patients were included, with a mean age of 43 years [20-71 years] and a M/F sex ratio of0.59. Forty patients had Crohn's disease and seven had ulcerative colitis. Only 19 patients were recently (less than two years) diagnosed of IBD. Whereas, 20 patients were followed for more than 10years. All were undergoing maintainance therapy with azathioprine in 34%, anti TNF in 19%, combotherapy in 19%, 5 ASA in 8.5%. Among our population, 17% presented a flare and were under corticosteroids during our study.Most of our patients did not have a secondary or a university degree (n= 22). When it comes to patients’ perceptions of the disease, 14 patients showed a good understanding while seven showed poor knowledge. The remaining 26 patients had average knowledge about the disease and its management.Regarding the level of stress caused by their disease, 40% were able to cope with it, while 25.5% had major difficulty in stress management.Fifty-one patients were considered to be well compliant according to the MMAS-8, 32% were moderately compliant and 17% were not compliant. The results were comparable using both scores(Morisky and Girerd). The main predictors of poor compliance were level of education (p=0.042),degree of knowledge of the disease (p=0.011) and poor stress coping (p=0.001).

Conclusion
Adherence to treatment is the most important predictor of success or failure of therapeutic care. It isimportant to educate patients about the importance of compliance both at treatment initiation andduring periodic visits. It is also important to identify and act on the factors that lead to non-adherence.
P408 Dual therapy with vedolizumab and tofacitinib in refractory ulcerative colitis patients – single centre experience
Authors: Kolar M , Kastylova K , Lukas M , Duricova D , Hruba V , Machkova N , Cerna K , Jirsa J , Kubickova K , Vojtechova G , Lukás M 
Published: January 2023

Abstract

Background
Despite significant impact biological treatment had on prospects of patients with ulcerative colitis, there is still a substantial proportion of patients with non-response to multiple drugs. Beside dose optimization and selection of agents with different mechanism of action, combination of two different targeted molecules has recently been proposed in cases where inflammatory activity cannot get under control. This case series provide promising results of vedolizumab in combination with tofacitinib in treatment resistent UC patients.

Methods
Patients with complicated refractory or acute severe colitis, in whom combined treatment with vedolizumab and tofacitinib based on shared clinical decision was started, were included. Data on demographics, treatment details, persistence and disease activity including laboratory markers, clinical activity index (partial Mayo score) during regular visits every 2 months up to one year after treatment initiation were collected. Currently available data were analyzed at 6 months. Endoscopic disease activity before and 2-6 months after dual therapy start was evaluated.

Results
In total, 21 UC patients who were started on vedolizumab and tofacitinib dual therapy between Oct 2020 and Sep 2022 were included. Tofacitinib dose was 10mg bid in all patients and all patients on vedolizumab maintenance treatment had intensified dosing regimen. Mean patients age was 36.4±8.1 years, 47.6% were males and 52.4% females. Mean disease duration at baseline was 7.5±5.8 years. All patients had advanced disease including 61.9% with extensive colitis and 38.1% with left-sided colitis. At least 2 previous biologics in monotherapy were used in 85.7% of patients. Mean pMayo score at baseline was 5.6±1.9 and decreased to 0.5±0.9 at 6 months (p=0.0020). Initial fecal calprotectin in the cohort was 1829±2520µg/g vs. 225±257µg/g at 6 months (p=0.0068) and mean CRP changed from 11.4±17.1 to 5.4±7.2mg/l (p=ns). Endoscopic Mayo score before dual treatment initiation averaged 2.8±0.5 indicating mostly severe disease activity and decreased to 1.4±1.2 during follow-up endoscopy (p=0.0005) with half of the patients having only no to mild activity (eMayo 0-1). Up to now, dual therapy had to be terminated in 7 patients – 4 patients failed on the treatment, 1 refused to continue with dual therapy, 1 patient experienced adverse event (liver lesion) and 1 was discontinued for reimbursement reasons.

Conclusion
In the presented small cohort of patients with refractory ulcerative colitis, in whom other modalities were depleted or colectomy was considered, combined vedolizumab and tofacitinib treatment has proven to be efficient with half of the patients reaching mucosal healing after 6 months and without raising significant safety concerns.
P418 Dose escalation of oral 5-aminosalicylic acid for ulcerative colitis with Mayo endoscopic subscore of one improves long-term prognosis: a one-year multicentre, open-label, randomized controlled trial.
Authors: Aoki Y , Fukuda T , Kiyohara H , Yokoyama A , Nakazawa A , Yoshimatsu Y , Sugimoto S , Nanki K , Mikami Y , Fukuhara K , Mizuno S , Sujino T , Mutaguchi M , Takabayashi K , Morohoshi Y , Hosoda Y , Ogata H , Iwao Y , Naganuma M , Kanai T 
Published: January 2023

Abstract

Background
Endoscopic healing, one of the treatment targets for ulcerative colitis (UC), is commonly defined as Mayo endoscopic sub-score (MES) ≤1. Furthermore, patients in whom MES of 0 is achieved are at a lower risk of relapse than those with MES of 1. However, it is unclarified whether the therapeutic intervention of dose escalation of oral 5-aminosalicylic acid (5-ASA) improves the prognosis of UC patients in clinical remission with MES of 1.

Methods
A multicentre, open-label, randomized, controlled trial was conducted among 5 hospitals in Japan from March 2018 to June 2022. Patients with UC, aged 16 years or older, treated with 5-ASA, in clinical remission and confirmed MES of 1 were enrolled. Patients receiving maintenance therapy other than oral 5-ASA and thiopurine (e.g., topical therapy, biologics) were excluded. Patients were randomly assigned to either the therapeutic intervention group (increased the dose of 5-ASA) or the control group (without any intervention). Concomitant use of immunomodulator (IM) was used for the stratification factor in the randomization. The primary endpoint was clinical relapse within one year. Relapse was defined as both (1) pMayo ≥3 or rectal bleeding sub-score ≥1, and (2) addition of any induction treatments for UC including topical agents. Predictive factors for relapse and adverse events (AEs) were investigated as the secondary outcomes. The predictive factors were explored in the multivariable Cox regression analysis.

Results
Eighty-one patients were enrolled and randomly assigned into the therapeutic intervention or the control group, and two patients were excluded due to important protocol violations after the randomization. Finally, 79 patients (n=39; therapeutic intervention, n=40; control) were included in the full analysis set (FAS). In the FAS, 46 (58.2%) patients were male, and 20 (25.3%) patients were treated with IMs. The relapse within one year was less in the therapeutic intervention group (6/39; 15.4%) than the control group (15/40; 37.5%), significantly (P =0.026) (Fig.1). In the exploratory analysis for the predictors, concomitant use of IM was associated with relapse (hazard ratio, 2.52; 95% confidence interval, 1.04-6.12, P =0.041). There were three AEs in the therapeutic intervention group. Two patients complained of nausea, and the other complained of diarrhea and melena. All the AEs were improved after turning back the treatment to that before the intervention.

Fig. 1. The proportion of patients relapsed within one year in the full analysis set (primary analysis).

Conclusion
The dose escalation of oral 5-ASA reduced the relapse within one year in UC patients in clinical remission with MES of 1.
P421 Real-world effectiveness and safety of vedolizumab induction therapy for Crohn’s disease in Poland – a prospective, observational POLONEZ II study considering patients reported outcomes
Authors: Liebert A , Kłopocka M , Cichoż-Lach H , Michalak A , Talar-Wojnarowska R , Domżał-Magrowska D , Filipiuk A , Krogulecki M , Kopertowska-Majchrzak M , Eder P , Stawczyk-Eder K , Waszak K , Zagórowicz E , Wojciechowski K , Drygała S 
Published: January 2023

Abstract

Background
Vedolizumab (VDZ) is a gut-selective anti-lymphocyte trafficking drug, used to treat ulcerative colitis (UC) and Crohn’s disease (CD), lifelong conditions with unknown aetiology with frequent relapses and remitting course which are a burden for patients and a challenge for health care systems. We aimed to evaluate the real-world effectiveness of VDZ induction therapy for Polish patients with CD.

Methods
This was a multicenter, observational, prospective study involving patients with moderately to severely active CD qualified for reimbursed treatment with VDZ in 10 Polish centers between Apr 2020 and Nov 2021. The primary endpoints were clinical response (≥ 70-point reduction in Crohn's Disease Activity Index, CDAI) and remission rate (CDAI ≤ 150) at week 14. Other endpoints included changes from baseline (week 0, first dose of VDZ) to week 14 for patient-reported outcomes (PROs): quality of life (Inflammatory Bowel Disease Questionnaire, IBDQ), fatigue (Inflammatory Bowel Disease-Fatigue Self-assessment Scale, IBD-F), stool frequency (SF score) and abdominal pain score (APS).

Results
A total of 98 patients with CD were enrolled in the study. At baseline, the most common disease location in the cohort was ileocolonic CD (n=70/98, 72.9%). Fifty patients (51%) were on corticosteroids at week 0. Nine patients discontinued VDZ therapy before or at week 14, mainly due to lack of response (n=6/9, 66.7%). At week 14, 63.3% of patients (n=62/98) achieved clinical remission and 30% (n=15/50) steroid-free remission. Clinical response rate in overall study population was 90.8% (n=89/98). Median CDAI score decreased from 336.5 to 108.0 (p&lt;0.001) at week 14 (Fig. 1). Declines from baseline were also observed in median CDAI sub-scores: SF score (38.0 vs 10.0; p&lt;0.001) and APS (18.0 vs 2.0; p&lt;0.001) (Fig. 1). At week 14, median changes from baseline scores on the IBDQ (total and all subscales) were statistically significant (p&lt;0.001) (Fig. 2). Improvement was also observed after the VDZ 14-week treatment period in fatigue severity and frequency (p&lt;0.01) as well as its impact on daily activities (p&lt;0.001) based on IBD-F (Fig. 3). The percentage of patients without concomitant corticosteroids increased more than 1.5-fold from week 0 (49.0%) to week 14 (76.3%).

Conclusion
VDZ is effective in induction therapy and has significant impact on disease activity and Health-Related Quality of Life (HRQL) including fatigue in patients with CD.
P422 Transition from intravenous to subcutaneous infliximab and vedolizumab: adherence, satisfaction and safety profile in a cohort of patients with Inflammatory Bowel Disease
Authors: Todeschini A , Geccherle A , Signoretto P , Fasoli E , Variola A 
Published: January 2023

Abstract

Background
Inflammatory Bowel Disease (IBD), Ulcerative Colitis (UC) and Crohn’s Disease (CD), is a group of chronic inflammatory disorders. Biologics are indicated for patients failing conventional maintenance therapy with moderate to severe activity. Different routes of administration, intravenous (IV), subcutaneous (SC) or oral have been approved. For chronic diseases such as IBD, some patients may prefer self-administered SC dosing to IV dosing as a less time-intensive and more convenient treatment option. This aims to assess acceptance, safety and satisfaction of transition from IV to SC administration of infliximab (IFX) and vedolizumab (VDZ) in cohort of patients with IBD.

Methods
The transition from IV to SC administration was proposed to 91 patients. All patients were given two questionnaire: (a) before the switch, focused on the impact of the IV administration on their life and (b) 8 weeks after the switch focused on the level of satisfaction and onset of adverse event (AE). Data on medical history and treatment was collected from electronic health records.

Results
Overall, 91 patients were enrolled for switching from IV to SC therapy. All patients filled the first questionnaire. The IV therapy did not or minimally burden on patients’ life in 71% and 15 patients (16%) refused the transition. The main reasons why patients preferred to stay on IV administration were the fear of reducing follow-up visit with IBD staff and the fear of doing the therapy outside the hospital. On the other hand, 76 patients accepted and 8 weeks after the transition they completed the second questionnaire. of these 76, 39 CD and 51 male, 41 (53%) were treated with VDZ and the majority of patients (53%) were at the first line of treatment. Most of patients (67%) did not experience any difficulties in handling the device but “only” the 65% respected the correct time-table of administration. 20% of patients report at least one AE, the most common were erythema, swelling and pain in the injection site. Only the 5% should switch back to IV treament. 8 patients (10%) were switched back to IV administration due to AEs and 1 swaped to Ustekinumab.

Conclusion
In this cohort of IBD patients, we found a good acceptance rate (83.5%). The vast majority of patients (95%) was satisfied of transition from IV to SC. Moreover, we reported a good safety profile of SC therapy, AEs were mostly self-limited and local.
P427 One Year Follow up of Three Phase IB/IIA Clinical Trials of Ex Vivo Expanded Allogeneic Bone Marrow Derived Mesenchymal Stem Cells for the Treatment of Fistulizing Crohn’s Disease
Authors: Lightner A , Otero Pineiro A , Reese J , Ream J , Nachand D , Obi M , Adams A , VanDenBossche A , Dadgar N , Hull T 
Published: January 2023

Abstract

Background
Mesenchymal stem cells (MSCs) have been used for the treatment of perianal Crohn’s fistulizing disease by direction injection. However, to date, studies have excluded patients with proctitis, anal canal involvement, vaginal involvement, and an ileal pouch in situ. We sought to assess the safety and efficacy of a direct injection of MSCs for the treatment of perianal, rectovaginal, and peripouch Crohn’s fistula(s).

Methods
Three phase IB/IIA randomized control trials of perianal (n=23), rectovaginal (n=19) and peripouch (n=22) Crohn’s related fistulas were conducted to determine safety and efficacy of MSCs for refractory phenotypes of perianal Crohn’s disease. Crohn’s patients with perianal, rectovaginal, and peripouch Crohn’s fistulizing disease were offered enrollment into a clinical trial. A total of 75 million MSCs were administered with a 22G needle by direct injection after curettage and primary closure of the fistula tract. A repeat injection of 75 million MSCs was administered at 3 months if complete clinical and radiographic healing were not achieved. Adverse and serious adverse events were collected at post procedure day 1, week 2, week 6, month 3, month 6 and month 12. Clinical healing, radiographic healing per magnetic resonance imaging, and patient reported outcomes were assessed at the same time points.

Results
A total of 64 patients were enrolled and treated; 49 were treatment and 15 were control. There were no adverse or serious adverse events reported related to investigational product. At twelve months, overall combined clinical and radiographic healing was achieved in 70% of perianal, 37.5% of rectovaginal, and 46.2% of ileal pouch fistulas, respectfully. In the control cohorts, 12 month healing was 0%, 0%, and 0% in the three clincial trials respectively. The perianal Crohn’s disease activity index and VanAssche score all significantly decreased in treatment patients at six and twelve months, but not in the control groups.

Conclusion
Allogeneic bone marrow derived MSCs offer a safe and effective alternative treatment approach for severe phenotypes of perianal fistulizing Crohn’s disease.
P429 Patient skeletal muscle area and postoperative clinical recurrence in Crohn’s disease: a retrospective study
Authors: Inniss S , Simpson K , Fragkos K , Wood C , Smith A , Rahman F 
Published: January 2023

Abstract

Background
Sarcopenia, a reduction in muscle mass and function, is a poorly recognised phenomenon in Crohn’s disease (CD) despite occurring in 16%-68% of CD patients [1-5]. It has been linked to both an increased need for surgery and increased risk of postoperative complications. However, the role of sarcopenia in CD and its long-term impact on surgical outcomes are unknown. We aimed to assess the link between sarcopenia and postoperative clinical recurrence.

Methods
Retrospective data was collected between 2015 and 2021 from CD patients who had undergone gastrointestinal surgery and a MR or CT scan within 3 months prior to surgery. Follow up data was retrospectively collected for 6 months. MR and CT scans were used to determine skeletal muscle area (SMA) from the cross-sectional L3 vertebrae, which was used to identify patients as sarcopenic or not. Clinical recurrence was defined as a Harvey-Bradshaw Index of 5 or more. Statistical analysis included demographics and inferential analyses. Missing data was attributed to the absence in clinic notes.

Results
This single centre study included 64 CD patients [56.3% male, median age of 30.0 (18.0-76.0), 87.7% non-smokers] who had undergone gastrointestinal surgery. Most patients had ileocolonic CD (74.6%, 47/63) and either stricturing (46.9%, 30/64) or penetrating (31.3%, 20/64) disease behaviour, and 23.4% (15/64) had perianal disease. 45.3% (29/64) of patients had had at least one previous surgery. Preoperatively, 20.6% (13/63) of patients were on steroids and 55.6% (35/63) were on combined drug therapy. Patient median SMA was 113.6 (61.8 – 281.7) cm2 with sarcopenia found in 74.1% (43/58) of patients. SMA was lower in females (females: 92.1±19.3 cm2 vs males: 137±39.5 cm2, p&lt;0.001) and patients with a BMI&lt;18.5 kg/m2 (BMI&lt;18.5 kg/m2: 91.8±19.1 cm2 vs BMI≥18.5 kg /m2: 120.3±33.3 cm2, p=0.004) (figure 1). Postoperative clinical recurrence was observed in 17.8% (8/45) of patients at 6 months. Patients with clinical recurrence had a significantly lower SMA (87.4 ± 18.5 cm2) compared to those without clinical recurrence (120.9 ± 39.2 cm2) (p=0.001) (figure 2). Patients with a lower SMA were 1.1 times more likely to have clinical recurrence at 6 months compared to patients with a higher SMA (OR 1.05 (CI 1.01-1.10)(p=0.022)).

Conclusion
Sarcopenia is highly prevalent in preoperative CD patients. Patients with early clinical recurrence had a significantly lower SMA. SMA may be useful in predicting CD patients at risk of early postoperative clinical recurrence. However, more research is needed to confirm study findings.
P430 Mesalazine dose modification based on fecal calprotectin levels in ulcerative colitis patients in clinical remission
Authors: Piñero G S , Mañosa M , Cañete F , Calafat M , González L , Ruffinengo O , Domènech E 
Published: January 2023

Abstract

Background
Mesalazine is the most widely used maintenance therapy for ulcerative colitis (UC). The lowest effective dose recommended is 2g/day, although higher doses are often prescribed. Fecal calprotectin (FC) is a monitoring biomarker that correlates well with endoscopic remission and predicts clinical relapse. Our aim was to evaluate the suitability of mesalazine dose modification based on FC levels in asymptomatic UC patients.

Methods
Retrospective study in asymptomatic UC patients treated with oral mesalazine therapy which dose was modified in clinical practice according to FC levels between 2016-2022. Sustained clinical remission, clinical relapse and treatment escalation (increase in dose or introduction of rescue therapy) after dose change were assessed during follow-up.

Results
Mesalazine dose was reduced in 47 patients because of persistent low FC (mean 36ug/g; IQR 22-85); 51% extensive UC, median age of 55 years (IQR 43-63), median duration of clinical remission before dose-reduction 17 months (IQR 8-32) and mean baseline dose 3.2g/day (IQR 2-4). Mesalazine was reduced to 2g/day (IQR 0-2.4). A FC value &gt;250 ug/g was observed at least once in 10% of subjects during follow-up. The cumulative probability of maintaining clinical remission after dose reduction was 90% and 82% at 12 and 24 months, respectively. Rescue therapy was used in 27%, 17% being corticosteroids.
In 17 patients, mesalazine dose was increased due to high FC levels (mean 524ug/g; IQR 393-739); 47% extensive UC, median age 54 years (IQR 39-72), median duration of clinical remission before dose increase 16 months (IQR 11-33) and mean baseline dose 2.4g/day (IQR 1.5 -2.4). Dose was increased to 3.2g/day (IQR 3-4.4) and 58% presented FC &lt;250 ug/g at least once during the follow-up. The cumulative probability of clinical recurrence after dose escalation was 14% and 28% at 12 and 24 months, respectively, and 29% needed rescue therapy (6% steroids).

Conclusion
Mesalazine dose modification based on CF levels in asymptomatic patients with UC appears to be a safe strategy and is followed by a low probability of clinical recurrence in the mid-term.