scholarly journals P276 Influence of vedolizumab on extraintestinal manifestations in Inflammatory Bowel Disease: a nationwide multicenter study of the GETECCU Eneida registry

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S308-S309
Author(s):  
P Pérez Galindo ◽  
J P Gisbert ◽  
M Carrillo-Palau ◽  
F Bertoletti ◽  
M González-Vivó ◽  
...  

Abstract Background Evidence regarding vedolizumab (VDZ) influence on extraintestinal manifestations (EIMs) in inflammatory bowel disease patients (IBD) is scarce. Our aim was to analyze the effectiveness of VDZ in pre-existing EIMs and the occurrence of de novo EIMs during VDZ therapy in IBD. Methods We performed an observational, multicenter, retrospective cohort study including patients from the Spanish ENEIDA registry promoted by GETECCU. We retrospectively identified 551 patients from 20 centers. The co-primary outcomes were to evaluate the response of EIMs to VDZ and to assess the frequency of de novo EIMs during therapy. Secondary outcomes were to analyze associated factors with EIMs response to VDZ, time from VDZ initiation to occurrence of de novo EIMs and the discontinuation rate of VDZ because of worsening/de novo EIMs. Response and worsening of IBD and EIMs were defined by clinical and laboratory criteria according to the physician’s assessment. Results The median age of the cohort was 49.7 years (IQR 38-60), 50.8% were female, 50.8% had Crohn’s disease and 90.4% had prior biologic exposure (more than 1 biologic drug in 57.9%). At baseline 133 patients (24.1%) had pre-existing EIMs of whom 21 showed more than 1 EIM; 76.7% of EIMs were articular and 31% cutaneous. Regarding 77 patients with active EIMs at baseline, response of EIMs to VDZ at 3 months was observed in 23 (29.9%), worsening in 13 (16.9%) and no change in 41 (53.2%). Response rates for active EIMs were 35.4% for peripheral arthritis (PA), 11.8% for axial arthropathy (AA), 35.7% for cutaneous EIMs and 33.3% for ocular EIMs. Response of IBD at 3 months was the only associated factor with response of EIMs to VDZ (OR=3.72; CI 95% [1.08-12.83]). Among 56 patients with inactive EIMs at baseline, worsening of EIMs was observed in 5 patients after 12 months of VDZ therapy (13.5%) (3 cases of PA and 2 of AA). During follow-up 25 patients (4.5%) developed 27 de novo EIMs (17 cases of PA, 4 of AA, 4 of erythema nodosum, 1 of pyoderma gangrenosum and 1 of episcleritis). Median time from VDZ initiation to onset of de novo EIMs was 244 days (IQR 115-693). Presence of more than 1 pre-existing EIM was the only associated factor with de novo EIM onset during first year of VDZ therapy (OR=14.5; 95% CI [3.3-62]). Worsening of pre-existing EIMs or de novo EIMs was the cause of VDZ discontinuation in 15 patients (5.8% of all patients who discontinued VDZ). Conclusion VDZ achieved clinical response of active EIMs in nearly a third of patients after 3 months of therapy, being the response of IBD to VDZ the only associated factor. Worsening of inactive EIMs or de novo EIMs during VDZ therapy was infrequent.

2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 201-202
Author(s):  
Z Chattha ◽  
R Chattha ◽  
S Reza ◽  
M Moradshahi ◽  
M Fadida ◽  
...  

Abstract Background The relationship between older age and extraintestinal manifestations (EIMs) in patients with inflammatory bowel disease (IBD) remains unknown. Aims This study aims to determine whether older age is associated with increased risk of EIMs in IBD patients. Methods This was a retrospective study of IBD patients seen at the McMaster University Medical Centre, in Hamilton, ON, Canada from 2012–2020. Patients were identified to have the primary outcome of interest if their gastroenterologist documented the presence of any EIM either during the baseline assessment or during the period of follow up. The independent variable, age at start of follow-up, was dichotomized into two categories age >=40 vs. <40.Prior knowledge in combination with forward selection was used to develop a logistic regression model. The variables utilized for the forward selection model included gender, disease duration, and current biologic use. Results A total of 995 IBD patients (625 with CD) were considered for the regression analysis, all for whom the EIM status was recorded. Out of the 995 patients, 270 patients reported at least one EIM – 99 with arthritis/arthralgia, 79 with dermatologic manifestations, 16 with ophthalmic manifestations, 30 with liver manifestations, and 116 with other EIMs. A univariate regression analysis foundincreased odds of EIMs in older patientsas compared to younger patients (odds ratio (OR) 1.41 (95% CI, 1.05 – 1.89)). In the multivariate regression analysis, current biologic use was found to have a significant relationship with odds of having EIMs (OR 1.49; 95% CI, 1.06 – 2.09). After adjustment for biologic use, patients aged 40 or over had 1.46 times higher odds of having EIMs (95% CI 1.03 – 2.05). A sub-analysis of individual EIM categoriesdid not show a significant association with older age. Conclusions Older age is associated with increased risk of EIMs in IBD patients. Patients with EIMs were also more likely to be treated with biological therapies. Clinicians should inquire about the presence of EIMs in older IBD patients. Funding Agencies None


2018 ◽  
Vol 154 (6) ◽  
pp. S-360 ◽  
Author(s):  
Su Bin Kim ◽  
Liege I. Diaz ◽  
Fernando Calmet ◽  
Maria A. Quintero ◽  
Ingrid Schwartz ◽  
...  

Author(s):  
Guilherme Piovezani Ramos ◽  
Christina Dimopoulos ◽  
Nicholas M McDonald ◽  
Laurens P Janssens ◽  
Kenneth W Hung ◽  
...  

Abstract Background There are limited data on how vedolizumab (VDZ) impacts extraintestinal manifestations (EIMs) in inflammatory bowel disease (IBD). The aim of this study was to determine the clinical outcomes of EIMs after initiation of VDZ for patients with IBD. Methods A multicenter retrospective study of patients with IBD who received at least 1 dose of VDZ between January 1, 2014 and August 1, 2019 was conducted. The primary outcome was the rate of worsening EIMs after VDZ. Secondary outcomes were factors associated with worsening EIMs and peripheral arthritis (PA) specifically after VDZ. Results A total of 201 patients with IBD (72.6% with Crohn disease; median age 38.4 years (interquartile range, 29-52.4 years); 62.2% female) with EIMs before VDZ treatment were included. The most common type of EIM before VDZ was peripheral arthritis (PA) (68.2%). Worsening of EIMs after VDZ occurred in 34.8% of patients. There were no statistically significant differences between the worsened EIM (n = 70) and the stable EIM (n = 131) groups in term of age, IBD subtype, or previous and current medical therapy. We found that PA was significantly more common in the worsening EIM group (84.3% vs 59.6%; P < 0.01). Worsening of EIMs was associated with a higher rate of discontinuation of VDZ during study follow-up when compared with the stable EIM group (61.4% vs 44%; P = 0.02). Treatment using VDZ was discontinued specifically because of EIMs in 9.5% of patients. Conclusions Almost one-third of patients had worsening EIMs after VDZ, which resulted in VDZ discontinuation in approximately 10% of patients. Previous biologic use or concurrent immunosuppressant or corticosteroid therapy did not predict EIM course after VDZ.


2021 ◽  
Vol 4 (Supplement_1) ◽  
pp. 207-209
Author(s):  
A Eindor ◽  
L Meleady ◽  
L Alam ◽  
K Gena ◽  
Z Hamilton ◽  
...  

Abstract Background Early onset inflammatory bowel disease (EOIBD) and Very early onset inflammatory bowel disease (VEOIBD) prevalence has been increasing over the last decades. These young patients have been known to have special disease characteristics and disease location. Although it is known that only a low percentage of these patients require biologic treatment after diagnosis, there is only scarce evidence about their long- term outcome and biologic requirements. Aims To assess the ten year outcome of early onset and very early onset IBD patients. Methods We retrospectively reviewed IBD patients diagnosed under 10 years of age, between January 2005 and December 2009, from the British Columbia (BC) Pediatric IBD database. Disease characteristics and symptoms at diagnosis were documented. The disease location and severity at diagnosis were documented according to the Paris classification. Data collected retrospectively included a ten year treatment follow up period, number of hospitalizations, corticosteroid courses and surgeries. These parameters were documented at three time points: after the first year, after five years and ten years. Results 68 patients under the age of 10 were diagnosed with IBD during the study period. 2 patients failed to meet inclusion criteria and were excluded. Median age at diagnosis was 6.06 (IQR 4.5–8.6). 47.7% of patients had Crohn’s disease and 71.2% were males. 63 patients completed the 5 year follow up, and 52 the 10-year period due to lack of follow up or transfer to adult care. After the first year of follow up 0% patients in the VEOIBD group and 5% patients in the EOIBD group were treated with biologic treatment, whereas after the 10-year period 42.3% and 29.6% of patients were treated with biologic therapy respectively (p=0.282). Overall, 4 patients underwent colectomy and 2 a small bowel resection. Conclusions Although the percentage of VEIBD and EOIBD patients receiving biologic treatment after ten years is higher than after the first year, it is still lower than what is reported in the literature in older pediatric IBD patients and adults. Funding Agencies None


2020 ◽  
Vol 30 (Supplement_5) ◽  
Author(s):  
C Cassieri ◽  
A M Mastromatteo ◽  
R Pica ◽  
M Zippi ◽  
E S Corazziari ◽  
...  

Abstract Background Azathioprine (AZA) and thiopurine are widely used for induction and maintenance of remission in steroid dependent patients with inflammatory bowel disease (IBD). Methods Aim of this study has been to investigate its efficacy and safety in maintaining steroid-free remission in steroid dependent IBD patients seven year after the institution of treatment. Data from consecutive IBD outpatients referred in our Institution, between 1985-2016, were reviewed and all patients treated with AZA were included in this retrospective study. AZA was administered at the recommended dose of 2-2.5 mg/kg. Results Out of 2802 consecutive IBD outpatients visited in the index period, AZA was prescribed to 433 patients, 236 (54.5%) were affected by Crohn's disease (CD) and 197 (45.5%) by ulcerative colitis (UC). One hundred and seventy-nine patients with a follow-up < 84 months were excluded from the study. Two hundred and fifty-four patients were evaluated, 141 (55.5%) with CD and 113 (44.5%) with UC. One hundred and thirty-nine (54.7%) were male and 115 (45.3%) female (average age of 35.62 ± 14.20 SD years, range 14-74 y.). Seven year after the institution of treatment, 127 (50%) patients still were in steroid-free remission (83 CD vs 44 UC, 58.8% and 38.9%, respectively, p = 0.0024), 71 (27.9%) had a relapse requiring retreatment with steroids (29 CD vs 42 UC, 20.6% and 37.2%, respectively, p = 0.0047), 56 (22.1%) discontinued the treatment due to side effects (29 CD vs 27 UC, 20.6% and 23.9%, respectively). Loss of response from 1st to 7th year of follow-up was low, about 20%. Conclusions Seven year after the onset of treatment 50% of patients did not require further steroid courses. After the first year loss of response was low in six subsequent years. In the present series the maintenance of steroid-free remission was significantly higher in CD than in UC patients. The occurrence of side effects leading to the withdrawal of AZA treatment has been low. Key messages An important therapeutic moment of IBD is mantaining remission in steroid dipendent patients. AZA can be a viable and inexpensive alternative to treath these patients.


2020 ◽  
Vol 14 (7) ◽  
pp. 896-903 ◽  
Author(s):  
Antoine Martin ◽  
Maria Nachury ◽  
Laurent Peyrin-Biroulet ◽  
Yoram Bouhnik ◽  
Stephane Nancey ◽  
...  

Abstract Background and Aim It is unclear whether vedolizumab therapy can be discontinued in patients with inflammatory bowel disease [IBD] after achieving steroid-free clinical remission. The aim was to assess the risk of relapse after vedolizumab therapy was discontinued. Methods This was a retrospective observational study, collecting data from 21 tertiary centres affiliated with the GETAID from January 2017 to April 2019. Consecutive patients with IBD, who were in steroid-free clinical remission for at least 3 months and were treated with vedolizumab for at least 6 months, were included at the time of vedolizumab discontinuation. Results A total of 95 patients [58 with Crohn’s disease] discontinued vedolizumab after a median duration of therapy of 17.5 [10.6–25.4] months. After a median follow-up period of 11.2 [5.8–17.7] months, 61 [64%] patients experienced disease relapse. The probabilities of relapse-free survival were 83%, 59%, and 36% at 6, 12, and 18 months, respectively. According to the multivariate analysis, a C-reactive protein level less than 5 mg/L at vedolizumab discontinuation (hazard ratio [HR] = 0.56, 95% confidence interval [CI] [0.33–0.95], p = 0.03) and discontinuation due to patients’ elective choice (HR = 0.41, 95% CI [0.21–0.80], p = 0.009) were significantly associated with a lower risk of relapse. Re-treatment with vedolizumab was noted in 24 patients and provided steroid-free clinical remission in 71% and 62.5% at Week 14 and after a median follow-up of 11.0 [5.4–13.3] months, respectively, without any infusion reactions. Conclusions In this retrospective study, two-thirds of patients with IBD treated with vedolizumab experienced relapse within the first year after vedolizumab discontinuation. Re-treatment with vedolizumab was effective in two-thirds of patients.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1146-1147
Author(s):  
G. K. Yardimci ◽  
O. C. İçaçan ◽  
G. Kabadayi ◽  
B. Farisoğullari ◽  
B. Armagan ◽  
...  

Background:Patients with active inflammatory bowel diseases (IBD) fecal calprotectin (FC) levels are high and FC can be used for diagnosis [1].Objectives:This study aimed to investigate whether fecal calprotectin levels could predict future development of IBD in axSpA patients.Methods:This study was practiced in three centers using TReasure database and that are able to measure FC. Fecal calprotectin levels were measured in 137 axSpA patients as of September 2018 and FC level ≥200 µg/g was considered significant. All study subjects were evaluated for IBD symptoms (loose defecation, mucous diarrhea, bloody defecation, bloody diarrhea, abdominal pain, obstruction, or pseudo-obstruction) at beginning of the study and every 3 months for the first year. 25 RA patients and 24 healthy volunteers were included as a control group. Disease activity was evaluated by the ASDAS CRP, BASDAI,BASFI, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), visual analog scale (VAS)-pain, VAS-fatigue, and tender and swollen joint count for axSpA patients.Results:This study included 137 axSpA patients and all patients followed for 1 year. Of the 137 axSpA patients 33.6% were females and median (Q1-Q3) age was of 43 years (33-50 years), median (Q1-Q3) disease duration was 8.9 years (5.0-13.9 years). The median (Q1-Q3) fecal calprotectin level was 48 µg/g (30-122 µg/g) and FC level was ≥200 µg/g in 23/137 (16.8%) in axSpA patients. FC level was elevated in 15/24 (62.5%) RA patients and none of the healthy volunteers. Patients median (Q1-Q3) BASDAI was 2.2 (1.0-3.6) / 1.4 (0.4-2.2), median (Q1-Q3) BASFI 1.55 (0.4-3.4) / 1.5 (0.3-3.0) and median (Q1-Q3) ASDAS CRP 1.63 (1.3-2.2) / 1.5 (1.3-1.9) at baseline and first year respectively and there was no difference regarding fecal calprotectin level. In 1 year follow-up 9 (6.5%) patient had abdominal pain, 2 (1.4%) had bloody defecation, 1 (0.7%) had loose defecation and Crohn disease developed in an axSpA patient with high FC (266 µg/g) (Table 1). IBD occurrence rate was 0.73/100 patient-year for all SpA patients, and IBD occurrence rate was 4.34/100 patients year for SpA patients with ≥200 µg/g FC level.Table 1.IBD symptom inquiry and development of IBD in the first yearn (%)Loose defecation1 (0.73)Mucous diarrhea0Bloody defecation2 (1.45)Bloody diarrhea0Abdominal pain9 (6.56)Obstruction0Pseudo-obstruction0Inflammatory bowel disease1 (0.73)Conclusion:In one year follow-up, IBD occurrence rate was 0.73/100 patient-year, at a similar rate with DESIR cohort [2]. However, FC level may be a predictor for the development of IBD in SpA patients (occurrence rate 4.34/100 patients year). Further follow up duration and more patients may be needed to make conclusion in these field.References:[1]Simioni, J., et al.,Fecal Calprotectin, Gut Inflammation and Spondyloarthritis.Arch Med Res, 2019.50(1): p. 41-46.[2]Wendling, D., et al.,Effect of Gut Involvement in Patients with High Probability of Early Spondyloarthritis: Data from the DESIR Cohort.J Rheumatol, 2019.Disclosure of Interests:Gözde Kübra Yardimci: None declared, Ozan Cemal İçaçan: None declared, Gokhan Kabadayi: None declared, Bayram Farisoğullari: None declared, Berkan Armagan: None declared, Cemal Bes: None declared, Servet Akar: None declared, Umut Kalyoncu Consultant of: Abbvie, Amgen, Janssen, Lilly, Novartis, UCB


2016 ◽  
Vol 82 (10) ◽  
pp. 977-981 ◽  
Author(s):  
Karen Zaghiyan ◽  
Jan P. Kaminski ◽  
Galinos Barmparas ◽  
Phillip Fleshner

The risk of de novo Crohn's disease (CD) after ileal pouch-anal anastomosis (IPAA) for ulcerative colitis (UC) versus inflammatory bowel disease unclassified (IBDU) or indeterminate colitis (IC) remains debatable. Here, we present updated results after long-term follow-up of a previously studied cohort of 334 patients with UC, IBDU, or IC who underwent IPAA during a 10-year period ending 2007. Of 334 study patients, 56 per cent were male and median age was 38 years (range: 8–81). Patients were classified as UC (n = 237) or IBDU (n = 97) preoperatively and UC (n = 236) or IC (n = 98) postoperatively. After a median follow-up of 76 months (range: 3–236), 63 patients (19%) developed CD within a median of 22 months (range: 1–213) from ileostomy closure compared with the previously published 40 patients (12%) with 26-month follow-up ( P = 0.01). The development of de novo CD was similar for patients undergoing IPAA for UC (n = 40; 17%), IBDU (n = 21; 22%) or those classified as having UC (n = 42; 18%) or IC (n = 19; 19%) postoperatively; P > 0.05. Thus, patients with IBDU and IC can expect equivalent long-term outcome to patients with UC after IPAA. Pouch failure occurred in 13 (4%) study patients and was equal among all four groups.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S412-S414
Author(s):  
U Kopylov ◽  
J Burisch ◽  
S Ben-Horin ◽  
F Braegger ◽  
A Fernández-Nistal ◽  
...  

Abstract Background Vedolizumab is an α4β7 integrin monoclonal antibody indicated for moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). There are limited data on how vedolizumab impacts extraintestinal manifestations (EIM) in inflammatory bowel disease (IBD). The aim of the study was to analyse the effect of vedolizumab on EIM in a real-world cohort of IBD patients. Methods A multicentre retrospective study was conducted in Belgium, Denmark, Israel, the Netherlands and Switzerland. Adult patients with moderately to severely active IBD and concurrent active EIM with at least 6 months follow-up after vedolizumab initiation (index date) were enrolled. Improvement of EIM was defined as absence of symptoms (resolution) or partial response (reduction of symptoms). Results 99 patients were included (UC: 44, CD: 55); the majority of active EIM at index were musculoskeletal (Table 1). Median disease duration at index was 9 (IQR: 3-19) years and 77% of patients had been exposed to 1+ biologic. Overall, after 6 and 12 months of vedolizumab, 37% and 50% of EIM respectively were reported as improved, 22%, 25% as stable (no change) and 1% and 3% as worsened (Table 2), missing values were 5% and 4%, respectively. Median time since first EIM improvement was 0.5 months (Figure 1). At 6 and 12 months, 48% (10/21) and 33% (6/18) of patients experienced clinical response/remission of their IBD, respectively. Vedolizumab treatment persistence at 12 months was 83% overall (Figure 2). Adverse Events were reported for 18% patients; 96% of them non-serious. Conclusion Vedolizumab treatment was associated with an improvement in 37% and 50% of EIM at 6 and 12 months, respectively, in a real-world IBD cohort.


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