scholarly journals P574 Exploring treatment of Crohn’s disease and ulcerative colitis in the Middle East and Northern Africa: An analysis of the HARIR observational cohort study

2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S531-S532
Author(s):  
W Hamed ◽  
O E Salem ◽  
O Alharbi ◽  
M Sharaf ◽  
C Taylor ◽  
...  

Abstract Background This analysis of the HARIR study explored disease characteristics, treatment and outcomes of patients (pts) with diseases including Crohn’s disease (CD) or ulcerative colitis (UC) treated with biologics in clinical practice where data are limited: North Africa, the Middle East and Western Asia. Methods HARIR was a prospective, observational, multicentre, cohort, phase 4 study (NCT03006198). This analysis included adult pts with CD or UC who were starting infliximab, golimumab or ustekinumab (study period: March 2016–December 2018; terminated early). Pts needed to be previously untreated with study drugs or received ≤2 biologics prior to enrolment. Treatment was at physician’s discretion. Pts were followed for 1 year or until study withdrawal (amended from 2 years); pts who stopped the study due to study termination were considered to have completed the study. For CD, the main efficacy outcomes were Crohn’s Disease Activity Index (CDAI) treatment response, remission and change from baseline of inflammatory Bowel Disease Questionnaire (IBDQ). Adverse events (AEs) and serious AEs (SAEs) were recorded. Results A total of 86 pts with CD or UD from Algeria, Egypt, Kuwait, Qatar and Saudi Arabia were enrolled; 56 pts completed the study. Target enrolment was achieved for CD but was 1 pt short for UC. Mean (SD) age was 32.7 (11.5) years for CD and 29.6 (9.4) years for UC. Most pts with CD and UC had not previously received biologics (CD: 95.2%, 59/62; UC: 66.7%, 16/24). All pts with CD and UC received infliximab. Investigators noted lack of access to study drug and concomitant treatments as limiting factors for enrolment. Immunosuppressant use was low; methotrexate was used by 1 pt with UC prior to study treatment and azathioprine or mycophenolate mofetil were used by 19.4% (12/62) of pts with CD and 24.0% (6/25) of pts with UC during the study. At Month 3, 29.2% (14/48) of pts with CD had a positive treatment response (CDAI score ≥70 to ≥25% versus baseline; Figure). The percentage of pts with CD in clinical remission was 53.8% (28/52) at baseline and 70.8% (34/48) at Month 3 (Figure). Mean (SD) IBDQ score increased by 11.3 (39.6%) points from baseline to Month 3 (Figure). Overall, pt numbers were too low to analyse outcomes for CD after Month 3 and over the study duration for UC. In CD and UC, respectively, AEs were reported by 25.8% (16/62) and 37.5% (9/24) of pts and SAEs were reported by 12.9% (8/62) and 16.7% (4/24) of pts. Conclusion Infliximab treatment was well tolerated, and a moderate clinical response was observed for this Middle Eastern and Northern African population. Limited accessibility to biologics and concomitant treatments in these countries restricted conduct of the study.

2018 ◽  
Vol 12 (supplement_1) ◽  
pp. S355-S356
Author(s):  
B Jessen ◽  
D Lissner ◽  
E Sonnenberg ◽  
M Schumann ◽  
F Schmidt ◽  
...  

2018 ◽  
Vol 56 (10) ◽  
pp. 1267-1275 ◽  
Author(s):  
Angelika Hüppe ◽  
Jana Langbrandtner ◽  
Winfried Häuser ◽  
Heiner Raspe ◽  
Bernd Bokemeyer

Abstract Introduction Assessment of disease activity in Crohn’s disease (CD) and ulcerative colitis (UC) is usually based on the physician’s evaluation of clinical symptoms, endoscopic findings, and biomarker analysis. The German Inflammatory Bowel Disease Activity Index for CD (GIBDICD) and UC (GIBDIUC) uses data from patient-reported questionnaires. It is unclear to what extent the GIBDI agrees with the physicians’ documented activity indices. Methods Data from 2 studies were reanalyzed. In both, gastroenterologists had documented disease activity in UC with the partial Mayo Score (pMS) and in CD with the Harvey Bradshaw Index (HBI). Patient-completed GIBDI questionnaires had also been assessed. The analysis sample consisted of 151 UC and 150 CD patients. Kappa coefficients were determined as agreement measurements. Results Rank correlations were 0.56 (pMS, GIBDIUC) and 0.57 (HBI, GIBDICD), with p < 0.001. The absolute agreement for 2 categories of disease activity (remission yes/no) was 74.2 % (UC) and 76.6 % (CD), and for 4 categories (none/mild/moderate/severe) 60.3 % (UC) and 61.9 % (CD). The kappa values ranged between 0.47 for UC (2 categories) and 0.58 for CD (4 categories). Discussion There is satisfactory agreement of GIBDI with the physician-documented disease activity indices. GIBDI can be used in health care research without access to assessments of medical practitioners. In clinical practice, the index offers a supplementary source of information.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Carlijn R. Lamers ◽  
Nicole M. de Roos ◽  
Ben J. M. Witteman

Abstract Background Diet may play a role in disease status in patients with inflammatory bowel disease. We tested whether the inflammatory potential of diet, based on a summation of pro- and anti-inflammatory nutrients, is associated with disease activity in patients with Crohn’s disease and ulcerative colitis. Methods Participants completed a disease activity questionnaire (short Crohn’s Disease Activity (sCDAI) or Patient Simple Clinical Colitis Activity Index (P-SCCAI)) and a Food Frequency Questionnaire (FFQ). FFQ data were used to calculate the Dietary Inflammatory Index (DII) which enables categorization of individuals’ diets according to their inflammatory potential on a continuum from pro- to anti-inflammatory. Associations with disease activity were investigated by multiple linear regression. Results The analysis included 329 participants; 168 with Crohn’s disease (median sCDAI score 93 [IQR 47–156]), and 161 with ulcerative colitis (median P-SCCAI score 1 [IQR 1–3]). Mean DII was 0.71 ± 1.33, suggesting a slightly pro-inflammatory diet. In Crohn’s disease, the DII was positively associated with disease activity, even after adjustment for confounders (p = 0.008). The mean DII was significantly different between participants in remission and with mild and moderately active disease (0.64, 0.97 and 1.52 respectively, p = 0.027). In ulcerative colitis, the association was not significant. Conclusions Disease activity was higher in IBD participants with a more pro-inflammatory diet with statistical significance in Crohn’s disease. Although the direction of causality is not clear, this association strengthens the role for diet in medical treatment, which should be tested in an intervention study.


2021 ◽  
Vol 19 (3) ◽  
pp. 5-13
Author(s):  
P.V. Shumilov ◽  
◽  
A.E. Shchigoleva ◽  

Objective. To clarify the incidence of monogenic IBD-like diseases and the features of clinical course and response to therapy of major types of inflammatory bowel diseases (IBD) among children under the age of 6 with manifestation of the disease. Patients and methods. The study included 135 children under the age of 6 with manifestation of IBD; in the comparison group, there were 128 children after the age of 6 with manifestation of IBD (97 children with ulcerative colitis (UC) and 31 children with Crohn’s disease (CD)) who were observed for at least 1 year. All children underwent a standard examination, including calprotectin and antineutrophil antibodies testing, determination of activity by the Pediatric Ulcerative Colitis Activity Index (PUCAI) or the Pediatric Crohn’s Disease Activity Index (PCDAI), depending on the nosology. Children with the onset of IBD under 6 years of age underwent a genetic testing using Primary Immunodeficiency Panel by next-generation sequencing. All children were analyzed for efficacy of therapy during catamnestic observation. Results. It was revealed that in the study group the incidence of monogenic IBD-like diseases was 6.7%, of UC – 71.1%, of CD – 22.2%. Major types of IBD with very early onset differed little in their clinical, endoscopic and laboratory features from the forms with manifestation at an older age. In most cases, both CD (57%) and UC (71%) were characterized by low activity. Very earlyonset CD was characterized by isolated localization of the colon (53%, p = 0.037) and a non-stenotic and non-penetrating behaviour of the disease (60% of cases). The leading clinical symptoms were diarrhea (67%) and blood in the stool (63%, p = 0.04). Very early-onset UC was characterized by total lesion of the colon (84%, p = 0.001) and the development of anemia (48%, p = 0.01). Among children with very early-onset UC, the percentage of glucocorticosteroid-dependence and glucocorticosteroid-resistance was high, but anti-TNFα therapy was prescribed late. Conclusion. It is advisable to observe children with very early-onset IBD in federal multidisciplinary clinics, where there is experience in managing patients with this pathology. Key words: inflammatory bowel disease, very early onset, Crohn’s disease, ulcerative colitis, primary immunodeficiency, treatment, children


Diagnostics ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. 1090
Author(s):  
Flavia Maria Pavel ◽  
Cosmin Mihai Vesa ◽  
Gina Gheorghe ◽  
Camelia C. Diaconu ◽  
Manuela Stoicescu ◽  
...  

Two different conditions are included in inflammatory bowel disease (IBD), Crohn’s disease (CD) and ulcerative colitis (UC), being distinguished by chronic recurrence of gut inflammation in persons that are genetically predisposed and subjected to environmental causative factors. The normal structure of the gut microbiome and its alterations in IBD were defined in several microbial studies. An important factor in the prolonged inflammatory process in IBD is the impaired microbiome or “dysbiosis”. Thus, gut microbiome management is likely to be an objective in IBD treatment. In this review, we analyzed the existing data regarding the pathophysiological/therapeutic implications of intestinal microflora in the development and evolution of IBD. Furthermore, the main effects generated by the administration of probiotics, prebiotics, fecal transplantation, and phytochemicals supplementation were analyzed regarding their potential roles in improving the clinical and biochemical status of patients suffering from Crohn’s disease (CD) and ulcerative colitis (UC), and are depicted in the sections/subsections of the present paper. Data from the literature give evidence in support of probiotic and prebiotic therapy, showing effects such as improving remission rate, improving macroscopic and microscopic aspects of IBD, reducing the pro-inflammatory cytokines and interleukins, and improving the disease activity index. Therefore, the additional benefits of these therapies should not be ignored as adjuvants to medical therapy.


2021 ◽  
Vol 12 ◽  
Author(s):  
Li Li ◽  
Rirong Chen ◽  
Yingfan Zhang ◽  
Gaoshi Zhou ◽  
Baili Chen ◽  
...  

BackgroundInfliximab is effective in inducing and maintaining remission in patients with Crohn’s disease (CD), but primary non-response (PNR) occurs in 10-30% of cases. We investigated whether serum biomarkers are effective in predicting PNR in patients with CD.MethodsFrom January 2016 to April 2020, a total of 260 patients were recruited to this prospective and retrospective cohort study. Serum samples were collected at baseline and week 2 of infliximab treatment. Serum levels of 35 cytokines were assessed in 18 patients from the discovery cohort and were further evaluated in the 60-patient cohort 1. Then, candidate cytokines and other serological biomarkers were used to construct a predictive model by logistic regression in a 182-patient cohort 2. PNR was defined based on the change of CD activity index or clinical symptoms.ResultsAmong the 35 cytokines, matrix metalloproteinase 3(MMP3) and C-C motif ligand 2 (CCL2) were two effective serum biomarkers associated with PNR in both the discovery cohort and cohort 1. In cohort 2, serum level of MMP3, CCL2 and C-reactive protein (CRP) at 2 weeks after infliximab injection were independent predictors of PNR, with odds ratios (95% confidence interval) of 1.108(1.059-1.159), 0.940(0.920-0.965) and 1.102(1.031-1.117), respectively. A PNR classifier combining these three indicators had a large area under the curve [0.896(95% CI:0.895-0.897)] and negative predictive value [0.918(95%CI:0.917-0.919)] to predict PNR to infliximab.ConclusionsMMP3, CCL2, and CRP are promising biomarkers in prediction of PNR to infliximab, and PNR classifier could accurately predict PNR and may be useful in clinical practice for therapy selection.


2010 ◽  
Vol 57 (3) ◽  
pp. 89-95 ◽  
Author(s):  
V. Gligorijevic ◽  
N. Spasic ◽  
D. Bojic ◽  
M. Protic ◽  
P. Svorcan ◽  
...  

AIM: To evaluate the role of pelvic MRI in diagnosis and assesment of combined surgical and infliximab treatment of perianal Crohn's disease (PACD). METHOD: 24 patients with signs of PACD were prospectively evaluated. They were previously treated with azathyoprin for a period of 6 months to 7 years and antibiotics and than started on Infliximab 5 mg/kg (IFX) at 0,2 and 6 weeks induction protocol. Luminal CD activity was assesed by colonoscopy. Perianal Disease Activity Index (PDAI) was calculated to evaluate perianal fistulae activity. Surgical examination under anesthesia (EUA) was performed and noncutting seton placed where appropriate. Pelvic MRI was performed in each patient before Infliximab treatment, and in half of the patients after IFX. MRI criteria were used to asses activity and remission of PACD. RESULTS: 14/24(58.5%) patients had ileocolitis, 10/24 (41.5%) colitis, and in 22/24(91.7%) rectum was affected. Median disease duration was 5.5+2.5 years. MRI revealed simple fistula in 4/24 (16.7%) and complex fistula in 20/24 (83.3%) patients. Abscess was present in 19/24(79%) patients. Enterocutaneous and recto-vaginal fistula was found in 2(8.3%) and 3(12.5%) patients, respectively. Median PDAI before and 8 weeks after IFX treatment was 8.3+2.08 and 3.5+1.03, respectively (p=0.00064). Incomplete response (reduction fistulae drainage by 50%) was found in 10/24(42%) patients, complete response (no drainage) in 11/24 (46%) patients, while in 3/24(12.5%) new fistula opened. Control pelvic MRI was performed in 13/24 (54%) patients. Of those, 9/13(69%) had complete remission according to MRI criteria. Seton was removed after second IFX dose in 15/24 (62.5%) patients and placed again in 2/24 (8%) patients 4 months after completion of IFX treatment. CONCLUSION: In patients with PACD, pelvic MRI before and after IFX treatment is an important diagnostic tool to asses fistula tract localization, reveal abscess, planning adequate treatment approach and assess the effect of treatment. Surgical decision to remove seton was in accordance with MRI criteria for remission in PACD.


2014 ◽  
Vol 132 (3) ◽  
pp. 140-146 ◽  
Author(s):  
Rodrigo Andrade Alves ◽  
Sender Jankiel Miszputen ◽  
Maria Stella Figueiredo

CONTEXT AND OBJECTIVES:Anemia is the most frequent extraintestinal complication of inflammatory bowel disease. This study aimed to: 1) determine the prevalence of anemia among patients with inflammatory bowel disease; 2) investigate whether routine laboratory markers are useful for diagnosing anemia; and 3) evaluate whether any association exists between anemia and clinical/laboratory variables.DESIGN AND SETTING:Cross-sectional at a federal university.METHODS:44 outpatients with Crohn's disease and 55 with ulcerative colitis were evaluated. Clinical variables (disease activity index, location of disease and pharmacological treatment) and laboratory variables (blood count, iron laboratory, vitamin B12 and folic acid) were investigated.RESULTS:Anemia and/or iron laboratory disorders were present in 75% of the patients with Crohn's disease and in 78.2% with ulcerative colitis. Anemia was observed in 20.5% of the patients with Crohn's disease and in 23.6% with ulcerative colitis. Iron-deficiency anemia was highly prevalent in patients with Crohn's disease (69.6%) and ulcerative colitis (76.7%). Anemia of chronic disease in combination with iron deficiency anemia was present in 3% of the patients with Crohn's disease and in 7% of the patients with ulcerative colitis. There was no association between anemia and disease location. In ulcerative colitis, anemia was associated with the disease activity index.CONCLUSIONS:Most patients present iron laboratory disorders, with or without anemia, mainly due to iron deficiency. The differential diagnosis between the two most prevalent types of anemia was made based on clinical data and routine laboratory tests. In ulcerative colitis, anemia was associated with the disease activity index.


2021 ◽  
Vol 15 (Supplement_1) ◽  
pp. S015-S016
Author(s):  
T Berger ◽  
H Miin Lee ◽  
L Ramasamy Padmanaban ◽  
E Wine ◽  
A Yerushalmi ◽  
...  

Abstract Background Isolated colonic (L2) Crohn’s disease (CD) in adults is thought to have unique clinical and genetic features compared with ileal (L1) CD and ulcerative colitis (UC). Similar studies in paediatrics are scarce. Our goal was to characterize the clinical features of paediatric patients with isolated colonic CD and compare them to patients with ileo-cecal CD and those with UC. Methods This was a multi-center retrospective study including 21 sites affiliated with the Porto IBD group and IBD interest group of ESPGHAN. Data of paediatric patients diagnosed between 2014–2017 with L1 or L2 CD, or with UC, was collected, including information on demographic, clinical and laboratory parameters at diagnosis, end of induction, 1 year and 3 years after diagnosis (or at last follow-up). Results Data was collected on 300 children (102 L1, 94 L2, 104 UC) with similar demographic features. At diagnosis, bloody stools were identified in 45% of L2 patients, compared with 15% and 95% of L1 and UC patients, respectively (P&lt;0.001), while fever was documented in 27% of L2 patients, compared to 13% and 3% of L1 and UC patients, respectively (P&lt;0.001). At the time of diagnosis, the median pediatric Crohn’s disease activity index for patients with L1 and L2 was 25 (IQR 17.5–37) and 27.5 (20–40), respectively, while the median pediatric ulcerative colitis activity index was 40 (30–55) for patients with UC. C-reactive protein levels were significantly higher among CD patients (both L1 and L2), compared to patients with UC, and calprotectin values were comparable. ASCA was positive in 55%, 25% and 2% (P&lt;0.001) and pANCA in 2%, 17% and 53% (P&lt;0.001) in L1, L2 and UC patients, respectively. Granulomas were identified in 36% of L2 patients, similar to patients with L1 (33%). For induction therapy, exclusive enteral nutrition, oral steroids and mesalazine were used in 50%, 45% and 38% of patients with L2 CD, compared with 72%, 28% and 9%, and 0%, 52% and 75% of L1 and UC patients, respectively (P&lt;0.001). Steroid-free clinical remission at the end of induction was overall similar between groups, around 55%. At 1-year post-diagnosis, 62%, 68% and 40% were on an immunomodulator (P=0.03) and 41%, 26% and 22% were receiving anti-TNFα agent (P=0.01), of patients with L1, L2 and UC, respectively. While time to initiation of an anti-TNFα agent was significantly shorter in L1 patients compared with L2 and UC (P=0.03), time to admission and time to surgery were similar. Conclusion Paediatric patients with isolated colonic CD exhibit several clinical features which differentiate them from ileo-cecal CD and UC. Prospective studies are required to understand the pathogenesis of this unique entity and define short- and long-term outcomes.


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