ABSTRACT
INTRODUCTION: Risk factors for developing pancreatitis due to thiopurines in patients with inflammatory bowel disease (IBD) are not clearly identified. Our aim was to evaluate the predictive pharmacogenetic risk of pancreatitis in IBD patients treated with thiopurines. METHODS: We conducted an observational pharmacogenetic study of acute pancreatitis events in a cohort study of IBD patients treated with thiopurines from the prospectively maintained ENEIDA registry biobank of GETECCU. Samples were obtained and the CASR, CEL, CFTR, CDLN2, CTRC, SPINK1, CPA1, and PRSS1 genes, selected based on their known association with pancreatitis, were fully sequenced. RESULTS: Ninety-five cases and 105 controls were enrolled; a total of 57% were women. Median age at pancreatitis diagnosis was 39 years. We identified 81 benign variants (50 in cases and 67 in controls) and a total of 35 distinct rare pathogenic and unknown significance variants (10 in CEL, 21 in CFTR, 1 in CDLN2, and 3 in CPA1). None of the cases or controls carried pancreatitis-predisposing variants within the CASR, CPA1, PRSS1, and SPINK1 genes, nor a pathogenic CFTR mutation. Four different variants of unknown significance were detected in the CDLN and CPA1 genes; one of them was in the CDLN gene in a single patient with pancreatitis and 3 in the CPA1 gene in 5 controls. After the analysis of the variants detected, no significant differences were observed between cases and controls. CONCLUSION: In patients with IBD, genes known to cause pancreatitis seem not to be involved in thiopurine-related pancreatitis onset.
Subject(s)
Inflammatory Bowel Diseases , Pancreatitis , Registries , Humans , Female , Pancreatitis/chemically induced , Pancreatitis/genetics , Male , Adult , Case-Control Studies , Inflammatory Bowel Diseases/genetics , Inflammatory Bowel Diseases/drug therapy , Middle Aged , Genetic Predisposition to Disease , Risk Factors , Genetic Variation , Mercaptopurine/adverse effects , Mercaptopurine/therapeutic useABSTRACT
BACKGROUND: The gut-brain axis describes a complex bidirectional association between neurological and gastrointestinal (GI) disorders. In patients with migraine, GI comorbidities are common. We aimed to evaluate the presence of migraine among patients with inflammatory bowel disease (IBD) according to Migraine Screen-Questionnaire (MS-Q) and describe the headache characteristics compared to a control group. Additionally, we explored the relationship between migraine and IBD severities. METHODS: We performed a cross-sectional study through an online survey including patients from the IBD Unit at our tertiary hospital. Clinical and demographic variables were collected. MS-Q was used for migraine evaluation. Headache disability scale HIT-6, anxiety-depression scale HADS, sleep scale ISI, and activity scale Harvey-Bradshaw and Partial Mayo scores were also included. RESULTS: We evaluated 66 IBD patients and 47 controls. Among IBD patients, 28/66 (42%) were women, mean age 42 years and 23/66 (34.84%) had ulcerative colitis. MS-Q was positive in 13/49 (26.5%) of IBD patients and 4/31 (12.91%) controls (p=0.172). Among IBD patients, headache was unilateral in 5/13 (38%) and throbbing in 10/13 (77%). Migraine was associated with female sex (p=0.006), lower height (p=0.003) and weight (p=0.002), anti-TNF treatment (p=0.035). We did not find any association between HIT-6 and IBD activity scales scores. CONCLUSIONS: Migraine presence according to MS-Q could be higher in patients with IBD than controls. We recommend migraine screening in these patients, especially in female patients with lower height and weight and anti-TNF treatment.
Subject(s)
Colitis, Ulcerative , Crohn Disease , Inflammatory Bowel Diseases , Migraine Disorders , Humans , Female , Adult , Male , Crohn Disease/drug therapy , Prevalence , Cross-Sectional Studies , Tumor Necrosis Factor Inhibitors/therapeutic use , Inflammatory Bowel Diseases/complications , Inflammatory Bowel Diseases/epidemiology , Colitis, Ulcerative/drug therapy , Migraine Disorders/diagnosis , Migraine Disorders/epidemiology , Headache , Surveys and QuestionnairesABSTRACT
INTRODUCTION: The prevalence of penetrating complications in Crohn's disease (CD) increases progressively over time, but evidence on the medical treatment in this setting is limited. The aim of this study was to evaluate the effectiveness of biologic agents in CD complicated with internal fistulizing disease. METHODS: Adult patients with CD-related fistulae who received at least 1 biologic agent for this condition from the prospectively maintained ENEIDA registry were included. Exclusion criteria involved those receiving biologics for perianal disease, enterocutaneous, rectovaginal, anastomotic, or peristomal fistulae. The primary end point was fistula-related surgery. Predictive factors associated with surgery and fistula closure were evaluated by multivariate logistic regression and survival analyses. RESULTS: A total of 760 patients from 53 hospitals (673 receiving anti-tumor necrosis factors, 69 ustekinumab, and 18 vedolizumab) were included. After a median follow-up of 56 months (interquartile range, 26-102 months), 240 patients required surgery, with surgery rates of 32%, 41%, and 24% among those under anti-tumor necrosis factor, vedolizumab, or ustekinumab, respectively. Fistula closure was observed in 24% of patients. Older patients, ileocolonic disease, entero-urinary fistulae, or an intestinal stricture distal to the origin of the fistula were associated with a higher risk of surgery, whereas nonsmokers and combination therapy with an immunomodulator reduced this risk. DISCUSSION: Biologic therapy is beneficial in approximately three-quarters of patients with fistulizing CD, achieving fistula closure in 24%. However, around one-third still undergo surgery due to refractory disease. Some patient- and lesion-related factors can identify patients who will obtain more benefit from these drugs.
Subject(s)
Crohn Disease , Fistula , Rectal Fistula , Adult , Humans , Crohn Disease/complications , Crohn Disease/drug therapy , Crohn Disease/surgery , Ustekinumab/therapeutic use , Treatment Outcome , Biological Therapy , Necrosis , Retrospective Studies , Rectal Fistula/etiology , Rectal Fistula/therapyABSTRACT
Biological therapies only benefit one-third of patients with Crohn's disease (CD). For this reason, a deeper understanding of the mechanisms by which biologics elicit their effect on intestinal mucosa is needed. Increasing evidence points toward the involvement of long noncoding RNAs (lncRNAs) in the pathogenesis of CD, although their role remains poorly studied. We aimed to characterize lncRNA profiles in the ileum and colon from CD patients and evaluate the effect of anti-TNF-α treatment on their transcription. Terminal ileum and left colon samples from 30 patients (active CD = 10, quiescent CD = 10, and healthy controls (HCs) = 10) were collected for RNA-seq. The patients were classified according to endoscopic activity. Furthermore, biopsies were cultured with infliximab, and their transcriptome was determined by Illumina gene expression array. A total of 678 differentially expressed lncRNAs between the terminal ileum and left colon were identified in HCs, 438 in patients with quiescent CD, and 468 in patients with active CD. Additionally, we identified three new lncRNAs in the ileum associated with CD activity. No differences were observed when comparing the effect of infliximab according to intestinal location, presence of disease (CD vs. HC), and activity (active vs. quiescent). The expression profiles of lncRNAs are associated with the location of intestinal tissue, being very different in the ileum and colon. The presence of CD and disease activity are associated with the differential expression of lncRNAs. No modulatory effect of infliximab has been observed in the lncRNA transcriptome.
Subject(s)
Crohn Disease , RNA, Long Noncoding , Humans , Crohn Disease/drug therapy , Crohn Disease/genetics , Crohn Disease/metabolism , RNA, Long Noncoding/genetics , RNA, Long Noncoding/metabolism , Infliximab/pharmacology , Infliximab/therapeutic use , Tumor Necrosis Factor Inhibitors/pharmacology , Tumor Necrosis Factor-alpha/metabolism , Colon/pathology , Ileum/metabolism , Intestinal Mucosa/metabolismABSTRACT
OBJECTIVE: To study the epidemiological and clinical characteristics, and response to treatment in patients with microscopic colitis. PATIENTS AND METHOD: Epidemiological, clinical, blood test and endoscopic data were retrospectively collected from 113 patients with microscopic colitis. Response to treatment was analyzed in 104 of them. Efficacy and relapse after treatment with budesonide were assessed using survival curves (Kaplan-Meier). RESULTS: 78% of the patients were women, with a mean age of 65 ± 16 years. In smokers, the mean age was 10 years younger. 48% of them had some concomitant autoimmune disease; 60% suffered a single outbreak of the disease. The clinical presentation was similar in both subtypes, although patients with collagenous colitis had a chronic course more frequently (48% vs. 29%, p = 0.047). The remission rate with budesonide was 93% (95% CI 82-98). The cumulative incidence of relapse, after a median follow-up of 21 months, was 39% (95% CI 26-54%): 19% at one year, 32% at two years, and 46% at three years of follow-up. There were no differences in clinical response to budesonide based on smoking habit or microscopic colitis subtype. CONCLUSIONS: Microscopic colitis is more frequent in elderly women. Smoking was associated with earlier onset of the disease, although it did not influence the clinical course or response to treatment. The majority (> 90%) of patients treated with budesonide achieved remission, although nearly half subsequently relapsed.
Subject(s)
Colitis, Microscopic , Adult , Aged , Anti-Inflammatory Agents/therapeutic use , Budesonide/therapeutic use , Colitis, Collagenous/complications , Colitis, Collagenous/drug therapy , Colitis, Collagenous/epidemiology , Colitis, Collagenous/mortality , Colitis, Lymphocytic/complications , Colitis, Lymphocytic/drug therapy , Colitis, Lymphocytic/epidemiology , Colitis, Lymphocytic/mortality , Colitis, Microscopic/complications , Colitis, Microscopic/drug therapy , Colitis, Microscopic/epidemiology , Colitis, Microscopic/mortality , Colonoscopy , Ex-Smokers , Female , Humans , Incidence , Kaplan-Meier Estimate , Male , Middle Aged , Recurrence , Retrospective Studies , Smokers , Smoking/adverse effects , Treatment OutcomeABSTRACT
Javier P. Gisbert was listed incorrectly as Javier Pérez-Gisbert.
ABSTRACT
BACKGROUND: There is no information regarding the outcome of Crohn's disease (CD) patients treated with endoscopic balloon dilation (EBD) in non-referral hospitals, nor on the efficacy of EBD in ulcerative colitis (UC). We report herein the results of the largest series published to date. AIM: To assess the efficacy and safety of EBD for inflammatory bowel disease (IBD) stenosis performed in 19 hospitals with different levels of complexity and to determine factors related to therapeutic success. METHODS: We identified IBD patients undergoing EBD in the ENEIDA database. Efficacy of EBD was compared between CD and UC and between secondary and tertiary hospitals. Predictive factors of therapeutic success were assessed with multivariate analysis. RESULTS: Four-hundred dilations (41.2% anastomotic) were performed in 187 IBD patients (13 UC/Indeterminate colitis). Technical and therapeutic success per dilation was achieved in 79.5% and 55.3%, respectively. Therapeutic success per patient was achieved in 78.1% of cases (median follow-up: 40 months) with 49.7% requiring more than one dilation. No differences related to either diagnosis or hospital complexity was found. Technical success [OR 4.12 (95%CI 2.4-7.1)] and not receiving anti-TNF at the time of dilation [OR 1.7 (95% CI 1.1-2.6)] were independently related to therapeutic success per dilation. A stricture length ≤ 2 cm [HR 2.43 (95% CI 1.11-5.31)] was a predictive factor of long-term success per patient. The rate of major complications was 1.3%. CONCLUSIONS: EBD can be performed with similar efficacy and safety in hospitals with differing levels of complexity and it might be a suitable treatment for UC with short stenosis. To achieve a technical success and the short length of the stenosis seem to be critical for long-term therapeutic success.
Subject(s)
Colitis, Ulcerative/surgery , Crohn Disease/surgery , Endoscopy, Gastrointestinal/adverse effects , Registries , Colitis, Ulcerative/complications , Constriction, Pathologic/etiology , Crohn Disease/complications , Dilatation , Female , Humans , Male , Middle Aged , Multivariate Analysis , Probability , Tertiary Care Centers , Treatment OutcomeABSTRACT
Microscopic colitis is a common cause of chronic watery diarrhea with a great impact on patient quality of life. Microscopic colitis includes two histological subtypes: collagenous colitis and lymphocytic colitis. Due to the increasing incidence and awareness of this disease over the last decades, several international guidelines have been recently published. However, there is still significant heterogeneity in the management of these patients, and treatments without solid scientific evidence support are often used in clinical practice. This article reviews the therapeutic role of budesonide in microscopic colitis and summarizes the current evidence regarding other treatments available for this disease, especially for the management of refractory patients. Finally, an updated treatment algorithm is proposed.
Subject(s)
Anti-Inflammatory Agents/therapeutic use , Budesonide/therapeutic use , Colitis, Collagenous/drug therapy , Colitis, Lymphocytic/drug therapy , Adrenal Cortex Hormones/therapeutic use , Anti-Inflammatory Agents/adverse effects , Anti-Inflammatory Agents/metabolism , Antidiarrheals/therapeutic use , Antimetabolites/therapeutic use , Azathioprine/therapeutic use , Biological Products/adverse effects , Biological Products/therapeutic use , Budesonide/adverse effects , Budesonide/metabolism , Colitis, Collagenous/pathology , Colitis, Lymphocytic/pathology , Colitis, Microscopic/drug therapy , Colitis, Microscopic/pathology , Diarrhea/etiology , Humans , Loperamide/therapeutic use , Malabsorption Syndromes/drug therapy , Mesalamine/therapeutic use , Methotrexate/therapeutic use , Prednisolone/therapeutic use , Quality of Life , Randomized Controlled Trials as Topic , Recurrence , Remission Induction , Time FactorsABSTRACT
INTRODUCTION: the quality of care perceived by the patient is a fundamental aspect of the accreditation program of inflammatory bowel disease (IBD) units. The aim of this study was to evaluate the quality of healthcare from the patient's point of view in an IBD Unit. METHODS: consecutive patients diagnosed with Crohn's disease or ulcerative colitis that attended the IBD Unit of the Hospital Universitario de La Princesa and anonymously filled out the Quality of Care through the Patient's Eyes - Inflammatory Bowel Disease (QUOTE-IBD) questionnaire were included in the study. QUOTE-IBD is a validated 23-item questionnaire, which explores the Importance given by patients to care aspects and the Performance of medical practices and healthcare workers. Each item assesses eight care dimensions: Competence, Autonomy, Courtesy, Accessibility, Information, Costs, Continuity of care and Accommodation. RESULTS: one hundred patients from our IBD Unit completed the QUOTE-IBD. In terms of dimensions, patients gave the highest Importance score to aspects related to Information (8.24), followed by Competence in IBD care (7.86). Performance scores ranged from 0.4 for Continuity of care to 0.01 for Cost. CONCLUSIONS: the application of the QUOTE-IBD questionnaire to assess the level of satisfaction of our patients with the quality of healthcare provided by our unit has allowed us to identify areas of improvement in the Information and Continuity of care dimensions. The highest score according to the perspective of our patients was obtained in the Competence in care dimension.
Subject(s)
Colitis, Ulcerative , Inflammatory Bowel Diseases , Humans , Inflammatory Bowel Diseases/therapy , Patient Satisfaction , Quality of Health Care , Surveys and QuestionnairesABSTRACT
INTRODUCTION: Errors are very common in daily clinical practice; however, they can be prevented. Our aim was to identify the most common errors in the outpatient management of inflammatory bowel disease (IBD) patients. MATERIAL AND METHODS: Patients diagnosed with IBD, being treated at our IBD Unit and who were referred for a second opinion were consecutively enrolled. Data on the strategies implemented by their previous physicians were obtained. These strategies were compared with the currently recommended diagnostic and therapeutic procedures. RESULTS: Seventy-four IBD patients were enrolled. Prior to care in our Unit, screening for tobacco use had been performed in 50% of Crohn's disease patients, while smoking cessation counselling had been provided in 29%. At the time of IBD diagnosis, the hepatitis B virus immunization status had been investigated in 16% of the patients, the hepatitis C virus status in 15%, and the varicella status in 7%. Seven percent of the patients had been vaccinated against hepatitis B virus, and 3% against influenza, tetanus and pneumococcus. Sixty-seven percent of the patients with an indication for use of 5-aminosalicylic acid and 37% of those with an indication for immunosuppressants had received the indicated drug. DISCUSSION: Errors in the outpatient management of IBD patients are very common and relevant.
Subject(s)
Inflammatory Bowel Diseases/therapy , Medical Errors , Adrenal Cortex Hormones/adverse effects , Adrenal Cortex Hormones/therapeutic use , Adult , Aged , Aged, 80 and over , Ambulatory Care , Colonoscopy/statistics & numerical data , Colorectal Neoplasms/prevention & control , Cross-Sectional Studies , Disease Management , Female , Guideline Adherence , Humans , Immunosuppressive Agents/therapeutic use , Inflammatory Bowel Diseases/drug therapy , Male , Mesalamine/therapeutic use , Middle Aged , Osteoporosis/chemically induced , Osteoporosis/prevention & control , Outpatient Clinics, Hospital , Practice Guidelines as Topic , Procedures and Techniques Utilization , Referral and Consultation , Retrospective Studies , Smoking/epidemiology , Vaccination , Young AdultABSTRACT
BACKGROUND: The advent of new therapeutic agents and the improvement of supporting care might change the management of acute severe ulcerative colitis (ASUC) and avoid colectomy. AIMS: To evaluate the colectomy-free survival and safety of a third-line treatment in patients with ASUC refractory to intravenous steroids and who failed either infliximab or ciclosporin. METHODS: Multicentre retrospective cohort study of patients with ASUC refractory to intravenous steroids who had failed infliximab or ciclosporin and received a third-line treatment during the same hospitalisation. Patients who stopped second-line treatment due to disease activity or adverse events (AEs) were eligible. We assessed short-term colectomy-free survival by logistic regression analysis. Kaplan-Meier curves and Cox regression models were used for long-term assessment. RESULTS: Among 78 patients, 32 received infliximab and 46 ciclosporin as second-line rescue treatment. Third-line treatment was infliximab in 45 (58%), ciclosporin in 17 (22%), tofacitinib in 13 (17%) and ustekinumab in 3 (3.8%). Colectomy was performed in 29 patients (37%) during follow-up (median 21 weeks). Of the 78 patients, 32 and 18 were in clinical remission at, respectively, 12 and 52 weeks. At the last visit, 25 patients were still on third-line rescue treatment, while 12 had stopped it due to clinical remission. AEs were reported in 26 (33%) patients. Two patients died (2.6%), including one following colectomy. CONCLUSION: Third-line rescue treatment avoided colectomy in over half of the patients with ASUC and may be considered a therapeutic strategy.
Subject(s)
Colectomy , Colitis, Ulcerative , Cyclosporine , Gastrointestinal Agents , Infliximab , Humans , Colitis, Ulcerative/drug therapy , Colitis, Ulcerative/surgery , Infliximab/therapeutic use , Infliximab/adverse effects , Male , Female , Cyclosporine/therapeutic use , Cyclosporine/adverse effects , Retrospective Studies , Adult , Middle Aged , Gastrointestinal Agents/therapeutic use , Gastrointestinal Agents/adverse effects , Treatment Outcome , Acute Disease , Immunosuppressive Agents/therapeutic use , Immunosuppressive Agents/adverse effects , Severity of Illness IndexABSTRACT
BACKGROUND AND AIMS: No consensus exists on optimal strategy to prevent postoperative recurrence [POR] after ileocaecal resection [ICR] for Crohn's disease [CD]. We compared early medical prophylaxis versus expectant management with treatment driven by findings at elective endoscopy 6-12 months after ICR. METHODS: A retrospective, multicentric, observational study was performed. CD patients undergoing first ICR were assigned to Cohort 1 if a biologic or immunomodulator was [re]started prophylactically after ICR, or to Cohort 2 if no postoperative prophylaxis was given and treatment was started as reaction to elective endoscopic findings. Primary endpoint was rate of endoscopic POR [Rutgeerts >i1]. Secondary endpoints were severe endoscopic POR [Rutgeerts i3/i4], clinical POR, surgical POR, and treatment burden during follow-up. RESULTS: Of 346 included patients, 47.4% received prophylactic postoperative treatment [proactive/Cohort 1] and 52.6% did not [reactive/Cohort 2]. Endoscopic POR [Rutgeertsâ >i1] rate was significantly higher in Cohort 2 [41.5% vs 53.8%, OR 1.81, pâ =â 0.039] at endoscopy 6-12 months after surgery. No significant difference in severe endoscopic POR was found [OR 1.29, pâ =â 0.517]. Cohort 2 had significantly higher clinical POR rates [17.7% vs 35.7%, OR 3.05, pâ =â 0.002] and numerically higher surgical recurrence rates [6.7% vs 13.2%, OR 2.59, pâ =â 0.051]. Cox proportional hazards regression analysis showed no significant difference in time to surgical POR of proactive versus expectant/reactive approach [HR 2.50, pâ =â 0.057]. Quasi-Poisson regression revealed a significantly lower treatment burden for immunomodulator use in Cohort 2 [mean ratio 0.53, pâ =â 0.002], but no difference in burden of biologics or combination treatment. CONCLUSIONS: The PORCSE study showed lower rates of endoscopic POR with early postoperative medical treatment compared with expectant management after first ileocaecal resection for Crohn's disease.
Subject(s)
Crohn Disease , Secondary Prevention , Humans , Crohn Disease/surgery , Crohn Disease/prevention & control , Female , Retrospective Studies , Male , Adult , Secondary Prevention/methods , Secondary Prevention/statistics & numerical data , Ileum/surgery , Recurrence , Middle Aged , Immunologic Factors/therapeutic use , Biological Products/therapeutic use , Europe , Cecum/surgery , Colonoscopy/statistics & numerical data , Colonoscopy/methodsABSTRACT
BACKGROUND: Both vedolizumab and ustekinumab are approved for the management of Crohn's disease [CD]. Data on which one would be the most beneficial option when anti-tumour necrosis factor [anti-TNF] agents fail are limited. AIMS: To compare the durability, effectiveness, and safety of vedolizumab and ustekinumab after anti-TNF failure or intolerance in CD. METHODS: CD patients from the ENEIDA registry who received vedolizumab or ustekinumab after anti-TNF failure or intolerance were included. Durability and effectiveness were evaluated in both the short and the long term. Effectiveness was defined according to the Harvey-Bradshaw index [HBI]. The safety profile was compared between the two treatments. The propensity score was calculated by the inverse probability weighting method to balance confounder factors. RESULTS: A total of 835 patients from 30 centres were included, 207 treated with vedolizumab and 628 with ustekinumab. Dose intensification was performed in 295 patients. Vedolizumab [vs ustekinumab] was associated with a higher risk of treatment discontinuation (hazard ratio [HR] 2.55, 95% confidence interval [CI]: 2.02-3.21), adjusted by corticosteroids at baseline [HR 1.27; 95% CI: 1.00-1.62], moderate-severe activity in HBI [HR 1.79; 95% CI: 1.20-2.48], and high levels of C-reactive protein at baseline [HR 1.06; 95% CI: 1.02-1.10]. The inverse probability weighting method confirmed these results. Clinical response, remission, and corticosteroid-free clinical remission were higher with ustekinumab than with vedolizumab. Both drugs had a low risk of adverse events with no differences between them. CONCLUSION: In CD patients who have failed anti-TNF agents, ustekinumab seems to be superior to vedolizumab in terms of durability and effectiveness in clinical practice. The safety profile is good and similar for both treatments.
Subject(s)
Antibodies, Monoclonal, Humanized , Crohn Disease , Ustekinumab , Humans , Ustekinumab/therapeutic use , Crohn Disease/drug therapy , Tumor Necrosis Factor Inhibitors/therapeutic use , Remission Induction , Tumor Necrosis Factor-alpha , Registries , Treatment Outcome , Retrospective StudiesABSTRACT
BACKGROUND: The efficacy of ustekinumab and vedolizumab for treating complex perianal fistula in Crohn's disease has been barely studied. We aimed to assess treatment persistence, clinical remission, and safety of these drugs in this context. METHODS: Crohn's disease patients who had received ustekinumab or vedolizumab for the indication of active complex perianal fistula, were included. Clinical remission was defined according to Fistula Drainage Assessment Index (no drainage through the fistula upon gentle pressure) based on physicians' assessment. RESULTS: Of 155 patients, 136 received ustekinumab, and 35 vedolizumab (16 received both). Median follow-up for ustekinumab was 27 months. Among those on ustekinumab, 54 % achieved remission, and within this group, 27 % relapsed during follow-up. The incidence rate of relapse was 11 % per patient-year. Multivariate analysis found no variables associated with treatment discontinuation or relapse. Median follow-up time for patients receiving vedolizumab was 19 months. Remission was achieved in 46 % of the patients receiving vedolizumab, and among them, 20 % relapsed during follow-up. The incidence rate of relapse was 7 % per patient-year. Adverse events were mild in 6 % on ustekinumab and 8 % on vedolizumab. CONCLUSION: Ustekinumab and vedolizumab appear effective, achieving remission in around half of complex perianal fistula patients, with favorable safety profiles.
Subject(s)
Antibodies, Monoclonal, Humanized , Crohn Disease , Gastrointestinal Agents , Rectal Fistula , Remission Induction , Ustekinumab , Humans , Crohn Disease/drug therapy , Crohn Disease/complications , Antibodies, Monoclonal, Humanized/therapeutic use , Antibodies, Monoclonal, Humanized/adverse effects , Female , Male , Ustekinumab/therapeutic use , Ustekinumab/adverse effects , Adult , Rectal Fistula/drug therapy , Rectal Fistula/etiology , Gastrointestinal Agents/therapeutic use , Middle Aged , Recurrence , Treatment Outcome , Multivariate AnalysisABSTRACT
This article is the second in a series of two publications on the European Crohn's and Colitis Organisation [ECCO] evidence-based consensus on the management of Crohn's disease. The first article covers medical management; the present article addresses surgical management, including preoperative aspects and drug management before surgery. It also provides technical advice for a variety of common clinical situations. Both articles together represent the evidence-based recommendations of the ECCO for Crohn's disease and an update of prior ECCO Guidelines.
Subject(s)
Crohn Disease , Crohn Disease/surgery , Crohn Disease/drug therapy , Humans , Preoperative Care/methods , Preoperative Care/standards , Immunosuppressive Agents/therapeutic useABSTRACT
Markers that allow for the selection of tailored treatments for individual patients with inflammatory bowel diseases (IBD) are yet to be identified. Our aim was to describe trends in real-life treatment usage. For this purpose, patients from the ENEIDA registry who received their first targeted IBD treatment (biologics or tofacitinib) between 2015 and 2021 were included. A subsequent analysis with Machine Learning models was performed. The study included 10,009 patients [71% with Crohn's disease (CD) and 29% with ulcerative colitis (UC)]. In CD, anti-TNF (predominantly adalimumab) were the main agents in the 1st line of treatment (LoT), although their use declined over time. In UC, anti-TNF (mainly infliximab) use was predominant in 1st LoT, remaining stable over time. Ustekinumab and vedolizumab were the most prescribed drugs in 2nd and 3rd LoT in CD and UC, respectively. Overall, the use of biosimilars increased over time. Machine Learning failed to identify a model capable of predicting treatment patterns. In conclusion, drug positioning is different in CD and UC. Anti-TNF were the most used drugs in IBD 1st LoT, being adalimumab predominant in CD and infliximab in UC. Ustekinumab and vedolizumab have gained importance in CD and UC, respectively. The approval of biosimilars had a significant impact on treatment.
ABSTRACT
BACKGROUND: Ulcerative proctitis (UP) can have a milder, less aggressive course than left-sided colitis or extensive colitis. Therefore, immunosuppressants tend to be used less in patients with this condition. Evidence, however, is scarce because these patients are excluded from randomised controlled clinical trials. Our aim was to describe the characteristics of patients with refractory UP and their disease-related complications, and to identify the need for immunosuppressive therapies. METHODS: We identified patients with UP from the prospective ENEIDA registry sponsored by the GETECCU. We evaluated socio-demographic data and complications associated with immunosuppression. We defined immunosuppression as the use of immunomodulators, biologics and/or small molecules. We used logistic regression to identify factors associated with immunosuppressive therapy. RESULTS: From a total of 34,716 patients with ulcerative colitis, we identified 6281 (18.1%) with UP; mean ± SD age 53 ± 15 years, average disease duration of 12 ± 9 years. Immunosuppression was prescribed in 11% of patients, 4.2% needed one biologic agent and 1% needed two; 2% of patients required hospitalisation, and 0.5% underwent panproctocolectomy or subtotal colectomy. We identified 0.2% colorectal tumours and 5% extracolonic tumours. Patients with polyarthritis (OR 3.56, 95% CI 1.86-6.69; p < 0.001) required immunosuppressants. CONCLUSIONS: Among patients with refractory UP, 11% required immunosuppressant therapy, and 4.2% required at least one biologic agent.
Subject(s)
Colitis, Ulcerative , Immunosuppressive Agents , Proctitis , Registries , Humans , Male , Female , Middle Aged , Adult , Aged , Proctitis/drug therapy , Colitis, Ulcerative/drug therapy , Immunosuppressive Agents/therapeutic use , Prospective StudiesABSTRACT
There are now a growing number of licensed biological therapies for patients with Crohn's disease. However, there can be significant costs associated with long-term maintenance treatment, as well as some concerns about potential side-effects. As a result, there has been increasing interest in elective biological treatment discontinuation in selected patients, after a sustained period of remission. Following discontinuation, in cases of relapse, evidence to date has suggested that remission may often be regained by re-treatment with the same biological agent. Therefore, a concept has emerged in which cycles of biological therapy might be used. If this treatment strategy were to be applied in a subgroup of patients at low risk of relapse, cycling might allow a substantial number of patients to have a lower, overall therapeutic burden-ensuring decreased exposure to biological therapy but still enabling appropriate disease control. Currently, there remains uncertainty about the benefit-risk balance for using cycles of biological treatment for patients with Crohn's disease. Accordingly, an expert panel was convened by the European Crohn's and Colitis Organisation [ECCO] to review the published literature and agree a series of consensus practice points. The panel aimed to provide evidence-based guidance on multiple aspects of biological treatment discontinuation and cycling, including the risk of relapse after elective treatment discontinuation, predictors of probable relapse or remission, safety, patient preferences, and pharmacoeconomic aspects. Crucially, discussions about biological treatment discontinuation and cycling should be individualized, to enable shared decision-making by patients with their clinicians.
Subject(s)
Crohn Disease , Humans , Crohn Disease/complications , Remission Induction , Recurrence , Risk AssessmentABSTRACT
An increased risk of lymphoma has been described in patients with inflammatory bowel disease (IBD). The aims of our study were to determine the clinical presentation, the previous exposure to immunosuppressive and biologic therapies, and the evolution of lymphomas in patients with IBD. IBD patients with diagnosis of lymphoma from October 2006 to June 2021 were identified from the prospectively maintained ENEIDA registry of GETECCU. We identified 52 patients (2.4 cases of lymphoma/1000 patients with IBD; 95% CI 1.8-3.1). Thirty-five were men (67%), 52% had ulcerative colitis, 60% received thiopurines, and 38% an anti-TNF drug before lymphoma diagnosis. Age at lymphoma was lower in those patients treated with thiopurines (53 ± 17 years old) and anti-TNF drugs (47 ± 17) than in those patients not treated with these drugs (63 ± 12; p < 0.05). Five cases had relapse of lymphoma (1.7 cases/100 patient-years). Nine patients (17%) died after 19 months (IQR 0-48 months). Relapse and mortality were not related with the type of IBD or lymphoma, nor with thiopurines or biologic therapies. In conclusion, most IBD patients had been treated with thiopurines and/or anti-TNF agents before lymphoma diagnosis, and these patients were younger at diagnosis of lymphoma than those not treated with these drugs. Relapse and mortality of lymphoma were not related with these therapies.
ABSTRACT
(1) Background: Transition is a planned movement of paediatric patients to adult healthcare systems, and its implementation is not yet established in all inflammatory bowel disease (IBD) units. The aim of the study was to evaluate the impact of transition on IBD outcomes. (2) Methods: Multicentre, retrospective and observational study of IBD paediatric patients transferred to an adult IBD unit between 2017-2020. Two groups were compared: transition (≥1 joint visit involving the gastroenterologist, the paediatrician, a programme coordinator, the parents and the patient) and no-transition. Outcomes within one year after transfer were analysed. The main variable was poor clinical outcome (IBD flare, hospitalisation, surgery or any change in the treatment because of a flare). Predictive factors of poor clinical outcome were identified with multivariable analysis. (3) Results: A total of 278 patients from 34 Spanish hospitals were included. One hundred eighty-five patients (67%) from twenty-two hospitals (65%) performed a structured transition. Eighty-nine patients had poor clinical outcome at one year after transfer: 27% in the transition and 43% in the no-transition group (p = 0.005). One year after transfer, no-transition patients were more likely to have a flare (36% vs. 22%; p = 0.018) and reported more hospitalisations (10% vs. 3%; p = 0.025). The lack of transition, as well as parameters at transfer, including IBD activity, body mass index < 18.5 and corticosteroid treatment, were associated with poor clinical outcome. One patient in the transition group (0.4%) was lost to follow-up. (4) Conclusion: Transition care programmes improve patients' outcomes after the transfer from paediatric to adult IBD units. Active IBD at transfer impairs outcomes.