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Background: The response to SARS-CoV-2 vaccination decreases in inflammatory bowel disease (IBD) patients, specially under anti-TNF treatment. However, data on medium-term effectiveness are limited, specially using new recommended seroconversion rate (>260BAU/mL). Our aim was to evaluate the 6-month>260 BAU-seroconversion rate after full vaccination and after booster-dose., Methods: VACOVEII is a Spanish multicenter, prospective study promoted by GETECCU. IBD patients full vaccinated against SARS-CoV-2 and without previous COVID-19 infection, treated or not with immunosuppressants, were included. The booster dose was administered 6 months after the full vaccination. Seroconversion was set at 260BAU/mL, according to most recent recommendations and was assessed 6 months after the full vaccination and 6 months after booster-dose., Results: Between October 2021 and March 2022, 313 patients were included (124 no treatment or mesalazine; 55 immunomodulators; 87 anti-TNF; 19 anti-integrin; and 28 ustekinumab). Most patients received mRNA-vaccines (86%). Six months after full vaccination, overall seroconversion rate was 44.1%, being significantly lower among patients on anti-TNF (19.5%, p<0.001) and ustekinumab (35.7%, p=0.031). The seroconversion rate after booster was 92%. Again, anti-TNF patients had a significantly lower seroconversion rate (67%, p<0.001). mRNA-vaccine improved seroconversion rate (OR 11.720 [95% CI 2.26-60.512])., Conclusion: The full vaccination regimen achieves suboptimal response in IBD patients, specially among those anti-TNF or ustekinumab. The booster dose improves seroconversion rate in all patients, although it remains limited in those treated with anti-TNF. These results reinforce the need to prioritize future booster doses in patients on immunosuppressants therapy, specially under anti-TNF, and using mRNA-vaccines., (Copyright © 2023 Elsevier España, S.L.U. All rights reserved.)

Objective: The recommendations of the Spanish Ministry of Health on vaccination in risk groups include mesalazine among the treatments with a possible negative effect on its effectiveness. However, this is not the recommendation of most experts. Our objective was to evaluate the effect of mesalazine on the humoral response to the SARS-CoV-2 vaccine in patients with inflammatory bowel disease (IBD)., Methods: VACOVEII is a Spanish, prospective, multicenter study promoted by GETECCU, which evaluates the effectiveness of the SARS-CoV-2 vaccine in patients with IBD. This study includes IBD patients who have recieved the full vaccination schedule and without previous COVID-19 infection. Seroconversion was set at 260BAU/mL (centralized determination) and was assessed 6 months after full vaccination. In this subanalysis of the study, we compare the effectiveness of the vaccine between patients treated with mesalazine and patients without treatment., Results: A total of 124 patients without immunosuppressive therapy were included, of which 32 did not receive any treatment and 92 received only mesalazine. Six months after full vaccination, no significant differences are observed in the mean concentrations of IgG anti-S between both groups. In the multivariate analysis, antibody titers were independently associated with the use of mRNA vaccines and with SARS-CoV-2 infection., Conclusion: Mesalazine does not have a negative effect on the response to SARS-CoV-2 vaccines in IBD patients., (Copyright © 2024 Elsevier España, S.L.U. All rights reserved.)

Background and Aims: Data on the outcomes after switching from adalimumab (ADA) originator to ADA biosimilar are limited. The aim was to compare the treatment persistence, clinical efficacy, and safety outcomes in inflammatory bowel disease patients who maintained ADA originator vs. those who switched to ADA biosimilar., Methods: Patients receiving ADA originator who were in clinical remission at standard dose of ADA originator were included. Patients who maintained ADA originator formed the non-switch cohort (NSC), and those who switched to different ADA biosimilars constituted the switch cohort (SC). Clinical remission was defined as a Harvey-Bradshaw index ≤4 in Crohn's disease and a partial Mayo score ≤2 in ulcerative colitis. To control possible confounding effects on treatment discontinuation, an inverse probability treatment weighted proportional hazard Cox regression was performed., Results: Five hundred and twenty-four patients were included: 211 in the SC and 313 in the NSC. The median follow-up was 13 months in the SC and 24 months in the NSC (p < 0.001). The incidence rate of ADA discontinuation was 8% and 7% per patient-year in the SC and in the NSC, respectively (p > 0.05). In the multivariate analysis, switching from ADA originator to ADA biosimilar was not associated with therapy discontinuation. The incidence rate of relapse was 8% per patient-year in the SC and 6% per patient-year in the NSC (p > 0.05). Six percent of the patients had adverse events in the SC vs. 5% in the NSC (p > 0.05)., Conclusion: Switching to ADA biosimilar did not impair patients' outcomes in comparison with maintaining on the originator., (© 2023 John Wiley & Sons Ltd.)

Objective: Measurement of patient-perceived outcomes in inflammatory bowel disease (IBD) care is becoming increasingly important. A simple and validated tool exists in English for this purpose, the "IBD-Control". Our aim is to translate it into Spanish, adapt and validate it., Patients and Methods: The IBD-Control was translated into the Spanish instrument "EII-Control" and prospectively validated. Patients completed the EII-Control and other questionnaires that served as baseline comparators. The gastroenterologist performed a global assessment of the disease, calculated activity indices and recorded treatment. A subgroup of patients repeated the entire assessment at a second visit. The usefulness of IBD-Control summary scales (IBD-Control-8 and IBD-Control-VAS) was also analysed., Results: A total of 249 IBD patients were included (101 repeated the second visit). Psychometric standards of the test: internal consistency: Cronbach's α for EII-Control 0.83 with strong correlation between EII-Control-8 and EII-Control-EVA (r=0.5); reproducibility: intra-class correlation 0.70 for EII-Control; construct validity: moderate to strong correlations between IBD-Control, IBD-Control-8 and IBD-Control-VAS versus comparators; discriminant validity: P<.001; sensitivity to change: same response as quality of life index. Sensitivity and specificity at cut-off point 14 of 0.696 and 0.903, respectively, to determine quiescent status., Conclusions: The IBD-Control is a valid instrument to measure IBD-Control from the patient's perspective in our environment and culture. Its simplicity makes it a useful tool to support care., (Copyright © 2021 Elsevier España, S.L.U. All rights reserved.)

Background and Aims: Immunomediated adverse events [IAEs] are the most frequently reported infliximab [IFX]-related adverse events. Combination therapy may reduce their incidence, although this strategy is not recommended in elderly patients. We aimed to compare the rates of IFX-related IAEs and loss of response [LOR] in elderly and younger patients., Methods: Adult patients in the ENEIDA registry who had received a first course of IFX therapy were identified and grouped into two cohorts regarding age at the beginning of treatment [over 60 years and between 18 and 50 years]. The rates of IAEs and LOR were compared., Results: In total, 939 patients [12%] who started IFX over 60 years of age and 6844 [88%] below 50 years of age were included. Elderly patients presented a higher proportion of AEs related to IFX [23.2% vs 19%; p = 0.002], infections [7.1% vs 4.3%; p < 0.001] and neoplasms [2.2% vs 0.5%; p < 0.001]. In contrast, the rates of IAEs [14.8% vs 14.8%; p = 0.999], infusion reactions [8.1% vs 8.1%; p = 0.989], late hypersensitivity [1.3% vs 1.2%; p = 0.895], paradoxical psoriasis [1% vs 1.5%; p = 0.187] and drug-induced lupus erythematosus [0.6% vs 0.7%; p = 0.947] were similar in elderly and younger patients. LOR rates were also similar between the two groups [20.5% vs 19.3%; p = 0.438]. In the logistic regression analysis, IFX monotherapy, extraintestinal manifestations and female gender were the only risk factors for IAEs, whereas IFX monotherapy, extraintestinal manifestations and Crohn's disease were risk factors for LOR., Conclusions: Elderly patients with inflammatory bowel disease have a similar risk of developing IFX-related IAEs and LOR to that of younger patients., (© The Author(s) 2021. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Patients with inflammatory bowel disease (IBD) may present extraintestinal manifestations (EIMs) that affect the joints, skin, eyes, and hepatobiliary area, among others., Aims: Our aim was to analyse the prevalence and characteristics of EIMs in patients with IBD and to identify the possible risk factors associated with the development of EIMs in the largest series published to date., Methods: Observational, cross-sectional study including patients from the Spanish ENEIDA registry promoted by GETECCU. We retrospectively identified all cases of EIMs in the ENEIDA registry until January 2018., Results: The study included 31,077 patients, 5779 of whom had at least one EIM (global prevalence 19%; 95% CI 18.2-19.0). Among the different types of EIMs, rheumatic manifestations had a prevalence of 13% (95% CI 12.9-13.7; 63% of EIMs), with a prevalence of 5% (95% CI 4.7-5.2) for mucocutaneous manifestations, 2.1% (95% CI 1.9-2.2) for ocular manifestations, and 0.7% (95% CI 0.6-0.8) for hepatobiliary manifestations. The multivariable analysis showed that the type of IBD (Crohn's disease, p < 0.001), gender (female, p < 0.001), the need for an immunomodulator (p < 0.001) or biologic drugs (p < 0.001), a previous family history of IBD (p < 0.001), and an extensive location of IBD (p < 0.001) were risk factors for the presence of EIMs., Conclusions: One-fifth of patients with IBD may have associated EIMs, with rheumatic manifestations as the most frequent (> 60% of EIMs). Female patients with severe Crohn's disease represent the group with the highest risk of developing EIMs. These patients should therefore be specially monitored and referred to the corresponding specialist when suggestive symptoms appear.

Background and Aims: Although commonly used in inflammatory bowel disease [IBD], thiopurines frequently cause intolerance, and switching to a second thiopurine has only been reported in some small series. Ours aims in this study were to evaluate the safety of switching to a second thiopurine in a large cohort, and to assess the impact of age on tolerance., Methods: Adult IBD patients from the ENEIDA registry, who were switched to a second thiopurine due to adverse events [excluding malignancies and infections], were identified. At the beginning of thiopurine treatment, patients were divided by age into two groups: 18-50 and over 60 years of age. The rate and concordance of adverse events between the first and second thiopurines, treatment intolerance, and persistence with the second thiopurine were evaluated., Results: A total of 1278 patients [13% over 60 years of age] were switched to a second thiopurine. At 12 months, the cumulative probability of switch intolerance was 43%, and persistence with treatment was 49%. Independent risk factors of switch intolerance were age over 60 years (odds ratio [OR] 1.49; 95% confidence interval [CI] 1.07-2.07; p = 0.017) , previous gastrointestinal toxicity [OR 1.4; 95% CI 1.11-1.78; p = 0.005], previous acute pancreatitis [OR 6.78; 95% CI 2.55-18.05; p <0.001], and exposure to the first thiopurine <6 months [OR 1.59; 95% CI 1.14-2.23; p = 0.007]., Conclusions: In a large series in clinical practice, switching to a second thiopurine proved to be a valid strategy. Tight monitoring of elderly IBD patients switching to a second thiopurine because of adverse events is recommended., (© The Author(s) 2020. Published by Oxford University Press on behalf of European Crohn’s and Colitis Organisation. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Thiopurines are the most widely used immunosuppressants in IBD although drug-related adverse events (AE) occur in 20%-30% of cases., Aim: To evaluate the safety of thiopurines in elderly IBD patients METHODS: Cohort study including all adult patients in the ENEIDA registry who received thiopurines. Patients were grouped in terms of age at the beginning of thiopurine treatment, specifically in those who started thiopurines over 60 years or between 18 and 50 years of age. Thiopurine-related AEs registered in the ENEIDA database were compared., Results: Out of 48 752 patients, 1888 started thiopurines when over 60 years of age and 15 477 under 50 years of age. Median treatment duration was significantly shorter for those who started thiopurines >60 years (13 [IQR 2-55] vs 32 [IQR 5-82] months; P < .001). Patients starting >60 years had higher rates of all types of myelotoxicity, digestive intolerance and hepatotoxicity. Thiopurines were discontinued due to AEs (excluding malignancies and infections) in more patients starting >60 years (67.2% vs 63.1%; P < .001). Elderly age and female sex were independent risk factors for most AEs., Conclusion: In elderly IBD patients, thiopurines are associated with an increased risk of non-infectious, non-neoplastic, AEs., (© 2019 John Wiley & Sons Ltd.)

Background and Aims: The aims of this study were to determine the prevalence of fatigue in patients with inflammatory bowel disease [IBD], to identify the factors associated with fatigue and its severity, to assess the impact of fatigue on quality of life [QoL], and to evaluate the relationship between fatigue and sleep disorders., Methods: This was a prospective multicentre study conducted at 22 Spanish centres. Consecutive patients followed at IBD Units were included. Fatigue was evaluated with the Fatigue Severity Scale [FSS] and the Fatigue Impact Scale [FIS]. Quality of life and sleep quality were assessed using the IBD Questionnaire-Short Form [IBDQ-9] and the Pittsburgh Sleep Quality Index [PSQI], respectively., Results: A total of 544 consecutive adult IBD patients were included [50% women, mean age 44 years, 61% Crohn's disease]. The prevalence of fatigue was 41% (95% confidence interval [CI] = 37-45%). The variables associated with an increased risk of fatigue were: anxiety [OR = 2.5, 95% CI = 1.6-3.7], depression [OR = 2.4, 95% CI = 1.4-3.8], presence of extraintestinal manifestations [EIMs] [OR = 1.7, 95% CI = 1.1-2.6], and treatment with systemic steroids [OR = 2.8, 95% CI = 1.4-5.7]. The presence of EIMs [regression coefficient, RC = 8.2, 95% CI = 2.3-14.2], anxiety [RC = 25.8, 95% CI = 20.0-31.5], depression [RC = 30.6, 95% CI = 24.3-37.0], and sleep disturbances [RC = 15.0, 95% CI = 9.3-20.8] were associated with severity of fatigue. Patients with fatigue had a significantly decreased IBDQ-9 score [p < 0.001]., Conclusions: The prevalence of fatigue in IBD patients is remarkably high and has a negative impact on QoL. Therapy with systemic steroids is associated with an increased risk of fatigue. The severity of fatigue is associated with anxiety, depression, sleep disorders, and the presence of EIMs. Fatigue was not associated with anaemia, disease activity or anti-TNF therapy., (Copyright © 2019 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: Effectiveness of vedolizumab in real world clinical practice is unknown., Aim: To evaluate the short and long-term effectiveness of vedolizumab in patients with inflammatory bowel disease (IBD)., Methods: Patients who received at least 1 induction dose of vedolizumab were included. Effectiveness was defined based on Harvey-Bradshaw index (HBI) in Crohn's disease (CD) and Partial Mayo Score (PMS) in ulcerative colitis (UC). Short-term response was assessed at week 14. Variables associated with short-term remission were identified by logistic regression analysis. The Kaplan-Meier method was used to evaluate the long-term durability of vedolizumab treatment. Cox model was used to identify factors associated with discontinuation of treatment and loss of response., Results: 521 patients were included (median follow-up 10 months [interquartile range 5-18 months]). At week 14, 46.8% had remission and 15.7% clinical response. CD (vs UC), previous surgery, higher CRP concentration and disease severity at baseline were significantly associated with impaired response. The rate of vedolizumab discontinuation was 37% per patient-year of follow-up (27.6% in UC and 45.3% in CD, P < 0.01). CD (vs UC), anaemia at baseline, steroids during induction and CRP concentration were associated with lower durability of treatment. Seven per cent of patients developed adverse events, infections being the most frequent., Conclusions: Over 60% of IBD patients respond to vedolizumab. Many patients discontinue treatment over time. CD and disease burden impair both short- and long-term response. Vedolizumab seems to be safe in clinical practice., (© 2018 John Wiley & Sons Ltd.)

In Digestive Disease Week 2016, interesting data were presented on the eventual role of certain foods in inflammatory bowel disease, although the value of these data is relative. Also of interest were epidemiological studies, of which several analysed the natural history of the disease. Some presentations dealt with the search for individual predictive factors, a pressing need in clinical practice. Unfortunately, some of the findings presented were of dubious value. A study suggesting that a simple parameter as increased blood monocytes could be a clear predictive factor of poor outcome could perhaps be highlighted (the results were striking but had multiple limitations). In contrast, more interesting data were presented on monitoring and optimising biological therapy in the search for an individually-tailored approach. New studies were presented on the levels of distinct anti-TNF agents, vedolizumab and even ustekinumab. One study aimed to estimate the safety of anti-TNF agents on the basis of the patient's genetic (and clinical) features. There is no new evidence that will change our clinical practice. Equally, the data on colon cancer prevention will not modify our clinical practice, although one study reported a promising new strategy, consisting of the use of a new stool DNA test, with very promising results in the detection of high-grade dysplasia or colorectal cancer in these patients., (Copyright © 2016 Elsevier España, S.L.U. All rights reserved.)

Background: Anaemia and iron deficiency are very common in inflammatory bowel disease. Clinical trials have shown intravenous iron to be effective and well tolerated. However, published experience in clinical practice with specific evaluation of the effect on quality of life is limited., Material and Methods: We carried out a prospective, multicentre, observational study on the effects of ferric carboxymaltose in the treatment of iron deficiency anaemia in inflammatory bowel disease. Anaemia and iron deficiency were defined according to World Health Organization criteria. Efficacy and safety were evaluated at infusion, at 2 weeks and at 12 weeks. Quality of life was evaluated according to the SIBDQ-9 index. Complete response was defined as anaemia correction or more tan 2 g/dL increase in haemoglobin., Results: A total of 88 courses of ferric carboxymaltose in 72 patients were evaluated. Complete response was observed in 46% of patients at week 2, and 81.2% at week 12. Quality of life improved significatively at week 2 in both complete responders and partial responders (p<0.0005); complete responders showed siginficantly better response (p=0.016). No predictive factor was identified. Only one transient adverse effect was observed; however, this was severe., Discussion: Ferric carboxymaltose showed comparable efficacy to that demonstrated in clinical trials. After only two weeks of treatment, there was a significant improvement in quality of life, with a greater effect observed in those patients with a complete haematologic response. Intravenous iron can very quickly improve quality of life in inflammatory bowel disease.

There are no important new data on the aetiology of inflammatory bowel disease. However, some new data were presented on the possible importance of certain nutrients or drugs in the genesis of the disease, as well as other data related to genetic features and their relationship with the microbiota. A highly interesting study suggested the strong potential of serological studies in predicting the course of Crohn's disease. The value of magnetic resonance imaging and the potential of low-radiation-dose tomography were reaffirmed in the monitoring and follow-up of patients and their treatments. Studies also confirmed the utility confirmed of new (and more comfortable) methods of home measurement of faecal calprotectin levels. In individualized therapy, attempts are being made to increase the practical application of new results on anti-TNF levels and their antibodies, for example, by identifying the utility of non-trough levels. We believe that the results presented on the impact of the disease on patients themselves were especially important, from their own perspective and in diverse setting. This impact is important both for patients (not only because of the repercussions of the disease on their quality of life but also on their mental health, disability, stress, and financial situation, etc.) and for their families. Finally, interesting results were presented of well-performed studies on colorectal cancer prevention in inflammatory bowel disease. These results confirm chromoendoscopy as a key technique but suggest that technological advances could change this situation, thus simplifying prevention., (Copyright © 2015 Elsevier España, S.L.U. All rights reserved.)

Methotrexate is an immunosuppressant that may be useful in several clinical scenarios in inflammatory bowel disease. In this article, we review the available evidence in Crohn's disease and ulcerative colitis and establish general recommendations for its use in clinical practice. Although the available data are limited, it is very likely that methotrexate is underused because its effectiveness is underestimated and its toxicity is overestimated. Both in induction therapy and in maintenance of remission, methotrexate is useful in Crohn's disease. When prescribed in combination with biologic agents, immunogenicity is less frequent and consequently long-term response could potentially be improved. There are few published studies, but several data suggest that methotrexate could also be useful in ulcerative colitis. Although myelotoxicity and liver toxicity are well known risks, methotrexate is a drug that is well tolerated in many patients, even in the long term., (Copyright © 2014 Elsevier España, S.L.U. and AEEH y AEG. All rights reserved.)

A lot of data were reported about monitoring patients with inflammatory bowel disease, with varying degrees of practical applicability. Concerning the evaluation of disease activity, it was established that objective assessments are needed. Among the techniques that we use, although endoscopy is undoubtedly the reference standard, a lot of data were presented regarding less invasive techniques. The importance of MRIs, CTs and ultrasounds (with some variations) was thus reiterated. The importance of fecal calprotectin is also reiterated, not only for colon disease, but probably small intestine disease as well. Regarding treatment monitoring, a great deal was reported about anti-TNF therapy, demonstrating again its potential role when properly used. In addition to results with infliximab, results with adalimumab were reported as very consistent. For colon cancer prevention, it seems that the clinical guidelines are achieving their objective. It also seems clear that we must improve conventional endoscopic techniques. Finally, there are other aspects that need to be considered when monitoring our patients, such as adequate sleeping patterns, anxiety or depression., (Copyright © 2014 Elsevier España, S.L.U. All rights reserved.)

Multiple data were presented on inflammatory bowel disease (IBD) in Digestive Disease Week (DDW). Of particular interest to gastroenterologists were those on novel treatments and information on safety. Other data, such as those relating to disease "follow-up", were possibly of lesser interest. However, the information reported this year was, in my opinion, highly important, because it could lead to significant changes in clinical practice. Thus, results presented strongly suggest that patients with asymptomatic IBD, specifically Crohn's disease (CD), often develop complications during their clinical course. Moreover, this is especially true in patients with CD and biological signs of inflammation, despite being asymptomatic. In addition, it seems clear that the absence of symptoms does not imply an absence of inflammation. These observations indicate a dual practical message: patients should be followed-up and objectively evaluated. Multiple data were presented on how to objectively evaluate disease activity in IBD. The prognostic value and objectivity of endoscopy has been reaffirmed, specifically with new data on the only validated index, the UCEIS, in ulcerative colitis. Together with endoscopy, the role of less invasive techniques such as imaging tests (magnetic resonance enterography, computed tomography enterography and even echography, with and without contrast agent) and fecal markers has been reaffirmed in several conditions and these techniques have a certain predictive value. Finally, many studies were reported that confirm the therapeutic activity of levels of anti-TNF and its antibodies in certain conditions and with some limitations., (Copyright © 2013 Elsevier España, S.L. All rights reserved.)

Objectives: The safety of thiopurines and anti-tumor necrosis factor-α (TNF-α) drugs during pregnancy remains controversial, as the experience with these drugs in this situation is limited. Our aim is to assess the safety of thiopurines and anti-TNF-α drugs for the treatment of inflammatory bowel disease (IBD) during pregnancy., Methods: Retrospective, multicenter study in IBD patients. Pregnancies were classified according to the therapeutic regimens during pregnancy or during the 3 months before the conception: non-exposed group, pregnancies exposed to thiopurines alone (group A), and pregnancies exposed to anti-TNF-α drugs (group B). An unfavorable Global Pregnancy Outcome (GPO) was considered if pregnancy developed with obstetric complications in the mother and in the newborn., Results: A total of 187 pregnancies in the group A, 66 pregnancies in the group B, and 318 pregnancies in the non-exposed group were included. The rate of unfavorable GPO was different among the three groups (31.8% in non-exposed group, 21.9% in group A, and 34.8% in group B), being lower in pregnancies under thiopurines than among non-exposed (P = 0.01). The rate of pregnancy complications was similar among the three groups (27.7% in non-exposed, 20.9% in group A, and 30.3% in group B). The rate of neonatal complications was different among the three groups (23.3% in non-exposed group, 13.9% in group A, and 21.2% in group B), being lower in pregnancies under thiopurines than among non-exposed (P = 0.01). In the multivariate analysis, the treatment with thiopurines (odds ratio = 0.6; 95% confidence interval = 0.4-0.9, P = 0.02) was the only predictor of favorable GPO, whereas maternal age >35 years at conception was the only predictor of unfavorable GPO. The treatment with anti-TNF-α drugs was not associated with an unfavorable GPO., Conclusion: The treatment with thiopurines and anti-TNF-α drugs does not seem to increase the risk of complications during pregnancy and does seem to be safe for the newborn.

Azathioprine is currently the key drug in the maintenance treatment of inflammatory bowel diseases. However, there are still some practical issues to be resolved: one is how long we must maintain the drug. Given that inflammatory bowel diseases are to date chronic, non-curable conditions, treatment should be indefinite and only the loss of efficacy or the appearance of serious side effects may cause withdrawal. As regards to efficacy and their maintenance over time, evidence supports the continuous usefulness of the drug in the long term: in fact its withdrawal very substantially increases the risk of relapse. About side effects, azathioprine is a relatively well tolerated drug and even indefinite use seems safe. The main theoretical risks of prolonged use would be the myelotoxicity, hepatotoxicity, and the development of cancer. In fact, serious bone marrow suppression or serious liver damage are uncommon, and can be minimized with proper use of the drug. Recent meta-analysis suggests that the risk of lymphoma is real, but the individual risk is rather low, and decision analysis suggests a favorable benefit/risk ratio in the long term. Therefore, in patients with inflammatory bowel diseases in whom azathioprine is effective and well tolerated, the drug should not be stopped. This recommendation concerns the use of azathioprine as a single maintenance drug, and is not necessarily applicable to patients receiving concomitant biological therapy.

Summary: Background: There are limited data of ustekinumab administered according to the doses recommended in the UNITI studies. Aim: To assess the real‐world, short‐term effectiveness of ustekinumab in refractory Crohn's disease (CD) Methods: Multicentre study of CD patients starting ustekinumab after June 2017 at the recommend dose (260, 390 or 520 mg based on weight ~6 mg/kg IV week 0 and 90 mg subcutaneously week 8). Values for Harvey‐Bradshaw Index (HBI), C‐reactive protein (CRP) and faecal calprotectin (FC) were recorded at baseline and at weeks 8 and 14. Demographic and clinical data, previous treatments, AEs and hospitalisations were documented. Possible predictors of clinical remission were examined. Results: Three hundred and five patients were analysed (≥2 previous anti‐TNFα therapies 64% and vedolizumab 29%). At baseline, 217 (72%) had an HBI >4 points. Of these, 101 (47%) and 126 (58%) achieved clinical remission at weeks 8 and 14, respectively. FC levels returned to normal (<250 µg/g) in 46% and 54% of the patients at weeks 8 and 14 respectively. CRP returned to normal (<3 mg/L) in the 35% and 41% of the patients at week 8 and 14 respectively. AEs were recorded in 38, and 40 patients were hospitalised. Intolerance to the most recent anti‐TNF agent and fewer previous anti‐TNF agents were associated with clinical remission at week 14. Endoscopic severity was associated with poor response. Conclusion: This is the first study to show the real‐world effectiveness and safety of ustekinumab administered according to the recommended induction regimen in a cohort of highly refractory CD patients. [ABSTRACT FROM AUTHOR]