Randomized, double-blind, placebo-controlled clinical trial on the usefulness of probiotic Lactobacillus reuteri in bismuth-containing quadruple eradication therapy for infection with Helicobacter pylori.

INTRODUCTION: the primary goal of this study was to compare gastrointestinal symptom reduction in patients on bismuth-containing quadruple eradication therapy supplemented with Lactobacillus reuteri strains (DSM 17938 and ATCC PTA 6475) or placebo. MATERIALS AND METHODS: this was a randomized, double-blind, parallel-arm, placebo-controlled clinical trial. Patients received a first-line eradication regimen based on bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride (three-in-one capsules) and omeprazole 40 mg twice a day for ten days, plus a probiotic or placebo tablet for 30 days. During follow-up, gastrointestinal symptoms were assessed using an evaluation scale (GSRS), and adverse events were collected at 0, 14, 28 and 56 days. RESULTS: a total of 80 patients were included from February 2018 to May 2019 at a single site. Eradication therapy was effective in 85 % of patients, with no differences between treatment arms. In the group receiving the probiotic, abdominal pain decreased in 42 % of patients, compared with 19 % in the control group (OR: 0.27; CI, 0.13-0.58; p < 0.001), and abdominal distension decreased in 25 % versus 17 % in the control group (OR: 0.24; IC, 0.19-0.84; p < 0.001); Conclusions: treatment with L. reuteri only reduced abdominal pain and distension. Further studies are needed to establish the role of probiotics as adjuvant therapy in H. pylori eradication.

Ustekinumab in Crohn's disease: real-world outcomes and predictors of response.

BACKGROUND: ustekinumab is a monoclonal antibody that inhibits interleukins IL-12 and IL-23, and is approved for the treatment of Crohn's disease (CD) and, more recently, also ulcerative colitis (UC). The aim of this study was to evaluate the effectiveness and safety of ustekinumab, as well as to identify possible predictive factors of response in a real-life setting. METHODS: an observational, retrospective, multicenter study was carried out in 4 hospitals in Andalusia. Adult patients with a confirmed diagnosis of CD treated with ustekinumab from 2017 to 2019 were included. Clinical response was analyzed at 3, 6 and 12 months of treatment. Clinical disease activity was assessed with the Harvey-Bradshaw index (HBI) and the Crohn's Disease Activity Index (CDAI); biochemical response was assessed with lab parameters such as CRP and ESR. One-year ustekinumab drug-survival was analyzed. RESULTS: a total of 98 patients were analyzed (mean age, 43 years; 52 % were male); 56 % had failed with ≥ 2 previous biologicals therapies. At 3 months, 69 % of the patients were in response and 40.8 % in remission. At 6 months, 56 % were in clinical remission. At 12 months, 73.7 % were in clinical response and 60.5 % in remission. Corticosteroid-free remission was 32.4 %, 44 %, and 47.4 % at 3, 6, and 12 months, respectively. Cumulative survival after one year of treatment with ustekinumab was 85.3 %. Biochemical parameters such as CRP and ESR showed a statistically significant decrease between baseline and control levels at 3, 6, and 12 months. A lower HBI at baseline and female sex were predictors of corticosteroid-free clinical remission in a univariate analysis. In the multivariate analysis no variables were found as predictors of corticosteroid-free clinical remission. CONCLUSION: ustekinumab therapy is safe and useful, inducing clinical response in more than 50 % of patients, including patients who failed with other biological therapies.

Switch to subcutaneous infliximab during the SARS-CoV-2 pandemic: preliminary results.

A new subcutaneous formulation of the infliximab biosimilar CT-P13 has recently been developed for the treatment of inflammatory bowel disease (IBD), providing response rates similar to intravenous treatment. The use of this new formulation was requested, in an effort to limit patient attendance at intravenous infusion centers and to maintain biological treatment during the COVID-19 pandemic. The objective of this observational, retrospective and descriptive study was to assess CT-P13 efficacy and safety after switching from intravenous to a subcutaneous formulation in patients with IBD receiving maintenance therapy. This article shows preliminary results after six months of follow-up.

Rapidity of clinical response to adalimumab and improvement of quality of life in luminal Crohn's disease: RAPIDA study.

OBJECTIVE: No studies evaluating the rapidity of response to biological therapies are available for Crohn's disease (CD). The aim of this study was to evaluate rapidity of onset of clinical response and impact on quality of life (QoL) of adalimumab therapy in adult anti-TNF-naïve patients with moderately-to-severely active CD. PATIENTS AND METHODS: RAPIDA was an open-label, single-arm, prospective, multicenter clinical trial. Adult patients with moderately-to-severely active luminal CD, anti-TNF-naïve, and unresponsive to conventional therapy were treated with adalimumab. Clinical disease activity, QoL and inflammatory biomarkers were measured at day 4, and weeks 1, 2, 4, and 12 after treatment initiation. RESULTS: Eighty-six patients were included in the intention-to-treat (ITT) analyses. Clinical disease activity was reduced from a median of 9.0 points to 6.0 points at day 4. Clinical response (≥ 3-point reduction in the Harvey-Bradshaw Index, HBI) was achieved by 61.6% (d4) and 75.6% (w1) of patients in the ITT population (median 2.5 days) and with non-responder imputation (NRI), by 55.8% and 53.4%, respectively. The proportion of patients in clinical remission (HBI<5) at weeks 2 and 4 in the ITT population was 54.7% and 62.8%, respectively (median 7.0 days), and 38.4% and 45.3% in the NRI population. All QoL scores significantly improved and inflammatory biomarkers significantly decreased from day 4 onwards (p<0.0001). CONCLUSION: Rapid clinical response and remission, improvement in QoL and fatigue, and a reduction of inflammatory biomarkers were achieved with adalimumab as early as day 4 in adult anti-TNF-naïve patients with moderately-to-severely active CD.

Views of patients with inflammatory bowel disease during the COVID-19 pandemic: ACCU survey results.

INTRODUCTION AND OBJECTIVES: the SARS-COV-2 pandemic has forced a substantial change in the care of patients with digestive pathologies, especially for inflammatory bowel disease (IBD) patients taking immunosuppessive medications. In this regard, some national and international guidelines have indicated the standards to be taken into account. However, few studies have evaluated how patients have dealt with this infection. Therefore, this study was performed with the aim to determine how the SARS-COV-2 pandemic has affected our IBD patients. MATERIAL AND METHODS: an online survey was performed among the members (295) of the Association of Crohn's Disease and Ulcerative Colitis (ACCU), which consisted of 19 questions. Finally, it was completed by 168 patients. RESULTS: fifty-eight per cent of cases were female, 63.7 % had Crohn's disease (CD) and 53 % received biologic therapy. Five per cent were infected by SARS-CoV-2 and were male. The main concern of the patients was the fear of acquiring the infection (80.9 %). More than 90 % continued their treatments and half of the patients worked from home during the pandemic period. CONCLUSIONS: the perspective of the patients is necessary to achieve an adequate management and evolution of the disease. More studies are needed to assess the impact that exceptional situations, such as the COVID-19 pandemic, may have on IBD patients in order to improve adherence and control of the disease.

Vedolizumab response in inflammatory bowel disease. Two years of follow-up.

BACKGROUND: vedolizumab is an α4ß7 integrin antagonist. The aim of this study was to evaluate the clinical response and remission rates with vedolizumab. METHODS: this was a retrospective study of inflammatory bowel disease (IBD) patients who received vedolizumab between 2016 and 2019. Response and remission rates were analyzed at three, six, 12, 18 and 24 months after induction. RESULTS: fifty-five patients were included. Clinical remission rates in CD and UC at three, six, 12, 18 and 24 months were 19.35 %, 26.67 %, 30.43 %, 30 %, 38.89 % and 29.17 %, 26.09 %, 19.05 %, 26.67 % and 20 %, respectively. CONCLUSIONS: vedolizumab is effective for induction and maintenance of clinical remission, both in Crohn's disease and ulcerative colitis.

Cut-off ranges of infliximab serum levels in Crohn's disease in the clinical practice.

INTRODUCTION: between 30 % and 40 % of patients treated with infliximab lose response during maintenance. Therapeutic drug monitoring could be used to optimize management in these situations. However, infliximab serum levels are not well defined. The aim of this study was to determine the cut-off range of infliximab serum levels in Crohn's disease patients in remission in the clinical practice. METHODS: an observational retrospective study was performed from 2016 to 2017. Patients were included with established Crohn's disease, who had been on a maintenance dose schedule of infliximab. Infliximab levels and antibodies to infliximab were measured at least twice in all patients, after induction and after six months of treatment. Clinical remission was defined as ≤ 4 using the Harvey-Bradshaw index. Cluster analysis was used to analyze the results. RESULTS: one hundred and five Crohn's disease patients were included in the study; 57.1 % were male with a mean age of 39 years (SD ± 12.9). The median (range) time of the disease was eleven years (7-15) and the median (range) time of follow-up was 32 months (22-38). Patients who achieved remission had infliximab serum levels between 4.26-8.26 ug/ml versus 0.06-1.43 ug/ml in patients who did not achieve remission after induction. Infliximab serum levels were 2.84-7.75 ug/ml and 0.05-2.69 ug/ml in patients who achieved remission versus those who did not achieve remission after six months of treatment. Overall, 4.26-8.26 ug/ml was found to be the best cut-off range for remission. CONCLUSIONS: in our clinical practice, serum levels of infliximab in Crohn's disease patients should be higher than 4 ug/ml to achieve clinical remission.

Index of the Mayo Endoscopy and Ulcerative Colitis Endoscopy Index of Severity: are they equally valid?

INTRODUCTION: endoscopy plays an essential role in the management of patients with ulcerative colitis (UC), as it allows us to visualize and assess the severity of the disease. Different scores have been devised to standardize the findings because such assessments are not always objective. AIMS: the aim of this study was to assess the interobserver variability between the Index of Mayo Endoscopy (IME) and the Ulcerative Colitis Endoscopy Index of Severity (UCEIS), analyzing the severity of the endoscopic lesions in patients with UC. The secondary aim was to analyze if the cathartic preparation affected the degree of concordance amongst the endoscopists. MATERIAL AND METHODS: this was a single-cohort observational, comparative study in which a colonoscopy was performed in patients with UC, as the normal clinical practice. The results were classified according to the IME and the UCEIS by three endoscopic specialists. In order to assess the degree of interobserver correlation, the Kappa index for IME was used and the intraclass correlation coefficient was used for UCEIS. RESULTS: sixty-seven patients were included in the study. The average age was 51 (SD ± 16.7) and the average Mayo Clinic index was 3.07 (SD ± 2.54). The weighted Kappa index between endoscopists A and B for the IME was 0.8, 0.52 between A and C and 0.49 between B and C. The intraclass correlation coefficient for UCEIS was 0.922 between the three endoscopists (95 % CI: 0.832-0.959). A better interobserver correlation was found when the cathartic preparation was ≥ 8 based on the Boston Scale. CONCLUSIONS: there was a higher correlation between the different endoscopists for the UCEIS than for the IME. Thus, this should be considered to be the best index to use in the clinical practice. A good cleansing preparation is important to improve the interobserver correlation.

Switching from reference infliximab to CT-P13 in patients with inflammatory bowel disease: results of a multicenter study after 12 months.

BACKGROUND AND AIMS: infliximab has changed the natural history of inflammatory bowel disease (IBD). The advent of biosimilar treatments such as CT-P13 will hopefully improve the availability of biological therapies. Data with regard to drug switching are currently limited. The objective of the study was to assess the effectiveness and safety of switching from the reference product (RP), infliximab, to CT-P13 in patients with IBD. METHODS: this was a multicenter prospective observational study in patients with Crohn's disease (CD) and ulcerative colitis (UC). All patients had switched from infliximab RP (Remicade®) to CT-P13 treatment and were followed up for 12 months. The efficacy endpoint was the change in clinical remission assessed at 0 and 12 months, according to the Harvey-Bradshaw score and partial Mayo score for patients with CD and UC, respectively. Adverse events were monitored and recorded throughout the study. RESULTS: a total of 167 patients (116 CD/51 UC) were included; 88.8% (103/116) of patients with CD were in remission at the time of the drug switch and 69.7% were in remission at 12 months. The Harvey-Bradshaw (HB) score significantly changed at 12 months (p = 0.001); 84.3% (43/51) of patients with UC were in remission at the time of the drug switch and 76.7% were in remission at 12 months. No significant changes in the median partial Mayo score (p = 0.87) were observed at 12 months. Serious adverse events related to medication were reported in 12/167 (7.2%) cases. CONCLUSION: switching from infliximab RP to CT-P13 is safe and effective at 12 months. The loss of efficacy at 12 months was 15.7%.

A real life study of Helicobacter pylori eradication with bismuth quadruple therapy in naïve and previously treated patients.

OBJECTIVE: To evaluate the efficacy and safety of a quadruple regimen (BMTO) of the "3-in-1 capsule" (containing bismuth subcitrate potassium, metronidazole and tetracycline) plus omeprazole in naïve and previously treated patients diagnosed with Helicobacter pylori (H. pylori) infection in the clinical setting in Seville (Spain). METHODS: This is a prospective study carried out on consecutive patients with a confirmed H. pylori infection and upper gastrointestinal symptoms. After providing their informed consent, the patients were treated for ten days with a 3-in-1 capsule containing bismuth subcitrate potassium (140 mg), metronidazole (125 mg) and tetracycline (125 mg: Pylera®), three capsules four times daily, plus omeprazole (20 or 40 mg) twice daily. Eradication of infection was determined by a negative urea breath test at least 28 days after the end of treatment. RESULTS: A total of 58 consecutive patients were enrolled into this study, two of whom withdrew early due to vomiting on days three and five, respectively. In this cohort, 17 patients (29.3%) had a prior history of medication to treat H. pylori. In the intent-to-treat population, eradication was achieved in 97.6% (40/41) and 82.4% (14/17) of cases in patients treated with BMTO as a first-line or rescue therapy, respectively. At least one adverse event was reported by 28 (48%) patients, mostly mild effects (86%). CONCLUSION: A ten day treatment with BMTO is an effective and safe strategy to combat confirmed H. pylori infection in patients.

Evolution of the incidence of inflammatory bowel disease in Southern Spain.

BACKGROUND: The incidence of inflammatory bowel disease is increasing in Europe and in Spain. However, there is no recent data from Southern Spain. OBJECTIVES: To determine the evolution of the hospital incidence of inflammatory bowel disease in Southern Spain. MATERIAL AND METHODS: A retrospective study was performed in two hospitals in Southern Spain. Data was collected from inflammatory bowel disease patients, divided into two periods (1995-2000 and 2001-2014) and compared. The reference population from both areas was 1,011,555 inhabitants. RESULTS: A total of 430 patients were registered during the first period (1995-2000); 50% (215) had Crohn's disease that resulted in a cumulative incidence rate of 7.08 cases/100,000 inhabitants per year. The overall inflammatory bowel disease incidence was 3.54 cases/100,000 inhabitants per year. During the second period (2001-2014), 2,089 patients were collected; 51.7% had ulcerative colitis (1,081). The rate of cumulative incidence of inflammatory bowel disease was 14.7 cases/100,000 inhabitants per year (7.6 cases of ulcerative colitis/100,000 inhabitants/year and 7.1 cases of Crohn´s disease/100,000 inhabitants/year). CONCLUSIONS: The incidence of inflammatory bowel disease in Southern Spain has doubled in the last decade and is similar to that of the rest of the country and Europe.

Initial experience with golimumab in clinical practice for ulcerative colitis.

BACKGROUND: Golimumab is a TNF-blocking agent indicated as a second-line therapy in ulcerative colitis. PURPOSE: To research the effectiveness and safety of golimumab in patients with ulcerative colitis in clinical practice. METHODS: Retrospective study of the effectiveness and safety of golimumab in patients with ulcerative colitis. All patients received golimumab 200 mg subcutaneously at week 0, and golimumab 100 mg subcutaneously at week 2. After the induction treatment, each patient received 50 mg sc. every 4 weeks in patients with body weight less than 80 kg, and 100 mg every 4 weeks in patients with body weight greater than or equal to 80 kg. RESULTS: Study of a group of 23 ulcerative colitis patients, 7 of whom were naive to any anti-TNF therapy, and 16 patients who had previously been treated with an anti-TNF agent other than golimumab (non-naive patients). The average treatment time with golimumab was 14.3 weeks. Globally, withdrawal of corticosteroids was observed in 74% of cases. Clinical response was observed in 85.5% of patients who had not received biological treatment previously, and in patients who had previously received biological treatment the response rate was 75%. CONCLUSIONS: In this short study, golimumab seems to be an alternative treatment in naive and non-naive anti-TNF ulcerative colitis patients. It is also a safe therapy, given that there were no adverse effects in the patients studied.

Intravenous ustekinumab maintenance treatment in patients with loss of response to subcutaneous dosing.

Background: Ustekinumab (UST) is indicated for the treatment of Crohn's disease (CD) and Ulcerative Colitis (UC). Despite having shown clinical effectiveness in the real world, some patients may lose response over time or need a higher dose to achieve it. In this context, UST intravenous (IV) maintenance has been proposed. Objectives: The primary endpoint of our study was to evaluate the efficacy and safety of maintenance IV UST treatment in Inflammatory Bowel Disease (IBD) patients who present with partial response or loss of response to subcutaneous (SC) UST. Design: We performed a monocentric observational retrospective study including patients with active IBD on maintenance treatment with IV UST. Methods: The clinical response and remission was analyzed at week 12, defined as either Harvey-Bradshaw Index ⩽ 4 for CD or partial Mayo Score ⩽ 2 for UC. The reduction of objective markers of disease activity, fecal calprotectin, and C-reactive protein was evaluated. Moreover, UST trough levels were measured pre- and post-UST IV maintenance and any adverse events were assessed. Results: We included 23 patients. Clinical remission at week 12 was achieved by 43.5% of the patients. The proportion of patients in clinical response after 12 weeks on UST IV maintenance was 82.6%. After a median follow-up of 9.3 months all patients remained on IV UST maintenance. No adverse events were recorded in any patient for the duration of the study. Conclusions: IV UST maintenance treatment was able to recapture response in most of the patients who had lost response to SC maintenance.

Is safety infliximb during pregnancy in patients with inflammatory bowel disease?

BACKGROUND: in most cases, inflammatory bowel disease (IBD) debuts at reproductive age. The data available in the literature show infliximab (IFX) to be a safe drug during pregnancy but there is very little evidence about the activity of the disease following drug withdrawal during pregnancy. AIMS: determine the drug's safety in pregnant women in our setting and assess its effect on the foetus, drawing on the experience of several hospitals. Secondly, observe the effect of treatment withdrawal on disease activity during pregnancy. MATERIAL AND METHODS: a retrospective study was conducted of women with IBD who had received IFX treatment during pregnancy in five hospitals in Spain. Disease activity was assessed using Crohn's Disease Activity Index, while UC was assessed using the Truelove-Witts Index in each trimester of pregnancy. Gestational age, weight and diseases in the foetus were determined at birth. RESULTS: the study included 12 women with a mean age of 29 years; 4 had ulcerative colitis and 8 Crohn's disease, with mean disease duration of 7 years. All but one, who was diagnosed during pregnancy, was receiving IFX treatment at conception. Six patients received uninterrupted treatment throughout the pregnancy, 2 requested voluntary interruption and in 3 cases treatment was interrupted in the third trimester as a precaution. They received a mean IFX dose of 400 mg every 8 weeks. Of the 6 patients who received continuous treatment, in 50% disease was held in remission. The 6 remaining patients suspended treatment for different reasons, presenting disease recurrence in all but one case (83.3%). Eight deliveries were vaginal and 4 by caesarean section. Newborns presented no congenital anomalies, intrauterine growth retardation or low birth weight and there was only one premature delivery. CONCLUSIONS: although cases included in the study are not significant, in our experience, IFX during pregnancy is a safe treatment for the mother and the foetus. In fact, in our study and in some cases, its withdrawal may lead to a worsening of the disease. However, further control studies are required with larger samples to obtain more representative findings.

Comparison of the Mayo Endoscopy Score and the Ulcerative Colitis Endoscopy Index of Severity and the Ulcerative Colitis Colonoscopy Index of Severity.

Background and study aims: Endoscopy plays an essential role in managing patients with ulcerative colitis (UC), as it allows us to visualize and assess the severity of the disease. As such assessments are not always objective, different scores have been devised to standardize the findings. The main aim of this study was to assess the interobserver variability between the Mayo Endoscopy Score (MES), Ulcerative Colitis Endoscopy Index of Severity (UCEIS) and Ulcerative Colitis Colonoscopy Index of Severity (UCCIS) analyzing the severity of the endoscopic lesions in patients with ulcerative colitis. Patients and methods: This was a single-cohort observational study in which a colonoscopy was carried out on patients with UC, as normal clinical practice, and a video was recorded. The results from the video were classified according to the MES, UCEIS and UCCIS by three endoscopic specialists independently, and they were compared to each other. The Mayo Endoscopy Score (MES) was used to assess the clinical situation of the patient. The therapeutic impact was analyzed after colonoscopy was carried out. Results: Sixty-seven patients were included in the study. The average age was 51 (SD ±â€Š16.7) and the average MES was 3.07 (SD ±â€Š2.54). The weighted Kappa index between endoscopists A and B for the MES was 0.8; between A and C 0.52; and between B and C 0.49. The intraclass correlation coefficient for UCEIS was 0.92 among the three endoscopists (CI 95 %: 0.83-0.96) and 0.96 for UCCIS among the three endoscopists (CI 95 % 0.94-0.97). A change in treatment for 34.3 % of the patients was implemented on seeing the results of the colonoscopy. Conclusions: There was an adequate, but not perfect, correlation between the different endoscopists for MES, UCEIS, UCCIS. This was higher with the last two scores. Thus, there is still some subjectivity to be minimized through special training, on assessing the seriousness of the endoscopic lesions in patients with UC.

Erythema Nodosum: As an Extraintestinal Manifestation or Complication in Ulcerative Colitis?

In our case, we want to highlight the importance of screening for opportunistic infectious diseases in these immunosuppressed patients. We present the case of an erythema nodosum triggered by reactivation of Herpes Simplex Virus (HSV) in a patient with ulcerative colitis.

Long-term follow up after switching from original infliximab to an infliximab biosimilar: real-world data.

BACKGROUND: Several studies have reported positive efficacy outcomes for patients with inflammatory bowel disease treated with CT-P13, an infliximab biosimilar. Data from follow-up periods longer than 1 year are still scarce. Here, we assessed the long-term efficacy data, loss of response and safety after switching from infliximab to CT-P13 in patients with inflammatory bowel disease. METHODS: This was a prospective single-center observational study involving patients with moderate-to-severe Crohn's disease and ulcerative colitis switched from infliximab to CT-P13 treatment and reviewed up to 24 months. Efficacy and loss of response were measured using the Harvey-Bradshaw (HB) index and partial Mayo score for patients with Crohn's disease and ulcerative colitis respectively. C-reactive protein, infliximab drug levels, adverse events and antidrug antibodies were also monitored throughout the study. RESULTS: A total of 64 patients with Crohn's disease and 36 patients with ulcerative colitis were included. Most of them (72%) remained on CT-P13. Overall, 28% of patients discontinued the therapy due to loss of response, adverse events or long-lasting clinical remission. Remission at 18 and 24 months occurred in 69.9% and 68.5% of patients, respectively. Dose increase was performed in 22% of patients, with remission being reached in 60% of them. HB index, partial Mayo score, C-reactive protein and infliximab drug levels did not show significant changes. Serious adverse events were reported in 14% of patients. Overall, two patients developed low levels of antidrug antibodies. CONCLUSIONS: Most of the patients switching from original infliximab were maintained on CT-P13 at 2 years of follow up with a good profile of efficacy and safety.

Loss of efficacy and safety of the switch from infliximab original to infliximab biosimilar (CT-P13) in patients with inflammatory bowel disease.

BACKGROUND: Infliximab original has changed the natural history of inflammatory bowel diseases (IBD) over the past two decades. However, the recent expiration of its patent has allowed the entry of the first Infliximab biosimilar into the European and Spanish markets. Currently switching drugs data in IBD are limited. AIM: To compare the efficacy of infliximab biosimilar, CT-P13, against infliximab original, analyzing the loss of response of both at the 12 mo follow-up in patients with IBD. METHODS: An observational study of two cohorts has been conducted. One retrospective cohort that included patients with IBD treated with Infliximab original, and a prospective cohort of patients who were switching from infliximab original to infliximab biosimilar (CT-P13). We had analyzed the overall efficacy and loss of efficacy in patients in remission at the end of one year after treatment with the original drug compared to the results of the year of treatment with the biosimilar. RESULTS: 98 patients (CD 67, CU 31) were included in both cohorts. The overall efficacy for infliximab original per year of treatment was 71% vs 68.2% for infliximab biosimilar (P = 0.80). The loss of overall efficacy at 12 mo for infliximab original was 6.6% vs 14.5% for infliximab biosimilar (P = 0.806). The loss of efficacy in patients who were in basal remission was 16.3% for infliximab original vs 27.1% for infliximab biosimilar. Adverse events were 9.2% for infliximab original vs 11.2% for infliximab biosimilar. CONCLUSION: The overall efficacy and loss of treatment response with infliximab biosimilar (CT-P13) is similar to that observed with infliximab original in patients who were switching at the 12 mo follow-up. There is no difference in the rate of adverse events.

Prevalence of Malnutrition and Nutritional Characteristics of Patients With Inflammatory Bowel Disease.

BACKGROUND AND AIMS: This study sought to determine the prevalence of malnutrition in patients with inflammatory bowel disease, to analyse the dietary beliefs and behaviours of these patients, to study their body composition, to evaluate their muscular strength and to identify the factors associated with malnutrition in these patients. METHODS: This was a prospective, multicentre study. Crohn's disease and ulcerative colitis patients from 30 Spanish centres, from the outpatient clinics, were included. A questionnaire of 11 items was applied to obtain data from patients' dietary behaviour and beliefs. Patients who accepted were evaluated to assess their nutritional status using Subjective Global Assessment and body mass index. Body composition was evaluated through bioelectrical impedance. RESULTS: A total of 1271 patients were included [51% women, median age 45 years, 60% Crohn's disease]. Of these, 333 patients underwent the nutritional evaluation. A total of 77% of patients declared that they avoided some foods to prevent disease relapse. Eighty-six per cent of patients avoided some foods when they had disease activity because of fear of worsening the flare. Sixty-seven per cent of patients modified their dietary habits after disease diagnosis. The prevalence of malnutrition was 16% [95% confidence interval = 12-20%]. In the multivariate analysis, history of abdominal surgery, active disease and avoidance of some foods during flares were associated with higher risk of malnutrition. CONCLUSIONS: The prevalence of malnutrition in inflammatory bowel disease patients was high. We identified some predictive factors of malnutrition. Most of the patients had self-imposed food restrictions, based on their beliefs.