Prevalence of Steinert's Myotonic Dystrophy and Utilization of Healthcare Services: A Population-Based Cross-Sectional Study.

Myotonic dystrophy type I (MDI) is the most common muscular dystrophy in adults. The main objectives of this study were to determine the prevalence of MDI in the Community of Madrid (CM) (Spain) and to analyze the use of public healthcare services; a population-based cross-sectional descriptive study was carried out on patients with MDI in CM and data were obtained from a population-based registry (2010-2017). A total of 1101 patients were studied (49.1% women) with average age of 47.8 years; the prevalence of MDI was 14.4/100,000 inhabitants. In the women lineal regression model for hospital admissions, being in the fourth quartile of the deprivation index, was a risk factor (regression coef (rc): 0.80; 95%CI 0.25-1.37). In the overall multiple lineal regression model for primary health care (PHC) attendance, being a woman increased the probability of having a higher number of consultations (rc: 3.99; 95%CI: 3.95-5.04), as did being in the fourth quartile of the deprivation index (rc: 2.10; 95%CI: 0.58-3.63); having received influenza vaccines was a protective factor (rc: -0.46; 95%CI: -0.66-(-0.25)). The prevalence of MDI in the CM is high compared to other settings. Moreover, having any level of risk stratification of becoming ill (high, medium or low) has a positive association with increased PHC consultations and hospital admissions.

Psychological disorders and coping strategies in patients with inflammatory bowel disease. Their impact on health-related quality of life.

BACKGROUND AND OBJECTIVES: inflammatory bowel disease (IBD) has a major impact on psychological well-being. This condition is associated with a high level of anxiety and mood disorders, but stress prevalence and how an individual copes with IBD have not been sufficiently explored. The objective of this study was to assess the impact of the disease on psychological disorders and to identify coping strategies used by patients with IBD, as well as to analyze the relationship between these variables and sociodemographic and clinical variables. METHODS: a cross-sectional prospective study was performed including 126 consecutive patients. Those with psychiatric conditions prior to the onset of the IBD were excluded. Independent variables were measured using a sociodemographic and clinical questionnaire. The patients completed the Hospital Anxiety and Depression Scale (HADS), the Perceived Stress Scale (PSS) and the BRIEF COPE questionnaire. Quality of life was measured using the nine-item IBD Quality of Life (IBDQ-9). RESULTS: the final cohort comprised 100 patients (37 with ulcerative colitis and 63 with Crohn's disease). The prevalence rates of the variables of stress, anxiety and depression were high (44 %, 24 % and 14 %, respectively). Stress and depression were higher in females (p < 0.05), without differences regarding other sociodemographic and clinical variables. Moreover, higher levels of anxiety and depression were found to be associated with stress and dysfunctional coping strategies (p < 0.01). CONCLUSIONS: patients with IBD, particularly women, have high rates of psychological disorders. Those with anxiety and depression presented more stress and used more dysfunctional strategies. These conditions must be considered for a multidisciplinary management.

Psychological disorders and coping strategies in patients with inflammatory bowel disease. Their impact on health-related quality of life

Background and objectives: inflammatory bowel disease (IBD) has a major impact on psychological well-being. This condition is associated with a high level of anxiety and mood disorders, but stress prevalence and how an individual copes with IBD have not been sufficiently explored. The objective of this study was to assess the impact of the disease on psychological disorders and to identify coping strategies used by patients with IBD, as well as to analyze the relationship between these variables and sociodemographic and clinical variables. Methods: a cross-sectional prospective study was performed including 126 consecutive patients. Those with psychiatric conditions prior to the onset of the IBD were excluded. Independent variables were measured using a sociodemographic and clinical questionnaire. The patients completed the Hospital Anxiety and Depression Scale (HADS), the Perceived Stress Scale (PSS) and the BRIEF COPE questionnaire. Quality of life was measured using the nine-item IBD Quality of Life (IBDQ-9). Results: the final cohort comprised 100 patients (37 with ulcerative colitis and 63 with Crohn’s disease). The prevalence rates of the variables of stress, anxiety and depression were high (44 %, 24 % and 14 %, respectively). Stress and depression were higher in females (p < 0.05), without differences regarding other sociodemographic and clinical variables. Moreover, higher levels of anxiety and depression were found to be associated with stress and dysfunctional coping strategies (p < 0.01). Conclusions: patients with IBD, particularly women, have high rates of psychological disorders. Those with anxiety and depression presented more stress and used more dysfunctional strategies. These conditions must be considered for a multidisciplinary management. (AU)

Evaluación del impacto emocional de la pandemia COVID-19 en pacientes en hemodiálisis: un estudio transversal analítico / Evaluation Of The Emotional Impact Of The Covid-19 Pandemic On Hemodialysis Patients: An Analytical Cross-Sectional Study

Antecedentes: Los pacientes en hemodiálisis padecen, debido a su diagnóstico y tratamiento, mayores niveles de ansiedad y depresión que la población general. El objetivo de esta investigación es conocer el impacto emocional generado por la COVID-19 en pacientes hemodializados. Método: Estudio transversal analítico en una muestra total de 88 pacientes mayores de 18 años que reciben hemodiálisis entre abril de 2021 y marzo de 2022. Se recogen variables sociodemográficas y clínicas incluyendo aquellas relacionadas con COVID-19. A todos los pacientes se les administran las escalas HADS y Kessler-10. Resultados: La puntuación media de la escala HADS-A fue de 5,3 (±3,732), de la HADS-D de 5,45 (±4,052) y de la Kessler-10 de 20,11(±7,499). Se observaron diferencias significativas entre aislados y no aislados en las escalas clínicas HADS-A (p=,002) y HADS-D (p=,005). Igualmente, aquellos pacientes con antecedentes psicopatológicos fueron significativamente más jóvenes (p=,014) y con una mayor puntuación en las escalas HADS-D (p=,016) y Kessler-10 (p=,035) que aquellos sin antecedentes. Conclusiones: No hubo asociación entre infección por COVID-19 y la clínica ansioso-depresiva en pacientes hemodializados. El aislamiento, en estos pacientes, no se asocia a la aparición de clínica psicopatológica, mientras que el hecho de haber presentado antecedentes psicopatológicos previos se asocia a su desarrollo.(AU)

Background: Hemodialysis patients suffer, due to their diagnosis and treatment, higher levels of anxiety and depression than the general population. The aim of this research is to know the emotional impact generated by COVID-19 in hemodialysis patients. Method: Analytical cross-sectional study in a total sample of 88 patients over 18 years of age receiving hemodialysis between April 2021 and March 2022. Sociodemographic and clinical variables including those related to COVID-19 are collected. All patients were administered the HADS and Kessler-10 scales. Results: The mean score of the HADS-A scale was 5.3(±3.732) of the HADS-D 5.45 (±4.052) and of the Kessler-10 20.11(±7.499). Significant differences were observed between isolated and non-isolated patients in the clinical scales HADS-A (p=.002) and HADS-D (p=.005). Likewise, those patients with a psychopathological history were significantly younger (p=.014) and scored higher on the HADS-D (p=.016) and Kessler-10 (p=.035) scales than those without a history. Conclusions: There was no association between COVID-19 infection and anxious-depressive symptoms in hemodialyzed patients. Isolation, in these patients, was not associated with the appearance of psychopathological symptoms, while the fact of having a previous history of psychopathology was associated with their development.(AU)

Back to basics: likelihood ratios for olive and grass pollen specific IgE in seasonal allergic rhinitis.

Introduction: Specific IgE (sIgE) is merely a sensitization marker that cannot be used for allergy diagnosis if there are no associated clinical symptoms. As of 2023, there is still no evidence regarding the quantity of sIgE necessary to confirm or exclude clinical disease. Therefore, this study aimed to calculate cut-offs for sIgE, allowing us to effectively diagnose olive or grass pollen allergy and select allergenic immunotherapy (AIT) candidate patients in a region under high olive and grass allergenic pressure. Methods: An observational retrospective study consisting of the review of electronic medical records from 1,172 patients diagnosed with seasonal rhino-conjunctivitis and suspected allergy to olive or grass pollen. Symptoms correlated with sIgE to Poaceae and Oleaceae whole extracts and sIgE to genuine allergenic components were evaluated. Optimal cut-off values were calculated using receiver operating characteristic curves. Relevant clinical symptoms and AIT indications were taken into consideration when determining the clinical allergy diagnosis. Results: sIgE to Lolium showed the best area under the curve (AUC) for both diagnosis (0.957) and an indication of AIT (0.872). The optimal cut-off values for grass diagnosis and AIT indication were 1.79 kUA/L and 8.83 kUA/L, respectively. A value of 5.62 kUA/L was associated with a positive likelihood ratio (LR) of 10.08 set for grass allergy. Olea sIgE showed the best AUC for the diagnosis (0.950). The optimal cut-off for diagnosis was 2.41 kUA/L. A value of 6.49 kUA/L was associated with a positive LR of 9.98 to confirm olive pollen allergy. In regard to immunotherapy, Ole e 1 sIgE showed the best AUC (0.860). The optimal cut-off was 14.05 kUA/L. Ole e 1 sIgE value of 4.8 kUA/L was associated with a 0.09 negative LR to exclude olive AIT indication. Conclusions: The sIgE cut-offs found in this population under high olive and grass allergenic pressure reduce the gap between sensitization and clinical allergy, providing a new tool for the diagnosis of seasonal allergic rhinitis/asthma and helping to discriminate patients who will benefit from AIT.

Preclinical Study of DCD and Normothermic Perfusion for Visceral Transplantation.

Considering recent clinical and experimental evidence, expectations for using DCD-derived intestines have increased considerably. However, more knowledge about DCD procedure and long-term results after intestinal transplantation (ITx) is needed. We aimed to describe in detail a DCD procedure for ITx using normothermic regional perfusion (NRP) in a preclinical model. Small bowel was obtained from pigs donors after 1 h of NRP and transplanted to the recipients. Graft Intestinal samples were obtained during the procedure and after transplantation. Ischemia-reperfusion injury (Park-Chiu score), graft rejection and transplanted intestines absorptive function were evaluated. Seven of 8 DCD procedures with NRP and ITx were successful (87.5%), with a good graft reperfusion and an excellent recovery of the recipient. The architecture of grafts was well conserved during NRP. After an initial damage of Park-chiu score of 4, all grafts recovered from ischemia-reperfusion, with no or very subtle alterations 2 days after ITx. Most recipients (71.5%) did not show signs of rejection. Only two cases demonstrated histologic signs of mild rejection 7 days after ITx. Interestingly intestinal grafts showed good absorptive capacity. The study's results support the viability of intestinal grafts from DCD using NRP, contributing more evidence for the use of DCD for ITx.

Is cervical dysplasia a major concern in women with inflammatory bowel disease? A Spanish retrospective study.

Cervical cancer (CC) is the fourth most common cancer affecting women worldwide. The risk of women immunosuppressed due to AIDS or organ transplantation is well documented, as most cases are caused by persistent human papillomavirus (HPV) infection and immunosuppression can prevent clearing HPV. Although European guidelines advise that inflammatory bowel disease (IBD) women under immunosuppression should be screened for CC as regularly as high-risk patients, quality evidence is lacking in our country. We performed a retrospective case-control (2020-2021) study to analyse the risk factors associated with the appearance of low-grade (LSIL) or high-grade (HSIL) squamous intraepithelial cervical lesions in patients with IBD. We included all women aged 21-65 years , followed up at the University Hospital Fundación Alcorcón (Spain). Cases were defined as those patients with abnormalities in cervical cytology, while the control group consisted of the rest of the women. Disease characteristics, treatments and epidemiological data (smoking habit, sexual behaviour and reproductive history) were obtained. We documented the evolution of abnormalities over time and compare data between women under immunosuppressive treatment or not.

First case report of multivisceral transplant from a deceased cardiac death donor.

The current shortage of pediatric multivisceral donors accounts for the long time and mortality on the waiting list of pediatric patients. The use of donors after cardiac death, especially after the outbreak of normothermic regional perfusion, has increased in recent years for all solid organs except the intestine, mainly because of its higher susceptibility to ischemia-reperfusion injury. We present the first literature case of multivisceral donors after cardiac death transplantation in a 13-month-old recipient from a 2.5-month-old donor. Once exitus was certified, an extracorporeal membrane oxygenation circuit was established, cannulating the aorta and infrarenal vena cava, while the supra-aortic branches were clamped. The abdominal organs completely recovered from ischemia through normothermic regional perfusion (extracorporeal membrane oxygenation initially and beating heart later). After perfusion with the preservation solution, the multivisceral graft was uneventfully implanted. Two months later, the patient was discharged without any complications. This case demonstrates the possibility of reducing the time spent on the waiting list for these patients.

Effectiveness and Safety of Ustekinumab in Elderly Patients with Crohn's Disease: Real World Evidence From the ENEIDA Registry.

BACKGROUND AND AIMS: Clinical trials and real-life studies with ustekinumab in Crohn's disease [CD] have revealed a good efficacy and safety profile. However, these data are scarcely available in elderly patients. Therefore, we aim to assess the effectiveness and safety of ustekinumab in elderly patients with CD. METHODS: Elderly patients [>60 years old] from the prospectively maintained ENEIDA registry treated with ustekinumab due to CD were included. Every patient was matched with two controls under 60 years of age, according to anti-tumour necrosis factor use and smoking habit. Values for the Harvey-Bradshaw Index [HBI], endoscopic activity, C-reactive protein [CRP] and faecal calprotectin [FC] were recorded at baseline and at weeks 16, 32 and 54. RESULTS: In total, 648 patients were included, 212 of whom were elderly. Effectiveness was similar between young and elderly patients during the follow-up. Steroid-free remission was similar at week 16 [54.6 vs 51.4%, p = 0.20], 32 [53.0% vs 54.5%, p = 0.26] and 54 [57.8% vs 51.1%, p = 0.21]. Persistence of ustekinumab as maintenance therapy was similar in both age groups [log-rank test; p = 0.91]. There was no difference in the rate of adverse effects [14.2% vs 11.2%, p = 0.350], including severe infections [7.1% vs 7.3%, p = 1.00], except for the occurrence of de novo neoplasms, which was higher in older patients [0.7% vs 4.3%, p = 0.003]. CONCLUSIONS: Ustekinumab is as effective in elderly patients with CD as it is in non-elderly patients. The safety profile also seems to be similar except for a higher rate of de novo neoplasms, probably related to the age of the elderly patients.

Un caso raro de cervicalgia / A rare case of cervicalgia

OBJETIVO Subrayar la importancia del diagnóstico detallado del dolor y realizar autocrítica por la tardanza diagnóstica de una cervicalgia mecánica. MATERIAL Y MÉTODOS Se presenta una paciente con dolor súbito en el cuello, con radiografías y exploración normales. La resonancia magnética (RM) resultó aparentemente anodina y se trató como cervicalgia mecánica. Tras varias consultas con el Servicio de Urgencias, se realizó una radiografía que informó de anomalía entre las primeras vértebras y se amplió con una tomografía computarizada (TC) que reveló fractura de odontoides y destrucción de la segunda cervical de origen metastásico.RESULTADOS La paciente fue tratada con radioterapia más collarín cervical y varios ciclos de quimioterapia, y falleció a los dos años.DISCUSIÓN Los cánceres que más frecuentemente metastatizan en la columna vertebral son los de mama, pulmón y próstata, siendo las localizaciones más frecuentes la torácica (70%), la lumbar (20%) y, por último, la cervical (10%). Cuando el tumor se descubre como metástasis, como en nuestro caso, estos pacientes tienen una alta tasa de mortalidad. Según nuestro conocimiento, en la literatura hay pocos casos descritos de neoplasias descubiertas como fractura patológica de odontoides. CONCLUSIÓN El dolor cervical no mecánico debido a una metástasis en odontoides, a consecuencia de una neoplasia de pulmón no diagnosticada, es un caso raro en la literatura y de complejo diagnóstico, en que una historia clínica detallada de la evolución del dolor y la presencia de signos de alarma son de vital importancia para su sospecha y rápido diagnóstico, mediante técnicas como la RM.

OBJETIVE To underline the importance of a detailed diagnosis of pain and perform self-criticism regarding the delay in diagnosis of a case of mechanical cervicalgia. MATERIALS AND METHODS We present the case of a patient with sudden neck pain, with normal X-rays. The magnetic resonance imaging (MRI) scan was apparently unremarkable, and the condition was treated as mechanical cervicalgia. After several consultations in the Emergency Department, a new X-ray was performed, which showed an anomaly between the first vertebrae and is accompanied by a computed tomography (CT) scan that revealed a fracture of the odontoid apophysis and destruction of the second cervical vertebra of metastatic origin. RESULTS The patient was treated with radiotherapy plus cervical collar and several cycles of chemotherapy, and died two years later. DISCUSSION The cancers that most frequently metastasize to the spine are those of the breast, lung and prostate, with the most frequent location being thoracic (70%), lumbar (20%), and, finally, cervical (10%). When the tumor is discovered as a metastasis, as in our case, these patients have a high mortality rate. To our knowledge, few cases of neoplasms discovered as pathological fractures of the odontoid apophysis have been described in the literature. CONCLUSION Non-mechanical cervicalgia due to metastasis of the odontoid apophysis as a result of an undiagnosed lung neoplasm is a rare case in the literature and a complex diagnosis, in which a detailed clinical history of the evolution of pain and the presence of red flags are of vital importance for its suspicion and rapid diagnosis, through techniques such as MRI.

Natural and Induced Tolerance to Hymenoptera Venom: A Single Mechanism?

Inducing tolerance in Hymenoptera-allergic patients, bee venom immunotherapy (BVIT) is a widely accepted method to treat severe allergy to bee stings. In order to increase the existing knowledge on the underlying immunological mechanisms and look for possible biomarkers predictive of efficacy, a group of 20 bee-venom-allergic patients (AG) were thoroughly examined during their first year of BVIT. In addition, the results of treated patients with those of an untreated group of 20 tolerant beekeepers (TG) who had previously shown a firm suppressor-regulatory profile were compared. Tolerance in AG patients was invariably associated with a significant regulatory response characterised by the expansion of Helios- subpopulation and increased IL-10, specific IgG4 (sIgG4), and kynurenine levels. Although specific IgE (sIgE) levels increased transiently, surprisingly, the T helper type 2 (Th2) population and IL-4 levels rose significantly after one year of immunotherapy. Thus, the picture of two parallel phenomena emerges: a tolerogenic response and an allergenic one. Comparing these results with those obtained from the TG, different immunological mechanisms appear to govern natural and acquired tolerance to immunotherapy. Of particular interest, the kynurenine levels and T regulatory (Treg) Helios- population could be proposed as new biomarkers of response to BVIT.

Association of golimumab trough concentrations during maintenance with clinical, biological, endoscopic and histologic remission in patients with ulcerative colitis.

BACKGROUND: Optimal golimumab concentration thresholds for important outcomes during maintenance are lacking. AIMS: To investigate the association of golimumab trough concentrations during maintenance with key outcomes, including endoscopic and histologic remission, and long-term event-free persistence with golimumab, in patients with UC. METHODS: This multi-centre, cross-sectional study included patients with UC on golimumab maintenance recruited either in remission or during a flare. Colonoscopy was scheduled, and study-specific rectocolonic biopsies were taken for blind central histologic reading. Samples for golimumab trough concentrations were collected close to colonoscopy. RESULTS: Fifty-two patients were included. Median golimumab trough concentrations (µg/ml) were significantly higher in patients who had clinical remission (2.01 vs. 0.72, p = 0.047), combined clinical-biochemical remission (PMS ≤2 + faecal calprotectin <250 µg/g) (2.21 vs. 1.47, p = 0.041), endoscopic healing (Mayo endoscopic subscore 0) (2.52 vs. 1.47, p = 0.003), histologic remission (Geboes index ≤2.0) (2.33 vs. 1.50, p = 0.02) and disease clearance (clinical remission endoscopic healing + histologic remission) (2.52 vs. 1.70, p = 0.009), compared with those not meeting these criteria. Golimumab concentrations were significantly higher in patients who avoided golimumab dose escalation/discontinuation during follow-up (2.24 vs. 0.98, p = 0.012). Receiver-operating characteristic analyses identified golimumab thresholds [area under the curve] of 0.85 [0.76], 1.90 [0.76], 2.29 [0.75], 1.79 [0.68], 2.29 [0.72] and 1.56 [0.71] µg/ml as associated with clinical remission, combined remission, endoscopic healing, histologic remission, disease clearance and long-term event-free persistence with golimumab, respectively. CONCLUSIONS: Golimumab trough concentrations during maintenance are associated with favourable treatment outcomes including endoscopic healing, histologic remission and long-term persistence on golimumab. We identified the optimal golimumab thresholds most closely associated with key outcomes.

Management of Double Sensitization to Vespids in Europe.

Wasp allergy with a diagnostic profile of double sensitizations to vespid venom is a frequent clinical problem in areas where different genera of wasps are present. Identification of the insect responsible for serious reactions poses a diagnostic challenge as the only effective treatment to date is immunotherapy based on the specific venom. In southern Europe, the double sensitization to Vespula and Polistes venoms is highly frequent. It has been shown that the major allergenic proteins (Phospholipase A1 and Antigen 5) share sequences across the different genera and species, which would be the cause of cross-reactivity. Additionally, the minor allergens (Dipeptidyl-peptidases, Vitellogenins) have been found to share partial sequence identity. Furthermore, venom contains other homologous proteins whose allergenic nature still remains to be clarified. The traditional diagnostic tools available are insufficient to discriminate between allergy to Vespula and Polistes in a high number of cases. IgE inhibition is the technique that best identifies the cross-reactivity. When a double sensitization has indeed been shown to exist or great uncertainty surrounds the primary sensitization, therapy with two venoms is advisable to guarantee the safety of the patient. In this case, a strategy involving alternate administration that combines effectiveness with efficiency is possible.

Re-induction With Intravenous Ustekinumab in Patients With Crohn's Disease and a Loss of Response to This Therapy.

BACKGROUND: A significant percentage of patients treated with ustekinumab may lose response. Our aim was to evaluate the short-term efficacy and safety of intravenous re-induction with ustekinumab in patients with Crohn's disease who have lost the response to the treatment. METHODS: This is a retrospective, observational, multicenter study. Treatment efficacy was measured at week 8 and 16; clinical remission was defined when the Harvey-Bradshaw Index was ≤4 points, and clinical response was defined as a decrease of ≥3 points in the index compared with the baseline. Adverse events and treatment decisions after re-induction were also collected. RESULTS: Fifty-three patients from 13 centers were included. Forty-nine percent had previously failed to respond to 2 biological treatments, and 24.5% had failed to respond to 3. The average exposure time to ustekinumab before re-induction was 17.7 ± 12.8 months. In 56.6% of patients, the administration interval had been shortened to every 4 to 6 weeks before re-induction. At week 8 and 16 after re-induction, 49.0% (n = 26) and 43.3% (n = 23), respectively, were in remission, whereas 64.1% (n = 34) and 52.8% (n = 28) had a clinical response. Patients who achieved remission at week 16 had lower C-reactive protein levels than those who did not respond (2.8 ± 1.6 vs 12.5 ± 9.5 mg/dL; P = 0.001). No serious adverse events related to re-induction were observed. CONCLUSION: Intravenous re-induction with ustekinumab is an effective and safe strategy that recovers the response in approximately half of the patients with refractory Crohn's disease who experience a loss of response. Re-induction can be attempted before switching out of the therapy class.

ß-blockers and ACE inhibitors are not a risk factor for severe systemic sting reactions and adverse events during venom immunotherapy.

BACKGROUND: There is controversy whether taking ß-blockers or ACE inhibitors (ACEI) is a risk factor for more severe systemic insect sting reactions (SSR) and whether it increases the number or severity of adverse events (AE) during venom immunotherapy (VIT). METHODS: In this open, prospective, observational, multicenter trial, we recruited patients with a history of a SSR and indication for VIT. The primary objective of this study was to evaluate whether patients taking ß-blockers or ACEI show more systemic AE during VIT compared to patients without such treatment. RESULTS: In total, 1,425 patients were enrolled and VIT was performed in 1,342 patients. Of all patients included, 388 (27.2%) took antihypertensive (AHT) drugs (10.4% took ß-blockers, 11.9% ACEI, 5.0% ß-blockers and ACEI). Only 5.6% of patients under AHT treatment experienced systemic AE during VIT as compared with 7.4% of patients without these drugs (OR: 0.74, 95% CI: 0.43-1.22, p = 0.25). The severity of the initial sting reaction was not affected by the intake of ß-blockers or ACEI (OR: 1.14, 95% CI: 0.89-1.46, p = 0.29). In total, 210 (17.7%) patients were re-stung during VIT and 191 (91.0%) tolerated the sting without systemic symptoms. Of the 19 patients with VIT treatment failure, 4 took ß-blockers, none an ACEI. CONCLUSIONS: This trial provides robust evidence that taking ß-blockers or ACEI does neither increase the frequency of systemic AE during VIT nor aggravate SSR. Moreover, results suggest that these drugs do not impair effectiveness of VIT. (Funded by Medical University of Graz, Austria; Clinicaltrials.gov number, NCT04269629).

The COVID-19 pandemic shows us in which way the care of patients with inflammatory bowel disease should move.

The COVID-19 pandemic has forced major changes in the care of patients with inflammatory bowel disease (IBD). The articles by El Hajra et al. and Fernández Álvarez el al. show the modifications in patient management that were performed during the state of alarm in Spain.

Comparison of original and biosimilar infliximab (CTP-13) in biologic-naïve patients with Crohn's disease and ulcerative colitis: a retrospective, multicenter real-life study in Spain.

PURPOSE: biosimilar infliximab (CTP-13) has been recently approved for the treatment of several immune-mediated inflammatory disorders, including inflammatory bowel disease (IBD). Comparative studies between this biosimilar and original infliximab in the real clinical practice are scarce. The objective of this study was to compare short and long-term safety and efficacy of original (O) and biosimilar infliximab (B-IFX) in biologic-naïve, IBD patients in the real life clinical practice. METHODS: a retrospective, multicentric study was performed in five Spanish hospitals. Consecutive IBD, biologic-naïve patients from an historic cohort who initiated O-IFX from January 2013 were compared with biologic-naïve patients, who started treatment with B-IFX since its approval in January 2015. The evaluation of efficacy was assessed after the induction phase, at week 14 and week 54 of treatment. Time to dose escalation or treatment persistence of both O-IFX and B-IFX was also considered. The appearance of serious adverse events was recorded. RESULTS: two hundred and thirty-nine IBD biologic-naïve patients who started with O-IFX or B-IFX were included: 153 patients were diagnosed with Crohn's disease (95 treated with O- and 58 treated with B-IFX) and 86 with ulcerative colitis (40 received O- and 46 received B-IFX). At weeks 14 and 54, both O-IFX and B-IFX groups reached a similar clinical response and remission rates. Time to dose escalation, treatment persistence and safety profile were comparable between both groups. CONCLUSIONS: this long-term real-life experience provides additional evidence of the similarity of O- and B-IFX CTP-13 in terms of efficacy and safety in IBD patients.