Effectiveness and safety of adalimumab biosimilar in patients with inflammatory bowel disease.

BACKGROUND: Adalimumab biosimilar MSB11022 (Idacio ®) has been approved for the same indications as its originator (Humira ®), based on findings from clinical trials in plaque psoriasis. Data on its efficacy and safety in inflammatory bowel disease, however, are scarce. METHODS: Retrospective, observational study of 44 patients with inflammatory bowel disease: 30 were treated with originator adalimumab, 5 were directly started on MSB11022, and 9 switched from originator to biosimilar adalimumab. To evaluate the effectiveness of the use of adalimumab in inflammatory bowel disease, both laboratory markers (fecal calprotectin and C-reactive protein) and scales that measure the activity of inflammatory bowel disease using specific scales (Harvey-Bradshaw Index (HBI) have been usEd.) for Crohn's disease and Mayo Score for Ulcerative Colitis. Efficacy was evaluated by recording the adverse effects that could occur with the administration of adalimumab (original or biosimilar). The success of the switch was determined by analyzing meaningful differences in effectiveness and safety criteria. Concomitant therapy and the need for dose intensification were also analyzed. Objective of this study was to assess the effectiveness and safety of biosimilar adalimumab in adalimumab-naïve patients and patients switched from originator adalimumab. RESULTS: No significant differences were observed in clinical disease activity (P=.317) or biochemical parameters [fecal calprotectin (P=.445) and C-reactive protein P=.661)] after the switch from the originator adalimumab to MSB11022. There was not a significant reduction in the concomitant use of corticosteroids and thiopurines (P=.157). No emergency room visits or hospitalizations were observed during the study period and none of the patients experienced serious adverse effects. CONCLUSIONS: Between originator adalimumab and biosimilar-start cohorts, no differences were observed, between originator adalimumab and switch cohorts, no significant differences were found either, and with the pre- and post-switch to biosimilar comparison, 2 of the 9 patients experienced AEs after the switch. The biosimilar showed a favorable safety profile (one patient with a serious adverse effect (rash) with biosimilar discontinued treatment) and no significant changes to clinical or biochemical parameters were observed after the switch.

Freiburg personality inventory in inflammatory bowel disease: diagnosis and psychotherapeutic needs / Inventario de personalidad de Freiburg en la enfermedad inflamatoria intestinal: diagnóstico y necesidades psicoterapéuticas

A pesar de los descubrimientos recientes, los pacientes con enfermedad inflamatoria intestinal (EII) aún enfrentan desafíos para lograr la remisión. Los objetivos del estudio fueron identificar las características de los pacientes con el Inventario de Personalidad de Freiburg y la intensidad de la enfermedad colónica, comorbilidades que podrían estar relacionadas con la personalidad de los sujetos. Los datos se recopilaron en el período 2019-2020 de 46 pacientes y utilizaron métodos no paramétricos. En comparación con el grupo de control, las escalas de Inhibición, Problemas de salud y Emocionalidad tenían puntuaciones brutas significativamente más altas. Las escalas de Orientación Social, Franqueza y Extraversión tuvieron puntajes brutos significativamente más bajos. El estado de salud fue un factor médico que influyó en la escala de Quejas Somáticas, los pacientes que tenían lesiones o comorbilidades tenían puntuaciones brutas significativamente más altas. Los pacientes que tenían comorbilidades además de la EII tenían puntuaciones brutas considerablemente más altas en la escala de Excitabilidad. Se requieren intervenciones psicoterapéuticas de cambio en la percepción de la vida para abordar la descripción del sufrimiento subjetivo relacionado con molestias físicas (escala de quejas somáticas), una fuerte orientación hacia el rendimiento (escala de tensión), cambios de humor, ansiedad y pesimismo (escala de emocionalidad). Otra intervención es la reconsideración y (re)priorización de valores, como la familia, las relaciones íntimas, los amigos, la salud, el crecimiento, el desarrollo, el trabajo equilibrado, todos los cuales pueden promover una sensación de bienestar y equilibrio.(AU)

Despite recent discoveries, patients with inflammatory bowel disease (IBD) still face challenges with attainment of remission. The objectives of the study were to identify the characteristics of patients with the Freiburg Personality Inventory and the intensity of the intestinal disease, comorbidities that could be related to the personality of the subjects. Data were collected in the period 2019–2020 from 46 patients and used nonparametric methods. Compared to the normative sample, the Inhibitedness, Health Concerns, and Emotionality scales had significantly higher raw scores. The Social Orientation, Frankness, and Extraversionscales had significantly lower raw scores. Health status was a medical factor that influenced the Somatic Complaintsscale, patients who had lesions or comorbidities had significantly higher raw scores. Patients who had comorbidities in addition to IBD had considerably higher raw scores on the Excitability scale. Psychotherapeutic change interventions regarding life perception are required to tackle the description of subjective suffering related to physical inconveniences (Somatic Complaintsscale), a strong orientation toward performance (Strainscale), mood swings, anxiety, and pessimism (Emotionality scale). Another intervention is reconsidering values and (re) prioritization, such as family, intimate relationships, friends, health, growth, development, balanced work, all of which can promote a feeling of well-being and balance.(AU)

An in vitro analysis of the interaction between infliximab and granulocyte–monocyte apheresis / Análisis in vitro de la interacción entre infliximab y la aféresis de granulocitos y monocitos

Objective: Primary non-response and secondary loss of response to anti-TNF agents are common in inflammatory bowel disease. Increasing drug concentrations are correlated to better clinical response and remission rates. Combination of granulocyte–monocyte apheresis (GMA) with anti-tumor necrosis factor (TNF) agents could be an option in these patients. The objective of our study was to perform an in vitro assay to determine if the GMA device can lead to infliximab (IFX) adsorption. Patients and methods: A blood sample was obtained from a healthy control. It was incubated with three concentrations of IFX (3, 6, and 9μg/ml) at room temperature for 10min. At that time, 1ml was collected to determine the IFX concentration. Then, 10ml of each drug concentration was incubated with 5ml of cellulose acetate (CA) beads from the GMA device at 200rpm for 1h at 37°C to simulate physiological human conditions. A second sample of each concentration was collected and IFX levels were determined. Results: No statistically significant differences were observed in the IFX levels in the blood samples before and after incubation with the CA beads (p=0.41) and after repeated measurements (p=0.31). Mean change was 3.8μg/ml. Conclusions: The in vitro combination of GMA and IFX did not change the circulating levels of IFX at the three concentrations tested, suggesting that there is no interaction between the drug and the apheresis device in vitro and that they might be safely combined with each other. (AU)

Objetivo: La falta de respuesta primaria y la pérdida de respuesta secundaria a los agentes antifactor de necrosis tumoral (TNF) son comunes en la enfermedad inflamatoria intestinal. El aumento de los niveles de fármaco se correlaciona con una mejor respuesta clínica y de las tasas de remisión. La combinación de la aféresis selectiva de granulocitos y monocitos (GMA) con agentes anti-TNF podría ser una opción en estos pacientes. El objetivo de nuestro estudio fue realizar un ensayo in vitro para determinar si el dispositivo de GMA puede interaccionar con infliximab (IFX). Pacientes y métodos: Se obtuvo una muestra de sangre de un control sano. Se incubó con 3 concentraciones de IFX (3, 6 y 9μg/ml) a temperatura ambiente durante 10 minutos. En ese momento, se recogió 1ml para determinar la concentración de IFX. Luego, se incubaron 10ml de cada concentración de fármaco con 5ml de cuentas de acetato de celulosa del dispositivo GMA a 200rpm durante una hora a 37°C para simular las condiciones fisiológicas humanas. Se recogió una segunda muestra de cada concentración y se determinaron los niveles de IFX. Resultados: No se observaron diferencias estadísticamente significativas en los niveles de IFX en las muestras de sangre antes y después de la incubación con las cuentas de acetato de celulosa (p=0,41) ni tras mediciones repetidas (p=0,31). La media de cambio fue de 3,8μg/ml. Conclusiones: La combinación in vitro de IFX y GMA no modificó los niveles circulantes del fármaco en las 3 concentraciones probadas, lo que indica que no existe interacción entre el fármaco y el dispositivo de aféresis in vitro y que podrían combinarse de forma segura. (AU)

Is the use of secukinumab after anti-TNF therapy greater than expected for the risk of developing inflammatory bowel disease?

OBJECTIVE: In this study, our objective was to present real-life data on the incidence of inflammatory bowel disease (IBD) among patients receiving secukinumab treatment. METHODS: The study consisted of 209 patients who had prior exposure to anti-tumor necrosis factor (TNF) or were biologically naive. Patients with a pre-existing history of IBD were excluded from the study. RESULTS: Of the 209 patients in the study, 176 (84.3%) had ankylosing spondylitis, while 33 (15.7%) had psoriatic arthritis. 112 (53.6%) patients had prior exposure to at least one anti-TNF treatment before initiating secukinumab. IBD developed in 10 (4.8%) of the 209 patients. The incidence of IBD among patients who initiated secukinumab as their first biologic agent was 1%. For patients who had previously received any anti-TNF treatment and subsequently transitioned to secukinumab, the incidence of IBD was 8% (p=0.018, odds ratio (OR): 8.38, 95% CI: 1.04-67.45). A mean of 3.67 months (±4.3) after anti-TNF use, whereas IBD symptoms developed in the biologically naive patient after 15 months. CONCLUSION: Our study observed IBD incidence in 4.8% of patients using secukinumab. Patients who initiated secukinumab after previous anti-TNF treatment exhibited a significantly higher rate and risk of developing IBD. The onset of IBD occurred earlier in these patients (mean 3.67 months), whereas a single case of IBD showed a longer duration (15 months). Further studies with larger patient numbers are warranted to provide a more comprehensive understanding of our findings.

Is the use of secukinumab after anti-TNF therapy greater than expected for the risk of developing inflammatory bowel disease? / El uso de secukinumab tras la terapia anti-TNF es mayor de lo esperado por el riesgo de desarrollar enfermedad inflamatoria intestinal?

Objective: In this study, our objective was to present real-life data on the incidence of inflammatory bowel disease (IBD) among patients receiving secukinumab treatment. Methods: The study consisted of 209 patients who had prior exposure to anti-tumor necrosis factor (TNF) or were biologically naive. Patients with a pre-existing history of IBD were excluded from the study. Results: Of the 209 patients in the study, 176 (84.3%) had ankylosing spondylitis, while 33 (15.7%) had psoriatic arthritis. 112 (53.6%) patients had prior exposure to at least one anti-TNF treatment before initiating secukinumab. IBD developed in 10 (4.8%) of the 209 patients. The incidence of IBD among patients who initiated secukinumab as their first biologic agent was 1%. For patients who had previously received any anti-TNF treatment and subsequently transitioned to secukinumab, the incidence of IBD was 8% (p=0.018, odds ratio (OR): 8.38, 95% CI: 1.04–67.45). A mean of 3.67 months (±4.3) after anti-TNF use, whereas IBD symptoms developed in the biologically naive patient after 15 months. Conclusion: Our study observed IBD incidence in 4.8% of patients using secukinumab. Patients who initiated secukinumab after previous anti-TNF treatment exhibited a significantly higher rate and risk of developing IBD. The onset of IBD occurred earlier in these patients (mean 3.67 months), whereas a single case of IBD showed a longer duration (15 months). Further studies with larger patient numbers are warranted to provide a more comprehensive understanding of our findings.(AU)

Objetivo: En este estudio, nuestro objetivo fue presentar datos de la vida real sobre la incidencia de la enfermedad inflamatoria intestinal (EII) entre los pacientes que reciben tratamiento con secukinumab. Métodos: El estudio consistió en 209 pacientes que habían tenido una exposición previa al factor de necrosis antitumoral (TNF) o eran biológicamente naive. Los pacientes con antecedentes preexistentes de EII fueron excluidos del estudio. Resultados: De los 209 pacientes del estudio, 176 (84,3%) tenían espondilitis anquilosante, mientras que 33 (15,7%) tenían artritis psoriásica. 112 (53,6%) pacientes tenían exposición previa a al menos un tratamiento anti-TNF antes de iniciar secukinumab. La EII se desarrolló en 10 (4,8%) de los 209 pacientes. La incidencia de EII entre los pacientes que iniciaron secukinumab como primer agente biológico fue del 1%. Para los pacientes que habían recibido previamente algún tratamiento anti-TNF y posteriormente hicieron la transición a secukinumab, la incidencia de EII fue del 8% (p=0,018, odds ratio (OR): 8,38, IC del 95%: 1,04-67,45). Una media de 3,67 meses (±4,3) después del uso de anti-TNF, mientras que los síntomas de la EII se desarrollaron en el paciente biológicamente naive después de 15 meses. Conclusión: Nuestro estudio observó una incidencia de EII en el 4,8% de los pacientes que usaban secukinumab. Los pacientes que iniciaron secukinumab después de un tratamiento anti-TNF previo mostraron una tasa y un riesgo significativamente mayores de desarrollar EII. El inicio de la EII ocurrió antes en estos pacientes (media de 3,67 meses), mientras que un solo caso de EII mostró una duración más prolongada (15 meses). Se justifican más estudios con un mayor número de pacientes para proporcionar una comprensión más completa de nuestros hallazgos.(AU)

Therapeutic drug monitoring in inflammatory bowel diseases. Position statement of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis. / Monitorización terapéutica de los fármacos biológicos en la enfermedad inflamatoria intestinal. Documento de Posicionamiento del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU).

The treatment of inflammatory bowel disease has undergone a significant transformation following the introduction of biologic drugs. Thanks to these drugs, treatment goals have evolved from clinical response and remission to more ambitious objectives, such as endoscopic or radiologic remission. However, even though biologics are highly effective, a significant percentage of patients will not achieve an initial response or may lose it over time. We know that there is a direct relationship between the trough concentrations of the biologic and its therapeutic efficacy, with more demanding therapeutic goals requiring higher drug levels, and inadequate exposure being common. Therapeutic drug monitoring of biologic medications, along with pharmacokinetic models, provides us with the possibility of offering a personalized approach to treatment for patients with IBD. Over the past few years, relevant information has accumulated regarding its utility during or after induction, as well as in the maintenance of biologic treatment, in reactive or proactive strategies, and prior to withdrawal or treatment de-escalation. The aim of this document is to establish recommendations regarding the utility of therapeutic drug monitoring of biologics in patients with inflammatory bowel disease, in different clinical practice scenarios, and to identify areas where its utility is evident, promising, or controversial.

Cardiovascular risk assessment in inflammatory bowel disease with metabolic dysfunction-associated steatotic liver disease.

BACKGROUND AND AIMS: Inflammatory bowel disease (IBD) has been reported to increase the risk of early atherosclerosis even in young patients. Moreover, metabolic dysfunction-associated steatotic liver disease (MASLD), which has been linked to IBD, is a well-recognized but underdiagnosis entity related to cardiovascular risk. We analyze the impact of MASLD in IBD patients' cardiovascular risk through both advanced lipoprotein profile sorted by nuclear magnetic resonance spectroscopy, and carotid artery intima-media thickness (CIMT). METHODS: Cross-sectional cohort study which involves 941 IBD adult outpatients. Of them, 50 patients with IBD who met criteria for MASLD and 50 with IBD without MASLD, matched by sex and age were included. Alterations in CIMT were evaluated considering abnormal measures above the 75th percentile adjusted for sex and age. Specific advanced lipoprotein profile was also carried out. RESULTS: Most of the patients had an abnormal CIMT (58%). MASLD (OR=5.05, CI 95%=1.71-14.92) and female sex (OR=3.32, CI 95%=1.03-10) were significantly associated with CIMT alterations. Dense LDL particles (with high cholesterol composition in general cohort (OR=3.62, 95% CI=1.07-12.19) and high triglycerides density in young subgroup (OR=6.25, 95% CI=1.04-50) but not total LDL cholesterol were associated with CIMT alterations. CONCLUSIONS: MASLD and female sex are associated with early atherosclerosis in IBD patients. Dense LDL particle in combination with vascular imaging findings should be evaluated as non-invasive tools in the management of cardiovascular risk in IBD patients.

Real-world experience of vedolizumab use in Colombian patients with inflammatory bowel disease-EXVEDOCOL.

BACKGROUND: Real-world studies about the effectiveness and safety of vedolizumab (VDZ) in the treatment of inflammatory bowel disease (IBD) in Latin America are scarce. Our study describes the effectiveness and safety of VDZ in Colombian patients with IBD. METHODS: EXVEDOCOL (EXperience of VEDOlizumab in COLombia) was a retrospective, multicenter, observational study. Adults with IBD receiving a first dose of VDZ between July 2016 and October 2018 were included. The co-primary outcomes clinical response, and remission, were determined at week 14 and last visit during the maintenance phase (LVMP). The secondary outcomes, deep remission and loss of response were recorded at LVMP. RESULTS: Thirty-one patients (25 ulcerative colitis (UC), 6 Crohn's disease (CD)) were included. At week 14, clinical response was achieved by 87.1% (27/31) of the patients treated with VDZ, while loss of response was reported in 6.7% (2/30). The remission rate at week 14 was 65.5% (19/29) and 75.9% (22/29) at LVMP. Prior anti-TNF exposure was reported in 61.3% (19 patients) of whom 84.2% (16/19) achieved clinical response at week 14 and 89.5% (17/19) at LVMP. For anti-TNF naïve patients, clinical response was recorded in 91.7% (11/12) at week 14 and 100% (12/12) at LVMP. CONCLUSIONS: High clinical remission rates and safety profile highlight VDZ as a valuable treatment option for IBD patients. Anti-TNF naïve patients may derive greater benefit from therapy. Studies with larger cohorts could confirm these findings.

Incidence of herpes zoster in patients with inflammatory bowel disease. / Incidencia de herpes zóster en pacientes con enfermedad inflamatoria intestinal: estudio observacional y retrospectivo en dos hospitales españoles de tercer nivel.

BACKGROUND: Herpes zoster (HZ) is a prevalent disease caused by the reactivation of the varicella-zoster virus (VZV) and associated with chronic morbidity, particularly with post-herpetic neuralgia (PHN). Inflammatory bowel disease (IBD) has been associated with an increased risk of HZ, mainly when immunosuppressive treatment (IMT) is used. However, studies assessing the risk of HZ in IBD are scarce. AIMS: To evaluate the incidence rate and risk factors of HZ in IBD. METHODS: Retrospective study in IBD patients with a positive VVZ serology from two referral hospitals from the area of Barcelona. Diagnosis of HZ and its clinical features were recorded. RESULTS: A total of 398 IBD patients with a positive IgG-VVZ serology were identified. Fifty-eight percent of the patients received IMT (46.5% immunosuppressants monotherapy, 20.6% biologics monotherapy and, 32.7% combination therapy). After a median follow-up of 71 months (IQR 41.5-138.0), 17 (4.3%) patients developed HZ (cumulative incidence of 5.2 per 1000 person-year), 12 of them (70.6%) while receiving IMT. Median age at HZ episode was 38 years (IQR 27.5-52.5). Two (11%) developed PHN. Biological therapy was the only risk factor for developing HZ (OR 3.8 IC 95% 1.3-11.5; p=0.018). CONCLUSIONS: HZ is quite prevalent in IBD, occurring at early ages and particularly among patients using IMT. NPH appears to occur in a notable proportion of cases.

Combination of granulocyte-monocyte apheresis and tofacitinib: Multicentre and retrospective study.

OBJECTIVE: Granulocyte-monocyte apheresis (GMA) has shown to be safe and effective in treating ulcerative colitis (UC), also in combination with biologics. The objective of this study is to evaluate the efficacy and safety of combining GMA after primary non-response (PNR) or loss of response (LOR) to tofacitinib (TOFA) in patients with UC. PATIENTS AND METHODS: Retrospective study including all patients with refractory UC who received GMA plus TOFA. Efficacy was assessed 1 and 6 months after finishing GMA by partial Mayo score, C-reactive protein (CRP) and fecal calprotectin (FC). Descriptive statistics and non-parametric tests were used in the statistical analysis. RESULTS: Twelve patients were included (median 46 years [IQR, 37-58]; 67% female; 67% E3). Patients were mostly receiving TOFA 10mg bid (75%), and 33% also concomitant steroids at baseline. Median partial Mayo score at baseline was 7 (IQR, 5-7), and it decreased to a median of 2 (IQR, 0-3) and 0 (IQR, 0-3) after 1 and 6 months (p=0.027 and 0.020, respectively), while no differences were found in CRP and FC. Clinical remission was achieved by 6 patients both at 1 (50%) and 6 months (67%). CF values<250mg/kg were achieved by 2 and 4 patients at 1 and 6 months (data available in 5 and 7 patients, respectively). No patient required dose-escalation of TOFA, and one patient was able to de-escalate the drug. No patient required colectomy and all patients under steroids were able to stop them. CONCLUSION: The combination of GMA and TOFA can be effective in selected cases of UC after PNR or LOR to this drug.

Suboptimal response to tumor necrosis factor antagonists in inflammatory bowel disease in Latin America: EXPLORE LATAM study / Respuesta subóptima a los antagonistas del factor de necrosis tumoral en la enfermedad inflamatoria intestinal en Latinoamérica: Estudio EXPLORE LATAM

Objective Data on anti-tumor necrosis factor (anti-TNF) treatment and suboptimal response (SOR) among patients with inflammatory bowel diseases (IBD) in Latin America (LATAM) are scarce. This study evaluated the incidence and indicators of SOR to anti-TNF therapy in patients with ulcerative colitis (UC) and Crohn's disease (CD) from Argentina, Colombia and Mexico. Patients and methods We performed retrospective analysis of data from LATAM patients of the EXPLORE study (NCT03090139) including adult patients with IBD who initiated anti-TNF therapy between March 2010 to March 2015. The cumulative incidence of SOR to first-line anti-TNF therapy was assessed. A physician survey to assess barriers to anti-TNF therapies was also carried out. Results We included 185 IBD patients (UC/CD: 99/86) treated with first-line anti-TNF from Argentina (38 UC; 40 CD), Colombia (21 UC; 25 CD) and Mexico (40 UC; 21 CD). 36.4% of patients with UC and 46.5% of patients with CD experienced SOR to anti-TNF therapy during the median (interquartile range) observational period: 49.0 months (37.2–60.1) in UC, and 50.0 months (40.9–60.1) in CD. The most common indicator of SOR among patients was augmentation of non-biologic therapy (UC: 41.7%; CD: 35.0%). Affordability and late referral to IBD specialist care centers were the most common barriers to anti-TNF therapies. Conclusions SOR to anti-TNF therapy was common in LATAM IBD patients, where augmentation with non-biologic therapy represented the most frequent indicator of SOR across indications. Our findings contribute to the current evidence on the unmet needs associated with anti-TNF in LATAM (AU)

Objetivo Los datos sobre tratamiento con antagonistas del factor de necrosis tumoral (anti-TNF) y su respuesta subóptima (RSO) en las enfermedades inflamatorias intestinales (EII) en América Latina (LATAM) son escasos. Se evaluaron la incidencia e indicadores de RSO a anti-TNF en pacientes con colitis ulcerosa (CU) y enfermedad de Crohn (EC) de Argentina, Colombia y México. Pacientes y métodos Se realizó un análisis retrospectivo de datos del estudio EXPLORE LATAM (NCT03090139), incluyendo pacientes adultos con EII que iniciaron anti-TNF entre marzo de 2010 a marzo de 2015. Se evaluó la incidencia acumulada de RSO a los anti-TNF en primera línea. Además, se realizó una encuesta a especialistas sobre las barreras del tratamiento con anti-TNF. Resultados Se incluyeron 185 pacientes con EII (CU/EC: 99/86) tratados con anti-TNF en primera línea de Argentina (38 CU; 40 EC), Colombia (21 CU; 25 EC) y México (40 CU; 21 EC); 36,4% de los pacientes con CU y 46,5% de los pacientes con EC experimentaron RSO a anti-TNF durante la mediana (intervalo intercuartílico) de 49 meses (37,2-60,1) en CU y 50 meses (40,9-60,1) en EC. El indicador más común de RSO fue el aumento del tratamiento no biológico (CU: 41,7%; EC: 35,0%). La accesibilidad y la derivación tardía a centros especializados fueron las barreras más comunes para el tratamiento con anti-TNF. Conclusiones La RSO a anti-TNF fue frecuente en pacientes con EII de LATAM, el aumento del tratamiento no biológico representó el indicador más frecuente de RSO. Nuestros hallazgos contribuyen a la evidencia actual sobre las necesidades insatisfechas asociadas a los anti-TNF en LATAM (AU)

Headache in patients with inflammatory bowel disease: Migraine prevalence according to the Migraine Screening-Questionnaire (MS-Q) and headache characteristics / Cefalea en pacientes con enfermedad inflamatoria intestinal: prevalencia de migraña de acuerdo al Migraine Screening-Questionnaire (MS-Q) y características de la cefalea

Background The gut-brain axis describes a complex bidirectional association between neurological and gastrointestinal (GI) disorders. In patients with migraine, GI comorbidities are common. We aimed to evaluate the presence of migraine among patients with inflammatory bowel disease (IBD) according to Migraine Screen-Questionnaire (MS-Q) and describe the headache characteristics compared to a control group. Additionally, we explored the relationship between migraine and IBD severities. Methods We performed a cross-sectional study through an online survey including patients from the IBD Unit at our tertiary hospital. Clinical and demographic variables were collected. MS-Q was used for migraine evaluation. Headache disability scale HIT-6, anxiety-depression scale HADS, sleep scale ISI, and activity scale Harvey–Bradshaw and Partial Mayo scores were also included. Results We evaluated 66 IBD patients and 47 controls. Among IBD patients, 28/66 (42%) were women, mean age 42 years and 23/66 (34.84%) had ulcerative colitis. MS-Q was positive in 13/49 (26.5%) of IBD patients and 4/31 (12.91%) controls (p=0.172). Among IBD patients, headache was unilateral in 5/13 (38%) and throbbing in 10/13 (77%). Migraine was associated with female sex (p=0.006), lower height (p=0.003) and weight (p=0.002), anti-TNF treatment (p=0.035). We did not find any association between HIT-6 and IBD activity scales scores. Conclusions Migraine presence according to MS-Q could be higher in patients with IBD than controls. We recommend migraine screening in these patients, especially in female patients with lower height and weight and anti-TNF treatment (AU)

Introducción El eje intestino-cerebro describe una asociación bidireccional compleja entre las enfermedades neurológicas y gastrointestinales (GI). Las comorbilidades GI son frecuentes en la migraña. Nuestro objetivo fue evaluar la presencia de migraña en pacientes con enfermedad inflamatoria intestinal (EII) y describir las características de la cefalea. Además, analizamos la relación entre la gravedad de la migraña y la EII. Métodos Estudio transversal a través de encuesta electrónica en pacientes con EII de un hospital terciario. Se recogieron variables clínicas y demográficas. Se usó MS-Q para presencia de migraña. Se incluyeron escala de discapacidad de cefalea HIT-6, ansiedad-depresión HADS, sueño ISI y actividad de EII Harvey-Bradshaw y Partial Mayo. Resultados Se incluyeron 66EII y 47controles. Entre los EII, 28/66 (42%) eran mujeres, con una edad media de 42años, y 23/66 (34,84%) tenían colitis ulcerosa. El MS-Q fue positivo en 13/49 (26,5%) de EII y en 4/31 (12,91%) controles (p=0,172). Entre los pacientes con EII, la cefalea fue unilateral en 5/13 (38%) y pulsátil en 10/13 (77%). El sexo femenino (p=0.006), la altura (p=0,003) y el peso más bajos (p=0,002) y el tratamiento con anti-TNF (p=0,035) se relacionaron con la probabilidad de migraña. No encontramos asociación entre el HIT-6 y las escalas de actividad de EII. Conclusiones La presencia de migraña de acuerdo al MS-Q podría ser más alta en los pacientes con EII que en controles. Recomendamos realizar un cribado de migraña en estos pacientes, especialmente en mujeres de menor peso y altura y tratamiento anti-TNF (AU)

Infección por Leishmania en pacientes con enfermedad inflamatoria intestinal: Serie de casos y revisión de la literatura / Leishmania infection in patients with inflammatory bowel disease: Case series and literature review

La infección por Leishmania spp. en pacientes diagnosticados de enfermedad inflamatoria intestinal (EII) es rara. Considerada endémica en la cuenca del Mediterráneo, sus manifestaciones son casi exclusivas de pacientes con alteración de la inmunidad celular. La mayoría de la evidencia la encontramos a través de reportes de casos en la literatura; sin que existan guías para su manejo en pacientes con EII. Presentamos tres casos de infección por Leishmania en pacientes con EII que nos llevan a realizar una revisión de la literatura actual. La terapia inmunosupresora parece favorecer esta infección, presentándose de forma atípica, con diagnóstico desafiante. El tratamiento sistémico de entrada junto a la retirada del inmunosupresor parece ser la mejor estrategia terapéutica. Se precisan estudios en zona endémica que determinen su incidencia en pacientes con EII, así como su posible asociación con la terapia inmunosupresora. Se podría sugerir la necesidad de cribado serológico previa introducción de inmunosupresores (AU)

Infection by Leishmania spp. in patients diagnosed with inflammatory bowel disease (IBD) is rare. Considered endemic in the Mediterranean basin, its manifestations are almost exclusive of patients with impaired cellular immunity. Most of the evidence is found through case reports; without guidelines for its management in patients with IBD. In this study we present three cases of Leishmania infection in patients with IBD that lead us to carry out a review of the current literature. Immunosuppressive treatment contributes to this infection, which presents atypically, with a challenging diagnosis. Initial systemic treatment with withdrawal of the immunosuppressant drug seems to be the best therapeutic strategy. Studies are needed in endemic areas to determine its incidence in IBD patients, as well as its possible association with immunosuppressive therapy. The need for serological screening prior introduction of immunosuppressive drugs could be suggested (AU)

IMPACT OF MESALAZINE ON THE RESPONSE TO COVID-19 VACCINATION IN PATIENTS WITH INFLAMMATORY BOWEL DISEASE. RESULTS OF A PROSPECTIVE MULTICENTRE STUDY OF GETECCU (VACOVEII STUDY). / IMPACTO DE LA MESALAZINA EN LA RESPUESTA A LA VACUNACIÓN CONTRA EL COVID-19 EN PACIENTES CON ENFERMEDAD INFLAMATORIA INTESTINAL. RESULTADOS DE UN ESTUDIO PROSPECTIVO MULTICÉNTRICO DE GETECCU (VACOVEII).

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 260 BAU/mL (centralized determination) and was assessed 6 months after full vaccination. In this subanalysis of the study, we compare the effectivenes 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.

Selective granulocyte-monocyte apheresis during induction with vedolizumab in moderate-severe ulcerative colitis: Experience in a tertiary hospital.

AIM: Granulocyte and monocyte apheresis (GMA) is a potential therapeutic option when combined with various drugs for treatment of ulcerative colitis (UC). In this study, we analyze the efficacy and safety of GMA combined with vedolizumab (VDZ) during induction in patients with moderate-severe UC and incomplete response to steroids. PATIENTS AND METHODS: Single-center retrospective review of patients receiving GMA+VDZ. Data on the disease and previous treatments were collected. Clinical response was classified as no response, response without remission, and remission. Available data on biochemical and endoscopic response were included. Adverse events (AEs) were recorded. RESULTS: The study population comprised 6 patients with UC who had received GMA+VDZ during induction after failure of an anti-TNF agent. The median number of GMA sessions was 5 (IQR 4-5; 3-10). All the patients received VDZ 300mg iv at 0, 2, and 6 weeks, and 5 (83%) received an additional dose at week 10. During maintenance, all the patients continued VDZ iv every 8 weeks. The median follow-up was 57.6 months (IQR: 39-74). Four of the 6 patients achieved clinical remission after GMA+VDZ and continued in deep remission until the end of follow-up. A median, non-significant decrease of 1378µg/g (IQR: 924-5778µg/g) was observed for calprotectin and 42.2mg/l (IQR: 15.3-113.5) for CRP vs. baseline. No patient underwent colectomy. No treatment-related AEs were observed. CONCLUSIONS: GMA+VDZ during induction can be effective and safe in selected patients with moderate-severe UC and partial response to steroids.

Recommendations on the management of severe obesity in patients with inflammatory bowel disease of the Spanish Group on Crohn's Disease and Ulcerative Colitis (GETECCU), Spanish Society of Obesity (SEEDO), Spanish Association of Surgery (AEC) and Spanish Society of Digestive Endoscopy (SEED). / Recomendaciones sobre el manejo de la obesidad grave en pacientes con enfermedad inflamatoria intestinal del Grupo Español de Trabajo en Enfermedad Inflamatoria Intestinal (GETECCU), Sociedad Española de Obesidad (SEEDO), Asociación Española de Cirugía (AEC) y Sociedad Española de Endoscopia Digestiva (SEED).

Obesity is a multifactorial, chronic, progressive and recurrent disease considered a public health issue worldwide and an important determinant of disability and death. In Spain, its current prevalence in the adult population is about 24% and an estimated prevalence in 2035 of 37%. Obesity increases the probability of several diseases linked to higher mortality such as diabetes, cardiovascular disease, hyperlipidemia, arterial hypertension, non-alcoholic fatty liver disease, several types of cancer, or obstructive sleep apnea. On the other hand, although the incidence of inflammatory bowel disease (IBD) is stabilizing in Western countries, its prevalence already exceeds 0.3%. Paralleling to general population, the current prevalence of obesity in adult patients with IBD is estimated at 15-40%. Obesity in patients with IBD could entail, in addition to its already known impact on disability and mortality, a worse evolution of the IBD itself and a worse response to treatments. The aim of this document, performed in collaboration by four scientific societies involved in the clinical care of severe obesity and IBD, is to establish clear and concise recommendations on the therapeutic possibilities of severe or typeIII obesity in patients with IBD. The document establishes general recommendations on dietary, pharmacological, endoscopic, and surgical treatment of severe obesity in patients with IBD, as well as pre- and post-treatment evaluation.

Position statement of the Spanish Working Group on Crohn's Disease and Ulcerative Colitis on sexuality and inflammatory bowel disease. / Documento de posicionamiento. Recomendaciones del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa sobre sexualidad y enfermedad inflamatoria intestinal.

It is widely acknowledged that inflammatory bowel disease (IBD) is associated with a high prevalence of sexual dysfunction (SD). However, there is a notable paucity of specific literature in this field. This lack of information impacts various aspects, including the understanding and comprehensive care of SD in the context of IBD. Furthermore, patients themselves express a lack of necessary attention in this area within the treatment of their disease, thus creating an unmet need in terms of their well-being. The aim of this position statement by the Spanish Working Group on Crohn's Disease and Ulcerative Colitis (GETECCU) is to provide a review on the most relevant aspects and potential areas of improvement in the detection, assessment, and management of SD in patients with IBD and to integrate the approach to sexual health into our clinical practice. Recommendations are established based on available scientific evidence and expert opinion. The development of these recommendations by GETECCU has been carried out through a collaborative multidisciplinary approach involving gastroenterologists, gynecologists, urologists, surgeons, nurses, psychologists, sexologists, and, of course, patients with IBD.

Resultados del registro nacional de pacientes diagnosticados de enfermedad inflamatoria intestinal candidatos a cirugía bariátrica (ReNacEIBar) / Results of the national registry of patients diagnosed with inflammatory bowel disease candidates for bariatric surgery (ReNacEIBar)

Introducción: El objetivo principal es realizar un Registro Nacional de pacientes diagnosticados de enfermedad inflamatoria intestinal (EII) que son sometidos a cirugía bariátrica, así como evaluar los resultados y aspectos fundamentales del manejo de este tipo de pacientes en la práctica clínica habitual. Metodología: Estudio retrospectivo observacional multicéntrico nacional, en el que se incluyen pacientes diagnosticados previamente de EII, que hayan sido intervenidos de cirugía bariátrica desde enero de 2000 hasta diciembre de 2022. Resultados: Se han incluido un total de 41 pacientes: 43,9% diagnosticados previamente de colitis ulcerosa (CU), 53,7% de enfermedad de Crohn (EC), y una colitis indeterminada (2,4%). El índice de masa corporal (IMC) preoperatorio ha sido de 45,8 ± 6,1 kg/m2. Se han realizado 31 (75,6%) gastrectomías verticales, un (2,4%) bypass gástrico y nueve (22%) bypass gástrico de una anastomosis. Se han registrado 9,8% de complicaciones. A los 12 meses, el IMC medio fue de 29,5 ± 4,7 kg/m2, presentando en un porcentaje de peso total perdido (%PTP) de 33,9 ± 9,1%. Conclusiones: La cirugía bariátrica en pacientes previamente diagnosticados de EII se puede considerar eficaz en cuanto a pérdida de peso, y segura en relación con un porcentaje bajo de complicaciones.(AU)

Background: Our aim is to carry out a national registry of patients with inflammatory bowel disease (IBD) who underwent bariatric surgery, as well as evaluate the results and management of this type of patients in the usual clinical practice. Methods: National multicentric observational retrospective study, including patients, previously diagnosed with IBD who underwent bariatric surgery from January 2000 to December 2022. Results: Forty-one patients have been included: 43.9% previously diagnosed with ulcerative colitis, 57.3% Crohn's disease, and an indeterminate colitis (2.4%). The preoperative BMI was 45.8 ± 6.1 kg/m2. Among the bariatric surgeries, 31 (75.6%) sleeve gastrectomy, 1 (2.4%) gastric bypass and 9 (22%) one anastomosis gastric have been carried out. During the postoperative period, 9.8% complications have been recorded. BMI was 29.5 ± 4.7 kg/m2 and percent total weight lost was 33.9 ± 9.1% at 12 months. Conclusions: Bariatric surgery in patients with inflammatory bowel disease can be considered safe and effective.(AU)

Headache in patients with inflammatory bowel disease: Migraine prevalence according to the Migraine Screening-Questionnaire (MS-Q) and headache characteristics.

BACKGROUND: The gut-brain axis describes a complex bidirectional association between neurological and gastrointestinal (GI) disorders. In patients with migraine, GI comorbidities are common. We aimed to evaluate the presence of migraine among patients with inflammatory bowel disease (IBD) according to Migraine Screen-Questionnaire (MS-Q) and describe the headache characteristics compared to a control group. Additionally, we explored the relationship between migraine and IBD severities. METHODS: We performed a cross-sectional study through an online survey including patients from the IBD Unit at our tertiary hospital. Clinical and demographic variables were collected. MS-Q was used for migraine evaluation. Headache disability scale HIT-6, anxiety-depression scale HADS, sleep scale ISI, and activity scale Harvey-Bradshaw and Partial Mayo scores were also included. RESULTS: We evaluated 66 IBD patients and 47 controls. Among IBD patients, 28/66 (42%) were women, mean age 42 years and 23/66 (34.84%) had ulcerative colitis. MS-Q was positive in 13/49 (26.5%) of IBD patients and 4/31 (12.91%) controls (p=0.172). Among IBD patients, headache was unilateral in 5/13 (38%) and throbbing in 10/13 (77%). Migraine was associated with female sex (p=0.006), lower height (p=0.003) and weight (p=0.002), anti-TNF treatment (p=0.035). We did not find any association between HIT-6 and IBD activity scales scores. CONCLUSIONS: Migraine presence according to MS-Q could be higher in patients with IBD than controls. We recommend migraine screening in these patients, especially in female patients with lower height and weight and anti-TNF treatment.