Swallowed topical corticosteroids for eosinophilic esophagitis: Utilization and real-world efficacy from the EoE CONNECT registry.

BACKGROUND: Swallowed topical corticosteroids (tC) are common therapy for patients with eosinophilic esophagitis (EoE). Widely heterogeneous results have occurred due to their active ingredients, formulations and doses. OBJECTIVE: To assess the effectiveness of topical corticosteroid therapy for EoE in real-world practice. METHODS: Cross-sectional study analysis of the multicentre EoE CONNECT registry. Clinical remission was defined as a decrease of ≥50% in dysphagia symptom scores; histological remission was defined as a peak eosinophil count below 15 per high-power field. The effectiveness in achieving clinico-histological remission (CHR) was compared for the main tC formulations. RESULTS: Overall, data on 1456 prescriptions of tC in monotherapy used in 866 individual patients were assessed. Of those, 904 prescriptions with data on formulation were employed for the induction of remission; 234 reduced a previously effective dose for maintenance. Fluticasone propionate formulations dominated the first-line treatment, while budesonide was more common in later therapies. A swallowed nasal drop suspension was the most common formulation of fluticasone propionate. Doses ≥0.8 mg/day provided a 65% CHR rate and were superior to lower doses. Oral viscous solution prepared by a pharmacist was the most common prescription of budesonide; 4 mg/day provided no benefit over 2 mg/day (CHR rated being 72% and 80%, respectively). A multivariate analysis revealed budesonide orodispersible tablets as the most effective therapy (OR 18.9, p < 0.001); use of higher doses (OR 4.3, p = 0.03) and lower symptom scores (OR 0.9, p = 0.01) were also determinants of effectiveness. CONCLUSION: Reduced symptom severity, use of high doses, and use of budesonide orodispersible tablets particularly were all independent predictors of tC effectiveness.

Uso de la cápsula endoscópica en enfermedad inflamatoria intestinal en práctica clínica en España. Resultados de una encuesta nacional / Use of capsule endoscopy in inflammatory bowel disease in clinical practice in Spain. Results from a national survey

Introducción: La cápsula endoscópica de intestino delgado (CEID) es una técnica diagnóstica poco invasiva cuyo empleo en la enfermedad inflamatoria intestinal (EII) se ha extendido. Se ha desarrollado recientemente una cápsula panentérica, PillCamCrohn's (PCC). Carecemos de información sobre la disponibilidad y el uso de la CEID y la PCC en nuestro medio. Métodos: Realizamos una encuesta electrónica y anónima entre los miembros del Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa y la Asociación Española de Gastroenterología consistente en 37 preguntas de respuesta múltiple. Resultados: Participaron 150 miembros, la mayoría con dedicación especial a la EII (69,3%). El 72,8% trabajaban en centros con unidad de EII. El 79% tenían la CEID disponible en su hospital, y el 14% la derivaban a otro centro. El 22% tenían disponible la PCC, y el 9% la derivaban a otro centro. El 79,3% de encuestados con CEID disponible la utilizaban en un pequeño porcentaje de pacientes con EII y el 15,6% en la mayoría. Los escenarios más frecuentes fueron la sospecha de enfermedad de Crohn (76,3%), la valoración de actividad inflamatoria (54,7%) y la evaluación de la extensión de la enfermedad (54,7%). Más de la mitad (59,7%) utilizaban preferentemente la cápsula Patency® para valoración de la permeabilidad intestinal. Casi todos los encuestados (99,3%) consideraban que se deberían implementar recursos formativos en esta técnica. Conclusiones: La CEID cuenta con una amplia disponibilidad en los hospitales españoles para el manejo de la EII, si bien su uso es todavía limitado. Existe una oportunidad para aumentar la formación en esta técnica, y, con ella, su empleo.(AU)

Introduction: Small bowel capsule endoscopy (SBCE) is a non-invasive diagnostic technique whose use in inflammatory bowel disease (IBD) has spread. A panenteric capsule, PillCam Crohn's (PCC), has recently been developed. We lack information on the availability and use of the CEID and PCC in our environment. Methods: We conducted an electronic and anonymous survey among the members of the Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) [Spanish Working Group on Crohn's Disease and Ulcerative Colitis] and the Asociación Española de Gastroenterología (AEG) [Spanish Association of Gastroenterology], consisting of 37 multiple-choice questions. Results: One hundred and fifty members participated, the majority dedicated to IBD (69.3%). 72.8% worked at centres with an IBD unit. 79% had SBCE available at their hospital, 14% referred patients to another centre; 22% had a PCC available, 9% referred patients to another centre. 79.3% of respondents with available SBCE used it in a small percentage of patients with IBD and 15.6% in the majority. The most frequent scenarios were suspicion of Crohn's disease (76.3%), assessment of inflammatory activity (54.7%) and assessment of the extent of the disease (54.7%). More than half (59.7%) preferentially used the Patency capsule to assess intestinal patency. Almost all respondents (99.3%) considered that training resources should be implemented in this technique. Conclusions: SBCE is widely available in Spanish hospitals for the management of IBD, although its use is still limited. There is an opportunity to increase training in this technique, and consequently its use.(AU)

Use of capsule endoscopy in inflammatory bowel disease in clinical practice in Spain. Results from a national survey. / Uso de la cápsula endoscópica en enfermedad inflamatoria intestinal en práctica clínica en España. Resultados de una encuesta nacional.

INTRODUCTION: Small bowel capsule endoscopy (SBCE) is a non-invasive diagnostic technique whose use in inflammatory bowel disease (IBD) has spread. A panenteric capsule, PillCam Crohn's (PCC), has recently been developed. We lack information on the availability and use of the CEID and PCC in our environment. METHODS: We conducted an electronic and anonymous survey among the members of the Grupo Español de Trabajo en Enfermedad de Crohn y Colitis Ulcerosa (GETECCU) [Spanish Working Group on Crohn's Disease and Ulcerative Colitis] and the Asociación Española de Gastroenterología (AEG) [Spanish Association of Gastroenterology], consisting of 37 multiple-choice questions. RESULTS: One hundred and fifty members participated, the majority dedicated to IBD (69.3%). 72.8% worked at centres with an IBD unit. 79% had SBCE available at their hospital, 14% referred patients to another centre; 22% had a PCC available, 9% referred patients to another centre. 79.3% of respondents with available SBCE used it in a small percentage of patients with IBD and 15.6% in the majority. The most frequent scenarios were suspicion of Crohn's disease (76.3%), assessment of inflammatory activity (54.7%) and assessment of the extent of the disease (54.7%). More than half (59.7%) preferentially used the Patency capsule to assess intestinal patency. Almost all respondents (99.3%) considered that training resources should be implemented in this technique. CONCLUSIONS: SBCE is widely available in Spanish hospitals for the management of IBD, although its use is still limited. There is an opportunity to increase training in this technique, and consequently its use.

Tofacitinib, a useful option for the treatment of pyoderma gangrenosum in an ulcerative colitis patient.

Pyoderma gangrenosum (PG) is a difficult-to-manage ulcero-necrotizing dermatosis associated with inflammatory bowel disease (IBD). In this article, we report a refractory PG in a patient with severe ulcerative colitis (UC) that responded to tofacitinib 10 mg/12 h.

Ustekinumab en enfermedad de Crohn: efectividad y seguridad en práctica clínica / Ustekinumab in Crohn's disease: effectiveness and safety in clinical practice

INTRODUCCIÓN: Ustekinumab (UST) es un anticuerpo monoclonal frente a IL-12/23 aprobado en España (2017) para tratar el brote moderado/grave de enfermedad de Crohn. OBJETIVO: Evaluar la efectividad y seguridad en práctica clínica real en los pacientes tratados con UST en nuestro centro. MÉTODOS: Estudio prospectivo observacional unicéntrico incluyendo los pacientes que iniciaron UST desde el 1/08/2017 hasta el 28/02/2019 con seguimiento hasta esa fecha. Analizamos respuesta y remisión en semanas 16, 24 y 52, utilizando «Crohn's Disease Activity Index» (respuesta si descenso de 100 puntos y remisión si <150) y la «Valoración Global del especialista» traducción del «Physician's Global Assessment». RESULTADOS: Incluimos 61 pacientes con una mediana de duración de enfermedad de Crohn de 14,6 años (0-36). El 83,6% sin esteroides y el 73,8% sin inmunosupresores asociados. Previamente todos habían recibido anti-TNF y el 14,8%, además, vedolizumab. Observamos buena correlación entre Crohn's Disease Activity Index y Valoración Global del especialista (r = 0,89, p < 0,001). En la semana 16 (n = 45) un 75,6% de respuesta (57,8% remisión), en semana 24 (n = 35) 69,9% respuesta (45,7% remisión) y en semana 52 (n = 12) 75% respuesta (58,3% remisión). No se obtuvieron diferencias estadísticamente significativas en la tasa de respuesta/remisión en semana 16 ni 24 en función del motivo de inicio de UST o el número de biológicos previos. En 2 pacientes se retiró por toxicidad (artralgias/mialgias). CONCLUSIÓN: UST es un fármaco eficaz y seguro en práctica clínica real con altas tasas de remisión clínica en semana 16, 24 y 52 independientemente del orden de biológico utilizado y del motivo de inicio de UST

INTRODUCTION: Ustekinumab (UST) is a monoclonal antibody against IL-12/23 approved in Spain (2017) to treat moderate / severe Crohn's disease. OBJECTIVE: To evaluate the effectiveness and safety in real clinical practice in patients treated with UST in our center. METHODS: This is a prospective observational study including patients who started UST from 08/01/2017 to 02/28/2019 with follow-up up to that date. We analyze response and remission in weeks 16, 24 and 52, using "Crohn's Disease Activity Index" (response if 100 point decrease and remission if <150) and Physician's Global Assessment. RESULTS: We included 61 patients with a median duration of Crohn's disease of 14,6 years (0-36). The 83,6% of patients without steroids and 73,8% without associated immunosuppressors. Previously all patients had received anti-TNF and 14,8%, in addition, vedolizumab. We observed a good correlation between Crohn's Disease Activity Index and Physician's Global Assessment (r = 0,89, p <.001). In week 16 (n = 45) 75,6% response (57,8% remission), in week 24 (n = 35) 69,9% response (45,7% remission) and in week 52 (n = 12) 75% response (58.3% remission). There were no statistically significant differences in the response/remission rates at week 16 or 24 depending on the reason for the onset of UST or the number of previous biologics. In 2 patients it was withdrawn due to toxicity (arthralgia / myalgia). CONCLUSION: UST is an effective and safe treatment in real clinical practice with high rates of clinical remission at week 16, 24 and 52 regardless of the order of biological used and the reason for starting UST

Real-life experience with 4 years of golimumab persistence in ulcerative colitis patients.

Golimumab has demonstrated its long-term efficacy and safety in ulcerative colitis in clinical trials, but no data of long-term persistence has been published from real world. To estimate long-term persistence of golimumab, as well as factors associated with longer persistence, in patients with ulcerative colitis in real life. Observational multicentre study including adult patients with ulcerative colitis treated with golimumab and with at least twelve months of follow-up. We included 190 patients, 105 (55.26%) naive to anti-TNF, with mean disease duration of 9.32 ± 8.09 years. Probability of persistence was 63%, 46%, 39% and 27% at 1, 2, 3 and 4 years, respectively. Persistence was lower in patients with primary failure to previous anti-TNF. Eighty-two (43.16%) patients needed dose intensification during follow-up, with a mean time until intensification of 8.03 ± 8.64 months. Dose intensification and lower disease duration predicted higher persistence with golimumab (p = 0.037 and p = 0.008, respectively). During a follow-up of 17.25 ± 15.83 months, 32 (16.5%) patients needed hospitalisation and 11 (6%) underwent colectomy. No unexpected adverse events were reported. Golimumab has demonstrated good persistence and safety profile for long treatment in ulcerative colitis patients.

Ustekinumab in Crohn's disease: effectiveness and safety in clinical practice. / Ustekinumab en enfermedad de Crohn: efectividad y seguridad en práctica clínica.

INTRODUCTION: Ustekinumab (UST) is a monoclonal antibody against IL-12/23 approved in Spain (2017) to treat moderate / severe Crohn's disease. OBJECTIVE: To evaluate the effectiveness and safety in real clinical practice in patients treated with UST in our center. METHODS: This is a prospective observational study including patients who started UST from 08/01/2017 to 02/28/2019 with follow-up up to that date. We analyze response and remission in weeks 16, 24 and 52, using "Crohn's Disease Activity Index" (response if 100 point decrease and remission if <150) and Physician's Global Assessment. RESULTS: We included 61 patients with a median duration of Crohn's disease of 14,6 years (0-36). The 83,6% of patients without steroids and 73,8% without associated immunosuppressors. Previously all patients had received anti-TNF and 14,8%, in addition, vedolizumab. We observed a good correlation between Crohn's Disease Activity Index and Physician's Global Assessment (r = 0,89, p <.001). In week 16 (n = 45) 75,6% response (57,8% remission), in week 24 (n = 35) 69,9% response (45,7% remission) and in week 52 (n = 12) 75% response (58.3% remission). There were no statistically significant differences in the response/remission rates at week 16 or 24 depending on the reason for the onset of UST or the number of previous biologics. In 2 patients it was withdrawn due to toxicity (arthralgia / myalgia). CONCLUSION: UST is an effective and safe treatment in real clinical practice with high rates of clinical remission at week 16, 24 and 52 regardless of the order of biological used and the reason for starting UST.

Utilidad clínica de la determinación de niveles de CT-P13, biosimilar de infliximab, en el control de la enfermedad inflamatoria intestinal / Clinical value of CT-P13 trough levels, an infliximab biosimilar, in the management of inflammatory bowel disease

INTRODUCCIÓN: CT-P13 es un fármaco biosimilar de infliximab (IFX), efectivo en pacientes con enfermedad inflamatoria intestinal (EII). La medición de niveles de IFX y anticuerpos anti-IFX forma parte del tratamiento integral de dicha enfermedad. OBJETIVO: Comparar la respuesta clínica en función de un abordaje estrictamente clínico (CLN) o proactivo (PRO) basado en la medición de niveles en la semana 14, en la práctica clínica. MÉTODOS: Estudio prospectivo en pacientes que inician CT-P13 por EII. En el grupo PRO se midieron sistemáticamente los niveles de IFX y de anticuerpos postinducción (semana 14) y se intensificaron aquellos con niveles infraterapéuticos (<3μg/ml), independientemente de la respuesta clínica. RESULTADOS: Se incluyeron 77 pacientes (23 colitis ulcerosa y 54 enfermedad de Crohn). Ambos grupos, PRO (n=41) y CLN (n=36) presentaron una eficacia inicial y a largo plazo sin diferencias significativas. En la semana 14 hubo un 61% de remisión clínica (RC) (58,5% PRO, 63,9% CLN) y un 80,5% de al menos respuesta parcial (RP) (80,5% PRO, 80,6% CLN). En la semana 54 hubo un 68,8% de RC (61% PRO, 77,8% CLN) y un 76,6% de al menos RP (73,2% PRO, 80,6% CLN). De los pacientes en RC en la semana 14 (24 PRO, 23 CLN), 13 del grupo PRO fueron intensificados por niveles infraterapéuticos. En este subgrupo no se observaron diferencias significativas en la pérdida de respuesta secundaria (PRO 0%, CLN 8,7%). CONCLUSIÓN: Un manejo proactivo no mejoró las tasas de respuesta ni la remisión en el primer año. La intensificación de pacientes en RC y niveles infraterapéuticos postinducción no parece prevenir de forma significativa la pérdida de respuesta secundaria en el primer año

INTRODUCTION: CT-P13 is a biosimilar drug of infliximab (IFX), effective in patients with inflammatory bowel disease (IBD). The monitoring of levels of IFX and anti-IFX antibodies is now considered part of the integral management. OBJECTIVE: To compare the clinical response according to a strictly clinical (CLN) or proactive (PRO) approach based on the monitoring of levels in week 14, in clinical practice. METHODS: We conducted a prospective study in IBD patients starting CT-P13. In the PRO group, levels of IFX and post-induction antibodies were systematically measured (week 14) and those with infraterapeutic levels (<3μg/ml) were intensified, irrespective of the clinical response. RESULTS: We included 77 patients (23 ulcerative colitis and 54 Crohn's disease). Both PRO (n=41) and CLN (n=36) groups showed initial and long-term efficacy without significant differences. At week 14, 61% clinical remission (CR) (58.5% PRO, 63.9% CLN) and 80.5% at least partial response (PR) (80.5% PRO, 80.6% CLN). In week 54, 68.8% CR (61% PRO, 77.8% CLN) and 76.6% at least PR (73.2% PRO, 80.6% CLN). Of the patients in CR in week 14 (24 PRO, 23 CLN), 13 of the PRO group were intensified due to infra-therapeutic levels. In this subgroup no significant differences were observed in secondary loss of response (PRO 0%, CLN 8.7%). CONCLUSION: Proactive management does not improve response or remission rates in the first year. The intensification of clinical remission patients with post-induction infratherapeutic levels does not seem to significantly prevent secondary loss of response in the first year

Clinical value of CT-P13 trough levels, an infliximab biosimilar, in the management of inflammatory bowel disease. / Utilidad clínica de la determinación de niveles de CT-P13, biosimilar de infliximab, en el control de la enfermedad inflamatoria intestinal.

INTRODUCTION: CT-P13 is a biosimilar drug of infliximab (IFX), effective in patients with inflammatory bowel disease (IBD). The monitoring of levels of IFX and anti-IFX antibodies is now considered part of the integral management. OBJECTIVE: To compare the clinical response according to a strictly clinical (CLN) or proactive (PRO) approach based on the monitoring of levels in week 14, in clinical practice. METHODS: We conducted a prospective study in IBD patients starting CT-P13. In the PRO group, levels of IFX and post-induction antibodies were systematically measured (week 14) and those with infraterapeutic levels (<3µg/ml) were intensified, irrespective of the clinical response. RESULTS: We included 77 patients (23 ulcerative colitis and 54 Crohn's disease). Both PRO (n=41) and CLN (n=36) groups showed initial and long-term efficacy without significant differences. At week 14, 61% clinical remission (CR) (58.5% PRO, 63.9% CLN) and 80.5% at least partial response (PR) (80.5% PRO, 80.6% CLN). In week 54, 68.8% CR (61% PRO, 77.8% CLN) and 76.6% at least PR (73.2% PRO, 80.6% CLN). Of the patients in CR in week 14 (24 PRO, 23 CLN), 13 of the PRO group were intensified due to infra-therapeutic levels. In this subgroup no significant differences were observed in secondary loss of response (PRO 0%, CLN 8.7%). CONCLUSION: Proactive management does not improve response or remission rates in the first year. The intensification of clinical remission patients with post-induction infratherapeutic levels does not seem to significantly prevent secondary loss of response in the first year.

Sarcoma mieloide intestinal: una infrecuente presentación de una excepcional enfermedad / Intestinal myeloid sarcoma: an uncommon presentation of an exceptional disease

No disponible

[Acute generalized exanthematous pustulosis induced by omeprazole]. / Pustulosis exantemática aguda generalizada inducida por omeprazol.

Acute generalized exanthematous pustulosis (AGEP) comprises a group of eruptions characterized by several small sterile pustules over an erythematous-edematous skin. These eruptions are usually drug induced and show some characteristics that suggest an immunologic background. Treatment is based on withdrawal of the drug causing the eruption. Prognosis is generally good and the skin lesions usually resolve in a few days with characteristic postpustular pin-point desquamation. We report three cases of AGEP induced by omeprazole, a drug with a good safety profile. Some adverse cutaneous reactions have been described as secondary effects. However, to our knowledge, no cases of omeprazole-induced AGEP have previously been reported. AGEP related to other proton pump inhibitors is exceptional.

Pustulosis exantemática aguda generalizada inducida por omeprazol / Acute generalized exanthematous pustulosis induced by omeprazole

La pustulosis exantemática aguda generalizada (PEAG) englobaun subgrupo de erupciones, caracterizadas por la apariciónde numerosas pústulas estériles sobre un fondo eritematosoedematoso.Generalmente, son inducidas por fármacos y suscaracterísticas indican un trasfondo inmunológico. El tratamientoconsiste en la supresión del fármaco responsable. Engeneral, el pronóstico es bueno, y la lesión cutánea se resuelveen unos pocos días, con su peculiar descamación.Presentamos 3 casos de PEAG inducidos por omeprazol, unfármaco con un excelente perfil de seguridad, entre cuyosefectos secundarios se han descrito varios tipos de lesionescutáneas, sin que hayamos encontrado en la revisión bibliográficaninguna referencia a casos de PEAG por este fármaco.La PEAG relacionada con otros inhibidores de la bombade protones es excepcional (AU)

generalized exanthematous pustulosis (AGEP) comprisesa group of eruptions characterized by several smallsterile pustules over an erythematous-edematous skin. Theseeruptions are usually drug induced and show some characteristicsthat suggest an immunologic background. Treatmentis based on withdrawal of the drug causing the eruption.Prognosis is generally good and the skin lesions usuallyresolve in a few days with characteristic postpustular pinpointdesquamation.We report three cases of AGEP induced by omeprazole, adrug with a good safety profile. Some adverse cutaneous reactionshave been described as secondary effects. However,to our knowledge, no cases of omeprazole-induced AGEPhave previously been reported. AGEP related to other protonpump inhibitors is exceptional (AU)