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Ustekinumab (UST) is a monoclonal antibody against IL-12/23 approved in Spain (2017) to treat moderate / severe Crohn's disease.To evaluate the effectiveness and safety in real clinical practice in patients treated with UST in our center.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 if150) and Physician's Global Assessment.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 In 2 patients it was withdrawn due to toxicity (arthralgia / myalgia).UST is an effective and safe treatment in real clinical practice with high rates of clinical remission at week 16, 24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.

Resumen Introduccion Ustekinumab (UST) es un anticuerpo monoclonal frente a IL-12/23 aprobado en Espana (2017) para tratar el brote moderado/grave de enfermedad de Crohn. Objetivo Evaluar la efectividad y seguridad en practica clinica real en los pacientes tratados con UST en nuestro centro. Metodos Estudio prospectivo observacional unicentrico incluyendo los pacientes que iniciaron UST desde el 1/08/2017 hasta el 28/02/2019 con seguimiento hasta esa fecha. Analizamos respuesta y remision en semanas 16, 24 y 52, utilizando «Crohn's Disease Activity Index» (respuesta si descenso de 100 puntos y remision si Resultados Incluimos 61 pacientes con una mediana de duracion de enfermedad de Crohn de 14,6 anos (0-36). El 83,6% sin esteroides y el 73,8% sin inmunosupresores asociados. Previamente todos habian recibido anti-TNF y el 14,8%, ademas, vedolizumab. Observamos buena correlacion entre Crohn's Disease Activity Index y Valoracion Global del especialista (r = 0,89, p Conclusion UST es un farmaco eficaz y seguro en practica clinica real con altas tasas de remision clinica en semana 16, 24 y 52 independientemente del orden de biologico utilizado y del motivo de inicio de UST.

Resumen Introduccion CT-P13 es un farmaco biosimilar de infliximab (IFX), efectivo en pacientes con enfermedad inflamatoria intestinal (EII). La medicion de niveles de IFX y anticuerpos anti-IFX forma parte del tratamiento integral de dicha enfermedad. Objetivo Comparar la respuesta clinica en funcion de un abordaje estrictamente clinico (CLN) o proactivo (PRO) basado en la medicion de niveles en la semana 14, en la practica clinica. Metodos Estudio prospectivo en pacientes que inician CT-P13 por EII. En el grupo PRO se midieron sistematicamente los niveles de IFX y de anticuerpos postinduccion (semana 14) y se intensificaron aquellos con niveles infraterapeuticos ( 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 remision clinica (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 infraterapeuticos. En este subgrupo no se observaron diferencias significativas en la perdida de respuesta secundaria (PRO 0%, CLN 8,7%). Conclusion Un manejo proactivo no mejoro las tasas de respuesta ni la remision en el primer ano. La intensificacion de pacientes en RC y niveles infraterapeuticos postinduccion no parece prevenir de forma significativa la perdida de respuesta secundaria en el primer ano.

COVID-19; Immunosuppression; Inflammatory bowel disease COVID-19; Immunosupressió; Malaltia inflamatòria intestinal COVID-19; Inmunosupresión; Enfermedad inflamatoria intestinal (1) Scant information is available concerning the characteristics that may favour the acquisition of COVID-19 in patients with inflammatory bowel disease (IBD). Therefore, the aim of this study was to assess these differences between infected and noninfected patients with IBD. (2) This nationwide case−control study evaluated patients with inflammatory bowel disease with COVID-19 (cases) and without COVID-19 (controls) during the period March−July 2020 included in the ENEIDA of GETECCU. (3) A total of 496 cases and 964 controls from 73 Spanish centres were included. No differences were found in the basal characteristics between cases and controls. Cases had higher comorbidity Charlson scores (24% vs. 19%; p = 0.02) and occupational risk (28% vs. 10.5%; p < 0.0001) more frequently than did controls. Lockdown was the only protective measure against COVID-19 (50% vs. 70%; p < 0.0001). No differences were found in the use of systemic steroids, immunosuppressants or biologics between cases and controls. Cases were more often treated with 5-aminosalicylates (42% vs. 34%; p = 0.003). Having a moderate Charlson score (OR: 2.7; 95%CI: 1.3−5.9), occupational risk (OR: 2.9; 95%CI: 1.8−4.4) and the use of 5-aminosalicylates (OR: 1.7; 95%CI: 1.2−2.5) were factors for COVID-19. The strict lockdown was the only protective factor (OR: 0.1; 95%CI: 0.09−0.2). (4) Comorbidities and occupational exposure are the most relevant factors for COVID-19 in patients with IBD. The risk of COVID-19 seems not to be increased by immunosuppressants or biologics, with a potential effect of 5-aminosalicylates, which should be investigated further and interpreted with caution.

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.

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 ( 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.

Background: Athletes practicing strenuous physical activities may develop exercise-induced bronchoconstriction (EIB). We aimed to determine the prevalence and features of this condition in Mexico City (altitude, 2,240 m). Methods: In the present study, 208 high school and college athletes performed a standardized EIB test on a treadmill. Results: Responses to exercise had large between-subject variability in all physiological parameters (forced expiratory volume in one second [FEV1], heart rate, blood oxygen saturation level [SpO2], blood pressure), with nearly similar proportions of subjects in whom FEV1 increased or decreased. According to the recommended cut-off value of 10% FEV1 decrease, only 15 (7.2%) athletes had a positive EIB test. Weight lifters were more prone to develop EIB (three out of seven athletes; p = 0.01). Subjects with a positive EIB test already had a lower baseline forced expiratory volume in one second/forced vital capacity (FEV1/FVC) ratio (96.4 vs. 103.2% of predicted, respectively; p = 0.047), and developed more respiratory symptoms after exercise than subjects with a negative test. There were no differences with respect to age, gender, body mass index, history of asthma or atopic diseases, smoking habit, and exposure to potential indoor allergens. Conclusions: The relatively low prevalence of EIB in athletes from Mexico City raises the possibility that high altitude constitutes a protective factor for EIB. In contrast, weight lifters were especially prone to develop EIB, which suggests that repetitive Valsalva maneuvers could be a novel risk factor for EIB. There was a large betweensubject variability of all physiological responses to exercise. (Rev Inves ClIn. 2017;69:20-7)

Ulcerative colitis (UC) treatment is focused to achieve mucosal healing, avoiding disease progression. The study aimed to evaluate the real-world effectiveness of adalimumab (ADA) in UC and to identify predictors of remission to ADA.This cohort study used data from the ENEIDA registry. Clinical response, clinical remission, endoscopic remission, adverse events (AE), colectomy, and hospitalisations were evaluated; baseline characteristics and biological parameters were compared to determine predictors of response.We included 263 patients (87 naïve and 176 previously exposed to anti-tumour necrosis factor alpha, TNF). After 12 weeks, clinical response, clinical remission, and endoscopic remission rates were 51, 26, and 14 %, respectively. The naïve group demonstrated better response to treatment than the anti-TNF-exposed group at short-term. Clinical and endoscopic remission within 1 year of treatment was better in the naïve group (65 vs. 49 and 50 vs. 35 %, respectively). The rates of AE, dose-escalation, hospitalisations, and colectomy during the first year were higher in anti-TNF-exposed patients (40, 43, and 27 % vs. 26, 21, and 11 %, respectively). Patients with primary failure and intolerance to the first anti-TNF and severe disease were associated with worse clinical response. Primary non-response to prior anti-TNF treatment and severe disease were predictive of poorer clinical remission. Low levels of C-reactive protein (CRP) and faecal calprotectin (FC) at baseline were predictors of clinical remission.In clinical practice, ADA was effective in UC, especially in anti-TNF naïve patients. FC and CRP could be predictors of treatment effectiveness.

Celiac disease (CD) presents a wide clinical spectrum. There are asymptomatic or oligosymptomatic forms, which are difficult to diagnose. Since patients with untreated CD can develop severe complications, early diagnosis of these forms is important. Consequently, in groups at risk for CD, such as patients with type 1 diabetes (DM1), screening through determination of antigliadin (AGA), anti-tissue transglutaminase (ATG) and antiendomysial antibodies (EMA) is recommended. In the present study, 463 DM1 patients were screened for these antibodies. Patients who were positive for one or more were offered an upper endoscopy to obtain distal duodenum biopsies. Histological lesions, when present, were classified using Marsh's classification. Of the 463 patients, 62 (13.4%) were positive for at least one of the three antibodies, and 42 accepted to undergo an endoscopy. Fourteen patients (3% of the DM1 patients) were histologically diagnosed with CD. Most of these patients had no symptoms of CD, although some showed laboratory findings frequent in CD. The presence of clinical or analytical data compatible with CD was independent of the grade of histological lesions. Finally, we calculated the sensitivity and positive predictive value for each antibody. The most sensitive were ATG and EMA. Because of the technical simplicity of determining ATG with ELISA, in our opinion, this test should be the option of choice for screening.

Celiac disease (CD) presents a wide clinical spectrum. There are asymptomatic or oligosymptomatic forms, which are difficult to diagnose. Since patients with untreated CD can develop severe complications, early diagnosis of these forms is important. Consequently, in groups at risk for CD, such as patients with type 1 diabetes (DM1), screening through determination of antigliadin (AGA), anti-tissue transglutaminase (ATG) and antiendomysial antibodies (EMA) is recommended. In the present study, 463 DM1 patients were screened for these antibodies. Patients who were positive for one or more were offered an upper endoscopy to obtain distal duodenum biopsies. Histological lesions, when present, were classified using Marsh's classification. Of the 463 patients, 62 (13.4%) were positive for at least one of the three antibodies, and 42 accepted to undergo an endoscopy. Fourteen patients (3% of the DM1 patients) were histologically diagnosed with CD. Most of these patients had no symptoms of CD, although some showed laboratory findings frequent in CD. The presence of clinical or analytical data compatible with CD was independent of the grade of histological lesions. Finally, we calculated the sensitivity and positive predictive value for each antibody. The most sensitive were ATG and EMA. Because of the technical simplicity of determining ATG with ELISA, in our opinion, this test should be the option of choice for screening.