Abstract Background Ustekinumab (UTK) is a recently introduced biologic therapy for inflammatory bowel disease (IBD), and consequently, the clinical use of UTK trough concentrations is less standardized compared to other biologic therapies. Therefore, accurate measurement of serum UTK levels is essential for adjusting treatment efficacy. The objective of the present study is to compare two enzyme-linked immunosorbent assay (ELISA) methods to evaluate their correlation, concordance, and systematic bias, given the variability between methods. Methods The study assessed the correlation and the agreement between two different methods available for UTK measurement. Thirty-six blood samples from different patients, which had a previous diagnosis of IBD, were analyzed. All patients were recruited from September to November 2024 from the autoimmunity laboratory of the Hospital Universitario 12 de Octubre, Madrid. Serum UTK levels were measured using the two ELISA techniques: IDKmonitor® ELISA assay (Immundiagnostik AG; Bensheim, Germany) (T1) and the alternative Promonitor® ELISA assay (Grifols; Barcelona, Spain) (T2). Measurements were further categorized into therapeutic ranges for response classification: non-responders (0–1 µg/mL), clinical response (1–4.5 µg/mL), and endoscopic response (>4.5 µg/mL). Results A strong linear correlation was observed between the two methods (Pearson’s r = 0.9693, p < 0.0001, R² = 0.9395), confirming a proportional relationship despite systematic differences. Lin’s concordance coefficient was moderate-to-good (0.7025), indicating agreement despite systematic differences. Bland-Altman analysis revealed a mean difference of 2.79, with increasing variability at higher concentrations, consistent with proportional error. Passing-Bablok regression revealed a systematic bias, indicating an overestimation by the Promonitor-Grifols ELISA: the slope was 1.4342 (95% CI: 1.2530–1.6387) and the intercept 1.2591 (95% CI: 0.7591–1.8309). Considering these results, a linear regression adjustment was conducted. Categorization into therapeutic ranges revealed poor concordance between the methods (Kappa index = 0.28), suggesting that systematic errors substantially affect clinical interpretation. T2 consistently assigned higher therapeutic ranges, potentially impacting treatment decisions. Conclusion While the two ELISA methods show strong correlation, moderate concordance and significant systematic biases limit their interchangeability. Adjustment strategies should be adopted to harmonize results and ensure reliable therapeutic decisions in IBD management. References - Kwon Y, Kang B, Kim ES, Choe YH, Kim MJ. Comparison of Ustekinumab Trough Concentrations Measured by 2 ELISA Kits and Evaluation of Clinical Response in Crohn’s Disease. Ther Drug Monit. 2022;44(4):535-542. doi:10.1097/FTD.0000000000000976 - Rodríguez-Moranta F, Argüelles-Arias F, Hinojosa Del Val J, et al. Therapeutic drug monitoring in inflammatory bowel diseases. Position statement of the Spanish Working Group on Crohn’s Disease and Ulcerative Colitis (GETECCU). Gastroenterol Hepatol. 2024;47(5):522-552. doi:10.1016/j.gastrohep.2024.01.007

Abstract Background Tofacitinib, filgotinib, and upadacitinib, are Janus kinase inhibitors (iJAKs) approved for inflammatory bowel disease (IBD) treatment. Although no comparative studies exist, potential differences in efficacy and safety are attributed to in vitro-demonstrated affinity of each molecule for different JAK isoforms. JAK1 plays a crucial role in modulating cytokine-mediated immune responses, such as IL-6 and interferon, which are involved in inflammation and skin homeostasis. Its inhibition can promote conditions that may trigger acne. Acne may be increased in iJAK-treated patients, meaning a clinical challenge for gastroenterologists. This study aims to identify the proportion of patients treated with iJAKs who develop acne, describe acne characteristics, risk factors, and management strategies. Methods A retrospective study was conducted at two referral centers in Madrid, Spain, including all IBD patients who had received iJAK therapy. Demographic data, disease-related variables, and acne characteristics (if appropriate) were collected. Results A total of 152 patients included; 64 (42%) were women. Eighty-two patients (54%) had ulcerative colitis, 70 (46%) had Crohn’s disease. Median age was 42.5 years (IQR 33.5-55). Sixty patients (39%) were treated with tofacitinib, 82 (54%) with upadacitinib, and 10 (7%) with filgotinib. Twenty-four patients (16%) developed acne during iJAK treatment: 75% were mild, with only 1 severe case (4%). Acne occurred early (median onset 1.8 months, IQR 0-3), predominantly on the face (92%) and/or trunk (46%). Acne morphology included comedones (75%), papules (50%), pustules (37%), nodular-cystic (12%), scarring (12%); 42% showed more than one morphology. Eleven patients received specific acne treatment: 54% topical (antiseptics, benzoyl peroxide, retinoids), 41% systemic (antibiotics, retinoids, antiandrogens), and 29% combined treatment. Only 3 patients (12% of those with acne; 2% overall) had to discontinue iJAK treatment, with acne resolving in all cases. Variables associated with acne development included high iJAK doses (p=0.001), age <35 years (p=0.005), and a history of acne (p=0.02). Acne developed in 21%, 8% and 2% of upadacitinib, tofacitinib and filgotinib treated patients respectively, though these differences were not statistically significant (p=0.09). Conclusion Acne occurred in a significant proportion of iJAK treated patients, was typically mild and manageable with specific dermatological intervention. Only a minority of cases required treatment discontinuation. Risk factors for iJAK-associated acne included dosage, younger age, and acne history. A trend toward a higher incidence of acne associated with upadacitinib may reflect its greater affinity for JAK1.

Background and Aims: Inflammatory pouch disorders exhibit a heterogeneous clinical spectrum and therapeutic requirements have not been properly studied. Methods: This retrospective, multicentre study included ulcerative colitis patients with ileal pouch construction and were later diagnosed with an inflammatory pouch disorder between 1995 and 2020. Classifications, behaviour and therapies applied were recorded and compared in the long-term. Results: Overall, 338 patients were recruited. The most common disorders were pouchitis (n = 258, 76%), Crohn's disease of the pouch (n = 55, 16%) and cuffitis (n = 25, 7%). Pouchitis presented mainly as chronic (65.2%) and recurrent (87%) forms. Crohn's disease manifested as stricturing/penetrating in 53% of cases and perianal disease in 42%. Patients received multiple therapies: 86% antibiotics, 42% steroids, 27% immunosuppressants, 43% biologics and 27% surgery. Compared with pouchitis, Crohn's disease of the pouch was characterised by a later diagnosis (99 vs. 55 months, p < 0.001) and greater needs for immunosuppressants (OR 3.53, 1.79-6.94, p < 0.0001), biologics (OR 5.45, 2.78-10.6, p < 0.0001) and surgeries (OR 2.65, 1.43-4.89, p < 0.001). Conclusions: Chronic pouchitis is the most common pouch disorder presentation. These entities have diverse therapeutics requirements, particularly for Crohn's disease of the pouch.

Summary 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.

Abstract Background Adalimumab (ADA) dose escalation from 40 mg SC every other week (EOW) to 40 mg weekly is approved for IBD patients with loss of response. A recently registered device containing 80 mg of ADA will allow an alternative dose escalation regimen with SC doses of 80 mg EOW. The ADASCAL study aimed to evaluate the preferences and satisfaction of patients with modifying the ADA regimen from 40 mg weekly to 80 mg EOW. Methods This multicentre cross-sectional study included patients with IBD in whom the ADA regimen was changed from 40 mg weekly to 80 mg EOW according to clinical practice. Patients who have received at least 4 doses of 80 mg EOW completed a 4-item self-questionnaire (a Likert-like 5-point scale for preferences, 2 closed questions for convenience, and a 100-point visual analogue scale [VAS] to evaluate patient’s preference for weekly or EOW ADA) (Figure 1); and the 14-item Treatment Satisfaction Questionnaire for medication (TSQM 1.4) that covers 4 domains: effectiveness, side effects, convenience, and overall satisfaction. Results Seventy-seven patients (64 CD, 13 UC; 67.5% men; mean age 48 years, SD 14.1) were included. The overall mean duration of exposure to ADA was 66 months (SD 34), with mean exposure to ADA 40 mg weekly of 40 months (SD 25), and mean exposure to ADA 80 mg EOW of 12 months (SD 5). At the time of the survey, 87.1% of CD patients and all UC patients were in clinical remission (Harvey-Bradshaw index ≤4 for CD, Partial Mayo score ≤1 for UC). According to the results of the questionnaires, 74% of the patients preferred the 80 mg EOW ADA regimen (59.7% had a strong preference and 14.3% had a slight preference) (Figure 1). Patients referred that ADA EOW regimen interferes less with daily activity and with travel plans. Most patients wanted to continue with ADA 80 mg EOW, as reflected by a mean VAS score of 84.7 (SD 24.1), where 0 indicated a choice for weekly ADA, 100 for ADA EOW, and 50 indifferent. Overall, 77% of patients preferred to continue with ADA EOW, 4% with ADA weekly, and 17% were indifferent. Attending physicians also reported a greater preference for the EOW ADA regimen (mean VAS score 93, SD 7.8). The mean global satisfaction according to the TSQM was 84.3% (SD 13.5), where 0 indicated extremely dissatisfied and 100 extremely satisfied. Patients reported very high TSQM scores for individual components: effectiveness 77.6% (SD 16.9), convenience 83.7% (SD 14.5), and side effects 86.1% (SD 23.4). Conclusion IBD patients in whom the ADA regimen was changed from 40 mg weekly to 80 mg EOW reported a higher preference for the EOW regimen. TSQM results indicated that patients had a high level of satisfaction with the current EOW regimen. Therefore, most patients wanted to continue with ADA 80 mg EOW.

Abstract Background Pouchitis and Crohn′s-like disease of the pouch (CDP) can be refractory to conventional therapy. Evidence of biological therapy has been rarely reported in large patient cohorts. We explored the use and effectiveness of these therapies and compared the success of a second biologic after antiTNF failure. Methods This is a retrospective RESERVO study of the Spanish cohort of GETECCU, that included patients operated for ulcerative colitis, with pouch construction, and subsequent diagnosis of pouchitis, CDP or cuffitis second ECCO diagnostic criteria1. Patients treated with antiTNF, Vedolizumab and/or Ustekinumab were selected. Clinical effectiveness was evaluated at long-term. We defined clinical remission as returning to the previous stool frequency, no pain or defecatory urgency, clinical response as the improvement in these parameters without the achievement of remission and non-response as no change or worsening of these symptoms. We also compared the effectiveness of second biologic (antiTNF vs vedolizumab-ustekinumab) after antiTNF failure, using descriptive and comparative statistics. Results The cohort comprised 145 patients. Demographic and clinical characteristics are represented in Table 1. A total of 232 biologic therapies were indicated. Of the total cohort, 60 (41.3%), 21 (14.4%) and 6 (4.1%) used two, three and four lines, respectively. Biologics used were Infliximab (n=95), Adalimumab (n=69), Vedolizumab (n=35), Ustekinumab (n=26) and Golimumab (n=7). Therapy characteristics, clinical effectiveness, need for intensification, discontinuation, and therapy duration for each biological therapy are represented in Table 2. Global rates of clinical remission, response, non-response and loss of response to a first biologic were 21.8%, 27.5%, 21.1% and 29.6%. Female gender was the only factor associated with effectiveness to a first biologic in univariate analysis (OR 2.16, CI 1.08–4.32, p 0.027). There were no significant differences regarding efectiveness between type of pouch disorder (pouchitis vs CDP, 51.6 vs 47.6%, p 0.48) or biologic agents. Thirty-nine patients received a second biologic after prior antiTNF failure (28 a second antiTNF and 11 non-antiTNF: 6 Vedolizumab, 5 Ustekinumab). Basal characteristics in this subgroup showed no significant differences. Clinical response (21.4 vs 63.6%, p 0.02) and discontinuation therapy rates (82.2 vs 54.5 %, p 0.04) after 11 months showed a more favorable profile for non-antiTNF therapy. Conclusion Biologics represent an effective option in the management of pouchitis and Crohn′s like disease of the pouch. Despite our small sample size, non-antiTNF therapy could be the best option after antiTNF failure. 1Fernando Magro. J Crohns Colitis 2017; 11(6): 649–670.

Abstract Background Pouchitis and other inflammatory pouch diseases (IPD) are frequent in pouch-carrying patients operated for a previous diagnosis of ulcerative colitis. We evaluated characteristics and differences in therapeutic requirements between pouchitis, Crohn′s-like disease of the pouch (CDP) and cuffitis. Methods This is a retrospective and multicentric Spanish cohort of GETECCU (RESERVO Study), including pouch-carrying patients (operated 1995 to 2016) with previous ulcerative colitis, ileostomy closure and subsequent diagnosis of IPD (pouchitis, CDP or cuffitis), following ECCO diagnostic criteria1. Follow up extended to June 2020. Pouchitis was categorized attending current classifications. Use of medical and surgical therapies was collected and differences between pouchitis and CDP were analyzed using descriptive and comparative statistics. Results A total of 338 patients were included. Demographic and clinical characteristics are presented in Table 1. The most frequent IPD was pouchitis (n=258, 76%), followed by CDP (n=55, 16%) and cuffitis (n=25, 7.4%). Pouchitis was diagnosed at a median time of 27 (range 1–342) months. Prevalence according to pouchitis classification is presented in Figure 1. CDP was diagnosed at a median time of 77 (range 5–324) months, around 75% with a previous pouchitis diagnosis. Location of CDP (not mutually excludent) was pouch CDP (91%), 87% pre-pouch ileitis, and 41% perianal disease. Regarding behavior: 26 (47%) were inflammatory, 12 (22%) stricturing and 17 (31%) penetrating (8 rectovaginal fistulas). Cuffitis was diagnosed at a median time of 18 (range 1–219) months. Medical and surgical therapies used are shown in Figure 2. Immunosuppressants (58.2 vs 22.4%, p 0.001), biologics (74.5 vs 34.8%, p 0.0001), and surgery (41.8 vs 21.3%, p 0.003) were more used in CDP than in pouchitis. Conclusion Pouchitis and CDP are heterogeneous inflammatory pouch complications with a wide and high therapeutic requirement. CDP presents a later diagnosis and has higher therapeutic needs than pouchitis. 1. Fernando Magro, Paolo Gionchetti, Rami Eliakim et al, for the European Crohn’s and Colitis Organisation [ECCO], Third European Evidence-based Consensus on Diagnosis and Management of Ulcerative Colitis. Part 1: Definitions, Diagnosis, Extra-intestinal Manifestations, Pregnancy, Cancer Surveillance, Surgery, and Ileo-anal Pouch Disorders, J Crohns Colitis 2017; 11(6): 649–670.

AIM:To evaluate the use of health care resources and the associated costs of complex perianal Crohn's disease (CD) from the National Health System perspective.METHODS:We conducted a multicenter, retrospective, observational study in which gastroenterologists from 11 hospitals in the Community of Madrid took part. Data was collected on the direct healthcare resources (pharmacological treatments, surgical procedures, laboratory/diagnostic tests, visits to specialists and emergency departments, and hospitalizations) consumed by 97 adult patients with complex perianal CD which was active at some point between January 1, 2005, and case history review.RESULTS:We recorded 527 treatments: 73.1% pharmacological (32.3% antibiotic, 20.5% immunomodulator, 20.3% biological) and 26.9% surgical. Mean annual global cost was €8,289/patient, 75.3% (€6,242) of which was accounted for by pharmacological treatments (€13.44 antibiotics; €1,136 immunomodulators; €5,093 biological agents), 12.4% (€1,027) by hospitalizations and surgery, 7.7% (€640) by medical visits, 4.2% (€350) by laboratory/diagnostic tests, and 0.4% (€30) by emergency department visits.CONCLUSIONS:Pharmacological therapies, and in particular biological agents, are the main cost driver in complex perianal CD; costs due to surgery and hospitalizations are much lower.

Introducción: La ultrasonografía endoanal (USEA) es una técnica sencilla y de gran utilidad en el diagnóstico y manejo terapéutico de las enfermedades anorrectales, mejorando su resolución espacial con el uso de la sonda en 3D. Objetivo: Estudiar la utilidad de la USEA con la sonda rígida 3D desde su implantación en nuestro hospital. Material y Método: Estudio retrospectivo de las USEA-3D realizadas en nuestro centro desde noviembre-2008 hasta junio-2013. Analizamos las características demográficas de los pacientes, indicaciones y diagnósticos. Resultados: Se realizaron 755 USEA (exploraciones/año: 116/2009; 146/2010; 183/2011; 195/2012; 114/junio-2013); 58% mujeres/42% varones; edad 47 ± 14 años. Motivos de solicitud: sepsis perianal (fístula y/o absceso) (49%; 367/755); incontinencia (32%; 241/755); proctalgia (6%; 42/755); neoplasia anal (1%; 7/755); otros (12%; 92/755). Procedencia de peticiones: Ap. Digestivo (57%), Cirugía General (39%). Diagnósticos: sepsis perianal (41%); normalidad (25%); defectos esfinterianos (13%); cicatriz obstétrica (9%); otros (12%). La incontinencia se asoció a USEA normal en el 44% de casos; Características de las fístulas: transesfinterianas (44%; 140/316); interesfinterianas (32%; 101/316); extraesfinterianas (10%; 32/316); supraesfinterianas (6%; 19/316); otras (8%; 24/316); complejas 59% (186/316); asociadas a Crohn (22%; 71/316). Se inyectó H2O2 en 259/316 (82%), identificándose el orificio fistuloso interno (OFI) en 77% (199/259); Localización de abscesos: peri/postanal 66% (93/141), isquiorrectal 24% (34/141), otras 10% (14/141). Conclusiones: 1. En nuestro hospital, el numero de solicitudes de USEA ha aumentado progresivamente (fundamentalmente desde gastroenterología y cirugía general); 2. La principal indicación de USEA en nuestra serie ha sido la sepsis perianal; 3. Cerca de la mitad de los pacientes con incontinencia fecal no presentaron alteraciones en la USEA; 4. La fístula perianal fue el diagnóstico más frecuente en nuestro centro; 5. La inyección de H2O2 permitió localizar el OFI en el 77% de los casos; 6. El 66% de abscesos se localizaron en el espacio peri/postanal.

Clinical: Therapy and observation S225 our preliminary experience suggested that oral B12 could also be effective in CD.Objective: To analyze the efficacy of oral route to treat B12 deficiency in CD within a large group of patients, to confirm its convenience.Methods: We performed a retrospective analysis of B12 deficiency in CD patients treated by oral cobalamin, in 4 centers following quite similar protocol.CD diagnosis was established by Lennard-Jones criteria and Montreal Classification was used.Data on previous surgery, concomitant drugs and hematological values were reviewed.B12 deficiency was defined according to local laboratory criteria, measured by RIA (levels <200 250 pg/ml).We evaluate the efficacy both in the correction of the deficit and the ability to maintain normal levels long-term.Results: 95 CD patients were included in the analysis (49 men and 44 women, average age 44.4 years, range 72 21).The classification of the patients was (in %): Age at diagnosis (A): A1: 4, A2: 66, A3: 25; Location (L): L1: 44, L2: 3, L3: 43 and Behavior (B): B1: 42, B2: 26, B3: 32.Thirty-seven patients (38.9%, 37/95) had been operated on: 23 had any resection of distal ileum.Seventy-seven patients with B12 deficiency (average value prior to start oral therapy 152 pg/ml) were included.Oral supplements were effective in 90.1% of these cases (70/77), normalizing cobalamin levels (average value post therapy 456 pg/ml).Oral cobalamin was also used to maintain normal levels in 82 cases (those previous patients who get normal levels and were followed after, long term (n = 64) and 18 more patients in which parenteral therapy was changed to oral route).Efficacy to maintain normal levels was 80.4% (average level of 363.70 pg/ml, with a medium followup of 36.3 months).Poor adherence is one of the non-response causes, at least of 31.2% of cases.Conclusions: Our quite large data show that oral cobalamin seems to be an effective and convenient alternative to parenteral route.We suggest that oral route should be considered even as standard treatment also in CD related B12 deficiency.

of the 4th Congress of ECCO the European Crohn's and Colitis Organisation S73Conclusions: This study reveals discrepancy in psychosocial symptoms, and competence between reports of parents and adolescents with IBD.Chronically ill adolescents may deny their problems as part of coping strategy.Further, it is possible that the parents of chronically ill IBD patients observe their children more than the parents of healthy children, and thus report more concerns.Complementary methods should be used while assessing psychosocial well-being of adolescents with IBD.

La respuesta al tratamiento con IFX es inicialmente elevada, aunque con el paso del tiempo se ha observado, con cierta frecuencia, una pérdida de eficacia. En estos pacientes con pérdida de respuesta se ha recomendado “intensificar” el tratamiento con IFX. No obstante, se desconoce si el efecto beneficioso de esta estrategia se mantiene en el tiempo o es sólo transitorio. 1) Estudiar la respuesta (tanto a corto como a largo plazo) de los pacientes que precisan intensificar el tratamiento con IFX (aumentando la dosis o disminuyendo el intervalo). 2) Evaluar los efectos adversos asociados a la intensificación del tratamiento. Estudio multicéntrico retrospectivo. Se incluyeron pacientes con enfermedad de Crohn que hubieran recibido al menos las 3 dosis de inducción del tratamiento estándar con IFX (5 mg/kg) y que después precisaran intensificación del tratamiento (10 mg/kg cada 8 semanas o 5 mg/kg cada 4 semanas) por pérdida de respuesta. Se analizó la eficacia del tratamiento intensificado en el momento inicial (tras la 1a infusión de la dosis intensificada) y final (en la última revisión). Se utilizó el índice de Harvey-Bradshaw en el caso de enfermedad de Crohn no fistulizante. En la enfermedad fistulizante, la respuesta completa se definió como el cese del drenaje de todas las fístulas y la respuesta parcial como la reducción en al menos un 50% del número o del débito fistuloso. Se valoró la seguridad del tratamiento con la dosis intensificada. Se incluyeron 34 pacientes (edad media, 43 años; 50% varones; 31% fumadores; 64% con afectación ileocólica; 47% con patrón fistulizante; 60% con enfermedad perianal). La mayoría (72%) recibía tratamiento concomitante con inmunomoduladores. El tiempo medio de seguimiento con el tratamiento intensificado fue de 56 semanas (rango: 4–169 semanas). El tiempo medio de tratamiento con IFX antes de la intensificación de la dosis fue de 15 meses (rango: 3–43 meses). Con la primera dosis de tratamiento intensificado respondió el 78% de los pacientes (32% respuesta completa y 46% parcial). Mientras que con la última dosis de tratamiento intensificado sólo un 61% de los pacientes presentaban respuesta (22% respuesta completa y 39% respuesta parcial). Un paciente sufrió una reacción infusional tras 36 dosis de tratamiento intensificado, que se solucionó con el enlentecimiento de la infusión. Otro paciente presentó infección por virus del herpes zoster, no precisando suspensión del tratamiento. En ocasiones se requiere la intensificación del tratamiento con IFX, una media de 15 meses después del inicio del tratamiento con este fármaco. Un alto porcentaje de pacientes responden inicialmente al tratamiento intensificado, aunque éste pierde de nuevo su eficacia en más de un 10% de los casos. La intensificación del tratamiento presenta un buen perfil de seguridad, sin observarse reacciones adversas graves.

Background/Aims: Results of randomized controlled trials showing efficacy of infliximab in ulcerative colitis (UC) should be confirmed in clinical practice. We aimed to evaluate the efficacy and safety of infliximab in UC patients of the Madrid area, looking for clinical predictors of response.Methodology: Multicenter retrospective survey of all UC patients treated with infliximab in the region of Madrid (Spain).Results: 47 UC patients were included (45% males, mean age 44 15 yrs). mean follow Lip of 4.7 months (range 0.5-21). and a total number of 211 infliximab infusions. Clinical response and steroid-free remission rates were, respectively, 97/42% in the 2nd week, 93/69% in the 6th week, and 80/65% at the long-term follow up (mean 8.2 months, range 3.521). Colectomy rate was 10.6% (five patients). Age, gender, disease duration, indication (steroid-resistance/dependence), disease severity, C-reactive protein, concomitant thiopurinic therapy or smoking habit did not influence on efficacy. Extent of the disease was the only predictive factor (p=0.02). Only 4 cases of mild adverse events were reported.Conclusions: Infliximab is effective and safe for UC. Real life clinical practice may have better outcome than showed in randomized controlled trials. Extent of the disease was the only predictive factor for clinical response in our experience.

We report the case of a patient that developed hepatic hydrothorax as the first complication of liver cirrhosis. Due to the lack of response to diuretics, pleurodesis and TIPS, treatment with octreotide was started with resolution of hydrothorax. To the best of our knowledge, this is the third reported case of refractory hepatic hydrothorax with complete and sustained response to octreotide.