Effectiveness and Safety of the Switch from Remicade® to CT-P13 in Patients with Inflammatory Bowel Disease.

BACKGROUND AND AIMS: To evaluate the clinical outcomes in patients with IBD after switching from Remicade® to CT-P13 in comparison with patients who maintain Remicade®. METHODS: Patients under Remicade® who were in clinical remission with standard dosage at study entry were included. The 'switch cohort' [SC] comprised patients who made the switch from Remicade® to CT-P13, and the 'non-switch' cohort [NC] patients remained under Remicade®. RESULTS: A total of 476 patients were included: 199 [42%] in the SC and 277 [58%] in the NC. The median follow-up was 18 months in the SC and 23 months in the NC [p < 0.01]. Twenty-four out of 277 patients relapsed in the NC; the incidence of relapse was 5% per patient-year. The cumulative incidence of relapse was 2% at 6 months and 10% at 24 months in this group. Thirty-eight out of 199 patients relapsed in the SC; the incidence rate of relapse was 14% per patient-year. The cumulative incidence of relapse was 5% at 6 months and 28% at 24 months. In the multivariate analysis, the switch to CT-P13 was associated with a higher risk of relapse (HR = 3.5, 95% confidence interval [CI] = 2-6). Thirteen percent of patients had adverse events in the NC, compared with 6% in the SC [p < 0.05]. CONCLUSIONS: Switching from Remicade® to CT-P13 might be associated with a higher risk of clinical relapse, although this fact was not supported in our study by an increase in objective markers of inflammation. The nocebo effect might have influenced this result. Switching from Remicade® to CT-P13 was safe.

Phenotype and natural history of elderly onset inflammatory bowel disease: a multicentre, case-control study.

BACKGROUND: Onset during old age has been reported in upto 10% of total cases of inflammatory bowel disease (IBD). AIM: To evaluate phenotypic characteristics and the use of therapeutic resources in patients with elderly onset IBD. METHODS: Case-control study including all those patients diagnosed with IBD over the age of 60 years since 2000 who were followed-up for >12 months, identified from the IBD databases. Elderly onset cases were compared with IBD patients aged 18 to 40 years at diagnosis, matched by year of diagnosis, gender and type of IBD (adult-onset). RESULTS: One thousand three hundred and seventy-four elderly onset and 1374 adult-onset cases were included (62% ulcerative colitis (UC), 38% Crohn's disease (CD)). Among UC patients, elderly onset cases had a lower proportion of extensive disease (33% vs 39%; P < 0.0001). In CD, elderly onset cases showed an increased rate of stenosing pattern (24% vs 13%; P < 0.0001) and exclusive colonic location (28% vs 16%; P < 0.0001), whereas penetrating pattern (12% vs 19%; P < 0.0001) was significantly less frequent. Regarding the use of therapeutic resources, there was a significantly lower use of corticosteroids (P < 0.0001), immunosuppressants (P < 0.0001) and anti-TNFs agents (P < 0.0001) in elderly onset cases. Regarding surgery, we found a significantly higher surgery rate among elderly onset UC cases (8.3% vs 5.1%; P < 0.009). Finally, elderly onset cases were characterised by a higher rate of hospitalisations (66% vs 49%; P < 0.0001) and neoplasms (14% vs 0.5%; P < 0.0001). CONCLUSIONS: Elderly onset IBD shows specific characteristics and they are managed differently, with a lower use of immunosuppressants and a higher rate of surgery in UC.

Evolution After Anti-TNF Discontinuation in Patients With Inflammatory Bowel Disease: A Multicenter Long-Term Follow-Up Study.

OBJECTIVES: The aims of this study were to assess the risk of relapse after discontinuation of anti-tumor necrosis factor (anti-TNF) drugs in patients with inflammatory bowel disease (IBD), to identify the factors associated with relapse, and to evaluate the overcome after retreatment with the same anti-TNF in those who relapsed. METHODS: This was a retrospective, observational, multicenter study. IBD patients who had been treated with anti-TNFs and in whom these drugs were discontinued after clinical remission was achieved were included. RESULTS: A total of 1,055 patients were included. The incidence rate of relapse was 19% and 17% per patient-year in Crohn's disease and ulcerative colitis patients, respectively. In both Crohn's disease and ulcerative colitis patients in deep remission, the incidence rate of relapse was 19% per patient-year. The treatment with adalimumab vs. infliximab (hazard ratio (HR)=1.29; 95% confidence interval (CI)=1.01-1.66), elective discontinuation of anti-TNFs (HR=1.90; 95% CI=1.07-3.37) or discontinuation because of adverse events (HR=2.33; 95% CI=1.27-2.02) vs. a top-down strategy, colonic localization (HR=1.51; 95% CI=1.13-2.02) vs. ileal, and stricturing behavior (HR=1.5; 95% CI=1.09-2.05) vs. inflammatory were associated with a higher risk of relapse in Crohn's disease patients, whereas treatment with immunomodulators after discontinuation (HR=0.67; 95% CI=0.51-0.87) and age (HR=0.98; 95% CI=0.97-0.99) were protective factors. None of the factors were predictive in ulcerative colitis patients. Retreatment of relapse with the same anti-TNF was effective (80% responded) and safe. CONCLUSIONS: The incidence rate of inflammatory bowel disease relapse after anti-TNF discontinuation is relevant. Some predictive factors of relapse after anti-TNF withdrawal have been identified. Retreatment with the same anti-TNF drug was effective and safe.

Tuberculosis in Anti-Tumour Necrosis Factor-treated Inflammatory Bowel Disease Patients After the Implementation of Preventive Measures: Compliance With Recommendations and Safety of Retreatment.

BACKGROUND AND AIMS: Despite having adopted preventive measures, tuberculosis (TB) may still occur in patients with inflammatory bowel disease (IBD) treated with anti-tumour necrosis factor (anti-TNF). Data on the causes and characteristics of TB cases in this scenario are lacking. Our aim was to describe the characteristics of TB in anti-TNF-treated IBD patients after the publication of the Spanish TB prevention guidelines in IBD patients and to evaluate the safety of restarting anti-TNF after a TB diagnosis. METHODS: In this multicentre, retrospective, descriptive study, TB cases from Spanish hospitals were collected. Continuous variables were reported as mean and standard deviation or median and interquartile range. Categorical variables were described as absolute and relative frequencies and their confidence intervals when necessary. RESULTS: We collected 50 TB cases in anti-TNF-treated IBD patients, 60% male, median age 37.3 years (interquartile range [IQR] 30.4-47). Median latency between anti-TNF initiation and first TB symptoms was 155.5 days (IQR 88-301); 34% of TB cases were disseminated and 26% extrapulmonary. In 30 patients (60%), TB cases developed despite compliance with recommended preventive measures; *not performing 2-step TST (tuberculin skin test) was the main failure in compliance with recommendations. In 17 patients (34%) anti-TNF was restarted after a median of 13 months (IQR 7.1-17.3) and there were no cases of TB reactivation. CONCLUSIONS: Tuberculosis could still occur in anti-TNF-treated IBD patients despite compliance with recommended preventive measures. A significant number of cases developed when these recommendations were not followed. Restarting anti-TNF treatment in these patients seems to be safe.

Characteristics and treatment of pyoderma gangrenosum in inflammatory bowel disease.

BACKGROUND: Pyoderma gangrenosum is a serious cutaneous complication seen in approximately 1 % of patients with inflammatory bowel disease (IBD). Oral corticosteroids are the mainstay treatment, although the evidence supporting their use is weak. AIMS: The purpose of this study was to investigate the characteristics of pyoderma gangrenosum associated with Crohn's disease or ulcerative colitis and which treatments are prescribed in Spanish clinical practice. METHODS: In this retrospective, observational study, the medical records from all patients with IBD and a diagnosis of pyoderma gangrenosum attended by the gastroenterology departments of 12 Spanish hospitals were reviewed. Data on patient demographics and characteristics, underlying IBD and treatment, and pyoderma gangrenosum characteristics, treatment, and outcome were collected and analyzed. RESULTS: The data from 67 patients were analyzed (41 [61.2 %] women, 41 [61.2 %] with Crohn's disease, 25 [37.3 %] with ulcerative colitis, and 1 [1.5 %] with indeterminate disease). The underlying disease was in remission in approximately one-third of patients at the time of presentation of pyoderma gangrenosum. Healing was achieved in all patients (in 3 without any systemic therapy). Oral corticosteroids were taken by 51 patients (76.1 %), almost always as first-line treatment, although definitive healing was attained in 19 (28.4 %). Biologic agents such as infliximab and adalimumab were taken by 31 patients (46.3 %) at some point (first-line in 6 patients [9.0 %]), with definitive healing in 29 patients (93.5 %). CONCLUSIONS: Oral corticosteroid therapy remains the most common treatment for pyoderma gangrenosum associated with inflammatory bowel disease. Biologic therapies such as infliximab and adalimumab should also be considered.

Efficacy of infliximab rescue therapy in patients with chronic refractory pouchitis: a multicenter study.

BACKGROUND: Despite medical therapy, 30% of patients with ulcerative colitis (UC) need to undergo surgery. Around 50% of patients with proctocolectomy with ileal pouch-anal anastomosis (IPAA) develop complications of the pouch. Clinical evidence for the use of infliximab (IFX) in refractory pouchitis is limited. The aim of this study was to report efficacy of IFX in these patients. METHODS: A retrospective, multicenter study was designed. Patients older than 18 years with chronic refractory pouchitis treated with IFX (5 mg/kg) were included. Short-term IFX efficacy was evaluated at week 8 and mid-term efficacy at weeks 26 and 52. Complete response was defined as cessation of diarrhea and urgency and partial response as marked clinical improvement but persisting symptoms. The modified Pouchitis Disease Activity Index (mPDAI) without endoscopy was calculated when available. RESULTS: Thirty-three consecutive UC patients with chronic refractory pouchitis were included (18 male, mean age 45 years, range 21-67). At week 8, 21% patients achieved complete response and 63% showed partial clinical response. At weeks 26 and 52, 33% and 27% achieved complete response and 33% and 18% showed partial clinical response, respectively. Thirteen patients (39%) withdrew treatment (four for lack of efficacy, four for loss of response and five for adverse events). None of the potential factors analyzed had an influence on response to IFX. CONCLUSIONS: IFX was effective in the short- and mid-term in patients with chronic refractory pouchitis. However, medication had to be discontinued in a high number of patients.

Íleo biliar en paciente de edad avanzada / No disponible

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Incidence and factors influencing on Helicobacter pylori infection recurrence.

OBJECTIVES: a) To determine the rate of H. pylori reinfection after successful eradication in a 4-year follow-up study; and b) To evaluate the contribution of different factors in the infection relapse. PATIENTS AND METHODS: A total of 208 patients (age range 18-81 years; average 50 years; 87 women) who had been successfully treated for H. pylori infection were included. Annually, urea breath test was assessed to determine H. pylori status after eradication. Age, sex, rural/urban environment, smoking habit, treatment regimens against H. pylori and urea breath test values were evaluated. RESULTS: reinfection occurred in 9,6% of patients observed, 6,7% (14/208) in the first year, 1,9% (4/208) in the second year, 1% (2/208) in the third and 0% in the forth. Risk factors for infection recurrence were younger age and higher values of urea breath test in the multivariante analysis. CONCLUSIONS: annual reinfection rate was 2,4 pacients-year. Younger patients and higher values of urea breath test were factors associated with a higher rate of reinfection relapse. Annually, urea breath test should be performed to detect reinfection in order to avoid ulcer complications.

Diagnóstico de la infección por Helicobacter pylori en pacientes con hemorragia digestiva alta por úlcera péptica / Diagnosis of Helicobacter pylori infection in patients with upper gastrointestinal bleeding due to peptic ulcer

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Ranitidine bismuth citrate in the treatment of Helicobacter pylori infection.

OBJECTIVE: Examine the effectiveness of treatments that include ranitidine bismuth citrate (RBC) for Helicobacter pylori infection. DESIGN: Prospective and randomised study. PATIENTS AND METHOD: 137 patients were included (62 women, 75 males, average age 46.9 +/- 13) diagnosed with peptic ulcer and infection by Helicobacter pylori. None had received treatment previously. 67 patients were treated with RBC 400 mg bd and clarithromycin 500 mg bd for 14 days, and 70 patients with RBC 400 mg bd, clarithromycin 500 mg bd and amoxycillin 1 g bd for 7 days. The infection eradication was proven eight weeks after treatment end. The efficacy of treatment was evaluated using the intention-to-treat method. The Chisquare test (chi 2) was used for the statistical analysis of data. RESULTS: Infection in 48 out of 67 patients (71.64%) treated with RBC-clarithromycin for 14 days was eradicated, versus 88.57% (62 out of 70) among those treated with RBC-clarithromycin-amoxycillin for 7 days, with a significant difference between both regimens (p < 0.05). CONCLUSIONS: 7-day treatment with RBC-clarithromycin-amoxycillin has a good eradication rate (88.57%) and represents a valid alternative to regimens including a PPI and two antibiotics, as both regimens have a similar efficacy. Results obtained with the double therapy of RBC-clarithromycin for 14 days were not satisfactory, the rate of eradication being 71.64%. The use of an RBC treatment for Helicobacter pylori infection should always be accompanied by two antibiotics in a triple therapy.

Ranitidina citrato de bismuto en el tratamiento de la infección por Helicobacter pylori / Ranitidine bismuth citrate in the treat ment of Helicobacter pylori infection

Objetivo: conocer la eficacia en nuestro medio de las pautas erradicadoras que incluyen ranitidina citrato de bismuto (RCB) en el tratamiento erradicador de la infección por Helicobacter pylori. Diseño: estudio aleatorio y prospectivo en 137 pacientes. Pacientes y método: se incluyen 137 pacientes (62 mujeres, 75 varones, edad media 46,9ñ13) diagnosticados de infección por Helicobacter pylori. Ninguno de los pacientes había recibido tratamiento frente a Helicobacter pylori previamente. De forma aleatoria se trataron a 67 pacientes con RCB 400 mg/12h y claritromicina 500 mg/12h durante 14 días y a 70 pacientes con RCB 400mg/12h, claritromicina 500 mg/12h y amoxicilina 1g/12h durante 7 días. La erradicación de la infección fue comprobada a las 8 semanas de finalizar el tratamiento. La eficacia del tratamiento fue evaluada por intención de tratar. Para el análisis estadístico de los datos se empleó el test de Chi-cuadrado ( 2).Resultados: de los 67 pacientes tratados con RCB-claritromicina durante 14 días erradicaron 48, lo que supone una eficacia del 71,74 por ciento, frente al 88,85 por ciento (62/70) de los tratados con RCBclaritromicina-amoxicilina durante 7 días, siendo significativa la diferencia entre ambas pautas (p<0,05).C o n c l u s i o n e s : RCB-claritromicina-amoxicilina durante 7 días constituye una alternativa válida al tratamiento erradicador de H. Pylo ri con IBP más dos antibióticos, ya que ambos regímenes tienen una eficacia erradicadora similar. No hemos obtenido buenos resultados con la doble terapia con RBC - claritromicina 14 días, siendo la tasa de erradicación del 71,74 por ciento. Cuando se utilice RBC en el tratamiento erradicador, debe ser siempre en triple terapia con dos antibióticos. (AU)

Resistencia de Helicobacter pylori a los antimicrobianos en un área hospitalaria de Sevilla / Resistance of Helicobacter pylori to antimicrobial treatment in a Seville Hospital catchment area

OBJETIVO: conocer la sensibilidad a metronidazol, claritromicina, amoxicilina y tetraciclina de las cepas de Helicobacter pylori (H. pylori) aisladas en una serie prospectiva de pacientes referidos para endoscopia en un hospital universitario de nuestra ciudad. PACIENTES Y MÉTODOS: se estudiaron 117 pacientes con enfermedad ulcerosa desde marzo de 1998 a julio de 1999. El diagnóstico de la infección se realizó mediante el test de la ureasa rápida, estudio histológico, tinción de Gram y/o cultivo de biopsias gástricas (antro y cuerpo) obtenidas mediante gastroscopia. La determinación de la sensibilidad se realizó mediante el método de difusión con tiras de E-test. RESULTADOS: se demostró infección por H. pylori en 64 pacientes. Se pudieron cultivar 58 cepas, correspondiendo 40 a pacientes que no recibieron tratamiento erradicador previo (69 por ciento) y 18 a pacientes en los que había fallado uno o más tratamientos de erradicación (31 por ciento). En el primer grupo la resistencia a metronidazol fue del 42 por ciento, a claritromicina del 13 y 10 por ciento simultáneamente a los dos antimicrobianos. En el segundo grupo las tasas de resistencias fueron, respectivamente, del 39, 44 y 17 por ciento, incluyendo una cepa resistente también a tetraciclinas (2 por ciento). No encontramos resistencia a amoxicilina. CONCLUSIONES: hemos obtenido una elevada tasa de resistencia, especialmente a claritromicina, sobre todo en pacientes previamente tratados, por lo que en los tratamientos empíricos deberían emplearse pautas eficaces y evitar aquellas que utilizan un solo antibiótico. El cultivo de las muestras gástricas permite conocer la resistencia a los antimicrobianos en el medio donde se trate la infección y realizar así un tratamiento más racional de la misma (AU)

Resistance of Helicobacter pylori to antimicrobial treatment in a Seville hospital catchment area.

AIM: To determine the sensitivity to metronidazol, clarithromycin, amoxicillin and tetracycline of strains of Helicobacter pylori isolated in a prospective series of patients referred to a university hospital in Seville for endoscopic examination. METHODS: During the period from March 1998 to July 1999 we studied 117 patients with ulcer. The diagnosis of bacterial infection was based on the rapid urease test, histological study, Gram staining or culture of gastric biopsy material (from the antrum and corpus) obtained during gastroscopy. Susceptibility studies were done with the diffusion method using E-test strips. RESULTS: Helicobacter pylori infection was found in 64 patients. A total of 58 strains were grown, 40 of which were from patients who had received no previous treatment to eradicate the infection (69%), and 18 of which were from patients who had failed one or more eradication therapies (31%). In the first group, metronidazol resistance was found in 42%, clarithromycin resistance in 13%, and resistance to both in 10% of the patients. In the second group these rates were 39%, 44% and 17% respectively, and one strain was found which was also resistant to tetracyclines (2%). No strains resistant to amoxicillin were found. CONCLUSIONS: We found high rates of resistance, especially to clarithromycin, and especially in patients who had received previous eradication therapy. Empirical treatments should use effective antimicrobials and avoid regimens based on a single antibiotic. Culture of gastric biopsy samples provides information on the resistance to antimicrobials in a given setting, and this information can be used to develop the most rational treatment for the infection.