Effectiveness and Safety of CT-P13 (Biosimilar Infliximab) in Patients with Inflammatory Bowel Disease in Real Life at 6 Months.

BACKGROUND: CT-P13 is a biosimilar of Remicade®, an agent approved in some countries for use in inflammatory bowel disease (IBD). Controlled clinical trials have demonstrated the efficacy and safety of CT-P13 in rheumatic diseases, but not in IBD. AIMS: To assess the effectiveness and safety of CT-P13 in IBD patients in real clinical practice. METHODS: This is a prospective observational study in patients with moderate to severe Crohn's disease or ulcerative colitis treated with CT-P13. The study was performed in one single center. Patients included were naive or switched to anti-TNF treatment from the reference infliximab (Remicade®) to CT-P13. Efficacy and safety were assessed in naive and switched patients who were in remission at the time of the switch at months 3 and 6 of therapy. RESULTS: 87.5 and 83.9% of switched CD patients who were in remission at the time of the switch continued in remission, and 66.7 and 50% of naive CD patients reached remission, at months 3 and 6. In UC switched cases, 92 and 91.3% of patients in remission at the time of the switch continued in remission, at 3 and 6 months. In naive UC patients, the remission rates were 44.4 and 66.7%, at months 3 and 6. Adverse events occurred in 7.5% of patients during 6 months of study. CONCLUSIONS: CT-P13 was efficacious and well tolerated in patients with CD or UC.

[Influence of climatic factors on the incidence of upper gastrointestinal bleeding]. / Influencia de los factores climáticos en la incidencia de hemorragia digestiva alta.

OBJECTIVES: Several studies have suggested the existence of seasonal variation in the incidence of upper gastrointestinal bleeding (UGB). However, the role of climatic factors has not been elucidated. The aim of the present study was to investigate the role of these factors in the incidence of UGB secondary to esophageal varices (EV), gastric ulcer (GU), and duodenal ulcer (DU). MATERIAL AND METHODS: Based on the use of the Minimum Data Set and the International Classification of Diseases, cases of endoscopically-confirmed UGB secondary to EV, GU and DU were retrospectively included (1998-2001). The incidence of UGB was correlated with daily climatic factors (temperature, atmospheric pressure, humidity, direction and speed of wind) in Jerez de la Frontera (Spain) during the study period. RESULTS: A total of 499 patients were included (GU = 192, DU = 199, EV = 108). No significant differences were found in the monthly or seasonal incidence of UGB. Episodes of UGB were grouped according to the climatic conditions present on the day of admission. No significant relationship was found between UGB and any of the daily climatic factors studied. DISCUSSION: The results of our study do not support the existence of a seasonal pattern in the incidence of UGB secondary to GU, DU or EV and allow us to conclude that, in our geographical area, these factors are not involved in episodes of bleeding.

Anxiety during the performance of colonoscopies: modification using music therapy.

BACKGROUND AND STUDY AIMS: Colonoscopies are usually performed using pharmacological sedation. This process entails certain risks. In the search for alternative methods, some studies have analysed the effect music can have on patients during the procedure when used as a complement to sedation. We present a prospective, randomized study in which we assess the anxiolytic action music has when it is administered during a single colonoscopy. PATIENTS AND METHODS: We included 118 patients who were scheduled for ambulatory colonoscopies. They were randomly assigned to the control group (n = 55) and the experimental group (n = 63). We determined their levels of anxiety using the State-Trait Anxiety Inventory Test (STAI) form, which they filled in before and after the examination. Patients listened to music through personal headphones. RESULTS: The score on the STAI form before the examination was 25.25 +/- 10.49 and 28.16 +/- 11.43 in the control and experimental groups, respectively (P > 0.05). The decrease of the score on the STAI scale after the colonoscopy in the control and experimental groups was 6.27 (95% confidence interval, 3.26-9.28) and 11.35 (95% confidence interval, 8.64-14.05), respectively (P < 0.01). CONCLUSIONS: Listening to music during ambulatory colonoscopies decreases the level of anxiety that is inherent to the process without other anxiolytic methods.

[Pseudoachalasia and secondary amyloidosis in a patient with rheumatoid arthritis]. / Seudoacalasia y amiloidosis secundaria en paciente con artritis reumatoide.

Rheumatic diseases cover a wide spectrum of clinical syndromes and frequently present with gastrointestinal alterations. Systemic amyloidosis is associated with infectious diseases or chronic inflammatory processes such as rheumatoid arthritis and it can also affect the gastrointestinal tract. Although esophageal involvement is difficult to quantify because its course is frequently asymptomatic, systemic amyloidosis is recognized as a cause of motor disorders of the esophagus. Typical manometric patterns, including achalasia, are usually absent. Esophageal involvement due to amyloid deposits usually corresponds to primary amyloidosis as only a few cases of secondary esophageal deposits (type AA) have been described. We describe a new case of this exceptional association that first presented as dysphagia in a patient with rheumatoid arthritis. The initial suspicion of pseudoachalasia led to the definitive diagnosis of secondary amyloidosis.

[Familial colonic varices: report of two cases]. / Varices colónicas familiares: presentación de dos casos.

Idiopathic or familial colonic varices are an infrequent cause of gastrointestinal hemorrhage. It seems that congenital vascular abnormalities are involved in its etiopathogenesis. We present two cases in the same family. The disease first presented as intermittent episodes of rectorrhagia. In one case varices of the small intestine were detected by radiology. Both cases were given conservative treatment and we believe that surgery should be limited to selected cases and always after a careful observation period.

[Acute necrotizing esophagitis]. / Esofagitis necrosante aguda.

Acute necrotizing esophagitis is a rare disease. Its pathogenesis is influenced by situations of low systemic perfusion, such as hypertension, heart failure or sepsis, in which other factors, such as the application of a nasal tube, infections or drugs also play a role. We present a case of acute necrotizing esophagitis in a patient with copious vomiting, renal failure, gastric hemorrhage due to Mallory-Weiss syndrome and esophageal infection due to Actinomyces. The patient was undergoing coadjuvant chemotherapy for a surgically-treated colonic neoplasia. Maintenance therapy produced favorable evolution with restoration of esophageal epithelium and no stenotic complications.

[Alagille syndrome and isolated persistent ductus arteriosus]. / Síndrome de Alagille y ductus arterioso persistente aislado.

The clinical case of a 21-year-old patient diagnosed with a variant of intrahepatic biliary ductopenia or Alagille syndrome, a dominant inherited disorder associated with a chronic cholestatic syndrome and abnormalities in different organs and systems. The present article discusses the main clinical abnormalities found in this syndrome and we describe a persistent arterial ductus as an isolated cardiovascular manifestation not previously reported in association to this syndrome.

[Acute recurrent pancreatitis and ampullary tumor: a case report]. / Pancreatitis aguda recidivante y tumor ampular: presentación de un caso.

A case of ampullary cancer, the first clinical manifestation of which was two episodes of acute pancreatitis is presented with review of the literature on the possible role of this type of cancer as a causal agent of episodes of acute pancreatitis. We support the use of ERCP in all patients with acute idiopathic pancreatitis with the aim of discarding the possibility of a tributary ampullary tumor of curative removal.