Evaluation of the infliximab therapy of severe form of pediatric Crohn's disease in Poland: Retrospective, multicenter studies.

BACKGROUND: Registration of infliximab in Poland has increased chances to induce clinical remission and mucosal healing in the severe form of pediatric Crohn's disease. OBJECTIVES: The aim of this retrospective study was to assess the results and safety of infliximab therapy in the severe form of pediatric Crohn's disease. MATERIAL AND METHODS: The study included 153 children with severe form of non-fistulizing Crohn's disease treated with infliximab. The clinical activity of Crohn's disease was assessed according to PCDAI scale, endoscopic scoring was graded according to SES-CD, body mass was measured with body mass index (BMI). Infliximab was administered at the dose 5 mg/kg body mass in the 0.2 and 6th week, and then, after clinical response, every 8 for the period of 12 months. RESULTS: One hundred thirty-six children (88.89%) achieved clinical response after induction therapy and 75.21% of children after the maintenance therapy. 39.68% of children achieved remission as graded with endoscopic scoring SES-CD. There was a statistically significant increase in body weight following the treatment. Side effects such as anaphylaxis, rash, and the activation of EBV infection appeared in 9 children at the time of infliximab injection. In other children the drug was well tolerated. CONCLUSIONS: Induction and maintenance therapy with infliximab resulted in clinical remission of Crohn's disease in 75.21% of children, and in the intestinal mucosa healing in 39.68% of children.

Induction and Maintenance Infliximab Therapy for the Treatment of Crohn's Disease with Perianal Fistulas in Children: Retrospective, Multicenter Study.

BACKGROUND: Infliximab is a biological drug used for the treatment of Crohn's disease in children. OBJECTIVES: The aim of this retrospective study was the estimation of effectiveness and safety of infliximab in the treatment of Crohn's disease with perianal fistulas in children. MATERIAL AND METHODS: Analysis comprised 50 children with Crohn's disease with perianal fistulas aged 9 to 18 years (16 girls and 34 boys) who failed to respond to conventional therapy. The children were divided into two groups: the first group contained 23 children with simple fistulas and the second - 27 children with complex fistulas. All children were treated with infliximab, administered in the dose of 5 mg per kilogram of the body mass. In the induction phase infliximab was administered at weeks 0, 2 and 6 and after clinical response in maintenance phase the drug was administered every 8 weeks; together for 12 months. RESULTS: In 76% of children after induction therapy with infliximab and in 71.87% after maintenance therapy the complete closure of fistula occurred. During the first year after the treatment a recurrence of a fistula was observed in 30.43% of the children. In two children anaphylactic shock was observed during injection of infliximab. The remaining children tolerated the drug well. CONCLUSIONS: The treatment with infliximab was effective in the majority of fistulazing Crohn's disease and caused the closure of perianal fistula which improved quality of life.

Propofol-alfentanyl versus midazolam-alfentanyl in inducing procedural amnesia of upper gastrointestinal endoscopy in children--blind randomised trial.

UNLABELLED: In paediatric patients, esophagogastroduodenoscopy (EGD) is commonly performed with the use of sedation. The aim of the study was to compare the effectiveness of propofol and midazolam in providing procedural amnesia and controlling behaviour in children undergoing diagnostic EGD. Children (9-16 years), classified to the first or second class of the American Society of Anaesthesiologists' physical status classification referred for EGD, were randomly assigned to receive propofol with alfentanyl or midazolam with alfentanyl for sedation during the procedure. Within 120 min after the procedure, patients were repeatedly investigated for memory of the procedure and for memory of pain intensity during EGD with the use of the visual analogue scale. Activity and cooperation of the patient during the procedure was assessed with the relative adequacy scale. Of the 51 children, 48 completed the study. Propofol was significantly better than midazolam in inducing amnesia of procedural pain (mean difference 11.53 mm; 95 % confidence interval [CI] 0.96 to 22.10), loss of memory of the procedure (relative risk 0.4; 95 % CI 0.21 to 0.59) and controlling behaviour (relative risk 2.12; 95 % CI 1.33 to 3.36). CONCLUSION: In children sedated for EGD, propofol is significantly better than midazolam at providing procedural amnesia and controlling behaviour during the procedure.

Immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine in Pediatric Patients with Inflammatory Bowel Disease.

BACKGROUND: There are only a few studies on immune response to pneumococcal vaccines in patients with inflammatory bowel disease (IBD); all of them assessed polysaccharide vaccines only. The aim of the study was to evaluate the immunogenicity and safety of 13-valent pneumococcal conjugate vaccine (PCV13) in IBD pediatric patients compared with healthy controls. METHODS: This was a multicenter, prospective, and controlled study on children and adolescents aged 5 to 18 years with IBD with no history of pneumococcal immunization. The subjects for the study belonged to one of the following groups: patients with IBD on no immunosuppressive therapy (group A), those on tumor necrosis factor agents or immunomodulators (group B), and healthy controls (group C). The study population received 1 intramuscular injection of PCV13. The primary outcome measure was adequate vaccine response defined as postvaccination titer ≥0.35 µg/mL to all 13 serotypes. Geometric mean titers and geometric mean titer rises were measured for all serotypes. The evidence of local and systemic adverse effects for 5 days after the vaccine was registered. RESULTS: A total of 178 subjects (122 patients and 56 controls) completed the study course. There was no significant difference in the rate of adequate vaccine response between patients with IBD and controls measured 4 to 8 weeks after vaccination (90.4% versus 96.5%, P = 0.5281). Children in group A had higher geometric mean titer rises than children in group B (P = 0.0369). There were no serious adverse events related to PCV13 during the study. CONCLUSIONS: PCV13 is both immunogenic and safe in pediatric patients with IBD.

[Biological treatment of inflammatory bowel diseases in children in the years 2004-2013 in Poland]. / Leczenie biologiczne nieswoistych zapalen jelit u dzieci w latach 2004-2013 w Polsce.

UNLABELLED: In the last years an increase in Crohn's disease morbidity in children is observed together with constant morbidity of ulcerative colitis. The course of these diseases is severe, younger children are affected and the diseases are resistant to conventional treatment. Biological drugs are a chance for a longer remission and healing of the intestinal mucosa. OBJECTIVE OF THE WORK: Assessment of the use of biological drugs in treatment of inflammatory bowel disease in Poland was the objective of the work. MATERIAL AND METHODS: Gastroenterological centers treating inflammatory bowel disease during the years 2004-2013 were invited to a questionnaire retrospective study. RESULTS: The questionnaires of biological treatment of Crohn's disease and ulcerative colitis in children were received from 12 centers. In the years 2004-2013 the number of children aged 4 months to 18 years with Crohn's disease treated with biological drugs was 424. In the years 2004-2008--69 children were treated with infliximab and in the years 2009-2013--299 children, which was a four-fold increase. 56 children were treated with adalimumab in the years 2008-2013. In the years 2005-2013--72 children with ulcerative colitis were treated with infliximab and 11 with adalimumab. The age of the children ranged from 2 years to 18 years. The higher number of children treated was in the years 2009-2013: 59 with infliximab and 10 with adalimumab. CONCLUSIONS: In the last decade a significant increase on the number of children with Crohn's disease and ulcerative colitis treated with biological drugs was observed. It is connected not only to greater morbidity but above all to the introduction of a treatment program by the National Health Insurance Fund for children with Crohn's disease. There is an expectation that the introduction of biological treatment in inflammatory bowel disease will prolong clinical and endoscopic remission and diminish the number of surgeries.