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 in children with moderate to severe ulcerative colitis: Retrospective, multicenter study.

BACKGROUND: Pediatric ulcerative colitis (UC) is a severe disease characterised by the presence of extensive inflammatory lesions in the colon. The administration of intravenous corticosteroids is recommended in patients with acute relapse of the disease, whereas early treatment with cyclosporine, tacrolimus or infliximab is recommended if there is no improvement. OBJECTIVES: The aim of this study was to retrospectively evaluate the efficacy and safety of infliximab therapy in the treatment of moderate-to-severe and severe relapse of pediatric UC. MATERIAL AND METHODS: The analysis included 42 children aged 4-18 years (23 girls, 19 boys) treated in 7 pediatric gastroenterology departments in Poland during the past 4 years. The disease duration ranged from 2 to 100 months. The clinical activity of UC ranged from 35 to 85 points according to the PUCAI scale. Twenty-one children were diagnosed with pancolitis, 10 children with extensive UC, and the remaining with the left-sided UC. In the induction therapy infliximab was administered at doses of 5 mg/kg in the 0.2 and 6 weeks, and after the clinical response every 8 weeks to 12 months. Treatment results were assessed in 10 and 54 weeks. RESULTS: After the induction therapy the clinical response was achieved in 14 children (33.33%) and clinical remission in 11 children (26.19%). Two children required surgical treatment, and the remaining 2 suffered from anaphylactic shock. After the maintenance therapy clinical remission was maintained in 12 children (57.14%), whereas 3 children required surgery (colectomy). CONCLUSIONS: Infliximab therapy in children with moderate-to-severe UC induces remission and, in some children, proves to be effective in preventing early colectomy.

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.

Monotherapy with infliximab versus combination therapy in the maintenance of clinical remission in children with moderate to severe Crohn disease.

OBJECTIVES: The aim of the present study was to compare the efficacy and safety of 2 protocols of maintenance therapy with infliximab (IFX) and an immunomodulatory agent in pediatric patients with Crohn disease (CD): withdrawal of immunomodulators versus continuation of immunosuppressants. METHODS: The present multicenter randomized open-label trial included 99 patients with CD (ages 14.5 ±â€Š2.6 years) who were administered IFX (5 mg/kg body weight) along with an immunomodulatory agent (azathioprine 1.5-3 mg/kg body weight per day, methotrexate 10-25 mg/week). After 10 weeks of the induction therapy, 84 responders were centrally randomized into 1 of the following groups: group I (n = 45) in which IFX and an immunomodulatory agent were continued up to week 54 and group II (n = 39) in which the immunomodulatory agent was discontinued after 26 weeks. RESULTS: The induction therapy was reflected by a significant decrease in Pediatric Crohn's Disease Activity Index (PCDAI) and Simplified Endoscopic Activity Score for Crohn's Disease (SES-CD) values. After the maintenance phase, the analyzed groups did not differ significantly in terms of the clinical response loss rates and final PCDAI and SES-CD scores. Furthermore, no significant intragroup differences were documented between mean PCDAI scores determined at the end of induction and maintenance phases. Intensification/modification of the treatment was required in 13 of 45 (29%) and 11 of 39 (28%) patients of groups I and II, respectively. A total of 9 serious adverse events were documented; none of the patients died during the trial. CONCLUSIONS: Twenty-six weeks likely represent the safe duration of combined IFX/immunomodulatory therapy in our sample of pediatric patients with CD.

[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.