Induction Therapy With Biosimilar Infliximab in Children With Crohn Disease.

INTRODUCTION: In most European countries, an infliximab biosimilar (CT-P13) is currently in common use. In vitro and in vivo studies have proved a high similarity between CT-P13 and the reference infliximab. CT-P13 was licensed for use in patients with Crohn disease (CD) based on the extrapolation of data from preclinical studies and clinical trials in rheumatology indications. The aim of this study was to assess the similarity between CT-P13 and the originator infliximab in induction therapy in CD paediatric patients. METHODS: Thirty-six CD paediatric patients from 3 Polish academic centres who started biological therapy with CT-P13 were enrolled in this prospective, observational study. Patients received 3 induction doses (5 mg/kg) of CT-P13 at weeks 0, 2, 6. Assessment was performed before the first infusion and at week 14. RESULTS: Overall 34/36 (94.4%) patients completed induction therapy with CT-P13. A clinical response or remission after 3 initial doses was achieved in 31/36 (86%) and 24/36 (67%) of patients, respectively. Clinically and statistically significant decreases in Paediatric Crohn's Disease Activity Index, C-reactive protein, and erythrocyte sedimentation rate were observed in the responders group. An allergic reaction during infusion, which led to treatment discontinuation, was observed in one case. CONCLUSIONS: Induction therapy with CT-P13 in children with CD is effective. The profile appears similar to that reported for the reference infliximab. No unexpected adverse events occurred.

Oesophageal pH-Impedance for the Diagnosis of Gastro-Oesophageal Reflux Disease: Validation of General Population Reference Values in Children with Chronic Neurological Impairments.

Diagnosis of gastro-oesophageal reflux disease (GORD) in children with chronic neurological impairment (NI) remains a clinical challenge. The study aimed to validate the relevance of the reference values used to assess gastro-oesophageal reflux (GOR) in children with NI and to determine the optimal cut-off level of the pH-impedance parameter with the best predictive value for outcomes associated with endoscopic assessments of the oesophagus. Sixty-seven children (32 male, 35 female; age: interquartile range, 5 years 6 months-14 years 10 months; median, 11 years 3 months) with NI were prospectively recruited for the study. The exclusion criteria were previous fundoplication and lack of consent for the study. All patients underwent evaluations for GOR disease, including pH-impedance and gastroscopy. Based on endoscopy, oesophagitis was diagnosed in 22/67 children (32.8%); 9/67 (13.4%) were classified as having Hetzel-Dent grade III or IV. GOR was present in 18/67 children (26.9%), as determined by pH-impedance. Patients with endoscopic lesions had a significantly higher number of total reflux (p = 0.0404) and acidic episodes (p = 0.0219). The total number of reflux episodes, with a cut-off level of 44 episodes, was the pH-impedance parameter most strongly predictive of the presence of lesions in gastroscopy (specificity: 50%, sensitivity: 73%). These findings suggest that endoscopic lesions may be present in children with chronic NI with a low number of GOR episodes, as recorded by pH-impedance. The use of standardised reference norms determined for the general population may underestimate GOR episodes in this group of patients.

Esophageal Impedance-pH Monitoring and Pharyngeal pH Monitoring in the Diagnosis of Extraesophageal Reflux in Children.

Various clinical symptoms are attributed to extraesophageal reflux disease (EERD). Multichannel intraluminal impedance-pH monitoring (MII-pH) is considered to correlate symptoms with acid and nonacid gastroesophageal reflux (GER) events. Pharyngeal pH monitoring (Dx-pH) is considered to correlate the decrease in the pH level in the oropharynx with reported symptoms and to diagnose supraesophageal reflux. We aimed to assess the correlation between acid reflux episodes recorded by Dx-pH and GER detected via MII-pH in children with suspected EERD. The study enrolled 23 consecutive children (15 boys and 8 girls; median age 8.25 [range 3-16.5] years) with suspected EERD. MII-pH and Dx-pH were conducted concurrently in all patients. A total of 1228 reflux episodes were recorded by MII-pH. With the antimonic sensor placed inside the impedance probe, 1272 pH-only reflux episodes were recorded. Of these, 977 (76.81%) were associated with a retrograde bolus transit. Regarding GER, 630 full-column episodes extended to the most proximal pair of impedance sensors; 500 (83.33%) demonstrated an acidic character. The following acid reflux numbers were determined by the Dx-pH system: for pH < 4, n = 126; pH < 4.5, n = 136; pH < 5, n = 167; and pH < 5.5, n = 304, and for a decrease in pH > 10% relative to the baseline, n = 324. There was no significant correlation between the number of pharyngeal reflux episodes detected by Dx-pH and that of GERs identified by MII-pH. The proportion of oropharyngeal pH events that were temporally related to a GER episode increased with the extended pH criteria. The highest proportion was observed for a pH decrease of ≥10% from the baseline and did not exceed 5.2%. The application of the extended pH criteria in the Dx-pH system resulted in an increase in the number of diagnosed laryngopharyngeal refluxes; most were not temporally associated with GER episodes confirmed by MII-pH. Thus, the efficacy of the exclusive application of Dx-pH for supraesophageal gastric reflux diagnosis is uncertain.

[Rome III classification of functional gastrointestinal disorders in children with chronic abdominal pain]. / Ocena przydatnosci III klasyfikacji rzymskiej w diagnostyce przewleklych czynnosciowych bólów brzucha u dzieci.

BACKGROUND: The updated Rome III Classification of paediatric functional gastrointestinal disorders (FGIDs) associated with abdominal pain comprises: functional dyspepsia (FD), irritable bowel syndrome (IBS), abdominal migraine, functional abdominal pain (FAP), functional abdominal pain syndrome (FAPS). THE AIM OF THIS STUDY: To assess the value of the Rome criteria in identifying FGIDs in children with chronic abdominal pain. MATERIAL AND METHODS: The study group consisted of 439 consecutive paediatric patients (192 boys and 247 girls) aged 4-18 years (mean age was 11.95 +/- 3.89 years) referred to the Paediatric Gastroenterology Department at Medical University of Lodz from January 2008 to June 2009 for evaluation of abdominal pain of at least 2 months' duration. After exclusion of organic disease children suspected of functional chronic abdominal pain were categorized with the use of Rome III criteria of FGIDs associated with abdominal pain (H2a-H2d1) and the Questionnaire on Paediatric Gastrointestinal Symptoms (with the permission of doctor L. S. Walker). The patients with known nonabdominal organic disease, chronic illness or handicap were excluded. RESULTS: In 161 patients (36.58%) organic etiology was confirmed. Of the 278 children (63.42%) with functional chronic abdominal pain, 228 (82.02%) met the Rome III criteria for FGIDs associated with abdominal pain (FD, 15.5%; IBS, 21.6%; abdominal migraine, 5%; FAP 24.5%; FAPS, 15.9%). Fifty cases (17.98%) did not fulfill the criteria for subtypes of abdominal pain-related FGIDs--mainly due to different as defined by Rome III criteria (at least once per week) frequency of symptom presentation. CONCLUSIONS: (1) In the authors'investigations FGIDs was the most frequent cause of chronic abdominal pain in children. (2) The significant number of children with nonclassified FGIDs implies the need to modify the diagnostic criteria of Rome III classification concerning the prevalence of symptoms.