title: Prospective Evaluation of the Achievement of Mucosal Healing with Anti-TNF-α Therapy in a Paediatric Crohn's Disease Cohort.
abstract: OBJECTIVE
  There is growing evidence that in Crohn's disease the achievement and maintenance of mucosal healing (MH) through anti-TNFα antibodies may change the natural history of the disease. Few studies evaluating such outcome as a therapeutic goal are available in paediatrics. The primary aim of the study was to assess the efficacy of biologics in obtaining MH in a paediatric Crohn's disease cohort. The secondary aims were: (1) to assess response based on early or late treatment introduction and on combination therapy with immunomodulators versus biologics alone; and (2) to evaluate clinical outcome 2 years after the second endoscopy.
  
  
  METHODS
  Biologic-naive paediatric Crohn's disease patients starting anti-tumour necrosis factor α (TNFα) treatment were enrolled. Patients' demographic and treatment data were recorded. Clinical [Pediatric Crohn's Disease Activity Index (PCDAI)] and endoscopic [Simple Endoscopic Score for Crohn's Disease (SES-CD)] evaluations were performed at time 0 (T0) and after 9-12 months (follow-up). Appropriate induction and maintenance therapeutic schemes were applied.
  
  
  RESULTS
  Thirty-seven patients were enrolled. At enrolment, mean age was 12.3 ± 3.4 years and mean disease duration was 13.0 ± 16 months. At follow-up there was a significant decrease in PCDAI and SES-CD compared with T0 (p < 0.01). No statistical difference in frequency of MH between the early and late treatment introduction groups was found. Combination therapy was superior in obtaining complete plus partial MH (p < 0.01). One and 2 years after the second endoscopy, all and 79% of patients with complete MH and 75 and 67% of those with partial MH were still in clinical remission, respectively.
  
  
  CONCLUSIONS
  Biologics improve mucosal lesions, apparently more effectively if given in combination with immunomodulators. MH appears to sustain a better disease course.
authors.affiliation: Pediatric Gastroenterology and Hepatology Unit, Sapienza University Rome, Italy.
authors.forename: Federica
authors.initials: F
authors.lastname: Nuti
authors.affiliation: Pediatric Gastroenterology and Hepatology Unit, Sapienza University Rome, Italy.
authors.forename: Fortunata
authors.initials: F
authors.lastname: Civitelli
authors.affiliation: Pediatric Gastroenterology and Hepatology Unit, Sapienza University Rome, Italy.
authors.forename: Silvia
authors.initials: S
authors.lastname: Bloise
authors.affiliation: Pediatric Gastroenterology and Hepatology Unit, Sapienza University Rome, Italy.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Oliva
authors.affiliation: Pediatric Gastroenterology and Hepatology Unit, Sapienza University Rome, Italy.
authors.forename: Marina
authors.initials: M
authors.lastname: Aloi
authors.affiliation: Pediatric Gastroenterology and Hepatology Unit, Sapienza University Rome, Italy.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Latorre
authors.affiliation: Pediatric Gastroenterology and Hepatology Unit, Sapienza University Rome, Italy.
authors.forename: Franca
authors.initials: F
authors.lastname: Viola
authors.affiliation: Pediatric Gastroenterology and Hepatology Unit, Sapienza University Rome, Italy salvatore.cucchiara@uniroma1.it.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cucchiara
mesh_terms: D000068879:Adalimumab / Q000008:administration & dosage / Q000009:adverse effects; D000293:Adolescent; D001688:Biological Products / Q000008:administration & dosage*; D002648:Child; D015331:Cohort Studies; D003424:Crohn Disease / Q000175:diagnosis* / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007155:Immunologic Factors / Q000008:administration & dosage; D000069285:Infliximab / Q000008:administration & dosage / Q000009:adverse effects; D007413:Intestinal Mucosa / Q000187:drug effects* / Q000503:physiopathology; D053208:Kaplan-Meier Estimate; D008297:Male; D016017:Odds Ratio; D011446:Prospective Studies; D018570:Risk Assessment; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric; D016896:Treatment Outcome; D014409:Tumor Necrosis Factor-alpha / Q000008:administration & dosage / Q000037:antagonists & inhibitors*
chemical_list: D001688:Biological Products; D007155:Immunologic Factors; D014409:Tumor Necrosis Factor-alpha; D000069285:Infliximab; D000068879:Adalimumab
keywords: Anti-TNFα; agents; mucosal healing; paediatric Crohn’s disease