title: Monotherapy with infliximab versus combination therapy in the maintenance of clinical remission in children with moderate to severe Crohn disease.
abstract: OBJECTIVE
  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 ± 2.6 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.
authors.affiliation: *Children's Memorial Health Institute, Warsaw †Department of Pediatrics, Gastroenterology and Nutrition, Medical University of Wroclaw ‡Department of Paediatrics, Medical University of Silesia, Gastroenterology Unit, Upper-Silesian Child Health Care Centre, Katowice §Department of Pediatric Gastroenterology and Nutrition, Medical University of Warsaw ||Wl. Buszkowski Kielce Province Children's Hospital, Kielce ¶Department of Paediatric Allergology, Gastroenterology and Nutrition, Medical University of Lodz #Paediatric Nursery Unit of Pomeranian Medical University, Division of Paediatrics, Gastroenterology and Rheumatology of Zdroje Hospital in Szczecin **Department of Pediatrics, Allergology and Gastroenterology, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun ††Department of Pediatrics, Gastroenterology and Nutrition Jagiellonian University School of Medicine, Cracow, Poland.
authors.forename: Jarosław
authors.initials: J
authors.lastname: Kierkuś
authors.forename: Barbara
authors.initials: B
authors.lastname: Iwańczak
authors.forename: Agnieszka
authors.initials: A
authors.lastname: Wegner
authors.forename: Maciej
authors.initials: M
authors.lastname: Dadalski
authors.forename: Urszula
authors.initials: U
authors.lastname: Grzybowska-Chlebowczyk
authors.forename: Izabella
authors.initials: I
authors.lastname: Łazowska
authors.forename: Jolanta
authors.initials: J
authors.lastname: Maślana
authors.forename: Ewa
authors.initials: E
authors.lastname: Toporowska-Kowalska
authors.forename: Grażyna
authors.initials: G
authors.lastname: Czaja-Bulsa
authors.forename: Grażyna
authors.initials: G
authors.lastname: Mierzwa
authors.forename: Bartosz
authors.initials: B
authors.lastname: Korczowski
authors.forename: Elżbieta
authors.initials: E
authors.lastname: Czkwianianc
authors.forename: Alicja
authors.initials: A
authors.lastname: Żabka
authors.forename: Edyta
authors.initials: E
authors.lastname: Szymańska
authors.forename: Elżbieta
authors.initials: E
authors.lastname: Krzesiek
authors.forename: Sabina
authors.initials: S
authors.lastname: Więcek
authors.forename: Małgorzata
authors.initials: M
authors.lastname: Sładek
mesh_terms: D000293:Adolescent; D001379:Azathioprine / Q000627:therapeutic use; D002648:Child; D003424:Crohn Disease / Q000188:drug therapy*; D004359:Drug Therapy, Combination; D005260:Female; D005765:Gastrointestinal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007166:Immunosuppressive Agents / Q000627:therapeutic use*; D000069285:Infliximab / Q000009:adverse effects / Q000627:therapeutic use*; D060046:Maintenance Chemotherapy / Q000379:methods*; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use; D012074:Remission Induction; D012720:Severity of Illness Index
chemical_list: D005765:Gastrointestinal Agents; D007166:Immunosuppressive Agents; D000069285:Infliximab; D001379:Azathioprine; D008727:Methotrexate