BACKGROUND AND AIMS: The REACH study evaluated the safety and efficacy of infliximab in children with moderately to severely active Crohn's disease. METHODS:Patients (n = 112) with a Pediatric Crohn's Disease Activity Index (PCDAI) score >30 receivedinfliximab 5 mg/kg at weeks 0, 2, and 6. Patients responding to treatment at week 10 were randomized to infliximab 5 mg/kg every 8 or 12 weeks through week 46. A concurrent immunomodulator was required. Clinical response (decrease from baseline in the PCDAI score > or =15 points; total score < or =30) and clinical remission (PCDAI score < or =10 points) were evaluated at weeks 10, 30, and 54. RESULTS: At week 10, 99 of 112 (88.4%) patients responded to infliximab (95% confidence interval: [82.5%, 94.3%]) and 66 of 112 (58.9%) patients achieved clinical remission (95% confidence interval: [49.8%, 68.0%]). At week 54, 33 of 52 (63.5%) and 29 of 52 (55.8%) patients receiving infliximab every 8 weeks did not require dose adjustment and were in clinical response and clinical remission, respectively, compared with 17 of 51 (33.3%) and 12 of 51 (23.5%) patients receiving treatment every 12 weeks (P = .002 and P < .001, respectively). CONCLUSIONS:Pediatric patients responding to an induction regimen ofinfliximab were more likely to be in clinical response and remission at week 54 without dose adjustment when their maintenance therapy was given every 8 weeks rather than every 12 weeks. Allowing for dose intensification in the case of relapse, remission rates, but not response rates, at week 54 were superior with every 8-week dosing compared with every 12-week dosing.
RCT Entities:
BACKGROUND AND AIMS: The REACH study evaluated the safety and efficacy of infliximab in children with moderately to severely active Crohn's disease. METHODS:Patients (n = 112) with a Pediatric Crohn's Disease Activity Index (PCDAI) score >30 received infliximab 5 mg/kg at weeks 0, 2, and 6. Patients responding to treatment at week 10 were randomized to infliximab 5 mg/kg every 8 or 12 weeks through week 46. A concurrent immunomodulator was required. Clinical response (decrease from baseline in the PCDAI score > or =15 points; total score < or =30) and clinical remission (PCDAI score < or =10 points) were evaluated at weeks 10, 30, and 54. RESULTS: At week 10, 99 of 112 (88.4%) patients responded to infliximab (95% confidence interval: [82.5%, 94.3%]) and 66 of 112 (58.9%) patients achieved clinical remission (95% confidence interval: [49.8%, 68.0%]). At week 54, 33 of 52 (63.5%) and 29 of 52 (55.8%) patients receiving infliximab every 8 weeks did not require dose adjustment and were in clinical response and clinical remission, respectively, compared with 17 of 51 (33.3%) and 12 of 51 (23.5%) patients receiving treatment every 12 weeks (P = .002 and P < .001, respectively). CONCLUSIONS: Pediatric patients responding to an induction regimen of infliximab were more likely to be in clinical response and remission at week 54 without dose adjustment when their maintenance therapy was given every 8 weeks rather than every 12 weeks. Allowing for dose intensification in the case of relapse, remission rates, but not response rates, at week 54 were superior with every 8-week dosing compared with every 12-week dosing.
Authors: Lee A Denson; Mi-Ok Kim; Ramona Bezold; Rebecca Carey; Bankole Osuntokun; Cade Nylund; Tara Willson; Erin Bonkowski; Dandan Li; Edgar Ballard; Margaret Collins; M Susan Moyer; David J Klein Journal: J Pediatr Gastroenterol Nutr Date: 2010-08 Impact factor: 2.839
Authors: Mark D DeBoer; Barrett H Barnes; Nicholas A Stygles; James L Sutphen; Stephen M Borowitz Journal: J Pediatr Gastroenterol Nutr Date: 2012-04 Impact factor: 2.839
Authors: Jong Seung Lee; Jee Hyun Lee; Ji Hyuk Lee; Hye Jin Lee; Mi Jin Kim; Hae Jeong Lee; Yon Ho Choe Journal: World J Gastroenterol Date: 2010-04-14 Impact factor: 5.742
Authors: Tolulope O Falaiye; Keisha R Mitchell; Zengqi Lu; Benjamin R Saville; Sara N Horst; Dedrick E Moulton; David A Schwartz; Keith T Wilson; Michael J Rosen Journal: J Pediatr Gastroenterol Nutr Date: 2014-02 Impact factor: 2.839