Linear growth during infliximab therapy: Results of the REACH multicenter study

Abstract

Linear growth, a marker of therapeutic success in pediatric Crohn's disease (CD), was evaluated during maintenance infliximab (IFX) therapy in the context of the REACH multicenter, randomized open-label study comparing two dosing regimens. 112 children and adolescents (59% males; mean age 13.3 yrs, range 6-17 yrs) with moderately-to-severely active CD (Pediatric Crohn's Disease Activity Index [PCDAI >30]; mean 41.2, standard deviation 8.3) received a 3-dose induction of IFX 5mg/kg at weeks 0, 2 and 6. At week 10, responders (n = 103 [88%]) were randomized to receive IFX 5mg/kg at regularly scheduled infusions q8 or q12 weeks from week6 through week46 or42, respectively. 54 responders with a baseline bone age <13 yrs (female, n=20) or <14 yrs (male, n=34) were classified as having presumed growth potential (PGP). Their growth parameters (height and height velocity) before and after infliximab therapy (randomized: n=33 q8 week dosing; n=21 q12 week dosing) were analyzed after standardizing for age and gender. At IFX therapy initiation, mean z-scores for height (-1.0; 95% confidence interval [CI], -1.3 to -0.7) increased by a mean of 0.4 (95% CI 0.3 to 0.5). At week 54, 29/54 (54%) were in clinical response (delta PCDAI≥15 and PCDAI≤30), and 24/54 (44%) were in clinical remission (PCDAI≤10). The effects of IFX therapy on height velocity z-scores for various subgroups are presented below. Maintenance IFX therapy is associated with improved linear growth velocity and height centile in pediatric Crohn's patients treated before or in early puberty. Ultimate height in children with moderate-to-severe CD may be less compromised with IFX therapy than with conventional therapies.