Disease Duration Does Not Affect Outcome Following Infliximab in Children with Crohnʼs Disease

Abstract

Purpose: The REACH study showed that infliximab (IFX) was effective in inducing response and remission in moderate to severe Crohn's disease (CD) in children. Previous observations in both children and adults have suggested that longer disease duration adversely affects outcomes following IFX therapy. We assessed outcome following IFX therapy in relation to disease duration in the REACH study population. Methods: In REACH, patients (N = 112, median age 13 years) with a Pediatric Crohn's Disease Activity Index (PCDAI) score > 30 received IFX 5 mg/kg at weeks 0, 2, and 6. Patients responding to treatment at week 10 were randomized to receive IFX 5 mg/kg every 8 weeks or every 12 weeks through week 46 and followed through week 54. Clinical response (decrease from baseline in the PCDAI score ≥ 15 points, and a total score ≤ 30) and remission (PCDAI score ≤ 10 points) were assessed at weeks 10, 30, and 54. As the median disease duration in all patients was 1.6 years, we determined outcome in those with < 2 or ≥ 2 years disease duration. Results: At week 10, 99/112 (88%) patients responded to IFX and 66/112 (59%) patients achieved clinical remission. At week 54, 33/52 (64%) and 29 of 52 (56%) patients receiving IFX every 8 weeks were in clinical response and clinical remission, respectively, compared with 17 of 51 (33%) and 12 of 51 (24%) patients receiving treatment every 12 weeks (P= 0.002 and P < 0.001, respectively). Sub-group analysis revealed no effect of disease duration < 2 years vs. ≥2 years. Conclusion: Response and remission after IFX therapy in children with moderate to severe CD is similar when given < 2 years or ≥ 2 years following diagnosis.Table