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World J Gastroenterol. May 14, 2023; 29(18): 2784-2797
Published online May 14, 2023. doi: 10.3748/wjg.v29.i18.2784
Table 2 Studies evaluating infliximab efficacy in pediatric Crohn’s disease in the induction and maintenance phases
Ref.
Study group
Anti-TNF-α
Participants
Study design and aims
Definition of the outcome
Number of patients (n)
Age at diagnosis (yr)
Time
Clinical response
Clinical remission
Hyams et al[16], 2007REACHIFXCD with a PCDAI > 30Comparison of IFX maintenance intervals; every 8 vs 12 wk. Primary responders were randomised at week 10Response: ∆PCDAI = -15. Remission: PCDAI ≤ 10Total: 103. Every 8 wk: 52. Every 10 wk: 5113.3Week 10. Week 5488.4%. Every 8 wk: 63.5%. Every 12 wk: 33.3% (P = 0.002)58.9%. Every 8 wk: 55.8%. Every 12 wk: 23.5% (P < 0.001)
Ruemmele et al[17], 2009GFHGNPIFXCDComparison of IFX infusion every 8 wk at maintenance vs IFX on demand. Primary responders were randomised at week 10Remission: Harvey Bradshaw index < 5Total: 40. Every 8 wk: 18. On demand: 1313.9Week 10. Week 60N/A85%. Every 8 wk: 83%. On demand: 61% (P = 0.001)
Hyams et al[18], 2012IMAgINEADLModerate-to-severe CDComparison of ADL dose; HD (40 mg or 20 mg for body weight ≥ 40 kg or < 40 kg) vs LD (20 mg or 10 mg for body weight ≥ 40 kg or < 40 kg). Primary responders were randomised at week 4Response: ∆PCDAI = -15. Remission: PCDAI ≤ 10Total: 188. HD: 93. LD: 95HD: 13.7 ± 2.52. LD: 13.5 ± 2.47Week 26. Week 52HD: 59.1%, LD: 48.4%. HD: 41.9%, LD: 28.4%HD: 38.7%; LD: 28.4%. HD: 33.3%; LD: 23.2%
Assa et al[19], 2019PAILOTADLBiologic-naïve CDComparison of proactive TDM vs reactive TDM. Primary responders were randomised at week 4Remission: PCDAI ≤ 10Total: 78. Proactive: 38. Reactive: 40Proactive: 12.9 ± 2.6. Reactive: 13.5 ± 2.7Week 4. Week 72NANA. Proactive TDM: 82%; Reactive TDM: 48%