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], 2007	REACH	IFX	CD with a PCDAI > 30	Comparison of IFX maintenance intervals; every 8 vs 12 wk. Primary responders were randomised at week 10	Response: ∆PCDAI = -15. Remission: PCDAI ≤ 10	Total: 103. Every 8 wk: 52. Every 10 wk: 51	13.3	Week 10. Week 54	88.4%. 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], 2009	GFHGNP	IFX	CD	Comparison of IFX infusion every 8 wk at maintenance vs IFX on demand. Primary responders were randomised at week 10	Remission: Harvey Bradshaw index < 5	Total: 40. Every 8 wk: 18. On demand: 13	13.9	Week 10. Week 60	N/A	85%. Every 8 wk: 83%. On demand: 61% (P = 0.001)
Hyams et al[18], 2012	IMAgINE	ADL	Moderate-to-severe CD	Comparison 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 4	Response: ∆PCDAI = -15. Remission: PCDAI ≤ 10	Total: 188. HD: 93. LD: 95	HD: 13.7 ± 2.52. LD: 13.5 ± 2.47	Week 26. Week 52	HD: 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], 2019	PAILOT	ADL	Biologic-naïve CD	Comparison of proactive TDM vs reactive TDM. Primary responders were randomised at week 4	Remission: PCDAI ≤ 10	Total: 78. Proactive: 38. Reactive: 40	Proactive: 12.9 ± 2.6. Reactive: 13.5 ± 2.7	Week 4. Week 72	NA	NA. Proactive TDM: 82%; Reactive TDM: 48%

CD: Crohn’s disease; RCT: Randomised controlled trial; IFX: Infliximab; PCDAI: Pediatric Crohn’s disease activity index; NA: Not applicable; ADL: Adalimumab; HD: High dose; LD: Low dose; TDM: Therapeutic drug monitoring.