Inflammatory bowel diseases · 2026
Recovery of response and long-term outcomes following loss of response and dose escalation of subcutaneous infliximab: a post hoc analysis of the LIBERTY-CD & LIBERTY-UC trials.
Клиническое исследование III фазыСтатьяМногоцентровое исследованиеРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Dubinsky Marla C, Schreiber Stefan, Yarur Andres J, Sands Bruce E, Hanauer Stephen B, Danese Silvio, Yu Hyunseong, Kim Dong-Hyeon, Lee Young Nam, Colombel Jean-Frédéric
Аннотация
BACKGROUND: Rapidity of onset of efficacy following dose escalation of subcutaneous infliximab after loss of response remains unclear in Crohn's disease (CD) and ulcerative colitis (UC). This post hoc analysis of the LIBERTY-CD and LIBERTY-UC trials evaluated time to response recovery following dose escalation of subcutaneous infliximab after loss of response, and characterized patients who experienced early recovery.
METHODS: This analysis included week 10 responders to intravenous infliximab induction who were randomized to receive subcutaneous infliximab 120 mg every other week (Q2W) and underwent dose escalation to 240 mg Q2W following loss of response. Time to response recovery was assessed, and outcomes pre-/post-dose escalation were analyzed by recovery timing (early [≤8 weeks], late [>8 weeks], non-recovery). Week 102 outcomes and factors associated with early recovery were evaluated.
RESULTS: Response recovery was achieved in 85.1% (40/47) with CD and 82.3% (51/62) with UC, with early recovery in 66.0% (31/47) and 69.4% (43/62), respectively. Early recovery groups in CD and UC showed greater serum infliximab increases than late or non-recovery groups. At week 102, numerically higher rates of clinical response and clinical remission in CD, and endoscopic remission in UC, were observed in early versus late recovery group. Factors associated with early recovery differed between CD and UC: systemic inflammatory and pharmacokinetic parameters were linked to early recovery in CD, while mucosal and gut-specific factors predominated in UC.
CONCLUSION: Dose escalation of subcutaneous infliximab led to rapid response recovery in most patients with CD and UC. Early recovery was associated with favorable long-term outcomes.
CLINICAL TRIAL REGISTRATION NUMBERS: NCT03945019 and NCT04205643.
METHODS: This analysis included week 10 responders to intravenous infliximab induction who were randomized to receive subcutaneous infliximab 120 mg every other week (Q2W) and underwent dose escalation to 240 mg Q2W following loss of response. Time to response recovery was assessed, and outcomes pre-/post-dose escalation were analyzed by recovery timing (early [≤8 weeks], late [>8 weeks], non-recovery). Week 102 outcomes and factors associated with early recovery were evaluated.
RESULTS: Response recovery was achieved in 85.1% (40/47) with CD and 82.3% (51/62) with UC, with early recovery in 66.0% (31/47) and 69.4% (43/62), respectively. Early recovery groups in CD and UC showed greater serum infliximab increases than late or non-recovery groups. At week 102, numerically higher rates of clinical response and clinical remission in CD, and endoscopic remission in UC, were observed in early versus late recovery group. Factors associated with early recovery differed between CD and UC: systemic inflammatory and pharmacokinetic parameters were linked to early recovery in CD, while mucosal and gut-specific factors predominated in UC.
CONCLUSION: Dose escalation of subcutaneous infliximab led to rapid response recovery in most patients with CD and UC. Early recovery was associated with favorable long-term outcomes.
CLINICAL TRIAL REGISTRATION NUMBERS: NCT03945019 and NCT04205643.