Subcutaneous Infliximab was developed to expand patients’ choices and to improve administration convenience in the maintenance therapy. However, this novel exposure profile may lead to different safety and efficacy profile. The authors aimed to demonstrate superiority of subcutaneous Infliximab versus placebo as maintenance therapy in patients with Crohn’s disease (CD) and ulcerative colitis (UC).

The LIBERTY randomized, placebo-controlled, double-blind studies included 396 patients with CD and 548 patients with UC who received intravenous Infliximab at weeks 0, 2 and 6. At week 10, patients who were clinical responders were randomized to subcutaneous Infliximab and placebo every 2 weeks until week 54. Primary endpoints were clinical and endoscopic remission for CD and clinical remission for UC at week 54.

The subcutaneous infliximab, comparing with placebo, resulted in a statistically significant higher clinical remission (62.3% vs 32.1%; P < .0001) and endoscopic response (51.1% vs 17.9%; P < .0001) in patients with CD, and also regarding patients with UC (43.2% vs 20.8%; P < .0001). This therapy was well tolerated without new concerns on safety profile.

These studies reinforce the role of subcutaneous Infliximab as a maintenance therapy for CD/UC, promoting a more convenient mode of administration and offering robust evidence regarding its efficacy and safety profile.