RESUMEN
BACKGROUND & AIMS: CT-P13 subcutaneous (SC), an SC formulation of the intravenous (IV) infliximab biosimilar CT-P13 IV, creates a unique exposure profile. We aimed to demonstrate superiority of CT-P13 SC vs placebo as maintenance therapy in patients with Crohn's disease (CD) and ulcerative colitis (UC). METHODS: Two randomized, placebo-controlled, double-blind studies were conducted in patients with moderately to severely active CD or UC and inadequate response or intolerance to corticosteroids and immunomodulators. All patients received open-label CT-P13 IV 5 mg/kg at weeks 0, 2, and 6. At week 10, clinical responders were randomized (2:1) to CT-P13 SC 120 mg or placebo every 2 weeks until week 54 (maintenance phase) using prefilled syringes. Co-primary end points were clinical remission and endoscopic response (CD) and clinical remission (UC) at week 54 (all-randomized population). RESULTS: Overall, 396 patients with CD and 548 patients with UC received induction treatment. At week 54 in the CD study, statistically significant higher proportions of CT-P13 SC-treated patients vs placebo-treated patients achieved clinical remission (62.3% vs 32.1%; P < .0001) and endoscopic response (51.1% vs 17.9%; P < .0001). In the UC study, clinical remission rates at week 54 were statistically significantly higher with CT-P13 SC vs placebo (43.2% vs 20.8%; P < .0001). Achievement of key secondary end points was significantly higher with CT-P13 SC vs placebo across both studies. CT-P13 SC was well tolerated, with no new safety signals identified. CONCLUSIONS: CT-P13 SC was more effective than placebo as maintenance therapy and was well tolerated in patients with moderately to severely active CD or UC who responded to CT-P13 IV induction. CLINICALTRIALS: gov, Numbers: NCT03945019 (CD) and NCT04205643 (UC).
RESUMEN
Relapses in inflammatory bowel disease (IBD) complicated by Clostridium difficile infection (CDI) are associated with significant morbidity and mortality. CDI can exacerbate the course of IBD and may result in prolonged hospitalizations, admissions to intensive care, surgical interventions, or even death. Early detection and aggressive treatment with systemic corticosteroids or biologics such as infliximab are often needed in severe presentations. Five cases of relapsed ulcerative colitis complicated by fulminant CDI were retrospectively reviewed. Biological therapy with infliximab was initiated upon multidisciplinary team assessment as the cases were resistant to standard IBD therapy. All five patients improved clinically and avoided early surgical intervention. Some required prolonged therapy with infliximab to achieve remission. Early recognition of CDI and aggressive therapy with biologics may be required to avoid complications in the IBD patients experiencing a relapse. Infliximab therapy should be considered early on, especially where the disease is resistant to standard therapy.