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May 24, 2022
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Researchers observe no difference between subcutaneous and IV infliximab treatment in IBD

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SAN DIEGO — Subcutaneous infliximab maintained remission among patients with inflammatory bowel disease who switched from IV dosing, according to research presented at Digestive Disease Week 2022.

“A subcutaneous (SC) formulation of infliximab (IFX) has recently been shown to be as effective as IV IFX in a randomized trial, but there are no real-world data to support elective switching,” Philip J. Smith, MD, a consultant luminal gastroenterologist and honorary senior lecturer at the University of Liverpool and Royal Liverpool Hospital in the United Kingdom, and colleagues wrote. “We aimed to assess the effectiveness of an elective switching program from IV to SC IFX.”

IV bags
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In a retrospective, multicenter cohort study, Smith and colleagues evaluated 184 patients (mean age, 39.6 years; 102 men) with IBD (118 Crohn’s disease, 60 ulcerative colitis and 6 IBD-unclassified) who switched from IV IFX to SC IFX since April 2020. Investigators monitored disease activity using Harvey-Bradshaw Index (HBI) and simple clinical colitis activity index (SCCAI), as well as fecal calprotectin, C-reactive protein and IFX levels at 3 months, 6 months and 12 months. Patient satisfaction was also evaluated.

Patients dosed with IV IFX 5 mg/kg every 8 weeks switched to SC IFX 120 mg every other week, followed by patients dosed with 6 mg/kg or 4 mg/kg weekly to either every other week or weekly SC dosing. A total of 157 patients were switched to every other week dosing.

From baseline to 12-months post-switch, HBI, SCCAI and fecal calprotectin remained stable (P > .05), and CRP improved at both 3 months and 12 months (P < .05). Mean IFX levels increased from baseline to 3 months (9.4 ug/mL vs. 15 u/mL) and remained elevated between 6 months and 12 months (15.1 ug/mL and 16.1 ug/mL). Researchers observed no difference between patients of differing weights or treatment regimens, and no serious adverse events were reported.

Compared with IV IFX, 85.2% of patients reported being happier on SC IFX, 88.6% felt at least the same or better, 92% thought SC IFX was easy to use and 86.4% felt safe.

“SC IFX is effective at maintaining remission in IBD patients who switched from IV to SC IFX with no evidence of inferiority at 12-months follow-up,” Smith concluded. “There is a significant increase in IFX levels from baseline to 3 months, which is maintained to 12 months post-switch. SC IFX appears to be safe with low rates of adverse events and is well tolerated by patients.”