Remicade, an IBD Treatment, Seen as Effective and Safe at Higher Than Usual Doses

Higher doses of Remicade (infliximab) can ease the symptoms of inflammatory bowel disease (IBD) by better controlling inflammation with raising the risk of adverse effects — like more infections — in patients, researchers report.

Their study, “Success and safety of high infliximab trough levels in inflammatory bowel disease,” was published in the Scandinavian Journal of Gastroenterology.

Remicade an antibody biological treatment that works against tumor necrosis factor alpha (TNF-α), one of the most potent inflammatory molecules in the body.

Remicade is an approved infusion treatment for several autoimmune disorders, including moderately to severely active Crohn’s disease, ulcerative colitis, and rheumatoid arthritis.

A previous prospective trial suggested that a Remicade dose with trough levels between three and seven µg/mL is appropriated to treat patients with IBD. (A trough level is the lowest concentration of a medicine in a patient’s bloodstream, a level estimated just prior to a next administration of a treatment.)

But some researchers propose higher doses might better treat the disease, including 10 µg/mL or even 18 µg/mL of Remicade.

“It is important to delineate the TL [trough level] of infliximab above which no clinical benefit can be expected, since those patients should be offered other treatment options, such as vedolizumab or ustekinumab,” the researchers wrote. “But it is equally important not to discontinue infliximab and switch to a different class of biologics too soon as second line non-TNF biologicals are only modestly effective in patients who failed TNF inhibitors.”

In this study, a research team from Ljubljana, Slovenia, hypothesized that Remicade at a dose higher than the current suggested therapeutic dose may result in an additional control over inflammation, without compromising the body’s ability to fight infections.

They evaluated 183 IBD patients (109 with Crohn’s disease and 74 with ulcerative colitis) using Remicade between 2010 and 2015. Patients were divided in two groups, according to the medicine dose: those being treated with less and those with more than seven µg/mL.

Levels of efficacy (fecal calprotectin and C-reactive protein, two inflammatory proteins) and safety (rate of infections) were measured at different time points.

Analysis of the data demonstrated that patients taking Remicade at doses over seven µg/mL had lower levels of fecal calprotectin (66 mg/kg) than patients on doses below seven µg/mL (155 mg/kg). Levels of C-reactive protein were similar among the two groups (three mg/L).

Researchers also found no significant differences in the rates of infections of patients taking high (12.4%) and low (9.3%) doses of Remicade.

Researchers concluded that taking higher doses of Remicade resulted in 32% increase in the consumption of the medicine, but also in a better control of inflammation, with no increased risks of infections.

“In this large cohort of 183 infliximab treated IBD patients we analyzed the success and safety of high infliximab trough levels,” the researchers concluded. “Our data suggest that infliximab dose optimization to high infliximab trough levels, although linked to a 30% increase in infliximab consumption, is a valuable option for patients with active disease at lower infliximab trough levels.”

For Crohn’s patients, for example, FDA-recommended dosing for Remicade is 5 mg/kg at initiation, and at two and six weeks, then every eight weeks. The dose can be increased to 10 mg/kg in adults who experience a decline in benefits over time.

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