March 16, 2020
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Adalimumab trials show low rate of IBD adverse events

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A review of 75 adalimumab clinical trials in adult and pediatric patients demonstrated low rates of inflammatory bowel disease adverse events, according to data published in Arthritis Care & Research.

“Adalimumab is approved for the treatment of 15 indications worldwide, including adult and pediatric Crohn’s disease and adult ulcerative colitis,” Dirk Elewaut, MD, PhD, of Ghent University, in Belgium, and colleagues wrote. “Therefore, it may be postulated that exacerbations of existing or new-onset IBD are rare events in patients treated with adalimumab for non-IBD indications,”

They added, “The overall rate of new onset or worsening of IBD across adalimumab clinical trials is unknown and is of particular interest in patients with axial spondyloarthritis (axSpA) who have a high prevalence of both overt IBD and subclinical gut inflammation.”

To study the incidence of IBD adverse events associated with adalimumab (Humira, AbbVie), Elewaut and colleagues conducted a post-hoc analysis of 75 interventional clinical trials. According to the researchers, these trials included 24,114 patients with various conditions, including rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, pediatric enthesitisrelated arthritis, uveitis, hidradenitis suppurativa, adult and pediatric psoriasis, psoriatic arthritis, nonpsoriatic arthritis peripheral spondyloarthritis and axial spondyloarthritis, including nonradiographic axSpA and ankylosing spondylitis.

A review of 75 adalimumab clinical trials in adult and pediatric patients demonstrated low rates of inflammatory bowel disease adverse events.
A review of 75 adalimumab clinical trials in adult and pediatric patients demonstrated low rates of IBD adverse events, according to data.

The analysis included 36,508 patientyears of adalimumab exposure. The researchers used search terms for IBD adverse events — new onset, worsening and flares — such as “IBD,” “ulcerative colitis,” “Crohn’s disease” and “ulcerative proctitis.”

According to the researchers, the overall rate of IBD adverse events in patients treated with adalimumab was 0.1 (95% CI, 0.1-0.2) per 100 patient years — a total of 41 events. This rate ranged from no events in the psoriatic arthritis, uveitis and pediatric trials to 0.8 (95% CI, 0.2-2.2) per 100 patient years in the nonpsoriatic arthritis peripheral SpA trial. The rate of IBD events in the axial SpA trial was 0.6 (95% CI, 0.4-1.0) per 100 patient years.

In placebocontrolled trials, the overall rate of IBD adverse events was 0.1 (95% CI, 0-0.3) per 100 patient years for adalimumab and 0.1 (95% CI, 0-0.4) for placebo. In axial SpA placebo-controlled trials, rates of IBD events in were 0.5 (95% CI, 0.1-1.4) per 100 patient years for adalimumab, compared with 0.6 (95% CI, 0-3.1) for the placebo.

“The rates of IBD AEs in adalimumab trials were generally low across diseases,” Elewaut and colleagues wrote. “In patients with axSpA, who are known to be at an increased risk of IBD, the rates of IBD events were comparable between adalimumab- and placebo-treated patients as well as with published pooled placebo rates across multiple AS clinical trials with TNF inhibitors.”

“Based on the observed low rates of IBD and its approved indications for Crohn’s disease and ulcerative colitis, adalimumab is a reasonable therapeutic option for patients who are eligible for a biologic therapy and at risk for development or worsening of IBD,” they added. “This analysis provides a benchmark for IBD AEs that other therapies, now and in the future, might be compared against.” – by Jason Laday

Disclosure: Elewaut reports grants, consulting fees and speaking fees from AbbVie. Please see the study for all other authors’ relevant financial disclosures.