October 24, 2016
By Will Boggs MD
NEW YORK (Reuters Health) - Higher disease activity and corticosteroid use are associated with an increased risk of infections in patients with Crohn's disease (CD) treated with adalimumab, according to a pooled analysis of 2266 patients.
"Active disease is an important risk factor for the development of infection in our patients," Dr. Mark T. Osterman from University of Pennsylvania Perelman School of Medicine in Philadelphia told Reuters Health. "Moderate-to-severe disease should be treated aggressively."
Treatment of moderate-to-severe CD includes immunosuppressants (corticosteroids, anti-tumor necrosis factor drugs, and immunomodulators), which alone and in combination are associated with the risk of infection.
Dr. Osterman and colleagues undertook a pooled analysis of patients with CD who were treated with adalimumab during clinical trials for the induction or maintenance of remission or mucosal healing in an effort to determine the relative risk of serious and opportunistic infections associated with increasing disease activity and concomitant immunomodulators and corticosteroids.
A third of patients received adalimumab monotherapy, 28% received adalimumab with immunomodulators but without corticosteroids, 20% received adalimumab with corticosteroids but without immunomodulators, and 19% received triple immunosuppression, according to the September 27th online report in The American Journal of Gastroenterology.
During one year of follow-up, 3.7% of patients developed serious infections (1.3% CD-related) and 2.2% developed opportunistic infections (half due to Candida and 40% due to herpes zoster).
Higher disease activity was associated with a significantly increased risk of both serious and opportunistic infection, independent of concomitant use of corticosteroids and immunomodulators.
In multivariable analysis, the use of concomitant immunomodulators was associated with a reduced risk of serious infection through one year, whereas concomitant corticosteroids appeared to increase the short-term, but not long-term, risk of serious infection.
Concomitant use of immunomodulators or corticosteroids doubled the short-term risk of opportunistic infection, but this increased risk was no longer apparent when follow-up was extended to one year.
"As many of the opportunistic infections were herpes zoster in this relatively young population, consideration should be given for early herpes zoster vaccination for adult patients who will receive immunosuppressants, regardless of age," Dr. Osterman concluded. "Efforts to reduce corticosteroid use should be a goal in treating these patients."
AbbVie funded the studies, employed two of the seven authors, and had various relationships with the other five authors.
Am J Gastroenterol 2016.
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