Concomitant therapy with corticosteroids and anti-tumor necrosis factor (TNF) agents may not be necessary to induce remission in patients with Crohn's disease, a new study found.
Researchers performed a systematic review and meta-analysis of studies published from Jan. 1, 1980, through Jan. 20, 2016, to determine whether rates of clinical improvement were higher in patients with active Crohn's disease who received corticosteroids during anti-TNF induction therapy than in those who did not. Fourteen randomized trials were included, five involving adalimumab, five involving certolizumab, and four involving infliximab. The researchers conducted a pooled meta-analysis of individual patient and aggregated data, with end points of clinical remission (defined as a Crohn's disease activity index [CDAI] score <150) and clinical response (defined as a decrease in CDAI of 100 points) at the end of induction, defined as weeks 4 to 14 of treatment. Results were published June 19 by Clinical Gastroenterology and Hepatology.
Overall, data from 4,354 patients who received induction therapy with anti-TNF agents were included. Of these, 2,742 (62.0%) received anti-TNF therapy alone and 1,653 (38.0%) received both anti-TNF therapy and corticosteroids. Rates of clinical remission were 32.0% in those taking combination therapy and 35.5% in those receiving anti-TNF monotherapy (odds ratio, 0.93; 95% CI, 0.74 to 1.17). Rates of clinical response were 42.7% in those receiving combination therapy and 46.8% in those receiving anti-TNF monotherapy (odds ratio, 0.84; 95% CI, 0.73 to 0.96). No change in the results was seen after adjustment for baseline CDAI scores and concurrent use of immunomodulators.
Among other limitations, the study was a post hoc analysis of data from randomized controlled trials, and no safety data stratified by steroid exposure were available, the authors noted. They concluded that based on their analysis, patients receiving concomitant corticosteroids during induction therapy with anti-TNF agents did not have higher rates of clinical improvement than those receiving anti-TNF monotherapy. “Given these findings and the risks of corticosteroid use, clinicians should consider early weaning of corticosteroids during induction therapy with anti-TNF agents for patients with corticosteroid-refractory [Crohn's disease],” the authors wrote.
A related study on steroids in Crohn's disease found that younger patients who received steroid-sparing therapy had a lower risk for perianal fistulizing complications. The comparative effectiveness analysis used commercial administrative claims data and propensity score matching to compare 972 Crohn's disease patients ages 5 through 24 years who received steroid-sparing therapy with 972 who did not. The use of steroid-sparing therapy was associated with a 59% decreased risk of perianal fistulizing complications (hazard ratio [HR], 0.41; 95% CI, 0.33 to 0.52; P<0.001) in two years versus no use of steroid-sparing therapy. Immunomodulators alone, anti-TNF agents alone, and combination therapy were associated with 52% (HR, 0.48; 95% CI, 0.37 to 0.62; P<0.001), 47% (HR, 0.53; 95% CI, 0.36 to 0.78; P=0.001), and 83% (HR, 0.17; 95% CI, 0.09 to 0.30; P<0.001) reductions in two-year risk for development of perianal fistulizing complications, respectively, versus no use of steroid-sparing therapy. The study was published June 9 by JAMA Network Open.
An accompanying commentary said the study added significant information to the literature. “Given that in a short amount of time (2 years) there was a 59% decreased risk of perianal complications associated with the use of [steroid-sparing therapy], the findings should be compelling to parents and patients,” the commentary author wrote. “The benefits of avoiding surgery, pain, and physiologic dysfunction cannot be understated.”