Remission and response to biologic therapy are not influenced by disease duration in patients with ulcerative colitis (UC) or Crohn disease (CD), according to a study published in Gastroenterology.
Biologic therapies have had a significant impact on the treatment of inflammatory bowel disease (IBD); however, optimal strategies and timing for their initiation have yet to be clarified. Therefore, researchers performed a systematic review and individual-patient-data meta-analysis of all placebo-controlled trials of biologic agents approved for use in the adult IBD population as of October 2015.
They utilized the Vivli data-sharing platform, with the goal of determining the impact of CD/UC disease duration on the rate of remission and response to biologic therapy. The proportional biologic/placebo treatment effect on induction of remission in patients with short-duration (≤18 months) disease compared against those with long-duration (>18 months) disease (analyzed separately for CD and UC) was the primary outcome of the study.
The researchers analyzed 25 trials involving infliximab, adalimumab, certolizumab, golimumab, natalizumab, or vedolizumab in 6168 patients with CD (16 trials) and 3277 patients with UC (9 trials). Mean patient age in the CD and UC trials were 37.5 and 40.1 years, 43% and 58% were men, and mean duration of disease was 8.9 and 6.61 years, respectively.
Investigators found that in patients with CD, induction of remission rates were higher in the pooled placebo and active arms among patients with short-duration disease (41.4%; 244/589 patients) compared with long-duration disease (29.8%; 852/2857 patients). However, the primary outcome was not different in short-duration compared with long-duration disease.
In patients with UC, the researchers found that both the proportional biologic/placebo remission-induction effect and the pooled biologic-placebo effect were unchanged, independent of disease duration. In addition, the primary outcome results remained the same when tested using alternative temporal cut-offs and when modeled for patient covariates.
Research limitations included heterogeneity among the included studies and a lack of data on endoscopic outcomes. Additionally, the risk for and prevention of complications were not included in the analysis, though researchers acknowledge these factors should be weighed by clinicians when deciding to begin early intensive therapy in high-risk patients.
Investigators concluded, “[T]he proportional biologic/placebo treatment effect on remission and response to biologics was not influenced by disease duration in UC or CD patients.” “In CD, the absolute rate for induction of remission and response was higher in short-duration disease compared with long-duration CD for both biologics and placebo, but such impact of disease duration was not observed in UC,” they noted.
Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
Ben-Horin S, Novack L, Mao R, et al. Efficacy of biologic drugs in short-duration versus long-duration inflammatory bowel disease: a systematic review and an individual-patient data meta-analysis of randomized controlled trials. Gastroenterol. Published online October 29, 2021. doi: 10.1053/j.gastro.2021.10.037