Biologic de-escalation tied to clinical relapse

Dose de-escalation of biologic therapy appears to result in higher rates of clinical relapse, according to results of a systematic review, but the quality of evidence is very low.

“De-escalation of biologic therapy is a commonly encountered clinical scenario,” the investigators said.

The databases of Embase, Medline, and the Cochrane Central Register of Controlled Trials were searched from inception to October 2019. Randomized controlled trials and observational studies assessing dose de-escalation of biologic therapy in adults with inflammatory bowel disease were eligible. Those analysing biologic discontinuation only and those lacking outcomes after dose de-escalation were excluded. The Newcastle-Ottawa Scale was used to evaluate risk of bias.

A total of 1,537 unique citations with 20 eligible studies after full-text review were identified. Overall, 995 patients were included from 18 observational studies (four prospective and 14 retrospective), one nonrandomized controlled trial, and one subgroup analysis of a randomized controlled trial. Seven studies included patients with Crohn’s disease, one included those with ulcerative colitis, and 12 included both.

Clinical relapse occurred in 0–54 percent of patients who dose de-escalated their biologic therapy (17 studies). The clinical relapse rate at 1 year ranged from 7 to 50 percent (six studies). However, 18 studies were found to have high risk of bias, driven primarily by the lack of a control group.

Additional controlled prospective studies are needed to clarify the effectiveness of biologic de-escalation and identify predictors of success.