Stopping infliximab but not antimetabolites leads to more relapses in Crohn’s disease

In patients with Crohn’s disease (CD) who achieved sustained remission on infliximab plus antimetabolite therapy, infliximab discontinuation was associated with an increased risk of relapse in the phase 4 SPARE trial. In contrast, antimetabolite discontinuation did not lead to significantly higher relapse rates compared with continuation of the combination treatment. Since physicians often contemplate de-escalation of infliximab plus antimetabolite therapy, these results may inform the decision-making process of treatment de-escalation in patients with CD.

“Infliximab in combination with antimetabolite therapy is a standard option for patients with CD,” explained Prof. Edouard Louis (University Hospital Liège, Belgium) [1]. “Clinicians may contemplate de-escalation of this therapy if sustained remission is achieved.” The current, prospective, randomised-controlled, phase 4 SPARE trial (NCT02177071) aimed to assess the relapse rates in patients who continued or withdrew from this combination therapy. Participants with CD (n=211) treated with infliximab and antimetabolites who achieved sustained steroid-free remission (>6 months) were randomised to infliximab withdrawal (n=71), antimetabolite withdrawal (n=69), or therapy continuation (n=71). If relapse occurred, participants were retreated with the agent they withdrew from. The primary endpoints were relapse rate and time spent in remission over 2 years.

Participants who withdrew from infliximab showed significantly higher 2-year relapse rates than participants who continued the combination therapy (40% vs 14%; log-rank P=0.0003) or than participants who discontinued antimetabolite treatment (40% vs 10%; log-rank P<0.0001; see Figure). Notably, 22 out of 23 participants in the infliximab discontinuation arm who relapsed and were subsequently retreated with infliximab achieved remission rapidly. This trend is reflected in the mean time spent in remission, which was only 6 days shorter in the infliximab arm compared with the continuation arm and 14 days shorter compared with the antimetabolite discontinuation arm. Although these differences are small, the pre-specified, non-inferiority criterion for stopping infliximab was not met.

Figure: Relapse rate over time [1]



 

 

 

 

 

1. Louis E, et al. Withdrawal of infliximab or anti-metabolite therapy in Crohn’s Disease patients in sustained remission on combination therapy: A randomized unblinded controlled trial (SPARE). OP01, ECCO 2022, 16–19 February.

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Posted on 12 April 20228 April 2024