Withdrawal of Infliximab in AS Leads to Relapse for Majority of Patients, Study Finds

The Center for Biosimilars Staff

After treatment withdrawal, 58.3% of patients with ankylosing spondylitis (AS) had relapsed. Half of the relapses appeared within 6 months.

Some recent data have indicated that it is feasible to reduce the dose of anti—tumor necrosis factor (anti-TNF) therapies in treating spondyloarthritis indications like ankylosing spondylitis (AS). In some cases, patients may stop biologic treatment entirely if they achieve sustained clinical remission, though data do not exist to support such a strategy.

One recent study sought to determine how long patients with AS in persistent clinical remission remained free of disease flares after withdrawing the anti-TNF infliximab, and it found that a majority of patients had clinical relapse within a year.

The multicenter, prospective, observational study included 36 Spanish patients with AS who had received infliximab as a first-line anti-TNF agent and who had been in remission for more than 6 months. Infliximab was withdrawn from these patients, and they were assessed every 6 to 8 weeks for 12 months. Clinical relapse was defined as a Bath Ankylosing Spondylitis Disease Activity Index score of 4 or higher. Among patients who relapsed, infliximab was reintroduced without an induction phase.

After treatment withdrawal, 12 (33.3%) of the patients remained free of clinical relapse, while 21 (58.3%) had relapsed and 3 patients were lost to follow-up. Half of the relapses appeared within 6 months of the anti-TNF withdrawal.

In the 21 patients who relapsed, infliximab was reintroduced, and 11 patients (52%) regained clinical remission. However, 10 patients (48%) did not regain remission. Among this group, 7 patients had a good clinical response, but in 3 patients, the reintroduced infliximab was ineffective, and the patients had to be cycled to a different anti-TNF agent altogether. No important adverse events were noted with the reintroduction of the drug.

According to the authors, this is the first study to show that, in a majority of patients with AS, withdrawal of infliximab was linked with relapse within 12 months. While reintroduction of infliximab was safe, many patients did not regain remission, and others had loss of efficacy.

While the study was limited by its small sample size, “Overall, the results we reported here suggest that the decision to withdraw treatment should be taken with considerable caution, and it seems unreasonable to propose withdrawal as an objective of the treatment strategy, at least at present, in the absence of any objective predictive factors of persistent clinical remission after treatment withdrawal,” write the authors.

Reference

Moreno M, Gratacós J, Torrente-Segarra T, et al. Withdrawal of infliximab therapy in ankylosing spondylitis in persistent clinical remission, results form the RIMINEA study. Arthritis Res Ther. 2019;21:88. doi: 10.1186/s13075-019-1873-3.