Evidence doesn’t back de-escalation of advanced IBD therapies


By Mardi Chapman

14 Sep 2023

De-escalation of IBD therapy is difficult, requires an honest discussion with patients about the possible ramifications and a plan B in the case of disease flare.

Speaking at AGW 2023, Professor Rupert Leong said the evidence was against deescalation for many people who wished to withdraw due to concerns about costs or adverse effects.

He said the STORI study [link here], testing infliximab discontinuation in patients with Crohn’s disease who were in stable remission on combination therapy with immunosuppressants, had shown about half relapsed at two years after stopping the TNFi.

The STORI extension study [link here] found that the proportion of patients without biological agents had decreased from 50% at two years to only 20% at seven years. Almost one in five patients had a major complication after infliximab withdrawal.

“It tells us that perhaps we need to monitor our patients very closely if they wish to stop their treatments …..using highly sensitive measures including CRP, faecal calprotectin, imaging and maybe endoscopy,” Professor Leong said.

He said the recent SPARE study [link here] tested treatment withdrawal options in patients with Crohn’s disease in sustained steroid-free remission on combination therapy.

It found the patients who stayed on infliximab, with or without the immunomodulator, were significantly protected against a flare compared to patients who continued with the immunomodulator alone.

The STOP-IT study [link here] also found discontinuation of infliximab for patients with Crohn’s disease receiving long-term infliximab therapy and in clinical, biochemical, and endoscopic remission leads to a considerable risk of relapse.

In both the SPARE and STOP-IT studies, no complications were associated with ongoing use of infliximab.

Professor Leong, Head of IBD Services at Concord Hospital, said ECCO guidelines on Crohn’s disease [link here] support the continuation of biologic therapy.

The guidelines say the risk of relapse after anti-TNF withdrawal is between 30–40% at one year and greater than 50% beyond two years.

Meanwhile, the clinical benefits of anti-TNF withdrawal, such as lower infection or cancer risk, are theoretical.

In ulcerative colitis, Professor Leong referenced the RIVETING study presented by Professor David Rubin at Digestive Disease Week earlier this year.

Patients in stable remission on 10mg tofacitinib twice daily were randomised to continue on their current dose or deescalate to 5mg twice daily.

Professor Leong said the proportion of patients who experienced loss of remission by month 30 was numerically higher in the 5mg than in the 10 mg BID dose group.

He concluded that despite remission, stopping advanced therapies for Crohn’s disease and ulcerative colitis was associated with disease relapse. However, cessation of the lower efficacy drug from combination therapy was possible.

“We should discourage withdrawal in patients who have active disease, are on monotherapy, have had multiple failures, have severe intestinal damage or short bowel, or are on chemoprophylaxis.”

Instead of withdrawal, there were options to switch to another advanced therapy.

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