Issue: May 2021

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April 06, 2021
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Dual biologic therapy offers possible option for refractory IBD

Issue: May 2021
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Simultaneous use of biologic agents in combination or with Xeljanz may be a viable treatment option for highly selected, refractory patients with inflammatory bowel disease, according to study results.

Robert Battat, MD, from the Jill Roberts Center for IBD at Weill Cornell Medicine, and colleagues wrote that many patients with IBD experience loss of response or are primary non-responders despite advances in therapies and drug optimization.

Blocks spelling out IBD
Dual biologic therapy may be effective in patients with refractory IBD.
Source: Adobe Stock.

“Approximately only 40% of patients with response to biologic therapies maintain clinical remission at 1 year,” they wrote. “Drug-related adverse effects and varying treatment efficacies for extraintestinal manifestations are further obstacles to effective management.”

Researchers conducted a systematic review and meta-analysis to summarize data on the safety and effectiveness of dual biologic therapy in combination or with Xeljanz (tofacitinib, Pfizer) in patients with refractory IBD.

They searched the literature for cohort or cases studies of more than 10 patients that reported the safety and effectiveness of simultaneous use of biologics. Then, investigators synthesized rates of adverse events, clinical remission and endoscopic remission and identified factors associated with successful dual therapy using pooled data.

Battat and colleagues identified 30 studies with data comprising 279 patients. The most common indications for dual therapy were medically refractory IBD (81%) and concurrent extraintestinal manifestations or rheumatologic disease (12%). Anti-TNF and anti-integrins was the most common combination (48%), followed by Stelara (ustekinumab, Janssen) and anti-integrins (19%). Additionally, 61% of patients had previously failed at least one of the two therapies used in combination.

During a median follow-up of 32 weeks, the pooled rate of adverse events was 31%, while the rate of serious adverse events was 6.5%.

Battat and colleagues found that 59% of patients experienced clinical remission and 34% experienced endoscopic remission. Overall, 12% of patients required surgery. Patients who were on dual therapy due to extraintestinal manifestations had the highest rates of success.

“This strategy still requires highly specialized care and should only be individualized to select patients with close monitoring,” Battat and colleagues wrote. “While established therapies and surgery may be reasonable alternatives in those without short bowel syndrome due to recurrent bowel resections, these data suggest that further study is needed on the use of dual biologic or small molecule therapy in treating refractory patients."