Working Group Releases Recommendations for Improving Treatment of IBD in Asia Through Biologics, Biosimilars

A new consensus paper from the Asia-Pacific Working Group on inflammatory bowel disease (IBD) released a set of best practices for improving IBD care with biologics and biosimilars.

The recommendations were developed in collaboration with the Asian Organization for Crohn’s and Colitis; the working group itself, based in the Philippines, is under the umbrella of the Asian Pacific Association of Gastroenterology.

The prevalence of IBD in Asia is rising, although it is not yet at the same level as it is in Western nations. The use of biologic agents and biosimilars is also becoming more common.

The intent of the paper was to discuss when and how to introduce biologic agents and biosimilars in conjunction with conventional treatments for ulcerative colitis (UC) and Crohn disease (CD) in Asia. It also addresses how pharmacogenetics influence the treatments of UC and CD and gives guidance on monitoring and strategies to restore lost response. Finally, the review provides clarity about how to manage treatment alongside possible hepatitis B and tuberculosis infections, both common in Asia.

Consensus was achieved when 80% of the members were in agreement (either completely or with some reservation) on an issue. Of the 29 statements, 1 dealt specifically with biosimilars; 50% of those voting agreed completely with a statement that reads: “Currently approved biosimilars are as safe and effective as reference products and can be used as induction and maintenance therapy for both CD and UC.”

Forty-four percent voted that they accept the statement with some reservations, and the classification of recommendation to support the statement was fair.

The paper said there should be shared decision making between the prescriber and the patient, and it also called for “a robust pharmacovigilance strategy to protect patients and develop the long-term evidence base required to provide patients and clinicians with the necessary assurances on safety and effectiveness.”

Biosimilars, beyond the use of just infliximab, may help reduce cost of IBD treatment throughout the Asia-Pacific region, the paper said.

Switching to a biosimilar will not prevent immunogenicity to the reference product, the paper said. The paper also said stated that evidence is lacking regarding reverse switching, multiple switching, and cross-switching among biosimilars.

The strongest recommendation was for the following statement: “Biologic therapy…should be initiated for the treatment of moderate-to-severe CD. This includes corticosteroid or immunosuppressant refractory/intolerant disease and corticosteroid dependence.”

However, because of financial constraints, biologics are not widely accessible in Asia.

Reference

Choon JO, Hilmi I, Banerjee R, et al. Best practices on immunomodulators and biologic agents for ulcerative colitis and Crohn’s disease in Asia [published online May 31, 2019]. Intest Res. doi: 10.5217/ir.2019.00026.