With the recent surge in treatment options for inflammatory bowel disease (IBD), which is represented by ulcerative colitis and Crohn's disease, developing an appropriate treatment strategy for IBD is emerging as a rising topic in clinical practice.

This is due to the recent health insurance reimbursement extensions granted for treatments by multinational pharmaceutical companies, which have lowered the burden on site.

#Amid intensifying sales and marketing competition within the industry, the medical community is expected to revise its guidelines on selecting appropriate treatments.

Until now, tumor necrosis factor (TNF) blockers Humira (adalimumab) and Remicade (infliximab) have dominated the field of IBD treatment in Korea.

According to the pharmaceutical industry and medical community on the 8th, the IBD treatment market has been rapidly reshaping with the competitive entry of global pharmaceutical companies’ treatments this year.

First, in the first half of this year, Lilly Korea received approval for its interleukin-23 (IL-23) inhibitor ‘Omvo (mirikizumab) from the Ministry of Food and Drug Safety. This added another IL inhibitor option to ‘Stelara (ustekinumab),’ the only anti-interleukin drug that had been available in the market until then.

As a result, the anti-integrin agent ‘Kynteles (vedolizumab, Takeda),’ and anti-interleukin agent ‘Stelara,’ ‘Omvo,’ and the Janus kinase (JAK) inhibitors ‘Xeljanz (tofacitinib, Pfizer),’ ‘Rinvoq (upadacitinib, AbbVie),’ ‘Jyseleca (filgotinib, Eisai) can now be prescribed for IBD in Korea.

Also, in addition to the JAK inhibitors, which were the only oral treatment options for severe IBD until the first half of this year, the launch and reimbursement approval of ‘Zeposia (ozanimod, BMS),’ a sphingosine-1-phosphate (S1P) receptor modulator broadened the options available on site.

This means that the doctors have more options to use on patients who have failed initial treatment.

In other words, the next treatment they choose can change the direction of each patient’s care.
As such, the choice of IBD therapies, typified by ulcerative colitis (UC), has risen as a hot topic in clinical practice. While clinical research has made it possible to customize treatment for each patient, it has also increased competition between pharmaceutical companies.

A professor of gastroenterology at A University Hospital in Busan said, "Previously, there were no options for IBD other than anti-TNF inhibitors. But many more options have become available in recent years, making the situation more complicated for prescribing clinicians.”

The pharmaceutical industry is also scrambling to prioritize the lines of their treatment amid the various options becoming available. One representative example is BMS's Zeposia, which entered into a co-marketing agreement with Yuhan Corp, which owns strong domestic sales and marketing capabilities.

An industry official said, "In fact, Yuhan Corp’s co-marketing agreement with BMS for Zeposia was considered quite unusual in the field. The collaboration seems to fall in line with the current situation, as the IBD market has recently become more competitive with an increasing number of treatment options and Yuhan had a need to increase its drug lineup."

Also, with the increasing number of therapies available from global pharmaceutical companies, "sequencing" between existing and new drugs has become a hot topic in clinical practice.

In other words, the increase in treatment options to use after initial treatment failure has created a "dilemma" as patients are allowed to switch between drugs, but not immediately.

Another professor of gastroenterology at a university hospital said, "Recently, JAK inhibitors and small molecule drugs have been approved for ulcerative colitis and are being used in practice. However, the issue of side effects needs to be considered as well as benefits. Because complications such as herpes zoster and blood clots can occur when using these drugs, the new drugs are more commonly used on patients that have received shingles vaccinations and relatively young patients."

He added, “In the JAK inhibitor class, Jyseleca is the only JAK inhibitor that can be prescribed directly after azathioprine. In clinical studies, RInvoq has shown promise in ulcerative colitis and Crohn's disease. However, the use of other JAK inhibitors requires azathioprine to be first removed, which is problematic for physicians because they have to remove azathioprine, which they consider effective for the patients.”

In other words, while prioritizing the use of the right treatment for each patient, the sequencing of the treatments is currently being determined at the doctors’ discretion based on clinical research.

As a result, therapies that are deemed to be the most effective based on the clinical studies that support their approval and reimbursement are being placed in the "last line of defense" and used as a last resort in practice.

However, there is an opinion that this approach is not optimal and that prescriptions should be based on a comprehensive analysis of the patient's disease severity and socioeconomic status.

There are also those who believe that they should wait and refer to the revisions made to the guidelines published by the Korean Association for the Study of Intestinal Diseases, which specializes in the disease.

Professor Byong Duk Ye, Professor at the University of Ulsan College and Treasurer of KASID, said, "This is always a problem because there is no right answer. Especially, in the case of Rinvoq, there are opinions that its use should be delayed as much as possible because it is superior in clinical or endoscopic aspects compared to other agents. The drug should be used in combination with the patient's personal disease status and socioeconomic status."

Ye added, "It is not necessarily a good treatment strategy to postpone the use of Rinvoq because it becomes less effective when used in later stages of the disease. It may be better to use it earlier to control inflammation. The final decision should be made in consultation with the patient, and we plan to publish revised KASID guidelines regarding the increased number of IBD treatment options available.”