Despite the size of the ever-growing inflammatory bowel disease (IBD) drug market and its diversity of modalities from JAK inhibitors to IL-23s, unmet needs and treatment gaps remain.
That’s according to a new paper from Nimbus Therapeutics and Back Bay Life Science Advisors, which surveyed 36 U.S. gastroenterologists to gauge physician perspectives on the current treatment landscape, what’s to come and what they want to see next.
When it comes to unmet needs, the doctors’ perceived gaps largely concern clinical remission. For patients with moderate-to-severe ulcerative colitis, which is one of the two diseases within the IBD umbrella, 81% of physicians surveyed marked achieving clinical remission as one of their top three “most urgent” unmet needs. Over half (56%) also ranked increased durability of clinical remission as one of their most urgent unmet needs, while 44% put achieving faster healing in the top three.
Beyond that, the survey also reflects a thriving interest in oral therapies.
The IBD treatment market is largely dominated by biologic medicines, which are often administered through infusions or autoinjector pens. According to the survey, however, patients are seeking oral options. Seventy-five percent of respondents agreed that more than half of their patients would have chosen an oral product with “equivalent efficacy and safety.” Fifty-three percent said more than 75% of their patients would have preferred an oral option, while 31% said more than 90% would have done so.
The leading oral therapies for IBD are currently JAK inhibitors, such as AbbVie’s Rinvoq and Pfizer’s Xeljanz. However, the drugs’ safety profiles remain a concern.
Among physicians surveyed, 56% cited the JAK inhibitors’ boxed warning related to major adverse cardiovascular events as one of the “greatest limitations” of currently available JAK drugs for ulcerative colitis. Meanwhile, 42% pointed to the boxed warning regarding an increased risk of all-cause mortality. Clinical remission was also cited as a concern, with 36% of physicians identifying the durability of remission as one of the drugs’ greatest limitations.
“The primary barrier to broader JAK inhibitor adoption is not the efficacy that these drugs can achieve, but the risk profile that comes with them,” Nimbus and Back Bay Life Science advisors explained in the paper.
As one GI key opinion leader that the paper cites put it, “If we had Rinvoq without the safety concerns and inability to use in pregnancy, that would be huge—we could use it in earlier lines of therapy.”
The survey suggests that a different approach might be needed for future IBD pills.
Among respondents, 67% ranked biologic-comparable efficacy as a top priority for future oral agents, while 50% prioritized improved patient-reported outcomes, such as quality of life. The findings suggest physicians are seeking both “deeper disease control and improvements in how patients feel and function,” the paper’s authors wrote.
More specifically, Nimbus and Back Bay said the most “valuable future oral therapies in IBD will be those that combine clinically meaningful efficacy, durable disease control, favorable safety, minimal monitoring burden, and a practical dosing profile.”
More options could be on the horizon. The paper points to a “rapidly expanding” oral IBD pipeline that includes TYK2 inhibitors, microRNA-modulating therapies and other agents. However, the available efficacy data suggest these prospects have not yet met the high bar set by JAK inhibitors. Despite physicians’ “enthusiasm” for oral therapies, emerging IBD drugs will need to demonstrate strong efficacy, durable disease control and favorable safety profiles.