AbbVie’s Rinvoq just recently reported a pivotal trial win in ulcerative colitis, and one team of analysts is already drawing a rosy future for the next-gen immunology drug based on a physician survey.
Among a list of five oral drugs for inflammatory bowel disease, the surveyed doctors ranked Rinvoq as their favorite, scoring it the highest across all the attributes listed—including clinical response, mucosal healing and safety. Bristol Myers Squibb’s recently approved multiple sclerosis drug Zeposia ranked as the least attractive.
That’s the message an SVB Leerink team received from a February survey of 50 U.S. gastroenterologists and internal medicine physicians who combined treat over 10,000 IBD patients.
Physicians intend to use more oral IBD meds in the next two to three years, and they appear open to prescribing a new drug even after a previous treatment failure in the same class. That’s “highly positive” for Rinvoq, the team said in a Monday note.
SVB Leerink did similar market research in 2017, and the new results suggest a 20% market growth in Crohn’s disease and 30% increase in ulcerative colitis. The growth in ulcerative colitis was driven almost entirely by Pfizer’s JAK inhibitor Xeljanz, which won that go-ahead in mid-2018. This suggests that novel oral meds may further boost the IBD market, the analysts noted.
While existing biologics—such as AbbVie’s TNF blocker Humira, Takeda’s integrin drug Entyvio and Johnson & Johnson’s IL-12/23 antibody Stelara—will collectively maintain the proportion of patients treated, physicians expect oral JAK inhibitors and S1P modulators to gain share to about 25% by 2024 from the current 17% held by Xeljanz.
For now, many physicians still expect to initially reserve those oral drugs for patients who fail on the injectables: They expect to use orals in about a quarter of first-line treatments. But the SVB Leerink analysts noted that patients typically cycle through treatment options every one to two years, providing “plenty of room for new drug entrants.”
What’s more, while current clinical trial data on the oral drugs are for moderate-to-severe patients, 70% of the physicians surveyed said they were willing to use these drugs in patients with mild disease, too. Roughly 38% of patients in both ulcerative colitis and Crohn's have mild disease, according to the surveyed doctors.
In a phase 3 induction study reported in December, AbbVie's Rinvoq helped 26% of previously untreated moderate-to-severe ulcerative colitis patients achieve remission after eight weeks, significantly more than the 5% for the placebo group. The drug also met a range of secondary endpoints, including mucosal healing. At the time, industry watchers noted Rinvoq’s showing as superior to Xeljanz’ in its own trial, as well as the TNFs and IL-12/23s.
Gilead Sciences has a Galapagos-partnered JAK inhibitor, Jyseleca (filgotinib), in the U.S. After abandoning a plan to seek U.S. approval in rheumatoid arthritis, the company still holds rights in Crohn's disease. But SVB Leerink’s Geoffrey Porges previously suggested that Gilead wouldn't proceed with that indication either, given the drug’s lackluster showing in UC.
As for Xeljanz, its use was recently linked to an increased risk of cancer and serious cardiovascular events. The safety problem raised concerns of pan-class implications for other JAK inhibitors. But in the SVB Leerink survey, 52% of physicians said they would be willing to try a new drug in a given class if it showed better efficacy or safety.
“We believe this bodes well for AbbVie’s Rinvoq in the JAKi class as well as Arena Pharmaceuticals’ etrasimod in the S1P1 class, as both agents have shown superior efficacy and safety than first-in-class agents Pfizer’s Xeljanz and Bristol Myers Squibb’s Zeposia,” the SVB Leerink team wrote in the report.
Zeposia’s expected to learn the FDA's verdict on its ulcerative colitis use by May 30, with the help of a priority review.
In contrast, etrasimod has yet to report phase 3 data. Nevertheless, based on impressive phase 2 data that showed a 25.6% placebo-corrected clinical remission, the SVB Leerink team expects etrasimod would “gain the majority of S1P1 share despite its second-to-market position.” Overall, the survey suggests the S1P class as a whole will nab 11% patient share in two to three years.