The U.S. inflammatory bowel disease (IBD) market is seeing a shift in what drugs patients are offered for their first prescriptions. Doctors appear to be favoring the most recently approved drugs from the likes of Bristol Myers Squibb and AbbVie over older TNF therapies, according to a new report by Spherix Global Insights, a healthcare data consultancy.
Anti-TNF drugs for IBD conditions such as Crohn’s disease (CD) and ulcerative colitis (UC) have been on the market for nearly three decades and include huge blockbuster drugs such as AbbVie’s $20 billion-a-year Humira, Johnson & Johnson’s Remicade and Simponi and UCB’s Cimzia. For years, TNF inhibitors have been the go-to drugs for patients after they failed on methotrexate and could also be used as a first-line treatment at a doctor's discretion.
While newer drugs like Takeda's Entyvio and J&J’s Stelara have stolen market share from TNFs over the years since their approval, Spherix's latest analysis shows that even newer drugs are growing their share of prescriptions. That conclusion comes from Spherix this year tracking and analyzing 1,013 charts of U.S. IBD patients who were starting on medication for the first time. TNFs are now “substantially less likely to be used first-line compared to prior years,” while newer brands with alternative mechanisms of action (AMOAs) are now “increasingly popular,” the consultancy Spherix said in a release.
Spherix has found that over the past 18 months in the U.S., drugs with different ways of working from anti-TNFs, specifically BMS’ Zeposia and AbbVie's Rinvoq for the treatment of UC and AbbVie's Skyrizi in CD, “have had material changes to new start IBD treatment patterns,” Spherix said in its report.
When looking at new starters in UC, Zeposia, a first-in-class S1P receptor modulator, “has made substantial inroads as a pre-biologic option, capturing a sizeable portion of first-line patients,” Spherix found.
This is because, Spherix notes, the drug (which is also approved in multiple sclerosis) can be taken orally, rather than as an injection, according to its report, with analysis saying the uptick in uptake is also down to “perceived efficacy and unique MOA.”
Zeposia was FDA-approved in UC last May and is slated to make anywhere from $1.6 billion to a high of $5 billion at peak, depending on which analyst you ask (and how many extra approvals it can pick up). Rinvoq got the FDA green light in UC in March, with sales forecasts reaching $7.5 billion at peak annual sales.
Zeposia had a tough launch in MS, coming after a two-year roller coaster (that included an FDA rejection) to even get approved, and COVID-19 issues also affected sales. The company hopes the drug will have a smoother ride in UC. This uptick in Zeposia most directly impacted AbbVie's Humira prescriptions, Spherix found.
Spherix also found that CD new prescription patterns changed because of the newest drug in the CD market: AbbVie’s Skyrizi. The drug nabbed an FDA approval in CD this June
“With just a few short months on the market, the IL-23 inhibitor has made significant advances in the first-line CD treatment algorithm, with prescribers stating the perceived efficacy and targeted MOA as the top drivers behind use,” the report’s authors note.
First-line use of two other AMOAs are seeing a mixed bag of results, Spherix noted. Takeda's Entyvio and J&J’s Stelara—older drugs compared to the likes of Zeposia, Rinvoq and Skyrizi—both “stabilized” this year after seeing year-over-year gains. Entyvio was FDA-approved for UC and Crohn's back in 2014, and J&J’s Stelara was greenlighted for UC in 2019.
It noted that Entyvio is “now the most widely prescribed first-line brand,” coming amid major TNF declines.
But the firm said both brands “are also leaving the most on the table.” Spherix’s so-called “missed opportunity analysis,” which shows how many patients use a different drug when their first choice is ruled out, shows both meds “were in consideration to garner an additional one-fifth of the new start patients but were ultimately passed over,” the report found.