The first look at pivotal data for Rinvoq (upadacitinib) as induction therapy for ulcerative colitis (UC) that did not disappoint as the JAK inhibitor proved clearly superior to placebo and, per cross-study comparisons, looks more effective than its classmate Xeljanz (tofacitinib) from Pfizer. AbbVie’s most important task for driving uptake appears to be assuaging fears about the risks tied to all JAK inhibitors.
To provide FirstWord readers with rapid feedback on where Rinvoq is likely to fit into the evolving UC treatment algorithm, we are hosting an expert call with a key opinion leader (KOL) next week.
Key topics that will be discussed during the call include, among other things… what stands out most about Rinvoq's top-line performance in the Phase IIb/III U-ACHIEVE trial; how do these initial results stack up relative to your expectations; how does Rinvoq's risk/benefit profile compare to potential competitors such as Xeljanz, Bristol Myers Squibb's Zeposia (ozanimod) and biologics like Takeda's Entyvio (vedolizumab) and Johnson & Johnson's Stelara (ustekinumab); is there enough of an improvement (based on cross-study comparisons) to conclude Rinvoq has an edge on efficacy over Xeljanz and/or the biologics; any obvious explanation for why Rinvoq's placebo-adjusted remission rate jumped from 10% in Phase II to 21% in Phase III; what are your biggest concerns about Rinvoq's safety profile and how, if at all, might this impact use of the drug in UC; is the risk of gastric perforation likely to be prohibitive for some/much of the population; will the existing black box warning be an issue for gastroenterologists; what drug(s) is Rinvoq likely to compete most directly with and how does it measure up; is there any reason to think that Rinvoq's risk/benefit will be different in the maintenance setting; do you foresee Jyseleca (filgotinib) from Gilead Sciences/Galapagos being a serious competitor in the UC arena; and if you had to estimate how much of the UC population will end up being treated with each of the available medicines?
Ask the expert!
Furthermore, we invite FirstWord Pharma readers to submit their own questions for consideration. Please click here to do so. We can't guarantee that all questions submitted will be asked due to time constraints, but we will do our utmost to cover the important issues relating to the use of JAK inhibitors and other new therapies for the treatment of UC.
We endeavour to provide feedback from KOLs as quickly as possible. Interview content will be published for FirstWord Pharma PLUS subscribers to read. To be notified when the interview content is available please click here.
As always, FirstWord Pharma would very much like to receive your feedback and suggestions.
To read more KOL Views articles, click here.