Pfizer's Xeljanz shores up case for ulcerative colitis expansion

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Pfizer's Xeljanz is in line to break the blockbuster barrier in 2017.

Pfizer’s Xeljanz may have recently come up short in a key rheumatoid arthritis trial meant to set the drug apart from its peers. But detailed results on three ulcerative colitis trials are out, and they could help the med snag another approval to keep sales going up.

On Thursday, the New England Journal of Medicine published detailed findings from three phase 3 studies showing that Xeljanz topped placebo in inducing and maintaining remission among UC patients with moderate to severe forms of the disease.

Two of the trials, dubbed OCTAVE 1 and OCTAVE 2, showed that a significantly greater proportion of patients on Xeljanz were in remission at week 8 than those on placebo. In OCTAVE 1, the Xeljanz arm boasted 18.5% of patients in remission at the marker, versus 8.2% of the placebo group; in OCTAVE 2, 16.6% of Xeljanz patients had reached remission, versus just 3.6% of the placebo cohort.

The third trial, OCTAVE Sustain, evaluated certain participants from the previous two studies, finding that 34.3% of patients on the 5-mg Xeljanz dose and 40.6% of patients on the 10-mg dose had reached remission at week 52. Just 11.1% of the placebo group had achieved remission at the 52-week point.

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Still, whether the med “will be an essential therapy for ulcerative colitis remains to be determined in future trials,” Sonia Friedman, M.D., of Brigham and Women’s Hospital Center for Crohn’s and Colitis wrote in an NEJM editorial.

“Only a continued combination of human ingenuity, worldwide cooperation, and enthusiastic funding will allow investigators to further explore the mechanisms by which JAK inhibition ameliorates inflammation in patients with ulcerative colitis and to identify the specific subsets of patients who will most likely benefit from this new therapy,” she noted.

RELATED: Pfizer's solo Xeljanz can't match AbbVie's Humira in big RA head-to-head miss

For now, the data will help Pfizer on its quest for a new indication for the med, which recently came up short in a head-to-head RA showdown with AbbVie’s Humira. Recently, the med has expanded significantly, putting it in line for a blockbuster 2017 after a $927 million 2016 showing. But as many of Pfizer’s products did, it fell short of first-quarter expectations, posting $250 million versus Wall Street’s $288 million expectations.