Daily J&J pill keeps ulcerative colitis in check for 76 weeks
A once-a-day pill from Johnson & Johnson kept working for many people with ulcerative colitis through 76 weeks, Medscape and HCPLive reported. The drug, icotrokinra, is already approved to treat the skin disease psoriasis. Both outlets said no new safety problems turned up in the long study.
A once-daily pill, icotrokinra, kept working for about a year and a half in adults with moderate to severe ulcerative colitis, according to long-term study results reported by Medscape and HCPLive.
The data from the ANTHEM-UC study were presented at the American College of Gastroenterology meeting in Nashville, both outlets reported. First results from the trial are being published this week in The New England Journal of Medicine, Medscape reported.
Icotrokinra, made by Johnson & Johnson, blocks a signal called IL-23, Medscape reported. Other drugs that block it must be given by shot or infusion. The pill was approved earlier this year as Icotyde for plaque psoriasis.
In the main trial, 252 patients got one of three doses or a placebo, Medscape reported. All three doses met the main goal at week 12.
Of 136 patients who entered the long-term extension, most still had a clinical response at week 76, Medscape and HCPLive reported. Clinical remission at week 76 ranged from 56.3% to 59.1% across the three doses, Medscape reported. Of those in remission, 97% were off steroids, both outlets reported.
"The big advance here is to have an oral agent, icotrokinra, that can inhibit IL-23 very well and is quite effective with a once-a-day dose," said first author Dr. Maria Abreu of Cedars-Sinai in a press statement, Medscape reported.
No new safety signals were found, both outlets reported. One case of ductal carcinoma in situ, a form of breast cancer, was reported in the 100 mg group, and it was not tied to the drug, Medscape reported.
"Before they get to a subQ or an IV infusion, I think this is going to be very, very legit," Abreu told HCPLive. "It's very effective. It's very safe."
The study was funded by Johnson & Johnson, and Abreu has ties to the company, Medscape reported.
What we know: Most patients in the extension still responded at week 76, with no new safety signals.
What we don't: Whether larger Phase 3 trials will confirm the results in ulcerative colitis.
Where outlets agree Medscape and HCPLive both report that most of the 136 extension patients still responded to icotrokinra at week 76.
Where they differ Medscape reports that 85% of extension patients stayed on treatment through week 78, while HCPLive reports that 87% did.