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Phase III Data Show Mucosal Healing With Humira (Adalimumab) in Ulcerative Colitis

‘Clinically relevant’ healing significantly greater versus placebo (Oct. 23)

Results have been announced from a post hoc subanalysis of the 52-week ULTRA 2 trial of Humira (adalimumab). Results of the analysis showed clinically meaningful rates of mucosal healing at week 52 in patients with moderately to severely active ulcerative colitis (UC) who failed, were intolerant of, or had contraindications to certain other medications and achieved a response to Humira induction therapy at 8 weeks.

The analysis of the ULTRA 2 trial focused on mucosal healing — defined as a Mayo endoscopy subscore of 0 or 1 — in adult patients with moderately to severely active UC who failed conventional therapy and who responded to induction therapy with Humira after 8 weeks. The results were based on the full Mayo score (FMS) or the partial Mayo score (PMS). The PMS evaluates stool frequency, rectal bleeding, and physician's global assessment as a measure of disease activity ranging from 0 to 9, but it does not include endoscopic findings, whereas the FMS does.

Of the 494 patients included in the analysis and who responded at 8 weeks, significantly more patients treated with Humira versus placebo achieved clinically relevant rates of mucosal healing at week 52 (FMS responders: 40.8%; PMS responders: 43.1%; placebo: 15.4%; P < 0.001). Similar treatment effects at week 52 were observed regardless of prior use of anti–tumor necrosis factor (TNF).

The results were presented this week at the American College of Gastroenterology (ACG) Annual Scientific Meeting in Las Vegas, Nev.

UC is an inflammatory bowel disease marked by ulcers in the colon and that may lead to life-threatening complications. It is estimated that 25% of patients with UC may undergo surgical removal of the colon during their lifetimes, leaving patients with a permanent colostomy or ileal pouch.

ULTRA 2 was a 52-week, double-blind, randomized, placebo-controlled phase III trial of 494 adult patients with moderately to severely active UC despite concurrent or prior treatment with immunosuppressants (i.e., corticosteroids, azathioprine, or 6-mercaptopurine). The patients were randomly assigned to receive Humira (160 mg at week 0; 80 mg at week 2; and 40 mg every other week starting at week 4) or placebo. Patients, including those assigned to receive placebo, continued concurrent therapy, such as corticosteroids, aminosalicylates, and immunosuppressants. Co-primary endpoints were the proportions of patients with clinical remission at week 8 and week 52. Clinical remission was defined as a Mayo score of 2 or less, with no individual subscore greater than 1.

Of the 248 patients treated with Humira in the ULTRA 2 trial, 17% achieved clinical remission compared with 9% of those given placebo at week 8 (P < 0.05). Similarly, 17% of the Humira group and 9% of the placebo group achieved clinical remission at week 52 (P < 0.05).

Humira is indicated for the treatment of moderately to severely active UC in adult patients who have had an inadequate response to conventional therapy, including corticosteroids and 6-mercaptopurine or azathioprine, or who are intolerant to or have medical contraindications for such therapies.

Source: Abbott, October 23, 2012.

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