Abbvie’s Phase III trial of Humira meets primary endpoint

14th September 2014 (Last Updated September 14th, 2014 18:30)

AbbVie has reported positive results from a Phase III pivotal trial, which was designed to evaluate the investigational use of Humira (adalimumab) in patients with moderate-to-severe hidradenitis suppurativa (HS).

AbbVie has reported positive results from a Phase III pivotal trial, which was designed to evaluate the investigational use of Humira (adalimumab) in patients with moderate-to-severe hidradenitis suppurativa (HS).

The Phase III PIONEER I trial met its primary endpoint and also showed that Humira is effective in reducing common clinical signs and symptoms in moderate-to-severe HS, specifically the number of abscesses and inflammatory nodules.

Dermatologists refer HS as acne inversa, which is a chronic skin disease characterised by inflamed areas typically located around the armpits, groin, on the buttocks, and under the breasts.

The trial showed that moderate-to-severe HS patients treated with Humira 40mg weekly achieved a significantly greater response versus those on placebo at week 12.

"Nodules and abscesses, sinus tracts and scarring are a number of physical symptoms associated with this skin disease."

Nodules and abscesses, sinus tracts and scarring are a number of physical symptoms associated with this skin disease.

Massachusetts General Physicians Organization medical director, Harvard Medical School Professor of Dermatology and PIONEER I Study Investigator Alexa Kimball said: "Results of this study expand on previous work demonstrating that adalimumab can reduce the nodules and abscesses in patients with moderate-to-severe HS."

Currently, there are no approved treatment options available for patients living with HS, which impacts about 1% of the adult population across the world.

AbbVie vice-president, Clinical Development, Immunology John Medich said: "This trial adds to our more than 17 years of clinical trial experience with Humira and demonstrates our ongoing commitment to addressing the unmet needs of patients with difficult-to-treat diseases like HS.

"We are encouraged by the results of PIONEER I and look forward to sharing results from our second Phase 3 trial, PIONEER II."

The most common adverse events (AEs) observed in PIONEER I with Humira versus placebo were exacerbation of HS, nasopharyngitis and headache. Serious AEs were observed in 2% of HUMIRA patients and 3.3% of placebo patients.

The company intends to report results at an upcoming medical congress from a second Phase III clinical trial called PIONEER II, also evaluating the safety and efficacy of Humira in patients with moderate-to-severe HS.