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news.US-based biopharmaceutical firm 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).
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The Phase III PIONEER I trial 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.
Sometimes dermatologists refer hidradenitis suppurativa as acne inversa, which is a chronic skin disease characterized by inflamed areas typically located around the armpits, groin, on the buttocks and under the breasts.
The trial demonstrated 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/or abscesses, sinus tracts and scarring are a number of physical symptoms associated with 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.
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.
AbbVie clinical development, immunology vice president John Medich said this trial adds to its more than 17 years of clinical trial experience with Humira and shows the company’s 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," Medich said.