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.
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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.
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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."
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By GlobalDataCurrently, 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.
