AbbVie (NYSE: ABBV) today announced results from a Phase 3 pivotal study demonstrating that HUMIRA® (adalimumab) is effective in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa (HS), specifically the number of abscesses and inflammatory nodules. These data were presented at the 44th Annual European Society for Dermatological Research (ESDR) Meeting in Copenhagen, Denmark.
HS, sometimes referred to as "acne inversa" by dermatologists, is a chronic skin disease characterized by inflamed areas typically located around the armpits, groin, on the buttocks and under the breasts. A number of physical symptoms are associated with HS - namely, nodules and/or abscesses, sinus tracts and scarring. These symptoms make it a painful disease and impact the lives of patients with HS. HS is estimated to affect 1 percent of the general adult population. However, HS can be challenging to diagnose and many patients experience a lengthy delay in diagnosis and treatment. There is currently no cure for HS and there are no approved medications for the treatment of the disease. HUMIRA is not currently approved by regulatory authorities for the treatment of HS.
"The clinical signs of HS include nodules or abscesses. These can cause severe pain and foul-smelling discharge that can be upsetting for patients," said Alexa Kimball, M.D., M.P.H., PIONEER I Study Investigator, Medical Director at Massachusetts General Physicians Organization and Professor of Dermatology at Harvard Medical School. "Results of this study expand on previous work demonstrating that adalimumab can reduce the nodules and abscesses in patients with moderate-to-severe HS."
Results from the PIONEER I study show that moderate-to-severe HS patients treated with HUMIRA 40 mg weekly achieved a significantly greater response versus those on placebo at week 12 (41.8% versus 26%, p = 0.003). Response was defined as an improvement of HS related abscesses and inflammatory nodules at 12 weeks using the Hidradenitis Suppurativa Clinical Response (HiSCR) measure. This is defined as at least 50% reduction from baseline in total abscess and inflammatory nodule (AN) count with no increase for either abscess or draining fistula count.
Results from a second Phase 3 clinical trial, PIONEER II, also evaluating the safety and efficacy of HUMIRA in patients with moderate-to-severe HS, will be presented at an upcoming medical congress.
"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," said John Medich, Ph.D., vice president, Clinical Development, Immunology, AbbVie. "We are encouraged by the results of PIONEER I and look forward to sharing results from our second Phase 3 trial, PIONEER II."
In addition, AbbVie will be presenting other abstracts at ESDR today that include information about treatment satisfaction and health-related quality of life (abstracts #177 and #197).