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AbbVie Presents Phase II Data Evaluating The Efficacy Of HUMIRA® (adalimumab) In Patients With Hidradenitis Suppurativa (HS), A Chronic Inflammatory Skin Disease

NORTH CHICAGO, Ill., Oct. 3, 2013 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced results from a post-hoc analysis of an investigational Phase II study, which evaluated HUMIRA ® (adalimumab) in the treatment of patients with moderate-to-severe hidradenitis suppurativa (HS) after 16 weeks of therapy. 1 Efficacy results were reported using a novel Hidradenitis Suppurativa Clinical Response (HiSCR) endpoint that was developed in consultation with regulatory health authorities. These data, which analyze the reduction of total abscess and inflammatory nodule (AN) count from baseline, were presented at the 22 nd Congress of the European Dermatology and Venereology (EADV) meeting in Istanbul, Turkey. 1 HUMIRA is not approved by health authorities for the treatment of HS.

The post-hoc analysis found that HUMIRA induced a significant response rate in adult patients with moderate-to-severe HS at week 16 versus placebo (pbo) for the two dosing regimens assessed. The efficacy of HUMIRA was re-assessed in this analysis by using the HiSCR measure, which is an endpoint defined as at least a 50 percent reduction from baseline in total AN count, with no increase in counts for abscesses and draining fistulas. Specifically, HiSCR response rates for HS patients given pbo, HUMIRA every other week (eow) or HUMIRA weekly (ew) were 25.6 percent (11/43), 33.3 percent (15/45) and 54.5 percent (24/44), respectively. 1 In addition, this analysis provides initial evidence that HiSCR is a more responsive method to determine improvement in patients than HS-physician-global assessment (PGA) based on clinical response and demonstrate that HiSCR may be a useful new tool to assess the efficacy of HS therapy in clinical practice and research trials.

"Although hidradenitis suppurativa affects a significant number of people, there is no approved treatment option for this underserved patient group," said Gregor Jemec, M.D., Department of Dermatology, University of Copenhagen, Roskilde Hospital. "These Phase II study results suggest HUMIRA could be a promising therapeutic option in patients with moderate-to-severe HS and will be further evaluated in Phase III trials."

Hidradenitis suppurativa is a chronic, often painful, immune-mediated disease characterized by inflamed areas, typically located around the armpits and groin. 2,3 Mild cases of HS can resemble small bumps or blackheads, while patients with more severe forms can have multiple interconnected sinus tracts and abscesses, which sometimes release fluid. Progression of the disease can lead to significant pain and discomfort and may result in scarring. 2,3,4 Currently, there is no cure or approved treatment for HS by any regulatory health authorities, which is estimated to affect one percent of the general adult population. 3

"AbbVie developed the HiSCR endpoint to help advance hidradenitis suppurativa research and address the need for a reliable and relatively simple measure of clinical response in HS," said John Medich, Ph.D., vice president, Clinical Development, Immunology, AbbVie. "We are excited that HiSCR has the potential to be a useful method to assess the efficacy of HS therapies in research and in clinical practice."

Two fully-enrolled Phase III clinical trials (PIONEER I and PIONEER II) are underway to evaluate the safety and efficacy of HUMIRA in approximately 600 adult patients with moderate-to-severe HS. Results of these Phase III trials are expected in 2014. More information on these trials is available at www.clinicaltrials.gov (NCT01468207 and NCT01468233).

About the Study

In the Phase II trial, the HS-PGA, one of the current methods for measuring HS severity, was used to evaluate the clinical response of HUMIRA at 16 weeks. 1,5 These study findings correlate with the HS-PGA data published previously, which was the primary efficacy variable of the study. At week 16, 3.9 percent (2/51), 9.6 percent (5/52) and 17.6 percent (9/51) of patients in the pbo, eow and ew groups, respectively, achieved an HS-PGA of clear, minimal, or mild, with at least a 2-grade improvement relative to baseline (P<0.05 for ew compared to pbo).

This post-hoc analysis evaluated HS patients with a baseline AN count of >3 and draining fistula count of <20 in the three study arms: pbo (n=43), HUMIRA 40 mg eow after an initial loading dose (n=45) or HUMIRA 40 mg ew after initial loading doses (n=44). 1,5 Patients were assessed based on several retrospective evaluations including achieving HS-PGA-based clinical response; HiSCR; 50 percent, 75 percent, 100 percent reduction in total AN count (AN50, AN75, AN100) relative to baseline and percent change from baseline in AN count.

The safety findings observed in the randomized study population (n=154) were consistent with those seen in previous HUMIRA studies. 5 The most common adverse events (AEs) ( >10 percent of subjects in any treatment group) observed in the HUMIRA eow arm at week 16 of the study versus placebo were headache (13.5 percent vs. 3.9 percent), nasopharyngitis (13.5 percent vs. 11.8 percent) and hidradenitis (13.5 percent vs. 11.8 percent). The most common AEs observed in the HUMIRA ew arm of the study versus placebo were headache (15.7 percent vs. 3.9 percent), nasopharyngitis (11.8 percent vs. 11.8 percent) and hidradenitis (7.8 percent vs. 11.8 percent).

The findings from this analysis supplement the initial presentation at the 2013 American Academy of Dermatology (AAD) Annual Meeting.

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