AbbVie, a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories, announced new results from PIONEER II, a pivotal phase 3 study, demonstrating the effect of Humira (adalimumab) in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa (HS), specifically the number of abscesses and inflammatory nodules.
Data were presented as a late-breaking abstract at the 23rd Congress of the European Academy of Dermatology and Venereology (EADV) meeting in Amsterdam. The results of this study, in combination with previously presented results from PIONEER I, will contribute to worldwide regulatory filings for an expanded use of Humira. Humira is not currently approved by regulatory authorities for the treatment of HS.
Results from the PIONEER II study found that at 12 weeks, patients with moderate-to-severe HS treated with HUMIRA 40 mg weekly, beginning at week 4 (after HUMIRA 160 mg at week 0 and 80 mg at week 2), achieved a statistically significant greater response compared to those on placebo (58.9 per cent versus 27.6 per cent, p<0.001). 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 percent reduction from baseline in total abscess and inflammatory nodule (AN) count with no increase for either abscess or draining fistula count.
"HS is painful due to abscesses and nodules, yet there are few treatment options available to help reduce symptoms," said Gregor Jemec, M.D., PIONEER II Study Investigator and Professor of Dermatology at University of Copenhagen, Roskilde Hospital. "Results from the PIONEER trials support the potential for adalimumab to be an important new treatment option for patients with HS."
HS, sometimes referred to as "acne inversa" by dermatologists, is a chronic skin disease characterised 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 per cent of the general adult population and can be challenging to diagnose as 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.
The PIONEER II study is the second pivotal registration study to evaluate the use of Humira in patients with moderate-to-severe HS. Results from PIONEER I also found that moderate-to-severe HS patients treated with Humira 40 mg weekly beginning at week 4 (after 160 mg at week 0 and 80 mg at week 2) achieved a significantly greater response (as measured with HiSCR) compared to placebo at week 12 (41.8 per cent versus 26 per cent, p = 0.003).
"AbbVie is committed to developing new treatment strategies as part of our focus to helping patients with the most pressing health issues, such as HS," said John Medich, Ph.D., vice president, Clinical Development, Immunology, AbbVie. "We are encouraged by these positive results from the PIONEER trials, which add to the wealth of Humira's clinical trial experience over the past 17 years."
PIONEER II is a phase 3, 36-week, multicenter, randomised, double-blind, two-period study in moderate-to-severe HS patients (n=326). In the first 12-week study period (known as Period A), patients were randomized to receive Humira 160 mg at week 0, 80 mg at week 2 and 40 mg once weekly (n = 163) starting at week 4, or placebo (n = 163). Following Period A, patients were eligible to enroll in a 24-week treatment period (known as Period B). In Period B, patients originally randomized to Humira were re-randomised to receive Humira 40 mg weekly, 40 mg every other week, or placebo. Patients randomised to placebo in Period A remained on placebo in Period B. The primary endpoint was the percentage of patients achieving significant response in improvement of HS severity at 12 weeks using the HISCR measure. The results for Period B have not been presented.
The most common adverse events (AEs) (>10 per cent of subjects in any treatment group) observed in PIONEER II with Humira versus placebo were headache (12.9 per cent versus 12.9 per cent) and exacerbation of HS (4.3 per cent versus 12.9 per cent). Serious AEs in patients receiving Humira included infection unknown source (n=1) and acute renal failure (n=1)
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