• Dermatology Clinical Trials
• Skin Diseases

• Dermatology
• Dermatology Clinical Trials
• Skin Diseases

Hidradenitis suppurativa (HS) is a chronic, painful skin disease for which there is currently no approved treatment. Results from the Efficacy and Safety Study of Adalimumab in the Treatment of Hidradenitis Suppurativa [PIONEER II; NCT01468233] presented by Gregor Jemec, MD, University of Copenhagen, Roskilde, Denmark, show that patients with moderate-to-severe HS who are treated with adalimumab experience a clinically relevant reduction in objective disease activity and pain after 12 weeks.

HS is characterized by recurrent inflamed nodules, abscesses, and fistulas predominantly in the axillary, inguinal, and breast folds and the anogenital regions [Kurzen H et al. Exp Dermatol. 2008]. Adalimumab has been shown to alleviate moderate-to-severe symptoms and pain [Kimball A et al. Ann Intern Med. 2012] and improve treatment satisfaction among patients with HS [Jemec GB et al. J Invest Dermatol. 2014].

PIONEER II was a 12-week, phase 3, placebo-controlled trial designed to evaluate the safety and efficacy of adalimumab versus placebo in patients with moderate-to-severe HS. Subjects (n = 326) with a diagnosis of HS for ≥ 1 year, a total abscess and inflammatory nodule count ≥ 3, HS lesions in ≥ 2 body areas (1 at Hurley stage II or III), and no prior tumor necrosis factor-α-inhibitor treatment were randomized 1:1 to adalimumab (40 mg weekly after a loading dose of 160 mg at week 0 and 80 mg at week 2) or matching placebo.

The primary efficacy measure was HS Clinical Response (HiSCR; defined as ≥ 50% reduction from baseline in abscess and inflammatory nodule count, and no increase in abscess or draining fistula counts) at week 12. Patients (about 66% women) had a mean age of about 35 years, mean duration of disease of about 11 years, and mean numeric rating scale skin pain (worst in the prior 24 hours) of 4.5.

At 12 weeks, the HiSCR rate was significantly higher for patients treated with adalimumab (58.9%) compared with those receiving placebo (27.6%; P < .001). The effect was seen as early as week 2 and sustained to week 12.

Among patients with Hurley stage II, significantly more adalimumab-treated patients had an abscess and inflammatory nodule count of 0, 1, or 2 (adalimumab 51.8% vs placebo 32.2%; P ≤ .01). The effect was seen at week 2 and sustained throughout time.

Among patients with a baseline numeric rating scale for pain ≥ 3, significantly more adalimumab-treated patients had a 30% reduction and ≥ 1 unit reduction in the Patients' Global Assessment of Skin Pain numerical rating scale based on 24-hour recall of worst pain (adalimumab 45.7% vs placebo 20.7%; P < .001). Adalimumab-treated patients also achieved a significantly greater mean reduction from baseline in modified Sartorius score (adalimumab −28.9 vs placebo −9.5; P < .001).

At least 1 treatment-emergent adverse event (TEAE) was reported by 57.7% of adalimumab-treated patients and 66.9% of placebo-treated patients. TEAEs reported by ≥ 5% of adalimumab-treated patients were headache (12.9% of patients) and nasopharyngitis and diarrhea (5.5% each). There were no deaths. Prof Jemec concluded that AEs were comparable to the placebo group and consistent with the safety profile of adalimumab.

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