Results from a phase 3 pivotal study demonstrating that Adalimumab ( Humira ) is effective in reducing common clinical signs and symptoms in moderate-to-severe hidradenitis suppurativa ( HS ), specifically the number of abscesses and inflammatory nodules, were presented at the 44th Annual European Society for Dermatological Research ( ESDR ) Meeting in Copenhagen, Denmark.
Hidradenitis suppurativa, 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 hidradenitis suppurativa - namely, nodules and/or abscesses, sinus tracts and scarring. These symptoms make it a painful disease and impact the lives of patients with hidradenitis suppurativa.
Hidradenitis suppurativa is estimated to affect 1% of the general adult population. However, hidradenitis suppurativa can be challenging to diagnose and many patients experience a lengthy delay in diagnosis and treatment.
There is currently no cure for hidradenitis suppurativa and there are no approved medications for the treatment of the disease.
Results from the PIONEER I study have shown that moderate-to-severe hidradenitis suppurativa patients treated with Adalimumab 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 hidradenitis suppurativa 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.
PIONEER I is a phase 3, 36-week, multicenter, randomized, double-blind, two-period study in moderate-to-severe hidradenitis suppurativa patients ( n=307 ). In the first 12-week study period ( known as Period A ), patients were randomized to receive Adalimumab 160 mg at week 0, 80 mg at week 2 and 40 mg once weekly ( n = 153 ) starting at week 4, or placebo ( n = 154 ).
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 Adalimumab were re-randomized to receive Adalimumab 40 mg weekly, 40 mg every other week, or placebo.
Patients randomized to placebo were assigned to receive Adalimumab weekly.
The primary endpoint was the percentage of patients achieving a clinical response in improvement of hidradenitis suppurativa severity at 12 weeks using the HiSCR measure.
The results for Period B have not been presented.
The most common adverse events ( more than 5% of subjects in any treatment group ) observed in PIONEER I with Adalimumab versus placebo were exacerbation of hidradenitis suppurativa ( 9.2% vs. 13.2% ), nasopharyngitis ( 5.9% vs. 10.5% ) and headache ( 9.2% vs. 9.9% ).
Serious adverse reactions were observed in 2% of Adalimumab patients and 3.3% of placebo patients.
The reason why patients develop hidradenitis suppurativa is unclear; however, it is thought that an abnormal response in the body's own immune system plays a role. ( Xagena )
Source: Abbvie, 2014