Clinical Trials

Date: 2014-09-11

Type of information: Presentation of results at a congress

phase: 3

Announcement: presentation of results at the 44th Annual European Society for Dermatological Research (ESDR) Meeting in Copenhagen, Denmark.

Company: Abbvie (USA - IL)

Product: Humira® (adalimumab)

Action mechanism: monoclonal antibody. Adalimumab binds specifically to TNF alpha and blocks its interaction with the p55 and p75 cell surface TNF receptors. Adalimumab also lyses surface TNF expressing cells in vitro in the presence of complement. Adalimumab also modulates biological responses that are induced or regulated by TNF, including changes in the levels of adhesion molecules responsible for leukocyte migration (ELAM-1, VCAM-1, and ICAM-1).

Disease: Hidradenitis Suppurativa

Therapeutic area: Dermatological diseases - Immunological diseases

Country:

Trial details: PIONEER I is a Phase 3, 36-week, multicenter, randomized, double-blind, two-period study in moderate-to-severe HS patients (n=307). 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 = 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 Humira® were re-randomized to receive Humira®  40 mg weekly, 40 mg every other week, or placebo. Patients randomized to placebo were assigned to receive Humira®  weekly. The primary endpoint was the percentage of patients achieving a clinical response in improvement of HS severity at 12 weeks using the HiSCR measure. The results for Period B have not been presented. (NCT01468207)

Latest news:

• • On September 11, 2014, AbbVie 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. 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).3 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 (NCT01468233), also evaluating the safety and efficacy of HUMIRA in patients with moderate-to-severe HS, will be presented at an upcoming medical congress.

Is general: Yes