Bimekizumab Demonstrated Long-Term Maintenance of Complete or Almost Complete Skin Disease Resolution for Psoriasis Patients in BE ABLE 2 Extension Study - Seite 3

About Bimekizumab
Bimekizumab is an investigational novel humanized monoclonal IgG1 antibody that potently and selectively neutralizes both IL-17A and IL-17F, two key cytokines driving inflammatory processes. IL-17A and IL-17F have similar pro-inflammatory functions and independently cooperate with other inflammatory mediators to drive chronic inflammation and damage across multiple tissues. 

Previous early phase clinical studies in psoriasis and psoriatic arthritis have suggested that bimekizumab's unique dual neutralization of both IL-17A and IL-17F may provide a new targeted approach for the treatment of immune-mediated inflammatory diseases.^{ix, x,xi} Preclinical results in disease-relevant cells have shown that neutralizing IL-17F in addition to IL-17A reduces skin and joint inflammation, as well as pathological bone formation to an extent greater than inhibition of IL-17A alone. ^{x, xii, xiii}

About BE ABLE
BE ABLE 1 is a multi-center, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study of bimekizumab compared with placebo in adult patients with moderate-to-severe chronic plaque psoriasis. In the 12-week BE ABLE 1 study, bimekizumab provided rapid, substantial clinical improvements in patients. After the initial 12-week treatment period, eligible patients enrolled in the Phase 2b extension study (BE ABLE 2), which assessed safety and efficacy of subcutaneous bimekizumab administered every four weeks for an additional 48 weeks. For those not enrolling in the extension study, a safety follow-up visit was conducted 20 weeks after the last dose of study medication.

BE ABLE 1 included 250 patients with chronic plaque psoriasis with an affected body surface area of at least 10% and PASI of at least 12. Patients were randomized into six dosing regimens to receive either placebo or bimekizumab every four weeks subcutaneously. Randomization was balanced across treatment groups.

BE ABLE 2 included 217 responders and non-responders from BE ABLE 1. Responders receiving placebo or bimekizumab 64mg, 160mg, 160mg (320mg loading dose [LD]) remained on the same dose. Non-responders, defined as

PASI is a score used by health care professionals to express the severity of psoriasis as measured by body surface area affected by the disease and severity of lesions. It is widely used to assess the skin improvement of people receiving treatment for psoriasis, particularly in clinical trials. In BE ABLE, efficacy was measured by the proportion of people who achieved a 90% improvement (PASI90, the primary efficacy variable) at week 12. By comparison, most previous trials in psoriasis have used the proportion of people who achieve a 75% improvement in the skin affected (PASI75), as the primary threshold for evaluating psoriatic skin clearance.