Pivotal trial results for bimekizumab (Bimzelx) in moderate to severe plaque psoriasis were published on 2021-01-01. The BE READY study confirmed the efficacy and safety profile of bimekizumab in adult subjects with this condition.

Background

The BE READY study investigated bimekizumab for the treatment of adult subjects diagnosed with moderate to severe chronic plaque psoriasis. This debilitating autoimmune condition is characterized by well-demarcated, erythematous plaques covered with silvery scales, often causing itching, pain, and significant impact on a patient's physical and psychological well-being. Effective treatments are crucial for managing symptoms and improving quality of life for individuals with this persistent inflammatory skin disorder.

Trial design

The BE READY study was a multicentre, double-blind, placebo-controlled, randomised withdrawal phase trial. This design typically involves an initial open-label or placebo-controlled induction period where all participants receive the active drug or placebo, followed by a randomized withdrawal period. In the withdrawal phase, responders to the active treatment are re-randomized to continue on the drug or switch to placebo, allowing for evaluation of sustained efficacy and safety. The study aimed to evaluate the long-term efficacy and safety profile of bimekizumab in adult subjects with moderate to severe chronic plaque psoriasis.

What this means

The publication of the BE READY study's pivotal results marks an important milestone for bimekizumab in the treatment of moderate to severe plaque psoriasis. Confirmation of its efficacy and safety profile in a placebo-controlled, randomised withdrawal trial supports its potential as a therapeutic option for patients living with this chronic skin condition. These findings are crucial for informing regulatory bodies and clinicians about the drug's benefits and risks.

Source

The information regarding the efficacy and safety of bimekizumab in moderate to severe plaque psoriasis was published in The Lancet on 2021-01-01. This pivotal publication, titled "Bimekizumab efficacy and safety in moderate to severe plaque psoriasis (BE READY): a multicentre, double-blind, placebo-controlled, randomised withdrawal phase", is accessible via PubMed at pubmed.ncbi.nlm.nih.gov.