Breaking News
April 20, 2019 - Texas A&M AgriLife becomes the newest member of NutriRECS international consortium
April 20, 2019 - In most states, insurance won’t cover addiction treatments
April 20, 2019 - Computer-based memory games may be beneficial for individuals with fragile X syndrome
April 20, 2019 - Timing of food intake influences molecular clock in the liver of mice
April 20, 2019 - Precise decoding of breast cancer cells paves way for new treatment option
April 20, 2019 - Scientists use 3D imaging to help model complex processes performed by placenta
April 20, 2019 - MediciNova Announces Plans to Move Forward with a Phase 3 Trial of MN-166 (ibudilast) in ALS
April 20, 2019 - Genetic variants that protect against obesity could aid new weight loss medicines
April 20, 2019 - New technology developed for microscopic imaging in living organisms
April 20, 2019 - when quitting cigarettes, consider using more nicotine, not less
April 20, 2019 - Key proteins can block Listeria without triggering the death of host cells
April 20, 2019 - Researchers create a working model of cerebral tract to study brain function
April 20, 2019 - New study shows that microbes can help break toxic chemical in dust
April 20, 2019 - Scientists use NIR light and injected DNA nanodevice to guide stem cells to injury
April 20, 2019 - Microbial Features ID’d for Pediatric Irritable Bowel Syndrome
April 20, 2019 - Study reveals patterns of drug intoxication deaths, organ donors across the US
April 20, 2019 - Scientists deploy CRISPR gene-editing tool to engineer multiple edits
April 20, 2019 - AHA News: Here’s How Middle-Aged People — Especially Women — Can Avoid a Heart Attack
April 20, 2019 - Charcot foot: MedlinePlus Medical Encyclopedia
April 20, 2019 - France to ban popular breast implants over cancer risk: media
April 20, 2019 - Researchers explore whether time of day can affect the body’s response to physical exertion
April 20, 2019 - CPAP brings longer life for obese people with sleep apnea: Study
April 20, 2019 - New discovery transforms conventional microfluidics into open-space microfluidics
April 20, 2019 - An accurate estimation of the overall cost of bacterial resistance in French hospitals during 2015 and 2016
April 20, 2019 - ‘PRO-cision Medicine’ approach helps personalize care for patients with cancer
April 19, 2019 - TG Therapeutics Receives Orphan Drug Designation for Umbralisib from the U.S. Food and Drug Administration for the Treatment of Marginal Zone Lymphoma
April 19, 2019 - Screen time—even before bed—has little impact on teen well-being: study
April 19, 2019 - Cytosurge’s first FluidFM User Conference
April 19, 2019 - New study finds that previously described differences among endoscopists are not true
April 19, 2019 - Study compares effectiveness and cost of gene therapy and HSCT in major beta-thalassemia
April 19, 2019 - Scientific breakthrough provides new hope for people living with multiple sclerosis
April 19, 2019 - New Virtual Reality Therapy game could offer relief for patients with chronic pain, mobility issues
April 19, 2019 - Emergency medicine doctors find better way to treat severe epileptic seizures in children
April 19, 2019 - MedlinePlus: Cholesterol Good and Bad
April 19, 2019 - For busy medical students, two-hour meditation study may be as beneficial as longer course
April 19, 2019 - Music therapy helps young patients feel better
April 19, 2019 - Molecular target UNC45A is essential for cancer cell proliferation and tumor growth
April 19, 2019 - Crackling and wheezing could be the sounds of a progressing lung disease
April 19, 2019 - Key research takeaways from ECCMID 2019
April 19, 2019 - AI Can Identify Model of Cardiac Rhythm Device From Chest X-Ray
April 19, 2019 - New way to combat childhood anxiety: treat the parents
April 19, 2019 - Women getting C-sections best judge of own pain medication needs | News Center
April 19, 2019 - Light-intensity physical activity associated with healthy brain aging
April 19, 2019 - Immune responses that prevent fungal infections may eliminate Trichinella spiralis
April 19, 2019 - Exercising in the morning, rather than at night, may yield better results, shows study
April 19, 2019 - Why eating ‘right’ could cause you to stray from your diet
April 19, 2019 - Health Tip: Antidepressant Precautions – Drugs.com MedNews
April 19, 2019 - Bigger portions lead to preschoolers eating more over time
April 19, 2019 - Specific strains of Staphylococcus aureus linked to wounds that do not heal
April 19, 2019 - Morning exercise may burn more calories
April 19, 2019 - Revolutionary discovery paves new way for treatment of necrotizing enterocolitis
April 19, 2019 - Drug that treats high blood pressure shows promise against neurodegenerative diseases
April 19, 2019 - More care is needed for patients after kidney transplantations, reports research
April 19, 2019 - Virtual reality offers benefits for Parkinson’s disease patients
April 19, 2019 - Liver Illness Strikes Latino Children Like A ‘Silent Tsunami’
April 19, 2019 - Disruptive behaviors in autistic children linked to reduced brain connectivity
April 19, 2019 - New insights into how vitamin D affects immune system
April 19, 2019 - Research sheds light on how hepatitis B virus establishes chronic infection
April 19, 2019 - New scoring system based on genetic markers predicts obesity risk at birth
April 19, 2019 - Pfizer Announces Presentation of Data from a Phase 2 Study of its 20-Valent Pneumococcal Conjugate Vaccine Candidate Being Investigated for the Prevention of Invasive Disease and Pneumonia in Adults Aged 18 Years and Older
April 19, 2019 - Exercise can improve non-motor symptoms of Parkinson’s disease
April 19, 2019 - Phasefocus to launch new cell imaging system
April 19, 2019 - KZFPs play a key role in the regulation of human genome
April 19, 2019 - DWK Life Sciences offers Workflow Solutions to improve productivity
April 19, 2019 - Bedfont wins 2nd accolade at the South East FSB Awards 2019
April 19, 2019 - Extracts of ginkgo seeds show antibacterial activity on pathogens that cause skin infections
April 19, 2019 - Groundbreaking experiment in pigs challenges the notion about brain damage
April 19, 2019 - Improving the quality of digital pathology imaging
April 19, 2019 - Scientists get closer to injecting artificial lymph nodes into people to fight disease
April 19, 2019 - Exercises and swimming goggles may reduce adverse effects on eye during long spaceflights
April 19, 2019 - Review suggests a reciprocal relationship between obesity and self-control
April 19, 2019 - Synthetic biologists add analog-to-digital signal processing to genetic circuitry of living cells
April 19, 2019 - Study identifies how enterococci bacteria cause antibiotic-resistant bloodstream infections
April 19, 2019 - Triple negative breast cancer develop resistance to chemotherapy by turning on molecular pathway
April 19, 2019 - Researchers identify key clues to brain and pancreas development
April 19, 2019 - Metformin May Cut Risk for Prematurity, Miscarriage in PCOS
April 19, 2019 - Obese mouse mothers trigger heart problems in offspring
April 19, 2019 - Research sheds light on how leukemia cells become resistant to drugs
April 19, 2019 - Health Tip: Stopping Nosebleeds – Drugs.com MedNews
April 19, 2019 - Pediatric endocrinologist gives iconic ‘Mona Lisa’ a second medical opinion
Bimekizumab Demonstrated Long-Term Maintenance of Complete or Almost Complete Skin Disease Resolution for Psoriasis Patients in BE ABLE 2 Extension Study

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

image_pdfDownload PDFimage_print

Brussels, Belgium – 2 March 2019 – UCB, a global biopharmaceutical company, presented positive data from the Phase 2b BE ABLE extension study of bimekizumab in patients with moderate-to-severe chronic plaque psoriasis, which showed nearly all BE ABLE 1 responders completing 60 weeks of bimekizumab treatment maintained complete or almost complete skin clearance. The results are the longest-term data so far investigating bimekizumab and further highlight the potential value of the molecule’s unique dual mechanism of action, which potently and selectively neutralizes IL-17F in addition to IL-17A, two key cytokines driving inflammatory processes. Findings were presented at a late breaker session at the American Academy of Dermatology Annual Meeting (AAD) in Washington, DC.

“The long-term results observed in the BE ABLE 2 Phase 2b study suggest the meaningful difference that IL-17F inhibition, along with IL-17A inhibition, can make for psoriasis patients who need significant, long-term skin clearance,” said Andrew Blauvelt, MD, MBA, an investigator in the trial and President of Oregon Medical Research Center in Portland, Oregon. “The results add to a growing body of evidence supporting the molecule’s unique dual neutralization of both IL-17A and IL-17F cytokines across multiple inflammatory diseases, suggesting exciting potential.”

“Despite recent advances in therapy, psoriasis patients still have profound unmet needs. Many patients do not experience long-term symptom resolution, and they often have limited confidence in long-term treatments. The positive results and rapid development of bimekizumab in psoriasis reflect UCB’s dedication to connecting scientific innovation with greater patient value,” said Emmanuel Caeymaex, Head of Immunology and Executive Vice President at UCB.

In the BE ABLE 1 study, up to 79% of patients achieved at least 90% skin clearance (PASI90) as soon as week 12, based on a dose range of 64mg, 160mg, 160mg with a 320mg loading dose, 320mg, or 480mg, administered every four weeks. Among these BE ABLE 1 responders, defined as achievement of PASI90 at week 12, 80-100% maintained the rigorous PASI90 measure for up to an additional 48 weeks based on a dose range of 160mg or 320mg, administered every 4 weeks, in the BE ABLE 2 extension study. Further, 70-83% and 78-100% of BE ABLE 1 responders maintained PASI100 and the Investigator’s Global Assessment of response, respectively. The safety profile was consistent with previous studies, with no new safety findings observed. The most frequent treatment-emergent adverse events were oral candidiasis and nasopharyngitis. No cases of suicidal ideation/behavior, major adverse cardiac events, or inflammatory bowel disease were reported.

UCB also presented findings this week from the BE AGILE study of bimekizumab in ankylosing spondylitis and the BE ACTIVE study of bimekizumab in psoriatic arthritis. The safety and efficacy of bimekizumab have not been established, and it is not approved by any regulatory authority worldwide.

About Psoriasis

Psoriasis is a chronic, immune-mediated inflammatory disease associated with prominent skin manifestations that affects approximately 1–3% of the population, or about 125 million people worldwide, although rates appear to vary by ethnicity, and estimates are sensitive to determination method.i Psoriatic arthritis occurs in up to 41% of patients with psoriasis,ii and is typically characterized by inflammation, pain and swollen joints.iii

Unmet needs remain in the treatment of psoriasis. A population-based survey identified that approximately 30% of psoriasis patients reported that their primary goals of therapy, including keeping symptoms at bay, reducing itching, and decreasing flaking were not met with their current treatment. iv Failure to achieve or retain complete and lasting disease resolution across the multiple manifestations of psoriatic disease, including joints and other musculoskeletal symptoms, negatively impacts risk of comorbidities, disease progression and quality of life, which is most likely multifactorial.v, vi, vii,viii

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.

The secondary efficacy variables assessed in BE ABLE were Investigator’s Global Assessment of response (IGA) defined as clear or almost clear skin with at least 2 category improvement from baseline at week 8 and at week 12, PASI90 response at week 8, PASI75 response at week 12, and PASI100 response at week 12.

Source: UCB

Posted: March 2019

Tagged with:

About author

Related Articles