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LEO Pharma announces more than half of patients on Kyntheum®cid:image002.png@01D32BE3.8EAE8950(brodalumab) maintain consistent levels of complete skin clearance for more than two years1

LEO Pharma
Posted on: 14 Sep 17

Ballerup, Denmark and Hurley, UK: LEO Pharma today announced new Phase III data broadening the evidence base for the efficacy, safety and quality of life benefits of Kyntheum® (brodalumab),1–3 a biologic treatment for people with moderate-to-severe plaque psoriasis. Results from a long-term open label extension study found brodalumab provided sustained high levels of skin clearance (PASI* 100) over more than two years in those with moderate-to-severe disease.1 Separate pooled analyses from the AMAGINE clinical trials showed that patients receiving brodalumab reported significant health-related quality of life improvements versus placebo.2,3 These data were presented at the 26th European Academy of Dermatology (EADV) annual congress in Geneva, Switzerland.

 

Psoriasis is a serious, lifelong condition impacting emotional, psychological and physical health.4 Although its systemic nature often remains unrecognised, people living with psoriasis are at an increased risk of developing serious associated conditions which further impact quality of life.5 The heavy and far-reaching burden of the disease can be disabling and stigmatising with a substantial negative impact on those affected and their families.4 For these reasons, lasting skin clearance of symptoms and plaques is an important treatment goal, especially for those with the most severe forms of the disease.6

 

Results from the AMAGINE-2 extension study confirmed brodalumab was able to deliver completely clear skin (PASI 100) in more than half of patients (56.2%, n=779) and almost clear skin (PASI 90) in more than three-quarters of patients (76.8%, n=779) after two years (120 weeks) of treatment.1 The proportions of patients achieving high levels of skin clearance were comparable to results at year one (week 52) (with 53% and 78% of patients achieving PASI 100 and PASI 90, in year one respectively).1 At week 120, brodalumab continued to be well-tolerated with a comparable safety profile, as observed in the 52-week study.1 The most common adverse events were nasopharyngitis (inflammation of the nose and pharynx), upper respiratory tract infection, arthralgia (joint pain), and headache.1

 

“These new data are encouraging as they demonstrate the potential long-term efficacy and safety of brodalumab and reinforce its ability to provide psoriasis patients with high levels of lasting skin clearance. It is important that people with moderate-to-severe plaque psoriasis have treatment options that help them to not only achieve clear, healthy skin, but also the capability to relieve the substantial burden the disease places on patients’ everyday lives, commented Professor Dr. Ulrich Mrowietz, Psoriasis Centre, University Medical Centre, Schleswig-Holstein, Germany.

 

The burden of psoriasis on quality of life is comparable to other chronic conditions like diabetes and heart diseases.7 Measuring improvements in health-related quality of life is important as they reflect a patient’s experience or perception of disease impact, which is not evaluated by PASI scores alone.8 New pooled analyses of the Phase III AMAGINE(-1,-2,-3) studies showed that significantly greater improvements in health-related quality of life were experienced with brodalumab compared with placebo, as measured by the Dermatology Quality of Life Index (DLQI) questionnaire.2,3 At week 12, up to 59% of brodalumab patients reported psoriasis had no impact on their overall quality of life compared to 6% of patients on placebo.3 This was experienced specifically with significant improvements across daily/leisure activities, as well as work/school lives.2 Furthermore, at week 12, 43% of brodalumab patients were no longer embarrassed or self-conscious about their psoriasis.3

 

“Psoriasis is not just a skin condition and the full impact of the disease is often underestimated,” said Gitte Pugholm Aabo, President and CEO, LEO Pharma. “At LEO Pharma we are dedicated to supporting patients with innovative treatment solutions such as brodalumab that can help patients to live a more positive life, clear of their skin condition.”

 

Brodalumab was granted marketing authorisation by the European Commission in July 20179 and is the first and only biologic that selectively targets the IL-17 receptor subunit A.10,11 By binding to this specific receptor on the cells of the skin, rather than targeting free inflammatory mediators, brodalumab blocks the biological activity of several pro-inflammatory IL-17 cytokines, which are involved in psoriasis plaque formation.10 This mechanism of action is different to all other psoriasis biologics currently available.11

A total of 16 brodalumab abstracts are being presented at the 2017 EADV annual congress.

 

* The Psoriasis Area and Severity Index (PASI) score is used in clinical trials to indicate a % change in disease, i.e. PASI 75 is defined as the proportion of patients that reach ≥ 75% improvement in Psoriasis Area and Severity Index score. PASI 90 or PASI 100 indicates patients who have achieved almost clear or complete skin clearance

The Dermatology Quality of Life Index (DLQI), is a tool commonly used by Dermatologists to assess the quality of life impact of skin disease across areas such as work and social activities as well as symptoms and patients’ feelings about their condition. The data presented at EADV refers to responses to specific sections of this overall DLQI questionnaire.

Editor's Details

Mike Wood
PharmiWeb.com
www.pharmiweb.com
editor@pharmiweb.com

Last updated on: 14/09/2017

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