LEO Pharma announces more than half of patients on Kyntheum® (brodalumab) maintain consistent levels of complete skin clearance for more than two years

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LEO Pharma today announced new Phase III data broadening the evidence base for the efficacy, safety and quality of life benefits of Kyntheum ^® (brodalumab), a biologic treatment for people with moderate-to-severe plaque psoriasis. Results from a long-term extension study found Kyntheum^® provided sustained high levels of skin clearance (PASI^I 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 Kyntheum^® reported significant health-related quality of life improvements versus placebo.^2,3 These data were presented at the 26^th European Academy of Dermatology (EADV) annual congress in Geneva, Switzerland.

Psoriasis is a serious, lifelong condition impacting emotional, psychological and physical health. 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.⁴ 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.⁵ 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.⁵

Results from the AMAGINE-2 extension study confirmed Kyntheum^® 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, Kyntheum^® 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 Kyntheum ^® 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.⁶ 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.⁷

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 Kyntheum^® compared with placebo, as measured by the Dermatology Life Quality Index (DLQI)^II questionnaire.^2,3 At week 12, 59% of Kyntheum^® 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 Kyntheum^® 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 Kyntheum ^® that can help patients live a more positive life, clear of their skin condition.”

Kyntheum^® was granted marketing authorisation by the European Commission in July 2017⁸ and is the first and only biologic that selectively targets the IL-17 receptor subunit A.^9,10 By binding to this specific receptor on the cells of the skin, rather than targeting free inflammatory mediators, Kyntheum^® blocks the biological activity of several pro-inflammatory IL-17 cytokines, which are involved in psoriasis plaque formation.^10,11,12 This mechanism of action is different to all other psoriasis biologics currently available.^10,13

A total of 16 Kyntheum^® abstracts are being presented at the 2017 EADV annual congress.

- ENDS-

NOTES TO EDITORS

About Kyntheum ^®

Kyntheum^® (brodalumab) is the only fully human monoclonal antibody that selectively targets the IL-17 receptor subunit A.^10,13 By binding to the receptor with high affinity, Kyntheum^® effectively blocks the biological activity of several pro-inflammatory IL-17 cytokines, which are important in psoriasis.^ý13,14

The psoriasis clinical studies programme for Kyntheum^® consisted of three clinical trials; AMAGINE-1 (n=661), AMAGINE-2 (n=1831) and AMAGINE-3 (n=1881).^15,16 Results showed Kyntheum^® 210mg offered more patients complete skin clearance (PASI 100) at 12 weeks compared to patients treated with ustekinumab [AMAGINE-2: 44% (n=272) versus 22% (n=65), p<0.001; AMAGINE-3: 37% (n=229) versus 19% (n=58), p<0.001].¹⁵

In AMAGINE-1 83% of patients on Kyntheum^® 210mg achieved PASI 75 compared to 3% of patients treated with placebo at 12 weeks [83.3% (n=185) versus 2.7% (n=6), p<0.001] and 76% of patients achieved sPGA^III success versus 1% of patients treated with placebo [75.7% (n=168) versus 1.4% (n=3), p<0.001].¹⁶

In the AMAGINE trials more than half (53-56%) of patients on continuous Kyntheum^® treatment achieved PASI 100 at week 52.^16,17

Patients also reported experiencing improved health-related quality of life after four weeks of treatment with Kyntheum^®.¹⁸ After 12 weeks of treatment, seven in 10 patients (72%, n=29/40, p<0.0001) reported psoriasis no longer impaired their health-related quality of life, (0/1 DLQI) compared with placebo (5%, n=2/37).¹⁸

Data from the three large randomised, controlled AMAGINE clinical trials, found Kyntheum^® to be well tolerated, with an acceptable safety profile.¹⁹ The most common adverse events were arthralgia (joint pain), headache, fatigue, diarrhoea and oropharyngeal (mouth and throat) pain.¹⁶

In July 2016, LEO Pharma entered into a partnership agreement with AstraZeneca granting LEO Pharma exclusive licence to develop and commercialise Kyntheum^® in Europe.^IV Outside of Europe, Valeant Pharmaceuticals has global commercial rights for brodalumab except in Japan and certain other Asian countries, where the rights are held by Kyowa Hakko Kirin Co. Ltd.

About psoriasis

Psoriasis is a common, chronic, immune-mediated, inflammatory disease that primarily involves the skin.⁵ The most frequently reported symptoms include thickening and scaling of the skin, itching and erythema (superficial reddening of the skin, usually in patches).⁵

An estimated 125 million people worldwide live with psoriasis,²⁰ including nearly 14 million Europeans.²¹

Psoriasis can be a painful, disabling and stigmatising condition with substantial social and psychological impact on a person’s life.²² People with psoriasis, especially those with more severe symptoms, are also at increased risk of developing other serious associated conditions,⁴ including heart disease^23,24,25 and metabolic diseases (a combination of diabetes, high blood pressure and obesity).²⁶ Mental health complications, such as depression and anxiety, are also more common in people with psoriasis.²⁷

According to the World Health Organization, the burden of living with psoriasis is underestimated and it urges for action to fight stigma and improve treatment.⁵

About LEO Pharma

LEO Pharma helps people achieve healthy skin. By offering care solutions to patients in more than 100 countries globally, LEO Pharma supports people in managing their skin conditions. LEO Pharma offers a comprehensive range of integrated care solutions for control and relief of psoriasis. By expanding its portfolio into biologics, through the approval of Kyntheum^®, the company is set to become the world’s leading dermatology company.

Founded in 1908 and owned by the LEO Foundation, the healthcare company has devoted decades of research and development to delivering products and solutions to people with skin conditions. LEO Pharma is headquartered in Denmark and employs around 5,000 people worldwide.

For more information, visit www.leo-pharma.com

Subscribe to our YouTube channel: www.youtube.com/leopharmaglobal

Follow us on Twitter: www.twitter.com/leohealthyskin

Visit us at LinkedIn: www.linkedin.com/company/leo-pharma

^I 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

^II The Dermatology Life Quality 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.

^III sPGA success is defined as patients who achieved a static Physician’s Global Assessment 0 or 1

^IV Kyntheum^® is not approved by Swissmedic for marketing in Switzerland.

References

1. Lebwohl M, et al. European Academy of Dermatology and Venereology annual congress 2017. Poster P1790

2. Mrowietz U, et al. European Academy of Dermatology and Venereology annual congress 2017. Poster P1791

3. Mrowietz U, et al. European Academy of Dermatology and Venereology annual congress 2017. Poster P1792

4. Reich K. Eur Acad Dermatol Venereol. 2012; 26(2):3-11

5. World Health Organization (WHO). Global Report on Psoriasis. Available from: http://apps.who.int/iris/bitstream/10665/204417/1/9789241565189_eng.pdf (Accessed September 2017)

6. Rapp SR, et al. J Am Acad Dermatol 1999;41:401-407

7. Grob JJ. J Invest Dermatol. 2007;127:2299-2301

8. European Medicines Agency, European public assessment report, Kyntheum^® (brodalumab). Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/003959/human_med_002054.jsp&mid=WC0b01ac058001d124 (Accessed September 2017)

9. Kyntheum^®. Summary of Product Characteristics. 2017

10. Campa M, et al. Dermatol Ther. 2016;6:1–12

11. Beringer A, et al. Trends Mol Med. 2016; 22: 230-41

12. Russell CB, et al. J Immunol. 2014; 192: 3828-36

13. Coimbra S, et al. Core Evidence. 2014;9:89-97

14. Papp K, et al. N Engl J Med 2012;336:1181-9

15. Lebwohl M, et al. N Engl J Med. 2015;373:1318-28

16. Papp K, et al. Br J Dermatol. 2016;175:273–286

17. Supplement to: Lebwohl M, et al. N Engl J Med. 2015;373:1318-28

18. Gordon KB, et al. Br J Dermatol. 2014;170:705–15

19. Attia A, et al. Clin Drug Investig. 2017; DOI: 10.1007/s40261-017-0500-9

20. The International Federation of Psoriasis Associations. Available at: https://ifpa-pso.com/ (Accessed September 2017)

21. Ortonne J, et al. Eur J Dermatol. 2004;14:41–45

22. National Institute for Health and Care Excellence (NICE) Psoriasis: assessment and management guidelines. Available at: https://www.nice.org.uk/guidance/cg153/chapter/1-Guidance#systemic-therapy (Accessed September 2017)

23. Gelfand JM, et al. JAMA. 2016;296:1735-41

24. Ahlehoff O, et al. Eur Heart J. 2012;33:2054-64

25. Lowes MA, et al. Ann Rev Immunol. 2014;32:227-35

26. Langan SM, et al. J Invest Dermatol. 2012 Mar; 132(3 0 1): 556–562

27. Dalgard F, et al. JID. 2015;135(4), 984-991

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