NOT FOR DISTRIBUTION IN THE UNITED STATES
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 (PASII 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 26th 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
sPGAIII 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 disease23,24,25 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
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170914005082/en/
LEO PharmaGlobal media contactsHenrik Steen
Heskjær KyndlevHead of Global External CommunicationEmail:
HDTDK@leo-pharma.comMobile: +45 3140 6180orMarie Schleimann
NordlundSnr Global Patient Communication ManagerEmail:
marie.nordlund@leo-pharma.comMobile: +45 3126 3734