CLEAR is the second head-to-head study for Cosentyx following the phase III Fixture study that showed Cosentyx was superior to Enbrel (etanercept)
Novartis announced that the phase IIIb CLEAR study for Cosentyx (secukinumab, formerly known as AIN457) demonstrated superiority to Stelara (ustekinumab) and met its primary endpoint of achieving PASI 90, which represents clear or almost clear skin at week 16 for psoriasis patients. The study also met the secondary endpoint of achieving PASI 75 at Week 4. Safety results were consistent with previously reported phase III clinical trials for Cosentyx.
The CLEAR study is the second head-to-head study for Cosentyx versus established psoriasis biologic treatments. It follows on from the phase III FIXTURE study, which showed that Cosentyx was superior to Enbrel (etanercept), a current standard-of-care, in clearing psoriasis skin with a comparable safety profile.
Achieving clear skin is the ultimate aim of psoriasis treatment for patients. Data from the Cosentyx clinical trial programme has also shown a significant positive relationship between achieving clear to almost clear skin and psoriasis patients’ health-related quality of life. Additionally, 50 per cent of psoriasis patients are not content with current therapies, including biologic treatments-.
“We are delighted that our IL-17A inhibitor Cosentyx showed superiority over Stelara, a widely-used biologic for moderate-to-severe psoriasis patients and a newer treatment alternative to TNF inhibitors,” said Vasant Narasimhan, Global Head of Development, Novartis Pharmaceuticals. “Patients need more effective treatment options for psoriasis and these impressive results add to the robust body of evidence that patients dramatically benefit and can achieve clear skin with Cosentyx.”
The study involved 679 moderate-to-severe plaque psoriasis patients and will be submitted for presentation at an international medical congress in 2015.
Topline results follow a positive CHMP opinion for Cosentyx as a first-line systemic treatment for patients with moderate-to-severe psoriasis. Currently, all biologic treatments for psoriasis, including anti-tumor necrosis factor therapies (anti-TNFs) and ustekinumab are recommended for second-line systemic therapy in Europe-. In addition, the FDA Advisory Committee voted unanimously for the approval of Cosentyx in the US. Cosentyx works by inhibiting the action of IL-17A, a protein that is found in high concentrations in skin affected by psoriasis-.
Psoriasis is a chronic immune-mediated disease associated with significant impairment of physical and psychological quality of life,,. Psoriasis affects up to three per cent of the world’s population, or more than 125 million people.
- Novartis, Data on file.
- Langley RG, Elewski BE, Lebwohl M, et al. “Secukinumab in plaque psoriasis: results of two phase three trials.” New Engl J Med. 2014. Jul 9;371(4):326-38.
- McLeod LD, Mallya UG, Fox T, Strober BE. “Psoriasis Patients With PASI 90 Response Achieve Greater Health-Related Quality-of-Life Improvements Than Those With PASI 75 Response.” European Association of Dermatology and Venereology Congress. Amsterdam, Netherlands. 10 October 2014.
- Stern RS, Nijsten T, Feldman S, et al. “Psoriasis Is Common, Carries a Substantial Burden Even When Not Extensive, and Is Associated with Widespread Treatment Dissatisfaction.” J Investig Dermatol Symp. 2004;9(2):136-9.
- Christophers E, Griffiths CEM, Gaitanis G, et al. “The unmet treatment need for moderate to severe psoriasis: results of a survey and chart review” J Eur Acad Dermatol Venereol. 2006;20:921-925.
- Krueger JG, Koo J, Lebwohl M, et al. “The impact of psoriasis on quality of life: Results for a 1998 National Psoriasis Foundation patient membership survey.” Arch Derm. 2001;137:280-284.
- Sterry W, Barker J, Boehncke WH, et al. “Biological therapies in the systemic management of psoriasis: International Consensus Conference.” Br J Dermatol. 2004;151 Suppl 69:3-17.
- European Medicines agency website, “Enbrel Summary of Product Characteristics” http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000262/WC500027361.pdf. Accessed November 2014.
- European Medicines agency website, “Humira Summary of Product Characteristics” http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000481/WC500050870.pdf. Accessed November 2014.
- European Medicines agency website, “Stelara Summary of Product Characteristics” http://www.ema.europa.eu/docs/en_GB/document_library/EPAR__Product_Information/human/000958/WC500058513.pdf. Accessed November 2014.
- Gaffen SL. “Structure and signaling in the IL-17 receptor family.” Nat Rev Immunol. 2009;9(8):556-67.
- Ivanov S, Linden A. “Interleukin-17 as a drug target in human disease.” Trends Pharmacol Sci. 2009;30(2):95-103
- Kopf M, Bachmann MF, Marsland BJ. “Averting inflammation by targeting the cytokine environment” Nat Rev Drug Discov. 2010; 9(9):703-18.
-  Onishi RM, Gaffen SL. “Interleukin-17 and its target genes: mechanisms of interleukin-17 function in disease.” Immunology. 2010;129(3):311-21.
- Krueger J, Fretzin S, Suárez-Fariñas M, et al. “IL-17A is essential for cell activation and inflammatory gene circuits in subjects with psoriasis.” J Allergy Clin Immunol. 2012;130(1):145-154.
- Johansen C, Usher PA, Kjellerup RB, et al. “Characterization of the interleukin-17 isoforms and receptors in lesional psoriatic skin.” Brit J Dermatol. 2009;160(2):319-24.
- Rapp SR, Feldman SR, Exum ML, Fleischer AB, Jr., Reboussin DM. “Psoriasis causes as much disability as other major medical diseases.” J Am Acad Dermatol. 1999; 41(3 Pt 1):401-7.
- Farley E et al. “Psoriasis: comorbidities and associations.” G Ital Dermatol Venereol. 2011 Feb;146(1):9-15.
- International Federation of Psoriasis Associations (IFPA) World Psoriasis Day website. “About Psoriasis.” http://www.worldpsoriasisday.com/web/page.aspx?refid=114. Accessed December 2014.
EP News Bureau – Mumbai