Cosentyx® demonstrates sustained results in psoriasis with 5-year Phase III data

• Latest data show that PASI 90 and PASI 100 response rates were nearly 100% maintained with Cosentyx from Year 1 to Year 5 in patients with moderate to severe plaque psoriasis¹ 

DORVAL, QC, Sept. 13, 2017 /CNW/ - Novartis announced today 5-year Phase III data showing Cosentyx^® (secukinumab) delivered long-lasting results in patients with moderate to severe plaque psoriasis, a chronic inflammatory condition that affects 1 million Canadians^1,2. These data were presented at the 26th European Academy of Dermatology and Venereology (EADV) Congress in Geneva, Switzerland.

Clear skin is the aim of psoriasis treatment, and a Psoriasis Area and Severity Index (PASI) 75, 90 or 100 response is considered an important measure of treatment success³.

"Data from this pivotal trial with five years follow up show that sustained efficacy over long periods of time is possible. This is positive news for psoriasis patients who struggle with the emotional and physical burden of this disease," said Hamilton dermatologist Dr. Ron Vender, MD FRCPC and principal investigator and director of Dermatrials Research Inc.

In this study, over the extended treatment period from Year 1 (Week 52) to the end of Year 5 (Week 260), PASI 75/90/100 response rates remained consistent¹. PASI 75 and PASI 90 response rates were achieved by 89% and 69% of psoriasis patients, respectively, at Year 1 ('as observed' analysis) and this rate was maintained to Year 5 (89% and 66%, respectively)¹. In addition, 44% of psoriasis patients achieved completely clear skin (PASI 100) at Year 1 and this rate was maintained to Year 5 (41%). The safety profile of Cosentyx also remained consistent over the five-year period of the study¹.

"These results represent an exciting milestone and it is very encouraging news for patients living with this often-debilitating condition," said Janice Murray, President Novartis Pharmaceuticals Canada Inc.

About Cosentyx (secukinumab) and interleukin-17A (IL-17A)
Secukinumab is a human monoclonal antibody that selectively neutralizes circulating interleukin-17A (IL-17A)⁴. IL-17A is one of the many proteins in the body called cytokines that help protect the body against infections⁴. It has been identified as playing a key role in a number of immune-mediated diseases including psoriasis⁵. Cosentyx is approved for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy or phototherapy⁴.

About the 5-year Cosentyx extension study (A2304E1)¹
A2304E1 is a multicenter, double-blind and open-label, 5-year extension to the pivotal Phase III SCULPTURE study. The primary objective of this extension study was to assess the long-term safety and tolerability of Cosentyx in patients with moderate-to-severe plaque psoriasis. Efficacy measures included the proportion of patients achieving PASI 75, PASI 90 and PASI 100.

In SCULPTURE, PASI 75 responders at Week 12 were randomized to double-blind maintenance treatment of Cosentyx 300 mg or 150 mg, given either at a 4-week fixed-interval regimen or in a retreatment-as-needed regimen. Patients who completed 52 weeks of the SCULPTURE study were eligible to continue the same dose and regimen in the extension study (N=642).

About psoriasis²
Psoriasis is a common chronic inflammatory skin condition that produces red elevated patches and flaking silvery scales. Symptoms can range from mild to severe. Psoriasis affects 1 million Canadians and 125 million people worldwide. The most common form is plaque psoriasis, affecting approximately 90% of patients. Up to 30% of patients with psoriasis have or will have arthritis and 5-10% may have some functional disability from arthritis of various joints. Psoriasis is typically seen in adults but can develop at any age. It occurs equally in men and women and across different races. A family history of psoriasis is a leading risk factor. Psoriasis may result from a malfunction of the immune system that produces inflammation and causes skin cells to rise to the surface and shed at an abnormally quick rate – every three to four days in psoriasis compared to 30 days in normal healthy skin.

About Novartis Pharmaceuticals Canada Inc.
Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2016, the company invested $48.8 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 750 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca.   

About Novartis
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2016, the Group achieved net sales of USD 48.5 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 118,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.

References

1.	Bissonnette R et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. Presented as an online abstract at the European Academy of Dermatology and Venereology 2017. 13th September 2017.
2.	Canadian Dermatology Association, Psoriasis, accessed September 10, 2017 at: http://dermatology.ca/public-patients/skin/psoriasis/.
3.	Langley RG et al. The 5‐point Investigator's Global Assessment (IGA) Scale: a modified tool for evaluating plaque psoriasis severity in clinical trials. Journal of Dermatology Treatment. 2015; 26:23–31.
4.	Novartis Pharmaceuticals Canada Inc. ^PrCosentyx^® (Secukinimab) Product Monograph. August 17, 2017.
5.	Kopf M. et al. Averting inflammation by targeting the cytokine environment. Drug Discovery. 2010. 703-718.

SOURCE Novartis Pharmaceuticals Canada Inc.

Novartis Media Relations: Julie Schneiderman, Novartis Pharmaceuticals Communications, [phone], E-mail: [email protected]; Spectrum Advisors: [phone], [email protected]