Novartis new data reinforces superiority of Cosentyx versus Stelara in achieving skin clearance for psoriasis patients.
Novartis announced today results from the head-to-head CLARITY study demonstrating the superiority of Cosentyx (secukinumab) compared to Janssen’s Stelara (ustekinumab) in delivering clear and almost clear skin in adults with moderate to severe plaque psoriasis at 12 weeks.
The study results show 66.5% and 72.3% of patients treated with Cosentyx (p < 0.0001) achieved both co-primary endpoints PASI 90 and IGA mod 2011 0/1, respectively, compared to 47.9% and 55.4% of patients, respectively, treated with Stelara (p < 0.0001).1
At Week 12, patients receiving Cosentyx had significantly greater PASI 100 responses (key secondary objective) compared to those taking Stelara (38.1% vs. 20.1%, respectively; p < 0.0001).
The study findings, which support previously presented data from the CLEAR study demonstrating the superiority of Cosentyx to Stelara in achieving sustained skin clearance (PASI 90 response rates) at 52 weeks, were presented as a poster on January 16th at the Winter Clinical Dermatology Conference in Hawaii.2
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 success.4-7 All key secondary endpoints in the CLARITY study were met.
At Week 4, PASI 75 response rates were significantly superior with Cosentyx compared to Stelara (40.2% vs. 16.3%; p < 0.0001).
At Week 16, Cosentyx demonstrated significantly superior response rates compared to Stelara® for PASI 75 (91.7% vs. 79.8%; p < 0.0001), PASI 90 (76.6% vs. 54.2%; p < 0.0001), PASI 100 (45.3% vs. 26.7%; p < 0.0001), and IGA mod 2011 0/1 (78.6% vs. 59.1%; p < 0.0001).1
“These data add to the robust body of evidence supporting the use of Cosentyx to treat moderate to severe plaque psoriasis,” said Mark Lebwohl, M.D. and chairman of the Waldman Department of Dermatology at the Icahn School of Medicine at Mount Sinai Hospital in New York City. “With these findings, clinicians can have even greater confidence including Cosentyx in their treatment plans.”
The safety profile of Cosentyx was in line with the known safety profile.1
To date, more than 125,000 patients worldwide have been prescribed Cosentyx in the post-marketing setting across all indications.8
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References:
- Bagel J, Nia J, Hashim P, et al. Secukinumab is Superior to Ustekinumab in Clearing Skin of Patients With Moderate to Severe Plaque Psoriasis: CLARITY, a Randomized, Controlled, Phase 3b Trial. Poster presented at Winter Clinical Dermatology Conference; January 12-17, 2018, Hawaii, USA. Poster #98.
- Blauvelt A, Reich K, Tsai T-F, et al. Secukinumab is superior to ustekinumab in clearing skin of subjects with moderate-to-severe plaque psoriasis up to 1 year: Results from the CLEAR study. J Am Acad Dermatol. 2017;76(1).
- Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favorable safety profile through 5 years of treatment in moderate to severe psoriasis. EPoster presented at 26th EADV Congress; September 13-17, 2017, Geneva, Switzerland. Poster #P2223.
- European Medicines Agency. Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis.
https://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003329.pdf. Published November 18, 2004. Accessed January 2, 2018.
- ACTAS Dermo-Sifiliográficas. Spanish Evidence-Based Guidelines on the Treatment of Psoriasis With Biologic Agents. https://www.actasdermo.org/en/spanish-evidence-based-guidelines-on-treatment/articulo/S1578219013001789/. Published September 7, 2013. Accessed January 2, 2018.
- Canadian Dermatology Association. Canadian Guidelines for the Management of Plaque Psoriasis. https://www.dermatology.ca/wp-content/uploads/2012/01/cdnpsoriasisguidelines.pdf. Published June 2009. Accessed January 20, 2018.
- Langley RGB, Feldman SR, Nyirady J, et al. The 5‐point Investigator’s Global Assessment (IGA) Scale: a modified tool for evaluating plaque psoriasis severity in clinical trials. J Dermatolog Treat. 2015;26(1):23‐31.
- Data on File. Number of Patients Prescribed Cosentyx. Novartis Pharmaceuticals Corp; Nov. 2017.
(Source: Novartis Pharmaceuticals Corp.)
Filed Under: Drug Discovery
