Press Release: Novartis Cosentyx(R) gains -2-

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References

1. Kimball AB, Jemec GBE, Alavi A, et al. Secukinumab in moderate to severe hidradenitis suppurativa (SUNSHINE and SUNRISE): week 16 and 52 results of two identical, double-blind, placebo-controlled, phase 3 randomised trials. Lancet 2023; 401: 747--761.

2. Data on file. NCT03713619 and NCT03713632 (SUNSHINE and SUNRISE): Pooled Data Tables. Novartis Pharmaceuticals Corp; 2022.

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4. Data on file. NCT03713619 and NCT03713632 (SUNSHINE and SUNRISE): Clinical Study Program post-hoc analysis of skin pain NRS severity. Novartis Pharmaceuticals Corp; 2022.

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6. Data on file. Novartis Pharmaceuticals Corp; March 2023.

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9. ClinicalTrials.gov. Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS) (SUNRISE). NCT03713632. Available at: https://clinicaltrials.gov/ct2/show/NCT03713632 [Last accessed: April 2023].

10. ClinicalTrials.gov. This is a Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS). (SUNSHINE). NCT03713619. Available at: https://clinicaltrials.gov/ct2/show/NCT03713619 [Last accessed: April 2023].

11. Girolomoni G, Mrowietz U, Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012; 167: 717--724.

12. Novartis Europharm Limited. Cosentyx(R) (secukinumab): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf [Last accessed: April 2023].

13. Baraliakos X, Braun J, Deodhar A, et al. Long-term efficacy and safety of secukinumab 150 mg in ankylosing spondylitis: 5-year results from the phase III MEASURE 1 extension study. RMD Open 2019; 5: e001005.

14. Bissonnette R, Luger T, Thaçi D, et al. Secukinumab demonstrates high sustained efficacy and a favourable safety profile in patients with moderate-to-severe psoriasis through 5 years of treatment (SCULPTURE Extension Study). J Eur Acad Dermatol Venereol 2018; 32: 1507--1514.

15. Mease PJ, Kavanaugh A, Reimold A, et al. Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study. ACR Open Rheumatol 2020; 2: 18--25.

16. Data on file. CAIN457F2310 (MEASURE 1 and 2): Pooled Safety Data. Novartis Pharmaceuticals Corp; July 23, 2018.

17. Data on file. CAIN457F2310 and CAIN457F2305 summary of 5-year clinical safety in (ankylosing spondylitis). Novartis Pharmaceuticals Corp; May 2019.

18. Data on file. CAIN457F2312 (FUTURE 2): 5 year-interim report. Novartis Pharmaceuticals Corp; May 2019.

19. McInnes IB, Mease PJ, Kirkham B, et al. Secukinumab, a human anti-interleukin-17A monoclonal antibody, in patients with psoriatic arthritis (FUTURE 2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet 2015; 386: 1137--1146.

20. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; January 2023.

21. Data on file. COSENTYX Approvals. Novartis Pharmaceuticals Corp; March 2023.

22. Novartis AG. 2021. Novartis Cosentyx(R) receives FDA approval for the treatment of children and adolescents with enthesitis-related arthritis and psoriatic arthritis. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-receives-fda-approval-treatment-children-and-adolescents-enthesitis-related-arthritis-and-psoriatic-arthritis [Last accessed: April 2023].

23. Novartis AG. 2022. Novartis Cosentyx(R) (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-secukinumab-receives-positive-chmp-opinion-expanded-use-childhood-arthritic-conditions [Last accessed: April 2023].

24. Kokolakis G, Wolk K, Schneider-Burrus S, et al. Delayed Diagnosis of Hidradenitis Suppurativa and Its Effect on Patients and Healthcare System. Dermatology 2020; 236: 421--430.

25. Mac Mahon J, Kirthi S, Byrne N, et al. An Update on Health-Related Quality of Life and Patient-Reported Outcomes in Hidradenitis Suppurativa. Patient Relat Outcome Meas 2020; 11: 21--26.

26. Montero-Vílchez T, Sánchez-Díaz M, Martínez-López A, et al. Quality of Life in Patients with Skin Disease and Their Cohabitants. In: Jasneth M, Sage A, Medhane C, Eds. Health-Related Quality of Life. Rijeka: IntechOpen; 2021: Ch. 5.

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(END) Dow Jones Newswires

April 26, 2023 12:42 ET (16:42 GMT)