10.09.2022 08:29:54

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

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References

1. Kimball AB, Alavi A, Jemec GBE, et al. Secukinumab in moderate to severe hidradenitis suppurativa: Primary endpoint analysis from the SUNSHINE and SUNRISE Phase 3 trials. LB-3549. Presented at the 31st European Academy of Dermatology and Venereology (EADV) Congress; September 7--10, 2022; Milan, Italy.

2. MedLine Plus. Hidradenitis suppurativa [online]. Available from: https://medlineplus.gov/genetics/condition/hidradenitis-suppurativa/ [Last accessed: September 2022].

3. 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.

4. Sabat R, Jemec GBE, Matusiak L, et al. Hidradenitis suppurativa. Nat Rev Dis Primers. 2020;6:18.

5. ClinicalTrials.gov. Study of Efficacy and Safety of Two Secukinumab Dose Regimens in Subjects With Moderate to Severe Hidradenitis Suppurativa (HS) (SUNRISE). NCT03713632. Available from: https://clinicaltrials.gov/ct2/show/NCT03713632. [Last accessed: September 2022].

6. 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 from: https://clinicaltrials.gov/ct2/show/NCT03713619. [Last accessed: September 2022].

7. Novartis Data on file. SUNSHINE and SUNRISE trials. [Last accessed: September 2022].

8. Montero-Vilchez T, Diaz-Calvillo P, Rodriguez-Pozo JA, et al. The Burden of Hidradenitis Suppurativa Signs and Symptoms in Quality of Life: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2021;18.

9. 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.

10. 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.

11. 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.

12. 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;386:1137-46.

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

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

15. Data on file. CAIN457F2312 Data Analysis Report. Novartis Pharmaceuticals Corp; November 2008.

16. Novartis Europharm Limited. Cosentyx(R) (secukinumab): Summary of Product Characteristics. Available from: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf [Last accessed: September 2022].

17. Ruperto N, Foeldvari I, Alexeeva E, et al. Efficacy and Safety of Secukinumab in Enthesitis-related Arthritis and Juvenile Psoriatic Arthritis: Primary Results from a Randomised, Double-blind, Placebo-controlled, Treatment Withdrawal, Phase 3 Study (JUNIPERA). Presented as a late-breaking abstract at European Alliance of Associations For Rheumatology (EULAR) Virtual Congress; June 2-5, 2021. Abstract LB0004.

18. Brunner H, Foeldvari I, Alexeeva E, et al. Secukinumab Treatment In Children And Adolescents with Enthesitis-Related Arthritis And Juvenile Psoriatic Arthritis: Efficacy And Safety Results From A Phase 3 Study. Presented at the American College of Rheumatology (ACR) Convergence; October 28-30, 2021. Abstract 1424.

19. Data on file. COSENTYX Access. Novartis Pharmaceuticals Corp; December 2021.

20. Data on file. AIN457A2102 Clinical Study Report. Novartis Pharmaceuticals Corp; December 2008.

21. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol. 2012;167:717-24.

22. McInnes IB, Behrens F, Mease PJ, et al. Secukinumab versus adalimumab for treatment of active psoriatic arthritis (EXCEED): a double-blind, parallel-group, randomised, active-controlled, phase 3b trial. Lancet. 2020;395:1496-1505.

23. National Institute of Health (NIH) Genetic and Rare Diseases Information Center (GARD). Hidradenitis suppurativa [online]. Available from: https://rarediseases.info.nih.gov/diseases/6658/hidradenitis-suppurativa#ref_15130 [Last accessed: September 2022].

24. Vinkel C and Thomsen SF. Hidradenitis Suppurativa: Causes, Features, and Current Treatments. J Clin Aesthet Dermatol. 2018;11:17-23.

25. Gill L, Williams M and Hamzavi I. Update on hidradenitis suppurativa: connecting the tracts. F1000Prime Rep. 2014;6:112.

26. Saunte DM, Boer J, Stratigos A, et al. Diagnostic delay in hidradenitis suppurativa is a global problem. Br J Dermatol. 2015;173:1546-9.

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(END) Dow Jones Newswires

September 10, 2022 02:30 ET (06:30 GMT)

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