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诺华宣布Cosentyx®在风湿性多肌痛（PMR）患者的III期试验中达到主要和所有次要终点

·7 days ago发布

  • Cosentyx® (secukinumab) achieved statistically significant and clinically meaningful sustained remission vs placebo at Week 521

  • Trial showed reduction in annual cumulative steroid dose vs placebo through Week 52; safety profile consistent with known profile of Cosentyx1

  • Data highlight potential of Cosentyx as novel targeted PMR treatment, second most common inflammatory disease in adults ≥502, with limited options available

 

Basel, October 22, 2025 – Novartis today announced that Cosentyx® (secukinumab) met the primary endpoint and all secondary endpoints in the Phase III REPLENISH trial1. Cosentyx demonstrated statistically significant and clinically meaningful sustained remission vs placebo at Week 52 in adults with polymyalgia rheumatica (PMR)1. Data will be presented at an upcoming medical congress and submitted to health authorities in the first half of 2026.

“Polymyalgia rheumatica is an inflammatory rheumatic disease characterized by bilateral pain of the neck, shoulders, or hips, morning stiffness, and fatigue. It tends to flare and significantly impact patients’ quality of life,” said Angelika Jahreis, Global Head, Immunology Development, Novartis. “These results highlight the potential of Cosentyx to help patients achieve and sustain disease remission and reduce corticosteroids, which can lead to significant side effects in this typically elderly patient population. Today’s results represent another breakthrough in transforming care in rheumatology.”

A key secondary endpoint of the REPLENISH trial was adjusted annual cumulative steroid dose through Week 52. Other secondary measures included complete sustained remission at Week 52, and time until patients needed additional treatment3.

About REPLENISH trial


The REPLENISH trial (NCT05767034) is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study conducted across 27 countries, evaluating the efficacy and safety of Cosentyx in patients with polymyalgia rheumatica (PMR). Patients were randomized into three treatment arms: Cosentyx 300mg, Cosentyx 150mg, or placebo, all in combination with a 24-week steroid taper regimen. The primary endpoint of the trial is to assess whether secukinumab 300mg sc. plus a 24-week steroid taper is superior to placebo plus a 24-week steroid taper in achieving sustained remission at Week 52. Key secondary endpoints include the proportion of patients achieving complete sustained remission at Week 52, the adjusted annual cumulative steroid dose, and the time to first use of escape or rescue treatment through Week 523.

 

About Cosentyx (secukinumab)


Cosentyx is a fully human biologic that directly inhibits interleukin-17A, an important cytokine involved in the inflammation underlying multiple immune-mediated inflammatory diseases. It is approved for use in adults with psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), and hidradenitis suppurativa (HS)4-6, as well as in pediatric patients with PsO, enthesitis-related arthritis (ERA), and juvenile psoriatic arthritis (JPsA)7-8.Cosentyx is supported by robust evidence and 10 years of real-world data demonstrating its long-term safety and sustained efficacy9-14. Since its launch in 2015, it has been used to treat more than 1.8 million patients worldwide and is now approved in over 100 countries9.

 

About polymyalgia rheumatica (PMR)


Polymyalgia rheumatica (PMR) is the second most common inflammatory rheumatic disease in adults aged 50 years and older, typically characterized by acute pain and stiffness in the shoulders, neck, and hips2. Relapses are frequent, affecting up to 40% of patients in the first year15, and long-term steroid use, the standard of care, carries significant risks including osteoporosis and diabetes16. Beyond physical complications, PMR substantially impairs quality of life through pain, fatigue, restricted mobility, and fear of relapse17.

 

About Novartis 


Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide.


References

  1. Novartis Data on File

  2. Espígol-Frigolé G, et al. Lancet. 2023;402(10411):1459–72.

  3. ClinicalTrials.gov. NCT05767034. [Last accessed: October 2025].

  4. Novartis Europharm Limited. Cosentyx® (secukinumab): Summary of Product Characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/cosentyx-epar-product-information_en.pdf [Last accessed: October 2025].

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

  6. Novartis Cosentyx shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa. [Press release]. Available at: https://www.novartis.com/news/media-releases/novartis-cosentyx-shows-clinically-meaningful-symptom-improvements-patients-hidradenitis-suppurativa-pivotal-phase-iii-trials [Last accessed: October 2025].

  7. Novartis Cosentyx 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: October 2025].

  8. Novartis Cosentyx 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: October 2025].

  9. Data on file_Cosentyx WW LTD patients Q1'25

  10. Uta Kiltz et al. Secukinumab Retention and Effectiveness in Patients with PsA and Radiographic Axial Spondyloarthritis: 5-year Final Results of a Prospective Real-world Study. Abstract no:2344. ACR 2024 [Link]

  11. Ippoliti et al. Long-Term Real-World Safety Profile of Secukinumab Assessed Through a 9-Year Experience in Patients Affected by Psoriasis, Psoriatic Arthritis and Ankylosing Spondylitis: Results From a Multicentric Retrospective Study. Dermatologic Therapy. 2025. Article Number: 9618241 [Link]

  12. Mease PJ, Kavanaugh A, Reimold A, Tahir H, Rech J, Hall S, Geusens P, Pascale P, Delicha EM, Pricop L, Mpofu S. “Secukinumab Provides Sustained Improvements in the Signs and Symptoms in Psoriatic Arthritis: Final 5‑Year Efficacy and Safety Results from a Phase 3 Trial”. ACR/ARHP 2020 Annual Meeting Abstract. Presented in ACR Open Rheumatology (2020); CONCL‑00511 (Secukinumab Provides Sustained Improvements in the Signs and Symptoms of Psoriatic Arthritis: Final 5-year Results from the Phase 3 FUTURE 1 Study - PubMed)

  13. McInnes IB, Mease PJ, Kivitz AJ, Nash P, Rahman P, Rech J, Conaghan PG, Kirkham B, Navarra S, Belsare AD, Delicha EM, Pricop L, Mpofu S; FUTURE 2 Study Group. “Long‑term efficacy and safety of secukinumab in patients with psoriatic arthritis: 5‑year (end‑of‑study) results from the phase III FUTURE 2 study.” Lancet Rheumatology. 2020; 2(4): e227–e235. (Long-term efficacy and safety of secukinumab in patients with psoriatic arthritis: 5-year (end-of-study) results from the phase 3 FUTURE 2 study)

  14. Bissonnette R, Luger T, Thaçi D, Toth D, Lacombe A, Xia S, Mazur R, Patekar M, Charef P, Milutinovic M, Leonardi C, Mrowietz U.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 Sep;32(9):1507–1514. (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) - PubMed)

  15. Floris A, et al. Clin Rheumatol. 2022;41(1):19–31.

  16. Gabriel SE, et al. Arthritis Rheum. 1997;40(10):1873–8.

  17. Hutchings A, et al. Arthritis Rheum. 2007;57(5):803–9; Espígol-Frigolé G, et al. Lancet.2023;402(10411):1459–72; Twohig H, et al. Patient Educ Couns. 2015;98(5):645–50.

文章关键词： 诺华Cosentyx®多肌痛风湿病（PMR）
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