Oct 22, 2025
  • 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

East Hanover, 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. Full 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.

INDICATIONS

COSENTYX® (secukinumab) is a prescription medicine used to treat:

  • people 6 years of age and older with moderate to severe plaque psoriasis (PsO) that involves large areas or many areas of the body, and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet or UV light alone or with systemic therapy)
  • people 2 years of age and older with active psoriatic arthritis (PsA)
  • adults with active ankylosing spondylitis (AS)
  • adults with active non-radiographic axial spondyloarthritis (nr-axSpA) and objective signs of inflammation
  • people 4 years of age and older with active enthesitis-related arthritis (ERA)
  • adults with moderate to severe hidradenitis suppurativa (HS)

IMPORTANT SAFETY INFORMATION

Do not use COSENTYX if you have had a severe allergic reaction to secukinumab or any of the other ingredients in COSENTYX. See the Medication Guide for a complete list of ingredients.

What is the most important information I should know about COSENTYX?

COSENTYX is a medicine that affects your immune system. COSENTYX may increase your risk of having serious side effects such as:

Infections
COSENTYX may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have had serious infections while taking COSENTYX, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have died from these infections.

  • Your doctor should check you for TB before starting treatment with COSENTYX.
  • If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with COSENTYX and during treatment with COSENTYX.
  • Your doctor should watch you closely for signs and symptoms of TB during treatment with COSENTYX. Do not use COSENTYX if you have an active TB infection.

Before starting COSENTYX, tell your doctor if you:

  • are being treated for an infection
  • have an infection that does not go away or that keeps coming back
  • have TB or have been in close contact with someone with TB
  • think you have an infection or have symptoms of an infection such as: fevers, sweats, or chills; muscle aches; cough; shortness of breath; blood in your phlegm; weight loss; warm, red, or painful skin or sores on your body; diarrhea or stomach pain; burning when you urinate or urinate more often than normal

After starting COSENTYX, call your doctor right away if you have any signs of infection listed above. Do not use COSENTYX if you have any signs of infection unless you are instructed to by your doctor.

What are the possible side effects of COSENTYX?

COSENTYX may cause serious side effects, including:

Serious allergic reactions

Serious allergic reactions can occur. Get emergency medical help right away if you get any of the following symptoms: feeling faint; swelling of your face, eyelids, lips, mouth, tongue, or throat; trouble breathing or throat tightness; chest tightness; skin rash or hives (red, itchy bumps).

If you have a severe allergic reaction, do not give another injection of COSENTYX.

Inflammatory bowel disease

New cases of inflammatory bowel disease or “flare-ups” can happen with COSENTYX, and can sometimes be serious. If you have inflammatory bowel disease (ulcerative colitis or Crohn’s disease), tell your doctor if you have worsening disease symptoms during treatment with COSENTYX or develop new symptoms of stomach pain or diarrhea.

Severe skin reactions that look like eczema can happen during treatment with COSENTYX from days to months after your first dose and can sometimes lead to hospitalization. Your doctor may temporarily stop treatment with COSENTYX if you develop severe skin reactions. Tell your doctor if you have any of the following signs or symptoms: redness or rash; itching; small bumps or patches; your skin is dry or feels like leather; blisters on the hands or feet that ooze or become crusty or skin peeling.

The most common side effects of COSENTYX include: cold symptoms, diarrhea, and upper respiratory tract infections.

These are not all of the possible side effects of COSENTYX. Call your doctor for medical advice about side effects.

Before using COSENTYX, tell your doctor if you:

  • have any of the conditions or symptoms listed [above] for infections.
  • have inflammatory bowel disease (Crohn’s disease or ulcerative colitis).
  • are allergic to latex. The needle cap on the COSENTYX Sensoready® pen, and 150 mg/mL and 75 mg/0.5 mL prefilled syringes contains latex.
  • have recently received or are scheduled to receive an immunization (vaccine). People who take COSENTYX should not receive live vaccines. Children should be brought up to date with all vaccines before starting COSENTYX.
  • have any other medical conditions and all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Keep a list of your medicines to show your healthcare provider and pharmacist when you get a new medicine.
  • are pregnant or plan to become pregnant. It is not known if COSENTYX can harm your unborn baby. You and your doctor should decide if you will use COSENTYX.
  • are breastfeeding or plan to breastfeed. It is not known if COSENTYX passes into your breast milk.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information, including Medication Guide.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

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.

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

References

  1. Novartis Data on File
  2. ClinicalTrials.gov. NCT05767034. [Last accessed: October 2025].
  3. 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].
  4. Girolomoni G, Mrowietz U and Paul C. Psoriasis: rationale for targeting interleukin-17. Br J Dermatol 2012; 167: 717-724.
  5. 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].
  6. 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].
  7. 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].
  8. Data on file_Cosentyx WW LTD patients Q1'25
  9. 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]
  10. 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]
  11. 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)
  12. 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)
  13. 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)
  14. Espígol-Frigolé G, et al. Lancet. 2023;402(10411):1459–72. 
  15. Floris A, et al. Clin Rheumatol. 2022;41(1):19–31.
  16. Gabriel SE, et al. Arthritis Rheum. 1997;40(10):1873–8.
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