---
title: "Secukinumab Phase 3 Trial Shows Higher Remission and Lower Glucocorticoid Use in Relapsing Polymya"
id: "pubmed-42234540"
canonical_url: "https://medichelpline.com/clinical-feed/pubmed-42234540"
content_type: "clinical_feed_article"
specialty: "Rheumatology"
source_name: "PubMed / NCBI"
source_url: "https://pubmed.ncbi.nlm.nih.gov/42234540/"
doi: "10.1056/NEJMoa2602567"
published_at: "2026-08-13T00:00:00.000Z"
evidence_level: "Journal Article"
license: "CC-BY-NC-4.0 / Informational Use"
---
# Secukinumab Phase 3 Trial Shows Higher Remission and Lower Glucocorticoid Use in Relapsing Polymya
## Provenance & Clinical Metadata
- **Canonical URL:** https://medichelpline.com/clinical-feed/pubmed-42234540
- **Specialty:** [Rheumatology](https://medichelpline.com/clinical-feed/rheumatology.md)
- **Primary Source:** PubMed / NCBI
- **Source URL:** [Original Journal Publication](https://pubmed.ncbi.nlm.nih.gov/42234540/)
- **DOI:** [10.1056/NEJMoa2602567](https://doi.org/10.1056%2FNEJMoa2602567)
- **Published At:** 2026-08-13T00:00:00.000Z
- **Evidence Rating:** Journal Article
## Executive GIST (TL;DR)
- This Phase 3, randomized, double-blind trial evaluated **secukinumab** (300 mg and 150 mg) versus placebo in patients with recently relapsed **polymyalgia rheumatica** receiving a 24-week prednisone taper. - A total of 381 patients were randomized 1:1:1 (127 per group) and followed for 52 weeks; the study is reported under the REPLENISH program (ClinicalTrials.gov NCT05767034). - The primary outcome was **sustained remission** at week 52, defined as remission from week 12 through week 52 without signs or symptoms attributable to polymyalgia rheumatica and without a new diagnosis of giant-cell arteritis that required escape/rescue treatment. - Sustained remission rates at 52 weeks were 41.2% (SEC-300), 40.6% (SEC-150), and 20.4% (placebo); both secukinumab doses were statistically superior to placebo (P<0.001 vs placebo for each dose). - Mean adjusted annual cumulative glucocorticoid dose was lower in the secukinumab groups (1603.7 mg for SEC-300; 1683.2 mg for SEC-150) than in placebo (2093.0 mg). - Serious adverse event rates were similar across groups (13.5% SEC-300; 15.9% SEC-150; 14.2% placebo). Certain adverse events — nasopharyngitis, hypersensitivity reactions, urinary tract infections, fungal infections, and back pain — were more common with secukinumab than with placebo. - The trial concludes that adding **secukinumab** to a 24-week glucocorticoid taper increased remission rates and reduced cumulative glucocorticoid exposure versus taper alone in relapsed polymyalgia rheumatica. - Funding was provided by Novartis. Additional protocol details, longer-term follow-up beyond 52 weeks, and subgroup analyses were not reported in the source abstract.
## Clinical Analysis & Structured Key Points
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Epub 2026 Jun 3. # Phase 3 Trial of Secukinumab in Polymyalgia Rheumatica [John H Stone](https://pubmed.ncbi.nlm.nih.gov/?term=Stone+JH&cauthor_id=42234540)[ 1 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-1 "Division of Rheumatology, Inflammation, and Immunology, Massachusetts General Hospital, Boston.")[ 2 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-2 "Division of Rheumatology, Inflammation, and Immunology, Harvard Medical School, Boston."), [Frank Buttgereit](https://pubmed.ncbi.nlm.nih.gov/?term=Buttgereit+F&cauthor_id=42234540)[ 3 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-3 "Department of Rheumatology and Clinical Immunology, Charité-Universitätsmedizin Berlin, Berlin.")[ 4 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-4 "Deutsches Rheuma-Forschungszentrum, Berlin."), [Alain Saraux](https://pubmed.ncbi.nlm.nih.gov/?term=Saraux+A&cauthor_id=42234540)[ 5 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-5 "Centre Hospitalier Universitaire Brest, Université de Bretagne Occidentale, INSERM Unité Mixte de Recherche 1227, Brest, France."), [Wolfgang A Schmidt](https://pubmed.ncbi.nlm.nih.gov/?term=Schmidt+WA&cauthor_id=42234540)[ 6 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-6 "Department of Rheumatology, Waldfriede Hospital, Berlin.")[ 7 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-7 "Rheumatology and Clinical Immunology, Immanuel Krankenhaus Berlin-Buch, Berlin."), [Christian Dejaco](https://pubmed.ncbi.nlm.nih.gov/?term=Dejaco+C&cauthor_id=42234540)[ 8 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-8 "Department of Rheumatology, Ospedale di Brunico, Azienda Sanitaria dell'Alto Adige, Brunico, Italy.")[ 9 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-9 "Department of Rheumatology, Medical University of Graz, Graz, Austria."), [Robert Spiera](https://pubmed.ncbi.nlm.nih.gov/?term=Spiera+R&cauthor_id=42234540)[ 10 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-10 "Hospital for Special Surgery, New York."), [Bhaskar Dasgupta](https://pubmed.ncbi.nlm.nih.gov/?term=Dasgupta+B&cauthor_id=42234540)[ 11 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-11 "Medical Technology Research Centre, Anglia Ruskin University, Chelmsford, United Kingdom."), [Edit Drescher](https://pubmed.ncbi.nlm.nih.gov/?term=Drescher+E&cauthor_id=42234540)[ 12 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-12 "Department of Rheumatology, Veszprém Csolnoky Ferenc County Hospital, Veszprém, Hungary."), [Andrew Jordan](https://pubmed.ncbi.nlm.nih.gov/?term=Jordan+A&cauthor_id=42234540)[ 13 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-13 "BJC Health, Sydney."), [Libor Novosad](https://pubmed.ncbi.nlm.nih.gov/?term=Novosad+L&cauthor_id=42234540)[ 14 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-14 "L.K.N. Arthrocentrum, Hlučín, Czech Republic."), [Daiki Nakagomi](https://pubmed.ncbi.nlm.nih.gov/?term=Nakagomi+D&cauthor_id=42234540)[ 15 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-15 "Department of Rheumatology, University of Yamanashi, Chuo, Japan."), [Yoshinobu Koyama](https://pubmed.ncbi.nlm.nih.gov/?term=Koyama+Y&cauthor_id=42234540)[ 16 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-16 "Division of Rheumatology, Center for Autoimmune Diseases, Japanese Red Cross Okayama Hospital, Okayama, Japan."), [Sergio Duran-Barragan](https://pubmed.ncbi.nlm.nih.gov/?term=Duran-Barragan+S&cauthor_id=42234540)[ 17 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-17 "Departamento de Clínicas Médicas del Centro Universitario de Ciencias de la Salud, Universidad de Guadalajara, Guadalajara, Mexico.")[ 18 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-18 "Clinica de Investigación en Reumatología y Obesidad, Guadalajara, Mexico."), [Gerald Tracey](https://pubmed.ncbi.nlm.nih.gov/?term=Tracey+G&cauthor_id=42234540)[ 19 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-19 "Paradise Arthritis and Rheumatology, Gold Coast, QLD, Australia.")[ 20 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-20 "Griffith University, Brisbane, QLD, Australia."), [Adeline Ruyssen-Witrand](https://pubmed.ncbi.nlm.nih.gov/?term=Ruyssen-Witrand+A&cauthor_id=42234540)[ 21 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-21 "Center of Rheumatology, Neo-I3D, Toulouse University Hospital, Centre d'Investigation Clinique 1436, INSERM, CRI-Imidiate, Toulouse University, Toulouse, France."), [Andrea Rubbert Roth](https://pubmed.ncbi.nlm.nih.gov/?term=Rubbert+Roth+A&cauthor_id=42234540)[ 22 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-22 "Department of Rheumatology, University of Zurich, Zurich, Switzerland."), [Juanzhi Fang](https://pubmed.ncbi.nlm.nih.gov/?term=Fang+J&cauthor_id=42234540)[ 23 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-23 "Novartis Pharmaceuticals, East Hanover, NJ."), [Jennifer Ng](https://pubmed.ncbi.nlm.nih.gov/?term=Ng+J&cauthor_id=42234540)[ 23 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-23 "Novartis Pharmaceuticals, East Hanover, NJ."), [Renuka Hiremath](https://pubmed.ncbi.nlm.nih.gov/?term=Hiremath+R&cauthor_id=42234540)[ 24 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-24 "Novartis Healthcare, Hyderabad, India."), [Roselyne Raffner](https://pubmed.ncbi.nlm.nih.gov/?term=Raffner+R&cauthor_id=42234540)[ 25 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-25 "Novartis Pharma, Basel, Switzerland."), [Ruvie Martin](https://pubmed.ncbi.nlm.nih.gov/?term=Martin+R&cauthor_id=42234540)[ 23 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-23 "Novartis Pharmaceuticals, East Hanover, NJ."), [Silvia Napoletano](https://pubmed.ncbi.nlm.nih.gov/?term=Napoletano+S&cauthor_id=42234540)[ 26 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-26 "Novartis Ireland, Dublin."), [Songqiao Huang](https://pubmed.ncbi.nlm.nih.gov/?term=Huang+S&cauthor_id=42234540)[ 23 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-23 "Novartis Pharmaceuticals, East Hanover, NJ."), [Julian Storim](https://pubmed.ncbi.nlm.nih.gov/?term=Storim+J&cauthor_id=42234540)[ 25 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-25 "Novartis Pharma, Basel, Switzerland."), [Manmath Patekar](https://pubmed.ncbi.nlm.nih.gov/?term=Patekar+M&cauthor_id=42234540)[ 25 ](https://pubmed.ncbi.nlm.nih.gov/42234540/#full-view-affiliation-25 "Novartis Pharma, Basel, Switzerland."); [REPLENISH Investigators](https://pubmed.ncbi.nlm.nih.gov/?term=REPLENISH+Investigators%5BCorporate+Author%5D) Collaborators, Affiliations Expand * PMID: **42234540** * DOI: [ 10.1056/NEJMoa2602567 ](https://doi.org/10.1056/nejmoa2602567) Item in Clipboard Clinical Trial # Phase 3 Trial of Secukinumab in Polymyalgia Rheumatica John H Stone et al. N Engl J Med. 2026. Show details Display options Display options Format Abstract PubMed PMID N Engl J Med Actions * [ Search in PubMed ](https://pubmed.ncbi.nlm.nih.gov/?term=%22N+Engl+J+Med%22%5Bjour%5D&sort=date&sort_order=desc) * [ Search in NLM Catalog ](https://www.ncbi.nlm.nih.gov/nlmcatalog?term=%22N+Engl+J+Med%22%5BTitle+Abbreviation%5D) * [ Add to Search ](https://pubmed.ncbi.nlm.nih.gov/42234540/) . 2026 Aug 13;395(7):637-647. doi: 10.1056/NEJMoa2602567. Epub 2026 Jun 3. * PMID: **42234540** * DOI: [ 10.1056/NEJMoa2602567 ](https://doi.org/10.1056/nejmoa2602567) Item in Clipboard Full text links Cite Display options Display options Format Abstract PubMed PMID ## Abstract **Background:** Polymyalgia rheumatica is a common inflammatory disease characterized by pain and stiffness in the shoulders and hips. Glucocorticoids are the first-line treatment, but relapses and glucocorticoid-related toxic effects are common, which underscores the need for effective alternatives. Secukinumab is a fully human monoclonal antibody that selectively inhibits interleukin-17A. **Methods:** We enrolled patients with recently relapsed polymyalgia rheumatica and randomly assigned them, in a 1:1:1 ratio, to receive secukinumab at a dose of 300 mg (SEC-300 group), secukinumab at a dose of 150 mg (SEC-150 group), or placebo for 52 weeks. Patients in all the groups also received prednisone on a tapering schedule for 24 weeks. The primary outcome was sustained remission at week 52, defined as remission (the absence of signs or symptoms attributable to polymyalgia rheumatica and no new diagnosis of giant-cell arteritis that warranted escape or rescue treatment) that was sustained from week 12 until week 52. The annual cumulative glucocorticoid dose was a secondary outcome. Safety was also assessed. **Results:** A total of 381 patients underwent randomization, and 127 were assigned to each group. At 52 weeks, sustained remission was observed in 41.2% (95% confidence interval [CI], 32.8 to 49.7) of the patients in the SEC-300 group, in 40.6% (95% CI, 32.2 to 49.0) of those in the SEC-150 group, and in 20.4% (95% CI, 13.6 to 27.2) of those in the placebo group (P<0.001 for the comparison of each secukinumab dose with placebo). The mean adjusted annual cumulative glucocorticoid dose was 1603.7 mg in the SEC-300 group, 1683.2 mg in the SEC-150 group, and 2093.0 mg in the placebo group. Serious adverse events occurred in 13.5% of the patients in the SEC-300 group, in 15.9% in the SEC-150 group, and in 14.2% in the placebo group. Nasopharyngitis, hypersensitivity reactions, urinary tract infections, fungal infections, and back pain were more common in the secukinumab groups than in the placebo group. **Conclusions:** Among patients with relapsed polymyalgia rheumatica, treatment with secukinumab plus a 24-week glucocorticoid taper resulted in a higher percentage of patients with remission and in lower cumulative glucocorticoid doses than a glucocorticoid taper alone. (Funded by Novartis; REPLENISH ClinicalTrials.gov number, [NCT05767034](http://clinicaltrials.gov/show/NCT05767034 "See in ClinicalTrials.gov").). Copyright © 2026 Massachusetts Medical Society. [PubMed Disclaimer](https://pubmed.ncbi.nlm.nih.gov/disclaimer/) ## Similar articles * [ Safety and efficacy of secukinumab in patients with giant cell arteritis (TitAIN): a randomised, double-blind, placebo-controlled, phase 2 trial. ](https://pubmed.ncbi.nlm.nih.gov/38251601/) Venhoff N, Schmidt WA, Bergner R, Rech J, Unger L, Tony HP, Finzel S, Andreica I, Kofler DM, Weiner SM, Lamprecht P, Schulze-Koops H, App C, Pournara E, Mendelson MH, Sieder C, Maricos M, Thiel J.Venhoff N, et al.Lancet Rheumatol. 2023 Jun;5(6):e341-e350. doi: 10.1016/S2665-9913(23)00101-7.Lancet Rheumatol. 2023.PMID: 38251601Clinical Trial. * [ Effect of Tocilizumab on Disease Activity in Patients With Active Polymyalgia Rheumatica Receiving Glucocorticoid Therapy: A Randomized Clinical Trial. ](https://pubmed.ncbi.nlm.nih.gov/36125471/) Devauchelle-Pensec V, Carvajal-Alegria G, Dernis E, Richez C, Truchetet ME, Wendling D, Toussirot E, Perdriger A, Gottenberg JE, Felten R, Fautrel BJ, Chiche L, Hilliquin P, Le Henaff C, Dervieux B, Direz G, Chary-Valckenaere I, Cornec D, Guellec D, Marhadour T, Nowak E, Saraux A.Devauchelle-Pensec V, et al.JAMA. 2022 Sep 20;328(11):1053-1062. doi: 10.1001/jama.2022.15459.JAMA. 2022.PMID: 36125471Free PMC article.Clinical Trial. * [ Sarilumab in relapsing polymyalgia rheumatica: patient-reported outcomes from a phase 3, double-blind, randomised controlled trial. ](https://pubmed.ncbi.nlm.nih.gov/40544861/) Strand V, Msihid J, Sloane J, Nivens MC, Chao J, Giannelou A, Fiore S, Araujo L, Dasgupta B.Strand V, et al.Lancet Rheumatol. 2025 Aug;7(8):e544-e553. doi: 10.1016/S2665-9913(25)00041-4. Epub 2025 Jun 19.Lancet Rheumatol. 2025.PMID: 40544861Clinical Trial. * [ Folic acid supplementation and malaria susceptibility and severity among people taking antifolate antimalarial drugs in endemic areas. ](https://pubmed.ncbi.nlm.nih.gov/36321557/) Crider K, Williams J, Qi YP, Gutman J, Yeung L, Mai C, Finkelstain J, Mehta S, Pons-Duran C, Menéndez C, Moraleda C, Rogers L, Daniels K, Green P.Crider K, et al.Cochrane Database Syst Rev. 2022 Feb 1;2(2022):CD014217. doi: 10.1002/14651858.CD014217.Cochrane Database Syst Rev. 2022.Update in: [Cochrane Database Syst Rev. 2026 Feb 18;2:CD014217. doi: 10.1002/14651858.CD014217.pub2.](https://pubmed.ncbi.nlm.nih.gov/41705996/)PMID: 36321557Free PMC article.Updated. * [ Tocilizumab for giant cell arteritis. ](https://pubmed.ncbi.nlm.nih.gov/35560150/) Antonio AA, Santos RN, Abariga SA.Antonio AA, et al.Cochrane Database Syst Rev. 2022 May 13;5(5):CD013484. doi: 10.1002/14651858.CD013484.pub3.Cochrane Database Syst Rev. 2022.PMID: 35560150Free PMC article. 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