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Abstract Number: 1175

Secukinumab In Patients with Giant Cell Arteritis with Polymyalgia Rheumatica Symptoms: A Post Hoc Analysis of the Phase 2 TitAIN Study

Nils Venhoff1, Wolfgang Schmidt2, Raoul Bergner3, Juergen Rech4, Leonore Unger5, Stephanie Finzel6, Ioana Andreica7, David Kofler8, Stefan Weiner9, Prof. Dr. med. Peter Lamprecht10, Hendrik Schulze-Koops11, Meryl Mendelson12, Weibin Bao13, Monica Keyport14, Meron Maricos15, Valeria Jordan M.16 and Jens Thiel17, 1University of Freiburg, Freiburg, Germany, 2Immanuel Krankenhaus Berlin, Medical Centre for Rheumatology Berlin-Buch; Waldfriede Hospital, Rheumatology, Berlin, Germany, 3Department of Internal Medicine A, Nephrology and Rheumatology, Municipal Hospital Ludwigshafen, Ludwigshafen, Germany, 4Uniklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg, Germany, Erlangen, Germany, 5Städtisches Klinikum Dresden, Dresden, Germany, 6Universitétsklinikum Freiburg, Freiburg im Breisgau, Germany, 7Rheumazentrum Ruhrgebiet Herne; Ruhr-Universität Bochum, Germany, Herne, Germany, 8University of Cologne, Cologne, Germany, 9Brüderkrankenhaus Trier, Trier, Germany, 10University of Lübeck, Lübeck, Germany, 11LMU Hospital, Division for Rheumatology and Clinical Immunology, Munich, Bayern, Germany, 12Novartis Pharmaceuticals, Larchmont, NY, 13Novartis Pharmaceuticals Corporation, Hanover, NJ, 14Novartis Pharmaceuticals, Stillwater, MN, 15Novartis, Nürnberg, Germany, 16Novartis Pharmaceuticals Corporation, Tenafly, NJ, 17University Hospital Freiburg, Medical University Graz, Freiburg, Germany

Meeting: ACR Convergence 2025

Keywords: Biologicals, clinical trial, giant cell arteritis, immunology, Polymyalgia Rheumatica (PMR)

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Session Information

Date: Monday, October 27, 2025

Title: (1147–1190) Miscellaneous Rheumatic & Inflammatory Diseases Poster II

Session Type: Poster Session B

Session Time: 10:30AM-12:30PM

Background/Purpose: GCA and PMR are closely related, immune-mediated chronic inflammatory diseases often occurring concurrently in individuals over 50.1,2 While glucocorticoids (GC) are the mainstay of treatment, relapses are common, and long-term use causes significant side effects, highlighting the need for GC-sparing therapies.2 Secukinumab (SEC), a monoclonal antibody that selectively neutralizes interleukin-17A, has shown efficacy and safety in various immune-mediated diseases.3 In the TitAIN phase 2 study, SEC resulted in a higher sustained remission rate in patients with GCA than in placebo (PBO) at week 28, with effects lasting for 52 weeks; safety was consistent with its known safety profile.4 This post hoc analysis evaluated SEC vs PBO in the subgroup of GCA patients with PMR symptoms within 12 weeks prior to and/or at baseline (BL).

Methods: TitAIN was a randomized, double-blind, PBO-controlled, multicenter, phase 2 study in patients aged ≥50 years with new-onset or relapsing GCA (unequivocal cranial symptoms of GCA and/or symptoms of PMR) who were naive to biological therapy and receiving GCs at BL with a prednisolone equivalent dose of 25–60 mg/day.4 Patients were assigned (1:1) to receive 300 mg SEC or PBO subcutaneously once a week up to week 4 and every 4 weeks thereafter. In both arms, prednisolone dose was tapered to 0 mg over a 26-week period.4

Results: In the TitAIN study, 27 patients received SEC and 25 received PBO; 44.4% (12/27) of patients in the SEC arm vs 32.0% (8/25) in the PBO arm had PMR symptoms and were included in this post hoc analysis. Among patients with PMR symptoms, 58.3% (7/12) in the SEC arm vs 12.5% (1/8) in the PBO arm were in sustained GCA remission at week 52, consistent with a previous finding in the overall study population (59% vs 8%).4Overall, only 3.7% (1 of 27) in the SEC arm vs 24.0% (6/25) in the PBO arm experienced PMR symptoms post BL up to week 52. In the subgroup of patients with PMR symptoms, only 8.3% (1/12) in the SEC arm had PMR symptoms post BL compared to 50.0% (4/8) in the PBO arm. Data for new-onset and relapsing GCA subgroups are presented in Table 1.All GCA patients with PMR symptoms had ≥1 adverse event (AE), in both arms. The most common AEs were consistent with those reported in the study population.4 Serious AEs were reported in 8.3% of patients (n=1; facial paralysis) in the SEC arm and 37.5% (n=3; gastrointestinal pain, dizziness, and chronic obstructive pulmonary disease) in the PBO arm.

Conclusion: This post hoc analysis showed a numerical reduction in patients with PMR symptoms with SEC treatment compared to PBO. The safety profile of SEC was similar to the overall GCA study population and consistent with its known safety profile. These results support the development of SEC for PMR. A phase 3 trial (NCT05767034) is evaluating the efficacy and safety of SEC in relapsed patients with PMR.ReferencesEspígol-Frigolé G, et al. Lancet. 2023;402(10411):1459-72.Man-Ger Sun M, et al. Best Pract Res Clin Rheumatol. 2022;36(4):101822.COSENTYX®. Prescribing information. Novartis; 2023. Accessed on April 29, 2025. Available at: label.Venhoff N, et al. Lancet Rheumatol 2023;5:e341-50.

Supporting image 1


Disclosures: N. Venhoff: AbbVie, 1, 6, 12, Consulting fees, meeting or travel grants, expert testimony, AstraZeneca, 6, Boehringer-Ingelheim, 6, Bristol-Myers Squibb(BMS), 5, 6, 12, Meeting or travel grants, Chugai, 1, 6, 12, Consulting fees, GlaxoSmithKlein(GSK), 6, Novartis, 1, 5, 6, 12, Consulting fees, meeting or travel grants, expert testimony, 12, Pending patent application on the use of secukinumab in GCA, Roche, 6, UCB, 1, 6, Vifor, 1, 6, 12, Expert testimony, Meeting or travel grants, Consulting fees; W. Schmidt: AbbVie, 1, 5, 6, Alfasigma, 6, Amgen, 6, Boehringer-Ingelheim, 1, Chugai, 6, Eli Lilly, 6, Fresenius Kabi, 1, GlaxoSmithKline, 6, Medac, 6, Novartis, 1, 5, 6, Pfizer, 6, UCB, 6; R. Bergner: AbbVie, 1, 6, Alfasigma, 1, 6, Bristol-Myers Squibb(BMS), 6, Chugai, 6, Eli Lilly, 6, German Rheumatology Society, 12, unpaid board member for Commission für student education, GlaxoSmithKlein(GSK), 1, 6, Janssen, 6, Merck/MSD, 6, Novartis, 1, 6, Vifor, 1, 5; J. Rech: AbbVie, 6, 12, Received consulting fees, Biogen, 6, 12, Received consulting fees, Bristol-Myers Squibb(BMS), 6, 12, Received consulting fees, Chugai, 6, 12, Received consulting fees, Eli Lilly, 6, 12, Received consulting fees, GlaxoSmithKlein(GSK), 6, 12, Received consulting fees, Janssen, 6, 12, Received consulting fees, MSD, 6, 12, Consulting fees, Novartis, Sobi, 1, 2, 5, 6, Roche, 6, 12, Received consulting fees, Sanofi, 6, 12, Received consulting fees, Sobi, 6, 12, Received consulting fees, UCB, 6, 12, Received consulting fees; L. Unger: Novartis, 12, Receives payments for speeches and seminar presentations; S. Finzel: AbbVie, 6, Alfasigma/Galapagos, 6, Biotest, 6, 12, Meeting or travel grants, Celltrion, 6, Chugai, 6, Eli Lilly, 12, Meeting or travel grants, Galapagos, 12, Meeting or travel grants, Johnson & Johnson, 6, 12, Consulting fees, meeting or travel grants, Novartis, 6, 12, Consulting fees, meeting or travel grants, Novo Nordisk, 12, Consulting fees, Sobi, 12, Meeting or travel grants, UCB, 6, 12, Consulting fees, meeting or travel grants; I. Andreica: Boehringer-Ingelheim, 6, Chugai, 2, 5, 12, Consulting fees, Eli Lilly, 2, 5, 6, 12, Consulting fees, Galapagos, 2, 5, 12, Consulting fees, Gilead, 2, 5, GSK, 2, 5, Janssen, 2, 5, MSD, 2, 5, 6, Novartis, 5, 12, Consulting fees, received payments for other services, Pfizer, 2, 5, Sobi, 2, 5, 6, takeda, 2, 5, UCB, 2, 6, 12, Consulting fees; D. Kofler: AbbVie, 1, UCB, 1; S. Weiner: AbbVie, 6, 12, Meeting or travel grants, Amgen, 6, 12, Meeting or travel grants, Arbeitskreis Nephrologie Saar-Pfalz Mosel, 12, Unpaid board member, AstraZeneca, 6, Bayer, 6, Bristol-Myers Squibb(BMS), 6, 12, Meeting or travel grants, Daiichi-Sankyo, 6, MSD, 6, Novartis, 1, 6, Otsuka, 6, 12, received meeting or travel grants, Pfizer, 6, 12, received meeting or travel grants, Roche, 6, Saarländisch-Pfälzische Internistengesellschaft, 12, Unpaid board member, UCB, 12, received meeting or travel grants; P. Lamprecht: AstraZeneca, 1, 6, Boehringer-Ingelheim, 6, Bristol-Myers Squibb(BMS), 6, Bundesministerium für Bildung und Forschung, 5, Deutsche Forschungsgemeinschaft, 5, GlaxoSmithKlein(GSK), 1, 6, Janssen, 6, John Grube Foundation, 5, Novartis, 6, UCB, 1, 6, Vifor, 1, 5, 6; H. Schulze-Koops: AbbVie, 2, 6, 12, Research support and principal investigator (clinical trials funds to institution), Amgen, 12, Research support and principal investigator (clinical trials funds to institution), Biogen Idec, 12, Research support and principal investigator (clinical trials funds to institution), Boehringer Ingelheim, 2, 6, 12, Research support and principal investigator (clinical trials funds to institution), Bristol Myers Squibb, 2, 6, 12, Research support and principal investigator (clinical trials funds to institution), Eli Lilly, 6, 12, Research support and principal investigator (clinical trials funds to institution), Galapagos, 2, GSK, 12, Research support and principal investigator (clinical trials funds to institution), Janssen, 6, Janssen-Cilag, 12, Research support and principal investigator (clinical trials funds to institution), Merck Sharp & Dohme, 6, 12, Research support and principal investigator (clinical trials funds to institution), Novartis, 2, 6, 12, Research support and principal investigator (clinical trials funds to institution), Pfizer, 2, 6, 12, Research support and principal investigator (clinical trials funds to institution), Roche, 12, Research support and principal investigator (clinical trials funds to institution), Sandoz-Hexal, 6, 12, Research support and principal investigator (clinical trials funds to institution), Sanofi, 6, 12, Research support and principal investigator (clinical trials funds to institution), UCB, 2, 6, 12, Research support and principal investigator (clinical trials funds to institution); M. Mendelson: Novartis, 3, 12, Shareholder; W. Bao: Novartis, 3, 11; M. Keyport: Novartis, 3, 12, Shareholder; M. Maricos: Novartis, 3, 12, Shareholder; V. Jordan M.: Novartis, 3, 12, Shareholder; J. Thiel: AstraZeneca, 6, Bristol-Myers Squibb(BMS), 5, 6, GlaxoSmithKlein(GSK), 6, 12, Consulting fees, Janssen, 12, Consulting fees, Novartis, 1, 5, 6, 12, consulting fees, 12, Pending patent application on the use of secukinumab in GCA, Roche, 6, Vifor, 6.

To cite this abstract in AMA style:

Venhoff N, Schmidt W, Bergner R, Rech J, Unger L, Finzel S, Andreica I, Kofler D, Weiner S, Lamprecht P, Schulze-Koops H, Mendelson M, Bao W, Keyport M, Maricos M, Jordan M. V, Thiel J. Secukinumab In Patients with Giant Cell Arteritis with Polymyalgia Rheumatica Symptoms: A Post Hoc Analysis of the Phase 2 TitAIN Study [abstract]. Arthritis Rheumatol. 2025; 77 (suppl 9). https://acrabstracts.org/abstract/secukinumab-in-patients-with-giant-cell-arteritis-with-polymyalgia-rheumatica-symptoms-a-post-hoc-analysis-of-the-phase-2-titain-study/. Accessed .
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