Real‐world effectiveness and safety of secukinumab in giant cell arteritis: an Italian multicentre cohort study

OBJECTIVE: The objective of this study was to evaluate the real-world effectiveness and safety of secukinumab in giant cell arteritis (GCA) patients. METHODS: This multicentre retrospective study included patients with GCA who received secukinumab at 14 Italian centres with at least 6 months of follow-up. Outcomes included clinical, complete and glucocorticoid (GC)-free remission, GC dose reduction, drug retention rate and adverse events. RESULTS: Thirty-six patients were included (66.7% women); median age at secukinumab initiation was 74 (IQR 70-80) years. Overall, 32/36 patients (88.9%) had previously relapsed and 26/36 (72.2%) had received tocilizumab. Clinical remission was observed in 85.2%, 80.6% and 83.3% at 3, 6 and 12 months, respectively. Complete remission occurred in 55.6%, 52.8% and 63.3%, while GC-free remission increased progressively, reaching 14.8%, 27.8% and 40.0% at 3, 6, and 12 months, respectively (p = 0.012). Median daily GC dose decreased from 8.7 [4.0-21.2] mg at baseline to 0 [0-5.0] mg at 12 months (p < 0.001); GCs were discontinued in 12/28 patients (42.9%). The 12-month retention rate was 77.0%. Adverse events occurred in 20/36 patients (55.6%); infections occurred in 18/36 (50.0%) patients, accounting for 21 infectious episodes. CONCLUSION: In this multicentre real-world cohort of patients with GCA, including those with relapsing disease and previous biologic exposure, secukinumab was associated with high observed remission rates, progressive GC dose reduction and increasing GC-free remission. Although the phase III GCAptAIN trial did not meet its primary endpoint, these findings suggest that IL-17A inhibition may warrant further evaluation in GCA patients.

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Journal
Arthritis Care & Research
Published
2026-09-21
DOI
https://doi.org/10.1002/acr.80167
Primary Topic
Vasculitis and related conditions
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article
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article

Real‐world effectiveness and safety of secukinumab in giant cell arteritis: an Italian multicentre cohort study

Ester Vivaldelli, Antonio Luca Brucato, Roberto Padoan, Jacopo Mora et al.
Arthritis Care & Research
Vasculitis and related conditions
article

Real‐world effectiveness and safety of secukinumab in giant cell arteritis: an Italian multicentre cohort study

Ester Vivaldelli, Antonio Luca Brucato, Roberto Padoan, Jacopo Mora, Francesco Pollastri, Alessandro Tomelleri, Francesca Cuzzocrea, Enrico Tombetti, Alessandra Milanesi, Milena Bond, Chiara Marvisi, Roberta Ramonda, Angelo Fassio, Ruggiero Mascolo, Francesca Regola, Edoardo Conticini, Paola Toniati, Sara M. Monti, Caterina Ricordi, Christian Dejaco, Paolo Delvino, Augusta Ortolan, Carlo Salvarani, Carlotta Nannini, Luca Quartuccio, The Italian Society of Rheumatology Vasculitis Study Group, Fabiola Atzeni, Luca Iorio, Federica Davanzo, Lorenzo Dagna
article en

Abstract

OBJECTIVE: The objective of this study was to evaluate the real-world effectiveness and safety of secukinumab in giant cell arteritis (GCA) patients. METHODS: This multicentre retrospective study included patients with GCA who received secukinumab at 14 Italian centres with at least 6 months of follow-up. Outcomes included clinical, complete and glucocorticoid (GC)-free remission, GC dose reduction, drug retention rate and adverse events. RESULTS: Thirty-six patients were included (66.7% women); median age at secukinumab initiation was 74 (IQR 70-80) years. Overall, 32/36 patients (88.9%) had previously relapsed and 26/36 (72.2%) had received tocilizumab. Clinical remission was observed in 85.2%, 80.6% and 83.3% at 3, 6 and 12 months, respectively. Complete remission occurred in 55.6%, 52.8% and 63.3%, while GC-free remission increased progressively, reaching 14.8%, 27.8% and 40.0% at 3, 6, and 12 months, respectively (p = 0.012). Median daily GC dose decreased from 8.7 [4.0-21.2] mg at baseline to 0 [0-5.0] mg at 12 months (p < 0.001); GCs were discontinued in 12/28 patients (42.9%). The 12-month retention rate was 77.0%. Adverse events occurred in 20/36 patients (55.6%); infections occurred in 18/36 (50.0%) patients, accounting for 21 infectious episodes. CONCLUSION: In this multicentre real-world cohort of patients with GCA, including those with relapsing disease and previous biologic exposure, secukinumab was associated with high observed remission rates, progressive GC dose reduction and increasing GC-free remission. Although the phase III GCAptAIN trial did not meet its primary endpoint, these findings suggest that IL-17A inhibition may warrant further evaluation in GCA patients.

Arthritis Care & Research
University of Siena (IT), Università Cattolica del Sacro Cuore (IT), University of Messina (IT), University of Verona (IT), University of Modena and Reggio Emilia (IT), University of Udine (IT), University of Padua (IT), Vita-Salute San Raffaele University (IT), University of Milan (IT), University of Pavia (IT), Agostino Gemelli University Polyclinic (IT), Krankenhaus Bruneck (IT), Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (IT), Azienda Ospedaliera San Gerardo (IT), IRCCS Istituto Auxologico Italiano (IT), Policlinico San Matteo Fondazione (IT), ASST Fatebenefratelli Sacco (IT), Hospital of Prato (IT), University of Milano-Bicocca (IT), University of Brescia (IT)
Good health and well-being
Openalex Percentile: Top 11%
Vasculitis and related conditions
DOIOpen Access PDFOpenAlex
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