POS0758 EFFECTIVENESS AND SAFETY OF JANUS KINASE INHIBITORS IN GIANT CELL ARTERITIS. REAL-WORLD CLINICAL PRACTICE STUDY AND LITERATURE REVIEW

Background: Patients with giant cell arteritis (GCA) can relapse despite glucocorticoids, methotrexate and tocilizumab treatment. The JAK/STAT signalling pathway is involved in the pathogenesis of GCA, and JAK inhibitors (JAKi) are a potential treatment alternative. Objectives: To evaluate the effectiveness and safety of JAKi in GCA. Methods: Real-world, retrospective clinical practice study of patients with GCA treated with JAKi. Outcomes assessed included clinical remission and EULAR remission (clinical remission+CRP and ESR normalization), disease relapse and safety. A literature search for other JAKi-treated GCA cases was conducted in PubMed from inception to 11/30/2024. Results: We include 40 patients (35 females/87.5%), mean age, 72.2 years, relapsing disease 40 (100%) that received JAKi. The initial JAKi was baricitinib (n=15), tofacitinib (n=10) and upadacitinib (n=15) (Table 1 and Figure 1). After a mean±SD follow-up of 12.4±6.8 months, 24 (60%) achieved a maintained remission, and 16 (40%) patients discontinued the initial JAKi due to relapse (n=12, 30%) or severe adverse events (SAEs) (n=4, 10%) including elevation of liver enzymes (n=1), disseminated herpes zoster (n=1), glioblastoma multiforme (n=1), and palpitations/dyspnea (n=1). Two patients developed an urinary tract infection and one patient anemia without requiring permanent JAKi discontinuation. The 12 patients failing the initial JAKi were switched to an alternative JAKi (n=2), biologic therapy (n=8) and azathioprine (n=1). One patient discontinued JAKi therapy due to sustained remission. The literature review identified another 37 GCA patients (26 females, mean age 71.4 years) treated with JAKi, mostly with baricitinib (n=35). Most of these patients benefited from JAKi therapy (Table 1). With respect to relevant adverse events, one patient suffered an Aspergillus fumigatus infection, other patient an Enterococcus faecalis bacteremia, and other thrombocytopenia (Table 1). Conclusion: This real-world analysis suggests that JAKi could be effective and relatively safe in GCA, including patients failing to other immunosuppressive therapies. REFERENCES: [1] Calderón-Goercke M, et al. Clin Exp Rheumatol. 2023 Apr;41(4):829-836. doi: 10.55563/clinexprheumatol/oqs8u9. [2] Loricera J et al. Clin Exp Rheumatol. 2014 May-Jun;32(3 Suppl 82):S79-89. Epub 2014 May 15. PMID: 24854377. [3] Prieto Peña D, et al. Clin Exp Rheumatol. 2021 Mar-Apr;39 Suppl 129(2):69-75. [4] Loricera J, et al. Ther Adv Musculoskelet Dis. 2022 Jul 22;14:1759720X221113747. doi: 10.1177/1759720X221113747. Figure 1Flow chart of the 40 GCA patients treated with JAKi. Table 1Current series and literature review of patients with GCA treated with JAKi.ReferenceNumber of casesSexAge,mean±SDJAKi receivedPrevious conventional synthetic immunosuppressive drugsPrevious biologic drugsFollow-up (months), mean±SDOutcomeAdverse eventsHerlihy et al1Female75RuxolitinibMethothrexate, mycophenolate mophetilNone9No outcome data reportedNonePrigent et al1Female76BaricitinibMethothrexateTocilizumab12Clinical improvementNoneSanada et al1Female72UpadacitinibSulfasalazineNone7.5Clinical improvementNoneCamellino et al4Female (n=4)70.5±11.7Baricitinib (n=4)Methothrexate (n=2), hydroxychloroquine (n=1), sulfasalazine (n=1), cyclosporine (n=1), mycophenolate mophetil (n=1)Tocilizumab (n=4)21.5±13.0; (no data in 1 patient)Clinical improvement (n=2); no clinical improvement (n=2)NoneKoster et al15Female (n=11), male (n=4)72.4±7.2Baricitinib (n=15)Methothrexate (n=2), Cyclophosphamide (n=1)Sirukumab (n=1)11.3±2.3Clinical improvement (n=13); no improvement (n=1); no outcome data reported (n=1)Thrombocytopenia (n=1), infections not requiring antibiotics (n=8), infections requiring antibiotics (n=5), nausea (n=6), leg oedema (n=2), fatigue (n=2), diarrhoea (n=1), abdominal pain (n=1), herpes zoster (n=1)Eriksson et al15Female (n=8), male (n=3)70.2±6.0Baricitinib/ tofacitinibMethotrexate (n=3)Tocilizumab (n=3), infliximab (n=1)19±10.5Clinical improvement (n=15)Aspergillus fumigatus infection (n=1); Enterococcus faecalis bacteriemia (n=1)Current series40Female (n=35), male (n=5)72.2±7.9Baricitinib (n=15), tofacitinib (n=10), upadacitinib (n=15)Methothrexate (n=25), hydroxychloroquine (n=3),leflunomide (n=1)Tocilizumab (n=29), sarilumab (n=3), abatacept (n=8), adalimumab (n=2), ustekinumab (n=2)12.4±6.9Clinical improvement (n=24); no improvement (n=12)Urinary tract infection (n=2); anemia (n=1); elevation of liver enzymes (n=1); palpitations (n=1); dyspnea (n=1), disseminated herpes zoster (n=1); glioblastoma multiforme (n=1) Acknowledgements: NIL . Disclosure of Interests: Fernando López-Gutiérrez Abbvie, Roche, Novartis, MSD, UCB Pharma, Celgene, Lilly, Pfizer, Galápagos, Javier Loricera Roche, Galápagos, Novartis, UCB Pharma, MSD, Celgene, Astra Zeneca, and Grünenthal, Janssen, Abbvie, Roche, Novartis, MSD, UCB Pharma, Celgene, Lilly, Pfizer, Galápagos, Toluwalase Tofade: None declared, Diana Prieto-Peña: None declared, Susana Romero-Yuste: None declared, Eugenio De Miguel: None declared, Anne Riveros-Frutos: None declared, Dalifer Freites Nuñez: None declared, Iván Ferraz-Amaro: None declared, Santos Castañeda: None declared, Eztizen Labrador-Sánchez: None declared, Olga Maiz: None declared, Francisco Javier Narváez Garcia: None declared, Eva Galíndez-Agirregoikoa: None declared, Ismael González: None declared, Ana Urruticoechea-Arana: None declared, Angel Ramos Calvo: None declared, Patricia Moya: None declared, Sebastian Unizony: None declared, Ricardo Blanco AbbVie, Pfizer, Roche, Bristol-Myers, Janssen, Lilly, UCB, and MSD, AbbVie, MSD, and Roche. © The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/). Neither EULAR nor the publisher make any representation as to the accuracy of the content. The authors are solely responsible for the content in their abstract including accuracy of the facts, statements, results, conclusion, citing resources etc.

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