0485: Assessing the Effectiveness of Tocilizumab in Newly Diagnosed Giant Cell Arteritis versus Refractory/recurrent Giant Cell Arteritis in Clinical Practice

Julio Sánchez-Martín¹, Javier Loricera², Clara Moriano³, Santos Castañeda⁴, F. Javier Narváez⁵, Vicente Aldasoro⁶, Olga Maiz⁷, Rafael Melero⁸, Juan Ignacio Villa Blanco⁹, Paloma Vela-Casasempere¹⁰, Susana Romero Yuste¹¹, José Luis Callejas¹², Eugenio De Miguel¹³, Eva Galíndez-Agirregoikoa¹⁴, Francisca Sivera¹⁵, Jesus Fernandez¹⁶, Carles Galisteo¹⁷, Ivan Ferraz Amaro¹⁸, Lara Sánchez-Bilbao¹, Monica Calderon-Goercke¹⁹, Miguel Ángel González-Gay²⁰ and Ricardo Blanco², ¹Hospital Universitario Marqués de Valdecilla, Santander, Spain, ²Hospital Universitario Marqués de Valdecilla, IDIVAL, Santander, Spain, ³Complejo Asistencial Universitario de León, León, Spain, ⁴Division of Rheumatology, Hospital Universitario de La Princesa, IIS-Princesa, Madrid, Spain, ⁵Rheumatology Department, Hospital Universitario de Bellvitge, Barcelona, Spain, ⁶Hospital Universitario de Navarra, Pamplona, Spain, ⁷Hospital Universitario de Donostia, San Sebastián, Spain, ⁸Complexo Hospitalario Universitario de Vigo, Vigo, Spain, ⁹Sierrallana Hospital, Torrelavega, Spain, ¹⁰Hospital General Universitario Alicante, Alicante, Spain, ¹¹Complexo Hospitalario Universitario, Pontevedra, Spain, ¹²Hospital San Cecilio, Granada, Spain, ¹³Hospital Universitario La Paz, Madrid, Spain, ¹⁴Basurto University Hospital, Bilbao, Spain, ¹⁵Hospital Universitario de Elda, San Vicente del Raspeig, Spain, ¹⁶Hospital de La Coruña, La Coruña, Spain, ¹⁷Hospital Parc Tauli,, Sabadel, Spain, ¹⁸Division of Rheumatology. Hospital Universitario de Canarias. Spain., Santa Cruz de Tenerife, Spain, ¹⁹Hospital de Sierrallana, Torrelavega, Spain, ²⁰Department of Medicine and Psychiatry, Universidad de Cantabria; Rheumatology Division, Hospital Universitario Marqués de Valdecilla; Research group on genetic epidemiology and atherosclerosis in systemic diseases and in metabolic diseases of the musculoskeletal system, IDIVAL, Santander, Spain. Cardiovascular Pathophysiology and Genomics Research Unit, School of Physiology, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa

Background/Purpose: Tocilizumab (TCZ) is the only biologic drug approved in giant cell arteritis (GCA), based in two clinical trials (CT) (1,2). CT included selected patients who may differ from those of clinical practice (CP). A high proportion of GCA patients treated with TCZ in CT had a newly diagnosed GCA, whereas in CP, most of them are refractory/recurrent GCA (3,4). Although in CT the efficacy of TCZ seems to be similar in patients with newly diagnosed GCA and in patients with refractory/recurrent GCA, in CP it is not documented.

The purpose of this study is to compare in CP, the effectiveness and safety of TCZ in newly diagnosed vs refractory/recurrent GCA.

Methods: Multicentre observational study on 471 GCA patients treated with TCZ. GCA was diagnosed by: a) ACR criteria, and/or b) temporal artery biopsy, and/or c) imaging techniques.A comparative study between patients with newly diagnosed GCA (< 6 weeks) and those with refractory/recurrent GCA ( >6 weeks) (according to GiACTA study definitions) (2). Sustained remission was based on EULAR definitions (5).

Results: The 471 GCA patients were divided into 2 subgroups: a) newly diagnosed GCA (n=91) and b) refractory/recurrent GCA (n=380) (TABLE).No significant differences were observed between both groups in sustained remission, although a greater tendency towards sustained remission is observed in newly diagnosed than in refractory/recurrent GCA patients (FIGURE). The decrease in glucocorticoids dose was faster in the first three months in the newly diagnosed GCA group, but thereafter, was similar in both groups, as well as the appearance of relevant adverse events and serious infections.

Conclusion: The effectiveness and safety of TCZ seems to be similar in patients with newly diagnosed GCA and in patients with refractory/recurrent GCA.

References
1. Villiger PM, et al. Lancet. 2016; 387:1921-1927. PMID: 26952547
2. Stone JH, et al. N Engl J Med. 2017; 377:317-328. PMID: 28745999
3. Calderón-Goercke M, et al. Semin Arthritis Rheum. 2019; 49: 126-135. PMID: 30655091
4. Calderón-Goercke M, et al. Clin Exp Rheumatol. 2020; 124: S112-119. PMID: 32441643
5. Hellmich B, et al. Ann Rheum Dis. 2020; 79: 19-30. PMID: 31270110
Main features of patients with newly diagnosed GCA and refractory/recurrent GCA treated with tocilizumab.

A) Sustained remission, and B) median prednisone dose required in patients with newly diagnosed GCA and in patients with refractory/recurrent GCA treated with tocilizumab.
Disclosures: J. Sánchez-Martín, None; J. Loricera, Novartis, UCB, Celgene, Roche; C. Moriano, None; S. Castañeda, Roche; F. Narváez, None; V. Aldasoro, None; O. Maiz, None; R. Melero, None; J. Villa Blanco, None; P. Vela-Casasempere, None; S. Romero Yuste, Pfizer, Lilly, AbbVie, Biogen, Sanofi; J. Callejas, None; E. De Miguel, None; E. Galíndez-Agirregoikoa, None; F. Sivera, None; J. Fernandez, None; C. Galisteo, None; I. Ferraz Amaro, AbbVie/Abbott, Merck/MSD, Janssen, Roche, AbbVie/Abbott, Pfizer, Roche, Amgen, Celgene, Merck/MSD; L. Sánchez-Bilbao, Eli Lilly; M. Calderon-Goercke, None; M. González-Gay, AbbVie/Abbott, Merck/MSD, Janssen, Roche, AbbVie/Abbott, Roche, Sanofi, Eli Lilly, Celgene, Sobi, Merck/MSD; R. Blanco, Eli Lilly, Pfizer, Roche, Janssen, MSD, AbbVie, Amgen, AstraZeneca, Bristol Myers Squibb, Galapagos, Novartis, Sanofi.