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POS0796 (2022)
TREATMENT, ADVERSE EVENTS AND FOLLOW UP IN PATIENTS WITH GIANT CELL ARTERITIS IN THE ARTESER MULTICENTER STUDY
J. T. Sánchez-Costa1, I. Hernández2, E. Fernández-Fernández3, M. T. Silva4, J. A. Valero Jaimes5, I. González Fernández6, J. Sanchez-Martin7, J. Lluch Pons8, E. Galíndez-Agirregoikoa9, J. Mendizabal10, P. Lois11, J. Loricera12, A. Muñoz Jimenez.13, C. Valero14, P. Moya15, C. Larena16, V. A. Navarro Angeles17, J. Calvet18, I. Casafont-Solé19, F. Ortiz-Sanjuán20, S. Labrada21, J. Calvo22, C. L. Iñíguez23, V. Hernández Hernández24, C. Campos Fernández25, M. Alcalde Villar26, A. J. Mas27, E. De Miguel3, J. Narváez8, M. A. González-Gay12, N. P. Garrido Puñal13, P. Estrada17, R. Blanco12, on behalf of ARTESER Group
1Spanish Society of Rheumatology, Research Unit, Madrid, Spain
2Complejo Hospitalario Universitario de Vigo, Rheumatology Department, Vigo, Spain
3La Paz University Hospital, Rheumatology Department, Madrid, Spain
4Coruña University Hospital, Rheumatology Department, A Coruña, Spain
5Donostia Unibertsitate Ospitalea, Rheumatology Department, Donostia, Spain
6University Hospital of León, Rheumatology Department, León, Spain
7University Hospital October 12, Rheumatology Department, Madrid, Spain
8Bellvitge University Hospital, Rheumatology Department, L’Hospitalet de Llobregat, Spain
9Basurto University Hospital, Rheumatology Department, Bilbo, Spain
10Hospital Universitario de Navarra (HUN), Rheumatology Department, Pamplona, Spain
11Hospital Clinico Universitario San Carlos, Rheumatology Department, Madrid, Spain
12Marqués de Valdecilla University Hospital, Rheumatology Department, Santander, Spain
13Virgen del Rocío University Hospital, Rheumatology Department, Sevilla, Spain
14Hospital de La Princesa, Rheumatology Department, Madrid, Spain
15Hospital de la Santa Creu i Sant Pau, Rheumatology Department, Barcelona, Spain
16Hospital Ramón y Cajal, Rheumatology Department, Madrid, Spain
17Hospital de Sant Joan Despí Moisès Broggi, Rheumatology Department, Sant Joan Despí, Spain
18Hospital Parc Taulí de Sabadell, Rheumatology Department, Sabadell, Spain
19Germans Trias i Pujol Hospital, Rheumatology Department, Badalona, Spain
20La Fe University and Polytechnic Hospital, Rheumatology Department, València, Spain
21Hospital del Mar, Rheumatology Department, Barcelona, Spain
22Hospital Universitario Araba, Rheumatology Department, Vitoria-Gasteiz, Spain
23Hospital Lucus Augusti, Rheumatology Department, Lugo, Spain
24Hospital Universitario de Canarias, Rheumatology Department, San Cristóbal de La Laguna, Spain
25Consorci Hospital General Universitari de València, Rheumatology Department, València, Spain
26Hospital Universitario Severo Ochoa, Rheumatology Department, Leganés, Spain
27Son Llàtzer Hospital, Rheumatology Department, Palma, Spain

Background: Glucocorticoids (GC) are the mainstay therapy in Giant Cell Arteritis (GCA), initially at high doses (40-60 mg/day) followed by gradual glucocorticoid tapering. This treatment, especially in older patients, is associated with numerous adverse effects (AE). In addition, there are frequent relapses. Therefore, conventional synthetic immunosuppressants such as methotrexate (MTX), leflunomide, azathioprine, cyclophosphamide or mycophenolate, have been used with controversial results. Studies with biological immunosuppressants, such as TNFi have been ineffective; in contrast, tocilizumab (TCZ) has obtained positive results and was approved for the treatment of GCA.


Objectives: In the ARTESER study we describe a ) treatment with GC, synthetic or biological immunosuppressants; b ) AE of CG; and c ) evolution.


Methods: ARTESER is a retrospective observational study sponsored by the Spanish Society of Rheumatology. 26 Spanish centers participated and all new patients diagnosed with GCA from June 1, 2013 to March 29, 2019 were included. Data on GC and immunosuppressants were collected at the beginning and during the follow-up of GCA patients. For the calculation of the cumulative dose of GC, an application was developed that, by including the periods of time, dose and type of GC received during follow-up, performs the automatic calculation in mg of prednisone.


Results: Of the 1675 patients included, GC treatment was adequately recorded in 1650 patients ( Table 1 ). All received oral treatment, being prednisone the most frequently drug used (N=1602, 97.09%). In addition, 426 (25.82%) patients received at least one iv pulse of methylprednisolone, being the 1000 mg regimen the most frequent (n=217; 50.9%). The total mean duration of GC treatment was 22.65 months. The mean cumulative dose per patient at the end of follow-up was 8514.98 mg of prednisone.

Corticosteroid treatment and immunosuppressive treatment

Patients taking oral corticosteroid 1650
 Prednisone, n (%) 1602 (97.09)
 Methylprednisolone, n (%) 164 (9.94)
 Deflazacort, n (%) 64 (3.88)
Patients receiving intravenous corticosteroid, n (%) 426 (25.82)
Mean duration of steroid treatment, mean (SD) 22.65 (17.36)
Mean cumulative dose at the end of follow-up per patient, mg of prednisone, mean (SD) 8514.98 (6570.21)
Methotrexate at diagnosis*, n (%) 165 (9.9)
Leflunomide at diagnosis*, n (%) 2 (0.1)
Azathioprine at diagnosis*, n (%) 3 (0.2)
Cyclophosphamide at diagnosis*, n (%) 7 (0.4)
Mycophenolate at diagnosis*, n (%) 1 (0.1)
Tocilizumab at diagnosis*, n (%) 22 (1.3)
Methotrexate during follow-up, n (%) 532 (31.8)
Leflunomide during follow-up, n (%) 19 (1.2)
Azathioprine during follow-up, n (%) 26 (1.5)
Cyclophosphamide during follow-up, n (%) 10 (0.6)
Mycophenolate during follow-up, n (%) 10 (0.6)
Tocilizumab during follow-up, n (%) 153 (9.1)

The most widely used immunosuppressant was MTX both at diagnosis (n=165; 9.9%) and during follow-up (n=532; 31.8%), followed by TCZ, at diagnosis (22; 1.3%) and at follow-up (153; 9.1%).

AE with GC were described in 393 patients (23.8%), highlighting serious infections (n=67; 10.03%) followed by diabetes mellitus (n=63; 9.43%), steroid myopathy (n=53; 7.9%), vertebral fractures (n=47; 7.04%), non-vertebral fractures (n=36; 5.39%), heart failure (n=36; 5.39%), arterial hypertension (n=34; 5.09%) and neuropsychiatric alterations (n=27; 4.04%).

During the follow-up, 334 (19.9%) patients had relapses, 532 (31.8%) were hospitalized on some occasion, and 142 patients (8.48%) died. The main cause of death were infections (n=44; 30.99%), neoplasms (n=23; 16.2%), cardiovascular (n=15; 10.56%), and cerebrovascular (n=10; 7.04%).


Conclusion: The main treatment for GCA was oral GC, which were required for almost two years on average, in a quarter of patients associated with IV pulses. The cumulative steroid dose was high as well as the side effects. MTX was the most widely used immunosuppressant and TCZ was prescribed in 10%. Relapses and admissions at the hospital were relatively frequent.


Acknowledgements: This study has been funded by ROCHE Farma. The funder has not participated in the design, analysis, or interpretation of the results


Disclosure of Interests: None declared

Citation: , volume 81, supplement 1, year 2022, page 686
Session: Vasculitis – large vessel vasculitis (POSTERS only)