Vitamin D Supplementation in the Prevention of Severe Adverse Effects Caused ByGlucocorticoids: Study from the ARTESER Registry of Giant Cell Arteritis

Gaston Ariel Ghio¹, Marta Domínguez-Álvaro², Ricardo Blanco-Alonso³, Santos Castañeda⁴, Iñigo Hernández-Rodríguez⁵, Elisa Fernández-Fernández:⁶, Maite Silva-Diaz⁷, Joaquin María Belzunegui:⁸, Clara Moriano⁹, Julio Sánchez-Martín¹⁰, Javier Narvaez-García¹¹, Eva Galindez¹², Anne Riveros Frutos¹³, Francisco Ortiz Sanjuán¹⁴, Tarek Carlos Salman Monte:¹⁵, Margarida Vasques Rocha:¹⁶, Carlota L Iñiguez:¹⁷, Alicia García Dorta¹⁸, Clara Molina Almela¹⁹ and María Alcalde Villar:²⁰, and ARTESER Project Collaborative Group, ¹Hospital Universitari Mutua Terrassa, Terrassa, Catalonia, Spain, ²Sociedad Española de Reumatología, Madrid, Spain, ³Division of Rheumatology, Hospital Universitario Marqués de Valdecilla. IDIVAL, Immunopathology group, Santander, Spain, ⁴Hospital Universitario de la Princesa, Madrid, Spain, ⁵Complejo Hospitalario Universitario de Vigo, Vigo, Spain, ⁶La Paz University Hospital, Alcalá de Henares, Madrid, Spain, ⁷Complejo Hospitalario Universitario A Coruña, A Coruña, Spain, ⁸H de Donostia, Donostia-San Sebasti, Spain, ⁹Hospital León, LEON, Spain, ¹⁰Hospital Universitario 12 de Octubre, Madrid, Spain, ¹¹Hospital Universitario de Bellvitge, Barcelona, Spain, ¹²Hospital Universitario de Cabueñes, Bilbao, Spain, ¹³Hospital Universitari Germans Trias i Pujol, Barcelona, Spain, ¹⁴Hospital Universitario de Cabueñes, Gijón, Asturias, Spain, ¹⁵Hospital del Mar/Parc de Salut Mar-IMIM, Barcelona, Spain, ¹⁶Hospital Universitario Araba, Vitoria, Spain, ¹⁷Hospital Universitario Lucus Augusti, Galicia, Spain, Galicia, Spain, ¹⁸Rheumatologist, La Laguna, Spain, ¹⁹Consorcio Hospital General Universitario de Valencia, Valencia, Comunidad Valenciana, Spain, ²⁰Hospital Universitario Severo Ochoa Leganés, Madrid, Spain, Madrid, Spain

Meeting: ACR Convergence 2024

Keywords: Bone density, diet, giant cell arteritis, glucocorticoids, Vasculitis

Session Information

Date: Sunday, November 17, 2024

Title: Vasculitis – Non-ANCA-Associated & Related Disorders Poster II

Session Type: Poster Session B

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

Background/Purpose: Glucocorticoids (GC) are the gold standard for the treatment of giant cell
arteritis (GCA). However, these drugs, when used at high doses and for prolonged periods,
especially in elderly patients with comorbidities, frequently produce adverse events (AEs),
some of which can be severe, thus limiting their use. Vitamin D3 (vD3) or Calcitriol (the
active form of vitamin D) is a steroid synthesized in the skin whose main function is to
regulate phosphorus and calcium metabolism. Multiple studies have associated low levels of
vitamin D with autoimmune and infectious diseases, as well as with an increased risk of
cardiovascular events, bone fractures, and all-cause mortality.
Objective
To determine whether vD3 acts as a protective factor against severe AEs
associated with GC in the Spanish ARTESER [Giant Cell Arteritis Registry (Spanish Society
of Rheumatology)] registry.

Methods: ARTESER is a national, longitudinal, observational study sponsored by the
Spanish Society of Rheumatology (SER), including patients diagnosed with GCA between
06/2013 and 03/2019 from 26 national hospitals. The project was approved by the Cantabria
Ethics and Research Committee and adhered to the Declaration of Helsinki. Severe AEs
were evaluated, with severity defined as a) fatal, b) life-threatening, c) requiring
hospitalization, and/or d) as per the attending physician’s criteria. Patients were classified
based on whether they received vD3 supplementation or not.
The incidence rate (event/person-year) and 95% CI of severe AEs were calculated for both
groups, and a Cox regression model was performed to determine the protective role of vD3.

Results: For this sub-analysis of the ARTESER registry, 1568 patients treated with steroids
were selected (1100 women; 70.1% and 468 men; 29.8%). The mean age at diagnosis was
76.9 years (SD ± 8.1). Severe AEs were observed in 120 of 1568 patients (7.6%), with an
incidence rate of 0.039 (95% CI 0.033-0.047).
Out of the total, 1186 patients (75.6%) received vD3 supplementation, while 382 (24.4%) did
not. Among the 382 patients without vD3, 31 (8.1%) presented severe AEs (incidence rate of
0.045, 95% CI 0.031-0.064). Among the 1186 patients with vD3, 89 (7.5%) presented severe
AEs, with an incidence rate of 0.038 (95% CI 0.030-0.046), with no statistically significant
differences found between the two groups of patients (p-value=0.387).
To examine the protective role of vD3, a Cox regression model was performed, revealing a
significant interaction between GC dose and vD3 supplementation. This interaction was
protective (HR=0.88).

Conclusion: In our ARTESER registry of GCA patients, we could not definitively determine
whether vD3 supplements provide a protective effect against GCs’ AEs. However, given the
beneficial role of vitamin D, further studies are necessary to elucidate this question more
definitively.

Socio-demographic, clinical, comorbidities and therapeutic baseline characteristics of patients with giant cell arteritis included in the ARTESER registry.
Abbreviations (in alphabetical order): CI: confidence interval; CV: cardiovascular; GC: glucocorticoids; n: number; SD: standard deviation; vD: vitamin D.

Protective role of vitamin D assessed by Cox Regression Analysis. (Forest Plot)

Disclosures: G. Ghio: None; M. Domínguez-Álvaro: None; R. Blanco-Alonso: AbbVie, 2, 5, 6, Bristol-Myers Squibb, 2, 6, Galapagos, 6, Janssen, 2, 6, Lilly, 2, 6, MSD, 2, 5, 6, Pfizer, 2, 6, Roche, 2, 5, 6; S. Castañeda: Bristol-Myers Squibb(BMS), 2, 6, Eli Lilly, 2, 6, Merck/MSD, 2, 5, 6, Pfizer, 5, Roche, 2, 6, UCB, 2, 5; I. Hernández-Rodríguez: None; E. Fernández-Fernández:: None; M. Silva-Diaz: None; J. María Belzunegui:: None; C. Moriano: None; J. Sánchez-Martín: None; J. Narvaez-García: None; E. Galindez: None; A. Riveros Frutos: None; F. Ortiz Sanjuán: None; T. Salman Monte:: AstraZeneca, 2, 5, 6, GlaxoSmithKlein(GSK), 2, 5, 6, Otsuka, 2, 6; M. Vasques Rocha:: None; C. L Iñiguez:: None; A. García Dorta: None; C. Molina Almela: None; M. Alcalde Villar:: None.

To cite this abstract in AMA style:

Ghio G, Domínguez-Álvaro M, Blanco-Alonso R, Castañeda S, Hernández-Rodríguez I, Fernández-Fernández: E, Silva-Diaz M, María Belzunegui: J, Moriano C, Sánchez-Martín J, Narvaez-García J, Galindez E, Riveros Frutos A, Ortiz Sanjuán F, Salman Monte: T, Vasques Rocha: M, L Iñiguez: C, García Dorta A, Molina Almela C, Alcalde Villar: M. Vitamin D Supplementation in the Prevention of Severe Adverse Effects Caused ByGlucocorticoids: Study from the ARTESER Registry of Giant Cell Arteritis [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/vitamin-d-supplementation-in-the-prevention-of-severe-adverse-effects-caused-byglucocorticoids-study-from-the-arteser-registry-of-giant-cell-arteritis/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/vitamin-d-supplementation-in-the-prevention-of-severe-adverse-effects-caused-byglucocorticoids-study-from-the-arteser-registry-of-giant-cell-arteritis/