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  • O2 Serious infection, including severe COVID19, seems not to be a major clinical problem in patients with systemic lupus erythematosus treated with Belimumab, according the data from a large multicenter cohort

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O2 Serious infection, including severe COVID19, seems not to be a major clinical problem in patients with systemic lupus erythematosus treated with Belimumab, according the data from a large multicenter cohort
  1. Iñigo Rua-Figueroa1,
  2. Irene Altabás González2,
  3. Norman Jiménez Otero2,
  4. Judit Font Urgelles3,
  5. Ivette Casafont Sole3,
  6. Marta De la Rubia Navarro4,
  7. José Andrés Roman Ivorra4,
  8. Andrea Hernández-Martín1,
  9. María Galindo Izquierdo5,
  10. Tarek Salman Montes6,
  11. Javier Narváez7,
  12. Paola Vidal-Montal7,
  13. María Jesús García Villanueva8,
  14. María Ángeles Blázquez Cañamero8,
  15. Carlos Marras Fernández9,
  16. María Piqueras García9,
  17. Julia Martínez Barrio10,
  18. Marina Sánchez Lucas10,
  19. Josefina Cortés Hernández11,
  20. Eleonora Penzo11,
  21. Jaime Calvo Alen12,
  22. Margarida Vasques Rocha12,
  23. Eva Tomero13,
  24. Raúl Menor Almagro14,
  25. Myriam Gandía Martínez14,
  26. José A Gómez-Puerta15,
  27. Beatriz Frade-Sosa15,
  28. Consuelo Ramos Giráldez16,
  29. Carmen Trapero Pérez16,
  30. Elvira Díez Álvarez17,
  31. Clara Moriano17,
  32. Alejandro Muñoz Jiménez18 and
  33. José María Pego Reigosa2
  1. 1Hospital de Gran Canaria Doctor Negrin, Gran Canaria, Spain
  2. 2Complejo Hospitalario universitario de Vigo. IRIDIS Group, Galicia, Spain
  3. 3Hospital Universitario Germans Trias i Pujol, Barcelona, Spain
  4. 4Hospital Universitario y Politécnico de la Fe, Valencia, Spain
  5. 5Hospital 12 de octubre, Madrid, Spain, Barcelona, Spain
  6. 6Hospital del Mar, Barcelona, Spain
  7. 7Hospital Universitario de Bellvitge, Barcelona, Spain
  8. 8Hospital Universitario Ramón y Cajal, Madrid, Spain
  9. 9Hospital Virgen de la Arrixaca de Murcia, Murcia, Spain
  10. 10Hospital General Universitario Gregorio Marañón, Madrid, Spain
  11. 11Hospital Universitario Valle d´ Hebrón, Barcelona, Spain
  12. 12Hospital Universitario Araba, Araba, Spain
  13. 13Hospital Universitario de La Princesa, Madrid, Spain
  14. 14Hospital Universitario de Jerez, Cádiz, Spain
  15. 15Hospital Clinic de Barcelona, Barcelona, Spain
  16. 16Hospital Universitario Nuestra Señora de Valme, Sevilla, Spain
  17. 17Hospital Universitario de León, León, Spain
  18. 18Hospital universitario Virgen del Rocío, Sevilla, Spain

Abstract

Objectives Belimumab (BLM) had been shown to be consistently effective in patients with systemic lupus erythematosus (SLE) and is increasingly being used. Although it comes a biologic agent with a good safety profile, limited data are available regarding serious infection in real world, particularly concerning to COVID19.

We aimed to assess the incidence of serious infection and COVID19 in patients with SLE, undergoing treatment with BLM and explore associated factors.

Methods Multicentre retrospective and longitudinal study of SLE patients treated with BLM, in Spanish rheumatology services. We collected activity status (AM-SLEDAI), organ damage (SLICC/ACR/DI) (SDI), treatments, outcomes and adverse effects, with special focus on serious infectious events. The data were collected at baseline, 6, 12 months and at the last available visit. A bivariate analysis of factors associated with serious infection was performed (Chi2 or Fisher’s test).

Results A total of 324 patients with SLE (ACR-97 or SLICC-12 criteria) were included; 91% women; mean age (± SD): 42.4 (±12.9) years. Median follow-up: 3.2 years (1.4–5.9). Median time on BLM treatment: 2.7 (±2.4) years; 106 patients (32.7%) discontinued BLM, 22 (6.8%) due to adverse effects, of which 4/22 (18.2%) suffered serious infections, none of them opportunistic.

A total of 51/324 patients (15.7%) had > 1 serious infection (up to 53 serious infections recorded.). Incidence density: 7.9 per 100 patient-years (for the first year); 94 out of 297 patients (31%) suffered from COVID19, of whom only 4 were severe, remarkably none of them being under treatment with BLM at the time of SARS-CoV2 infection. There were no deaths due to infection. Serious infection was associated with damage (median SDI (1 (0–2) vs 0 (0–1) (p = 0.023;95%CI: 0.10–1.33) and use of glucocorticoids (GC) (p=0.035; OR 2.25, 95%CI:1.04–5.17)

Conclusions 1° Incidence rate of serious infection in SLE patients treated with BLM does not differ from that reported in the clinical assays and only a few patients stopping BLM due to infection.

2° Organ damage and the use of glucocorticoids were both associated with serious infection.

3° Remarkably, no patient presented severe COVID19 or died as a result of an infection.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/ .

https://doi.org/10.1136/lupus-2024-el.12

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