Belimumab and Systemic Lupus Erythematosus: The Importance of Real-World Registries
PDF (Spanish)

Keywords

systemic lupus erythematosus
drug approved

How to Cite

1.
Ugarte-Gil MF. Belimumab and Systemic Lupus Erythematosus: The Importance of Real-World Registries. Rev. parag. reumatol. [Internet]. 2026 Jun. 30 [cited 2026 Jul. 15];12(1):1-2. Available from: https://revista.spr.org.py/index.php/spr/article/view/261

Abstract

Belimumab is the first biologic drug approved for the management of systemic lupus erythematosus (SLE), and it has demonstrated efficacy in patients with moderate-to-severe lupus and lupus nephritis; furthermore, post-hoc analyses have shown a higher likelihood of achieving remission and low disease activity compared with placebo. However, the problem with clinical trials is that they only include populations with homogeneous characteristics and do not necessarily reflect sufficient ethnic diversity. For this reason, real-world registries provide important information for clinicians that complements data from clinical trials, both in terms of the long-term safety of medications and in terms of differing responses among certain population groups.

Translated with DeepL.com (free version)

PDF (Spanish)

References

(1) Furie R, Petri M, Zamani O, Cervera R, Wallace DJ, Tegzová D, Sanchez-Guerrero J, Schwarting A, Merrill JT, Chatham WW, Stohl W, Ginzler EM, Hough DR, Zhong ZJ, Freimuth W, van Vollenhoven RF; BLISS-76 Study Group. A phase III, randomized, placebo-controlled study of belimumab, a monoclonal antibody that inhibits B lymphocyte stimulator, in patients with systemic lupus erythematosus. Arthritis Rheum. 2011 Dec;63(12):3918-30. Disponible en: https://doi.org/10.1002/art.30613

(2) Navarra SV, Guzman RM, Gallacher AE, Hall S, Levy RA, Jimenez RE, et al. Efficacy and safety of belimumab in patients with active systemic lupus erythematosus: a randomised, placebo-controlled, phase 3 trial. Lancet. 2011;377(9767):721-31. Disponible en: https://doi.org/10.1016/S0140-6736(10)61354-2

(3) Furie R, Rovin BH, Houssiau F, Malvar A, Teng YKO, Contreras G, et al. Two-Year, Randomized, Controlled Trial of Belimumab in Lupus Nephritis. N Engl J Med. 2020;383(12):1117-28. Disponible en: https://doi.org/10.1056/NEJMoa2001180

(4) Parodis I, Lindblom J, Levy RA, Zen M, Cetrez N, Gomez A, et al. Attainment of remission and low disease activity after treatment with belimumab in patients with systemic lupus erythematosus: a post-hoc analysis of pooled data from five randomised clinical trials. Lancet Rheumatol. 2024;6(11):e751-e61. Disponible en: https://doi.org/10.1016/S2665-9913(24)00162-0

(5) Moldaver D, Anderson S, Bracher M, Quasny HA, Wood R, Rottier E, et al. Long-term steroid-sparing effect of belimumab in systemic lupus erythematosus: Post hoc pooled analysis of OBSErve multi-country cohort data. Lupus. 2026;35(5):433-45. Disponible en: https://doi.org/10.1177/09612033261425747

(6) Sanchez E, Rasmussen A, Riba L, Acevedo-Vasquez E, Kelly JA, Langefeld CD, et al. Impact of genetic ancestry and sociodemographic status on the clinical expression of systemic lupus erythematosus in American Indian-European populations. Arthritis Rheum. 2012;64(11):3687-94. Disponible en: https://doi.org/10.1002/art.34650

(7) Sanchez E, Webb RD, Rasmussen A, Kelly JA, Riba L, Kaufman KM, et al. Genetically determined Amerindian ancestry correlates with increased frequency of risk alleles for systemic lupus erythematosus. Arthritis Rheum. 2010;62(12):3722-9. Disponible en: https://doi.org/10.1002/art.346507

(8) Lanata CM, Oppong RF, Horton MK, Borda V, Ugarte-Gil MF, Nititham J, et al. Uncovering Genetic Variation in Systemic Lupus Erythematosus Risk Variants in Indigenous Peruvians. ACR Open Rheumatol. 2025;7(5):e70053. Disponible en: https://doi.org/10.1002/acr2.70053

(9) Coronel C, Quiñonez A, Yinde Y, Acosta Colmán I. Registro BELLES: Registro de la respuesta y de los efectos adversos del Belimumab en pacientes con Lupus Eritematoso Sistémico. Rev. parag. reumatol. 12(1). Disponible en: https://www.revista.spr.org.py/index.php/spr/article/view/259

(10) Babini A, Cappuccio AM, Caprarulo C, Casado G, Eimon A, Figueredo H, et al. Evaluation of belimumab treatment in patients with systemic lupus erythematosus in a clinical practice setting: Results from a 24-month OBSErve study in Argentina. Lupus. 2020;29(11):1385-96. Disponible en: https://doi.org/10.1177/0961203320947814

Creative Commons License

This work is licensed under a Creative Commons Attribution 4.0 International License.

Copyright (c) 2026 Manuel F. Ugarte-Gil

Downloads

Download data is not yet available.