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Background: The management of SLE has evolved significantly over the years, with the introduction of targeted therapies such as belimumab (BLM), which has shown promise in improving patient outcomes. New treatment guidelines recommend early use of these drugs if there is no response to hydroxychloroquine or need for corticosteroid doses higher than 5 mg/day.
Objectives: To assess the early use of BLM in patients with SLE in Spain, and its impact on different outcomes.
Methods: Retrospective longitudinal and multicentre study of SLE patients, treated with BLM in Spanish rheumatology departments. Demographic and clinical features, activity (SLEDAI), treatments and outcomes (remission (DORIS -2021) and low disease activity (LLDAS), organ damage (SDI) were collected at baseline, at 6 months, 12 months and at the last visit of the patient.
A comparative analysis was performed between patients who used early belimumab versus those who did not.
We defined early used if BLM was used:
After HCQ and GC or only 1 prior immunosuppressant.
In the first 2 years since diagnosis.
In patients with SDI=0.
We analyzed each characteristic separately.
Results: A total of 442 patients were included in the registry at January 2025. Among these, 399 (90.2%) were female, and 389 (86.8%) were Caucasian. Mean (SD) age at diagnosis 27.8 (60) years, mean (SD) age at initiation of BLM 34,5 years. The mean (SD) baseline SLEDAI score was 9,8 (5,25), and the mean (SD) SLICC Damage Index at baseline was 0,79 (1,2). Mean time since initiation of BLM to last registered visit were 2,6 years. A total of 202 patients used BLM as first line therapy or after 1 IS. We observed significant differences compared with 212 patients who did used BLM after a second or more line therapy. Table 1. When we compared patients who started BLM within 2 years of diagnosis (n=89) versus those who started it later (n=333), we observed statistically significant differences in organ damage at 12 months (mean SDI (±SD)= 0.469 (±0.908) vs 0,799 (±1.21), p=0.015) and at the last visit (mean SDI (±SD)= 0.222 (±0.670) vs 0.937(±1.32), p< 0.001). When comparing BLM used in patients with (n=182) and without (n=234) prior damage, we observed statistically differences in terms of DORIS and LLDAS at 6 months as well as in damage at 12 month and last visit. Also, more patients completely withdraw steroids in the last visit. Table 2.
Comparison between the use of BLM in first or second line vs BLM used after at least 1 immunosuppressor
| BLM as first line or after 1 IS. Mean (SD) or n (%)
| BLM after >1 IS
| P value | |
|---|---|---|---|
| SLEDAI 6 months | 4.42 (4,10) | 5.09 (3.67) | 0.015 |
| NSJ 6 months | 0.509 (1.59) | 1 (2.58) | 0.003 |
| NTJ 6 months | 0.975 (2.68) | 1.54 (3.12) | 0.009 |
| PGA 6 months | 0.824 (0.676) | 0.998 (0.625) | 0.003 |
| SDI 12 months | 0.572 (1.01) | 0.888 (1.34) | 0.03 |
| SLEDAI 12 months | 3.31 (3.10) | 4.35 (4.05) | 0.02 |
| NSJ 12 months | 0.46 (1.66) | 0.672 (1.76) | 0.04 |
| NTJ 12 months | 0.65 (2.46) | 1.04 (2.46) | 0.005 |
| LLDAS last visit | 97 (80.8%) | 90 (65.7%) | 0.009 |
| Flare from 12m to last visit | 23 (22.5%) | 55 (40.7%) | 0.004 |
| Severe flare from 12 m to last visit | 6 (6.4%) | 109 (51.4%) | 0.005 |
| SLICC last visit | 0.449 (0.743) | 1.09 (1.51) | <0.001 |
NSJ: number of swollen joints, NTJ: number of tender joints.
Comparison between the use of BLM in patients with prior damage vs patients without damage-.
| With prior damage
| Without prior damage
| P value | |
|---|---|---|---|
| DORIS 6 months | 31 (18.8%) | 59 (29.8%) | 0.0216 |
| LLDAS 6 months | 66 (40.0%) | 105 (53.0%) | 0.0132 |
| SLEDAI 6 months | 5.33 (4.19) | 4.29 (3.61) | 0.0165 |
| NTJ 6 months | 1.64 (3.35) | 0.974 (2.48) | 0.0039 |
| SDI 12 months | 1.55 (1.41) | 0.136 (0.441) | <0.001 |
| NTJ 12 months | 0.882 (2.31) | 0.414 (1.97) | 0.00516 |
| SDI at last visit | 1.47 (1.41) | 0.238 (0.776) | <0.001 |
| Prednisone withdrawal | 36 (29.8%) | 66 (43.4%) | 0.028 |
NSJ: number of swollen joints, NTJ: number of tender joints.
Conclusion: The use of belimumab in the first 2 years after diagnosis, in patients without previous damage and as first or second lines of treatment offers benefits in different measures of activity and damage in the short and long term. More data are necessary to confirm our results.
REFERENCES: NIL.
Acknowledgements: NIL.
Disclosure of Interests: None declared.
© The Authors 2025. This abstract is an open access article published in Annals of Rheumatic Diseases under the CC BY-NC-ND license (