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Background: Glucocorticoids (GCs) are still the mainstay during treatment of systemic lupus erythematosus (SLE). However, since their long-term side effects are well known, GC discontinuation is becoming a crucial part of the treat-to-target approach in SLE management. To this date, it is unclear whether it is safe and feasible to withdraw GCs after the achievement of remission, and data regarding this issue are conflicting.
Objectives: We aim at assessing the risk of flares in stable remitted patients and comparing the risk of those who discontinued GCs and those who were kept on low-dose GCs despite remission.
Methods: A retrospective analysis of prospectively collected data was performed. SLE patients fulfilling ACR criteria and diagnosed between 1990 and 2023 were considered. During follow-up, remission was defined as clinical SLEDAI-2K=0 on prednisone ≤5 mg/day and/or stable immunosuppressive/antimalarial therapy. Flare-up was defined as any increase in clinical SLEDAI-2K>0 or the need for changes in SLE medications. Remitted patients who discontinued GCs (off-GCs) were compared with patients who maintained GC therapy (≤5 mg/day) despite the achievement of remission (on-GCs). Through Kaplan-Meier curve and Cox-regression analysis, flare-free remission and predictors of flare-free remission were evaluated respectively in on- vs- off-GCs remitted patients.
Results: 484 patients achieved remission at least once during follow-up. Remission was reached by 360 patients off-GCs (74.4%), while 124 (25.6%) on-GCs. Demographic and clinical characteristics were similar between the two groups (Table 1). 85 flares were observed, during a mean observational time of 87 (±76) months. Of these, 48 flares were encountered in off-GCs patients (0.13 flares/patient) and 37 in on-GCs patients (0.29 flares/patient) (p<0.01), with an annual flare rate of 1.65 flare/100 patients/year and 8.5 flares/100 patients/year respectively in remitted patients off- and on-GCs (p<0.001). Considering only patients in durable remission (i.e. lasting >2 consecutive years) at GC discontinuation/continuation, similar results were obtained, as annual flare rates were 1.36 among off-GCs and 5.9 among on-GCs patients. Higher flare-free remission in patients off-GCs (p=0.002) was demonstrated by Kaplan-Meier curve (Figure 1). Through Cox-regression, predictors for flare-free remission were disease duration (HR 0.943, 95%CI 0.892-0.998, p=0.05), and positive anti-U1RNP (HR 1.973, 95%CI 0.998-3.940, p=0.054).
Conclusion: In SLE patients, during clinical remission GC discontinuation after proper tapering is safe and associated with a low risk of flare. Notably, GC withdrawal does not increase the risk of flares, according to our results.
REFERENCES: NIL.
Characteristics of patients in remission off- and on-GCs.
| Characteristics | Remitted patients Off GCs
| Remitted patients On GCs
| P value |
|---|---|---|---|
| Age at remission mean ± SD | 41.16 ± 13.94 | 46.54 ±14.89 | < 0.001 |
| Sex, female, n (% ) | 309 (85.8) | 106 (85.5) | Ns |
| Rash n (% ) | 189 (54.2) | 64 (55.7) | Ns |
| Alopecia n (% ) | 38 (10.9) | 14 (12.2) | Ns |
| Arthritis/Myositis n (% ) | 257 (74.1) | 80 (69.6) | Ns |
| Serositis n (% ) | 66 (19.0) | 28 (24.1) | Ns |
| Proteinuria n (% ) | 196 (55.7) | 58 (48.7) | Ns |
| Thrombocytopenia n (% ) | 61 (17.6) | 26 (22.8) | Ns |
| Leukopenia n (% ) | 123 (35.3) | 56 (48.7) | 0.011 |
| Neuropsychiatric n (% ) | 54 (15.6) | 26 (22.4) | Ns |
| Vasculitis n (% ) | 34 (9.8) | 12 (10.5) | Ns |
| Renal involvement n (% ) | 166 (53.0) | 45 (47.9) | Ns |
| Anti-SSA/SSB n (% ) | 140 (40.8) | 59 (51.8) | 0.041 |
| Anti U1RNP n (% ) | 88 (25.7) | 39 (33.9) | Ns |
| APL syndrome n (% ) | 39 (11.5) | 11 (9.7) | Ns |
| Anti-DNA n (% ) | 255 (73.5) | 77 (67.0) | Ns |
| Anti-DNA at remission mean ± SD | 43.29 ±112.54 | 43.37 ±98.53 | Ns |
| C3 at remission mean ± SD | 0.87 ±0.13 | 0.85 ±0.15 | Ns |
| C4 at remission mean ± SD | 0.27 ±0.46 | 0.22 ±0.09 | Ns |
Kaplan-Meir curve for cumulative flare-free survival between patients on-GCs and off-GCs
Acknowledgements: NIL.
Disclosure of Interests: Filippo Vesentini: None declared, Federico Arru: None declared, Rosanna Somma: None declared, Noemi Merra: None declared, Cristina Cadore: None declared, Ilenia Anna Gennaio: None declared, Claudio Cruciani: None declared, Luca Iaccarino GSK, Astrazeneca, Margherita Zen GSK, Astrazeneca, Andrea Doria GSK, Astrazeneca.