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Abstract
Objective The chronic use of glucocorticoids (GCs) is linked to well-established side effects and GC discontinuation is a key treat-to-target endpoint in SLE management. Nevertheless, conflicting data on the safety and feasibility of GCs withdrawal after remission achievement exist. We aimed at assessing the risk of flare in patients in stable remission who discontinued GCs and to compare this risk with that of remitted patients kept on low-dose GCs despite remission.
Methods SLE patients (ACR criteria) diagnosed between 1990 and 2023, currently in follow-up were considered. Remission was defined as clinical SLEDAI-2K=0 on a stable immunosuppressive and/or antimalarial therapy and/or prednisone ≤5 mg/day. Flares were 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 remission achievement (on-GCs). Kaplan-Meir curve and Cox-regression analysis were used to evaluate flare-free remission and predictors of flare-free remission in on- vs- off-GCs remitted patients, respectively.
Results Prospectively collected data from 484 patients who achieved remission at least once during follow-up were retrospectively analysed. Three-hundred-eighty patients achieved remission off-GCs (74.4%), while 124 (25.6%) on-GCs. These patients had similar demographic and clinical characteristics (table 1). During a mean observational time of 87 (±76) months, 85 flares were observed, 48 in off-GCs patients (0.13 flares/patient) and 37 in on-GCs patients (0.29 flares/patient) (p<0.01), meaning an annual flare rate of 1.65 flare/100 patients/year and 8.5 flares/100 patients/year in remitted patients off- and on-GCs, respectively (p<0.001). Similar results were obtained when considering only patients in durable remission (i.e. lasting >2 consecutive years) at GCs discontinuation/continuation (annual flare rate: 1.36 among off-GCs and 5.9 among on-GCs patients). Kaplan-Meir curve (figure 1) demonstrated a higher flare-free remission in patients off-GCs (p=0.002), whose predictors by Cox-regression 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 According to our results, GCs tapering until withdrawal is associated with a low risk of flare in patients with SLE in stable clinical remission, and does not increase the risk of flares.
Characteristics of patients in remission off- and on-GCs
Kaplan-Meir curve for cumulative flare-free survival between patients on-GCs and off-GCs
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