Objectives To compare the efficacy to prevent flares of maintenance versus withdrawal of 5 mg/day prednisone in systemic lupus erythematosus (SLE) patients with clinically quiescent disease.
Methods A monocentric, 12-month, superiority, open-label, randomised (1:1) controlled trial was conducted with 61 patients continuing 5 mg/day prednisone and 63 stopping it. Eligibility criteria were SLE patients who, during the year preceding the inclusion, had a clinically inactive disease and a stable SLE treatment including 5 mg/day prednisone. The primary endpoint was the proportion of patient experiencing a flare defined with the SELENA-SLEDAI flare index (SFI) at 52 weeks. Secondary endpoints included time to flare, flare severity according to SFI and British Isles Lupus Assessment Group (BILAG) index and increase in the Systemic Lupus International Collaborating Clinics (SLICC) damage index (SDI).
Results Proportion of patients experiencing a flare was significantly lower in the maintenance group as compared with the withdrawal group (4 patients vs 17; RR 0.2 (95% CI 0.1 to 0.7), p=0.003). Maintenance of 5 mg prednisone was superior with respect to time to first flare (HR 0.2; 95% CI 0.1 to 0.6, p=0.002), occurrence of mild/moderate flares using the SFI (3 patients vs 12; RR 0.2 (95% CI 0.1 to 0.8), p=0.012) and occurrence of moderate/severe flares using the BILAG index (1 patient vs 8; RR 0.1 (95% CI 0.1 to 0.9), p=0.013). SDI increase and adverse events were similar in the two treatment groups. Subgroup analyses of the primary endpoint by predefined baseline characteristics did not show evidence of a different clinical response.
Conclusion Maintenance of long term 5 mg prednisone in SLE patients with inactive disease prevents relapse.
Trial registration number NCT02558517; Results
- systemic lupus erythematosus
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Handling editor Josef S Smolen
AM and MP contributed equally.
Contributors AM, MP, HD and ZA contributed to the conception and design of the study; AM, MP, JH, FC-A, MH, MPdC, THDB, MM, GG, PC and ZA were involved in the acquisition of data; AM, MP, JH, FC-A, MH, MPdC, THDB, MM, GG, HY, PC, HD and ZA contributed to the analysis and interpretation of data. All authors contributed to drafting and/or revising the manuscript.
Funding This work includes independent financial support by the Assistance Publique–Hôpitaux de Paris (AP-HP), Institut National de la Santé et de la Recherche Médicale (Inserm) and Sorbonne Université.
Competing interests Professor Devilliers reports personal fees from Johnson & Johson, personal fees from GSK, grants from LFB, non-financial support from Novartis, non-financial support from MSD, outside the submitted work
Ethics approval The study protocol was approved by the Comité de Protection des Personnes (CPP) EST I (Dijon). The study was conducted in accordance with the ethical principles of the Declaration of Helsinki.
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement Data are available upon reasonable request.