Withdrawal of low-dose prednisone in SLE patients with a clinically quiescent disease for more than 1 year: a randomised clinical trial

Abstract

ObjectivesTo 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.MethodsA 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).ResultsProportion 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.ConclusionMaintenance of long term 5 mg prednisone in SLE patients with inactive disease prevents relapse.Trial registration numberNCT02558517; Results

Effects of metformin on disease flares in patients with systemic lupus erythematosus: post hoc analyses from two randomised trials

“…After prednisone withdrawal, the 12-month flare incidence increased from 7% to 27%. 12 In other words, pursuing higher treatment goals such as glucocorticoid-free Doris remission 11 in patients with an established low disease activity may subject them to flare risks. Whether metformin add-on could facilitate achieving these higher treatment goals in low-activity patients with SLE by preventing flares is yet to be explored.…”

Glucocorticoid withdrawal in lupus – to do or not to do?

“…A retrospective study by Tani et al suggests that the time interval from the last flare to the steroid withdrawal may also play a role in future flares 5. Interestingly, the quiescent time was more in the withdrawal group in CORTICOLUP study, although not significant 1…”

“…The above-mentioned study by Mathian et al (CORTICOLUP study) provides scientific evidence addressing this issue. The study has successfully shown the superiority of glucocorticoid maintenance therapy over its withdrawal both in terms of all flares and severe flares 1. The follow-up period was only 52 weeks, yet the number of flares in the withdrawal group were quite high (27% vs 7%) with a HR of 0.2.…”

Response to: ‘Comments on the article: "Withdrawal of low-dose prednisone in SLE patients with a clinically quiescent disease for more than 1 year: a randomised clinical trial"’ by Mousavi and Taherifard

“…Response to: 'Comments on the article: "Withdrawal of low-dose prednisone in SLE patients with a clinically quiescent disease for more than 1 year: a randomised clinical trial"' by Mousavi and Taherifard We thank Mousavi et al for their interest in our study. 1 2 Mousavi et al regret that we did not take into account different factors determined in the literature to be associated with increased risk of flare of the disease, such as 'African American ethnicity', disease onset ≤25 years and B Lymphocyte Stimulator (BLyS) serum levels ≥2 ng/mL. 3 4 ), while in the CORTICOLUP study only clinically quiescent patients were included.…”