Comparison of high versus low–medium prednisone doses for the treatment of systemic lupus erythematosus patients with high activity at diagnosis

To compare the efficacy and safety of high vs. low–moderate oral doses of prednisone to treat patients with highly active lupus at diagnosis. Patients from the Lupus-Cruces cohort with an SLEDAI score ≥ 6 at diagnosis and treated with regimes containing low–medium prednisone doses (≤ 30 mg/day) were identified (group M). They were matched by sex and SLEDAI score with historical patients treated with high doses (> 30 mg/day) at diagnosis (group H). Patients with proliferative nephritis were excluded. The difference in SLEDAI scores between baseline (SLEDAI-0) and year one (SLEDAI-1) was the efficacy variable. Damage at 5 years was calculated using the SLICC damage index (SDI) and regarded as the safety variable. Glucocorticoid related damage was considered in the presence of cataracts, osteonecrosis, osteoporotic fractures and/or diabetes mellitus. 30 patients were included in each group. Patients in group H received 5-fold higher doses of prednisone, less hydroxychloroquine and less methyl-prednisolone pulses. SLEDAI improvement was similar in both groups. Patients in group H were more likely to accrue new damage (adjusted HR 3.85 (95% CI 1.03–14.2)). No patients in group M suffered glucocorticoid-related damage, vs. 5 patients in group H (p = 0.02). The average daily prednisone dose during the first year predicted accrual of new damage (adjusted HR 1.03, 95% CI 1.0–1.07, p = 0.056) and accrual of glucocorticoid-related damage (adjusted HR 1.06, 95% CI 1.01–1.13, p = 0.03). Likewise, average doses of prednisone > 7.5 mg/day were an independent predictor of new damage (adjusted HR 4.8, 95% CI 1.2–19.1). Prednisone doses ≤ 30 mg/day are similarly effective and safer than higher doses for treating active lupus.