Abstract
Background and Objectives
The efficacy of glucocorticoids (GCs) in treating systemic lupus erythematosus (SLE) is beyond doubt. However, GCs-related adverse effects (AEs) are multiple and serious. Despite the current available evidence suggesting to reduce daily doses of prednisone <7.5 mg/day, or even to withdraw it, in the real-life practice, it is not uncommon to see patients receiving medium doses (up to 30 mg/day prednisone or equivalent) or high doses (≥30 mg/day).
Methods
We systematically reviewed the literature with a priori strategy, to assess the rate of AEs related to medium or high doses of GCs in patients with SLE, analyzing randomized control trials with at least one of the treatment groups including GCs alone at medium or high doses.
Results
We found a rate of 9/100 patients/year for hyperglycemias/diabetes, 25/100 patients/year for infections, and 12/100 patients/year for avascular necrosis of the hip. Interestingly, when adjusting for GC dose and treatment duration, we observed no difference in terms of AEs comparing patients receiving medium versus high doses.
Conclusions
In the era when treat-to-target strategies have been proposed in order to control SLE disease activity, improved health-related quality of life, and reduced morbidity and mortality, using GCs in a more restrictive way should be a goal to prevent major complications in patients with SLE.
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References
Ruiz-Irastorza G, Danza A, Khamashta M. Glucocorticoid use and abuse in SLE. Rheumatology. 2012;51:1145–53.
Zahr ZA, Fang H, Magder L, Petri M. Predictors of corticosteroid tapering in SLE patients: the Hopkins Lupus Cohort. Lupus. 2013;22:697–701.
Gladman DD, Urowitz MB, Rahman P, Ibañez D, Tam L-S. Accrual of organ damage over time in patients with systemic lupus erythematosus. J Rheumatol. 2003;30:1955–9.
Buttgereit F. Standardised nomenclature for glucocorticoid dosages and glucocorticoid treatment regimens: current questions and tentative answers in rheumatology. Ann Rheum Dis. 2002;1(61):718–22.
Austin HA, Illei GG, Braun MJ, Balow JE. Randomized, controlled trial of prednisone, cyclophosphamide, and cyclosporine in lupus membranous nephropathy. J Am Soc Nephrol. 2009;20:901–11.
Barile-Fabris L, Ariza-Andraca R, Olguín-Ortega L, Jara LJ, Fraga-Mouret A, Miranda-Limón JM, et al. Controlled clinical trial of IV cyclophosphamide versus IV methylprednisolone in severe neurological manifestations in systemic lupus erythematosus. Ann Rheum Dis. 2005;64:620–5.
Barron KS, Person DA, Brewer EJ, Beale MG, Robson AM. Pulse methylprednisolone therapy in diffuse proliferative lupus nephritis. J Pediatr. 1982;101:137–41.
Belmont HM, Kitsis E, Skovron ML, Buyon J, McCullagh E, Abramson S. Misoprostol and prednisone treatment of lupus nephritis. Am J Ther. 1995;2:928–32.
Boumpas DT, Austin HA, Vaughn EM, Klippel JH, Steinberg AD, Yarboro CH, et al. Controlled trial of pulse methylprednisolone versus two regimens of pulse cyclophosphamide in severe lupus nephritis. Lancet (London, England). 1992;340:741–5.
Hahn BH, Kantor OS, Osterland CK. Azathioprine plus prednisone compared with prednisone alone in the treatment of systemic lupus erythematosus: report of a prospective controlled trial in 24 patients. Ann Intern Med. 1975;83(5):597–605.
Edwards JC, Snaith ML, Isenberg DA. A double blind controlled trial of methylprednisolone infusions in systemic lupus erythematosus using individualised outcome assessment. Ann Rheum Dis. 1987;46:773–6.
Gourley MF, Austin HA, Scott D, Yarboro CH, Vaughan EM, Muir J, et al. Methylprednisolone and cyclophosphamide, alone or in combination, in patients with lupus nephritis. A randomized, controlled trial. Ann Intern Med. 1996;125:549–57.
MedCalc. Steroid Equivalence Converter [cited 2017 Mar 12]. Available from: http://www.medcalc.com/steroid.html.
Shimmer BP, Funder JW, et al. ACTH, adrenal steroids, and pharmacology of the adrenal cortex. In: Brunton LL, Chabner BA, Knollmann BC, editors. Goodman & Gilman’s the pharmacological basis of therapeutics, Chapter 42, 12th edn. New York, USA: McGraw-Hill Companies; 2015. pp. 1202–25.
Buttgereit F, Straub RH, Wehling M, Burmester G-R. Glucocorticoids in the treatment of rheumatic diseases: an update on the mechanisms of action. Arthritis Rheum. 2004;50:3408–17.
Fortin PR, Abrahamowicz M, Ferland D, Lacaille D, Smith CD, Zummer M, et al. Steroid-sparing effects of methotrexate in systemic lupus erythematosus: a double-blind, randomized, placebo-controlled trial. Arthritis Rheum. 2008;59:1796–804.
Roccatello D, Sciascia S, Baldovino S, Rossi D, Alpa M, Naretto C, Di Simone D, Simoncini M, Menegatti E. A 4-year observation in lupus nephritis patients treated with an intensified B-lymphocyte depletion without immunosuppressive maintenance treatment-Clinical response compared to literature and immunological re-assessment. Autoimmun Rev. 2015;14:1123–30.
Sciascia S, Talavera-Garcia E, Roccatello D, Baldovino S, Mengatti E, Cuadrado MJ. Upcoming biological therapies in systemic lupus erythematosus. Int Immunopharmacol. 2015;27:189–93.
Ruiz-Irastorza G, Ramos-Casals M, Brito-Zeron P, Khamashta MA. Clinical efficacy and side effects of antimalarials in systemic lupus erythematosus: a systematic review. Ann Rheum Dis. 2010;69:20–8.
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SS, EM, MR, DR and MJC have no conflicts of interest.
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Sciascia, S., Mompean, E., Radin, M. et al. Rate of Adverse Effects of Medium- to High-Dose Glucocorticoid Therapy in Systemic Lupus Erythematosus: A Systematic Review of Randomized Control Trials. Clin Drug Investig 37, 519–524 (2017). https://doi.org/10.1007/s40261-017-0518-z
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DOI: https://doi.org/10.1007/s40261-017-0518-z