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We thank Acharya for her interest in our study showing that in patients with systemic lupus erythematosus (SLE) with a quiescent disease and a stable treatment regimen, for at least 1 year, withdrawal of 5 mg of prednisone was associated with a fourfold increase (ie, 27%), in the risk of flare onset, as defined by the SELENA-SLEDAI flare index and the British Isles Lupus Assessment Group index during a 1-year follow-up.1 2 Acharya states that these findings contrast with those from two previous published studies on the same subject.3 4 The latter studies are, however, not comparable to ours. As pointed out by Acharya, the Steroids In the Maintenance of remission of Proliferative Lupus nephritis (SIMPL) trial was a small pilot study, including only 15 patients, that was however not designed to assess the efficacy or safety of maintaining low-dose prednisone administration.3 With respect to the report of Moroni et al, in their study treatment withdrawal in patients with SLE with nephritis included not only glucocorticoids but also immunosuppressants.4 We would like to argue that the results of the CORTICOLUP trial are consistent with those of recently published observational studies, indicating that treatment with low-dose glucocorticoids prevents relapse in about one-fifth to one-third of patients with SLE with no or very low disease activity.5 6
As suggested by Acharya, the results might have been different had the majority of patients been on immunosuppressant therapy. We, of course, do acknowledge that the results of the CORTICOLUP study cannot be extrapolated to all patients in remission. The percentage of patients treated with an immunosuppressant in the CORTICOLUP study, amounting to 27%, reflects the clinical practice of our team. Moreover, our practice is comparable to that of other teams.5 7 Yet, the indication of an immunosuppressive treatment is not evidence based, especially in patients in remission, and depends to date on the decision of the physician and therefore varies according to his/her convictions. Finally, in the interaction analysis shown in figure 3 in our study,2 there was no significant interaction between the effect of prednisone maintenance and immunosuppressants or hydroxychloroquine.
To conclude, like Acharya, we believe that prescribing an immunosuppressant or a biologic might reduce the use of prolonged glucocorticoid therapy to prevent relapse of the disease. However, this belief has to be proved and balanced with the infectious and oncological risk possibly brought about by long-term exposure to this type of medication.
Handling editor Josef S Smolen
Contributors AM, MP and ZA contributed to drafting and revising the manuscript.
Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.
Competing interests None declared.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Patient consent for publication Not required.
Provenance and peer review Commissioned; internally peer reviewed.
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