medwireNews: Patients with systemic lupus erythematosus (SLE) who continue taking prednisone as maintenance therapy for at least a year after achieving clinically inactive disease experience fewer flares than those who stop taking prednisone, suggest results from the CORTICOLUP trial.
The researchers report a fourfold increased risk for flare among participants who discontinued prednisone maintenance therapy versus those who remained on treatment.
Despite these encouraging findings, Zahir Amoura (Sorbonne Université, Paris, France) and colleagues acknowledge: “Enthusiasm for long-term prednisone, even if effective, is also tempered by potential side effects such as infections, diabetes mellitus […] and cardiovascular disease, leading to the development of irreversible organ damage.”
All of the 124 patients included in the 12-month trial had clinically inactive disease lasting at least a year prior to enrollment, and they had received stable treatment – including prednisone 5 mg/day – for a minimum of 12 months.
The investigators used the SELENA-SLEDAI flare index and the BILAG index to record the occurrence of flares; both indices found that four (7%) of the 61 patients who were randomly assigned to continue taking prednisone maintenance therapy had a flare during the 12-month study period, compared with 17 (27%) of the 63 patients who withdrew.
Significantly fewer patients on prednisone maintenance therapy had mild-to-moderate flares compared with those who stopped taking it (three vs 12 patients), while there was a smaller, nonsignificant difference in the number experiencing severe flares (one vs five patients). Regardless of severity, time to the first flare was significantly longer among the patients who continued to take prednisone than those who did not.
Additionally, prednisone maintenance protected against any damage-related events, whereas four events – two osteoporosis-related fractures, one incidence of retinal toxicity due to antimalarials, and one occurrence of cataracts – occurred in three patients who stopped taking prednisone.
Due to the small number of patients and short follow-up period, the investigators say they were prevented from “drawing any meaningful conclusion on the tolerance of long-term prednisone maintenance,” and highlight this as a current research gap that needs to be addressed.
Reporting the findings in the Annals of the Rheumatic Diseases, Amoura et al say that “larger studies must be undertaken to determine whether clinical characteristics and new biomarkers, such as elevated serum interferon alpha levels, could help clinicians to identify a subgroup of SLE patients clinically in remission but who are at a higher risk of relapse and who would benefit from a continued intake of low doses of prednisone.”
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