Low dose prednisone prevents flares in SLE patients: BMJ
France: Maintenance of 5 mg/day prednisone versus its withdrawal, in systemic lupus erythematosus (SLE) patients with the inactive disease, prevents relapse, according to a recent study published in the BMJ journal Annals of the Rheumatic Diseases.
SLE is a complex autoimmune disease that arises when the body starts to make antibodies that target its own, healthy cells, often specifically recognizing DNA. The goals of care in SLE focus on the prevention of organ damage, attainment and maintenance of low disease activity, minimization of drug toxicity, and improvement of quality of life.
Prednisone, a glucocorticoid, is used for the treatment of the active form of SLE owing to its powerful immunosuppressant and anti-inflammatory properties. Glucocorticoid use and disease activity are closely linked in SLE.
Alexis Mathian, Centre d’Immunologie et des Maladies Infectieuses (CIMI-Paris), Paris, France, and colleagues compared the efficacy to prevent flares of maintenance versus withdrawal of 5 mg/day prednisone in SLE patients with clinically quiescent disease.
The 12-month randomized controlled trial was conducted with 61 patients continuing 5 mg/day prednisone and 63 stopping it. It included 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 patients 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 the British Isles Lupus Assessment Group (BILAG) index and increase in the Systemic Lupus International Collaborating Clinics (SLICC) damage index (SDI).
Key findings of the study include:
- The proportion 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).
- Maintenance of 5 mg prednisone was superior with respect to time to first flare (HR 0.2), the occurrence of mild/moderate flares using the SFI (3 patients vs 12; RR 0.2) and occurrence of moderate/severe flares using the BILAG index (1 patient vs 8; RR 0.1).
- SDI increases 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.
"Maintenance of long term 5 mg prednisone in SLE patients with clinically quiescent disease prevents relapse," concluded the authors.
The study, "Withdrawal of low-dose prednisone in SLE patients with a clinically quiescent disease for more than 1 year: a randomized clinical trial," is published in the BMJ journal Annals of the Rheumatic Diseases.