Low-dose modified-release prednisone in axial spondyloarthritis: 3-month efficacy and tolerability

Abstract

BackgroundOral glucocorticoids (GCs) have been shown to be effective in reducing the inflammatory symptoms of rheumatoid arthritis, but their use is not supported by evidence in spondyloarthritis (SpA). Modified-release (MR) oral prednisone taken at bedtime has been shown to be more effective than immediate-release prednisone taken in the morning. The efficacy of low-dose MR prednisolone in patients with SpA is unknown.Patients and methodsThis single-center cohort study retrospectively assessed the effectiveness and safety of 12-week low-dose MR prednisone (5 mg daily, bedtime administration) in GC-naïve adult patients with symptomatic axial SpA. A 50% improvement of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) or a final BASDAI score of <4 according to disease activity at baseline was chosen as the primary outcome parameter after MR prednisone.ResultsFifty-seven patients were evaluated; of them, 41 had an active disease (BASDAI score of ≥4) at baseline. MR prednisone significantly reduced BASDAI (from 5.5±2.6 to 3.0±2.8, P<0.001) as well as inflammatory symptoms, pain, fatigue and morning stiffness. The overall response rate after MR prednisone was 52.6% (53.7% in patients with active SpA and 50.0% in patients with low-active disease; nonsignificant). At multivariable analysis, none of the considered clinical findings independently predicted the response to MR prednisone in subjects with active SpA. Overall, seven patients (11.8%) had nonserious adverse drug reactions after MR prednisone.ConclusionIn patients with symptomatic SpA and naïve to GCs, low-dose MR prednisone reduced the symptoms and clinical indexes of disease activity and showed a positive safety profile.

The Brazilian Society of Rheumatology guidelines for axial spondyloarthritis – 2019

“…The results showed a significant decrease in disease activity (from 5.5 ± 2.6 to 3.0 ± 2.8 on the BAS-DAI; p = 0.001), but not concerning mobility (BASMI) or enthesitis index (Maastricht Ankylosing Spondylitis Enthesitis Score -MASES). No serious adverse event was observed during the 12-week follow-up period [68] (2C). Another short-term randomized, placebocontrolled trial, which included 34 patients with AS, found that daily treatment with two oral doses of prednisolone (20 or 50 mg) for two weeks improved activity indices compared with the placebo.…”

Turkish League Against Rheumatism Consensus Report: Recommendations For Management of Axial Spondyloarthritis

“…It was shown that shortterm high dose GC use is beneficial to improve clinical symptom and signs. 39,40 Therefore, the phrase 'there is no evidence in use of systemic GCs in ax-SpA' was altered as 'long-term systemic GCs are not recommended', which is compatible with 2016 update of the ASAS/ EULAR Management Recommendations for ax-SpA. 4…”