Efficacy of Short-course Oral Glucocorticoids for Peripheral Arthritis in Spondyloarthritis: Double-blind Randomised Controlled Pilot Trial

Background: There are limited randomised control trials (RCTs) on peripheral arthritis in spondyloarthritis (SpA) and none on oral glucocorticoids (GCs). This study aimed to evaluate the efficacy and safety of oral GCs in treating peripheral arthritis associated with SpA. Methods: This double-blind randomised controlled trial included patients of SpA (non-psoriatic) with active peripheral arthritis (TJC ≥ 2 and SJC ≥ 2) despite NSAIDs and randomised them to receive either oral GC or placebo for 24 weeks. Conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs) and intra-articular and/or intramuscular GCs were allowed in both groups. The primary endpoint was ACR50 at 24 weeks and the secondary endpoint included ACR70 and the Peripheral SpA Response Criterion (PSpARC). Analysis was intention-to-treat (ITT) with non-response imputation. Results: Ninety-four patients (76% male), with a mean age of 31.9 years, with a mean tender joint and swollen joint count of 10 and 3.6, were included and 47 were randomised to receive oral GC and 47 to placebo. Almost all (96%) were receiving csDMARDs by the end of the study. At 24 weeks, there was no significant difference in ACR50 in the GC group compared to placebo (+12.8%; 95% CI, −7.2, 32.7%; P = .213). Secondary endpoints were also not significantly different, including ACR70 (+14.9%, CI −3.2, 32.9%, P = .111) and PSpARC (+10.6%, CI −6.1, 27.3%, P = .216) at 24 weeks. GC was associated with higher adverse effects, specifically, hyperglycaemia. Conclusions: This study did not find oral GCs to be significantly efficacious in peripheral arthritis of SpA patients. However, there was a trend to improvement with GC and it may have missed a significant difference due to the small sample size included. Oral GC was associated with higher adverse effects. Trial registration: Clinical Trial Registry of India (CTRI/2021/08/035887).