Mixed results for prednisolone in axial spondyloarthritis
medwireNews: Treatment with oral prednisolone on a step-down regimen may reduce disease activity in people with axial spondyloarthritis (axSpA) but has minimal impact on other outcomes such as functional improvement, Indian researchers report.
The proof-of-concept COBRA-AS study included 65 patients (mean age 28.5 years) with active axSpA (BASDAI ≥4) who had predominantly axial disease (≤1 peripheral joint active; mean duration 5.6 years) and an inadequate response to treatment with nonsteroidal anti-inflammatory drugs. The majority (73%) of participants had ankylosing spondylitis.
The study participants were randomly assigned to receive either oral prednisolone (n=32) at a daily dose of 60 mg for the first week, then stepping down to 40 mg, 30 mg, 20 mg, 15 mg, and 10 mg for weeks 2 to 6, or to receive placebo (n=33). After the initial step-down period the participants received prednisolone 5 mg/day or placebo for a further 18 weeks. All participants also received calcium 1000 mg/day and vitamin D 800 IU/day supplementation.
Varun Dhir and colleagues from the Postgraduate Institute of Medical Education and Research in Chandigarh report that significantly more patients in the prednisolone arm than the placebo arm achieved the primary outcome of a 50% improvement in BASDAI score (BASDAI50 response) at 24 weeks, at 37.5% versus 9.1%.
The proportions achieving an ASDAS-CRP clinically important improvement (53.1 vs 18.2%) or major improvement (40.6 vs 6.1%) at 24 weeks were also significantly higher with prednisolone than with placebo.
There was also no significant differences between the two groups in the change in BASFI, BASMI, or the Bath Ankylosing Spondylitis Global score at 12 or 24 weeks, or in BASDAI50 response rates at 12 weeks.
The researchers report in Rheumatology that there were no serious adverse events recorded among the patients but note that the impact of prednisolone on bone loss was not studied.
Discussing their findings, Dhir et al say that “in line with previous studies, the current study suggests that the notion of axSpA being ‘steroid resistant’ does not seem to be completely correct.”
“However, at the same time it must be appreciated that although disease activity improved in the prednisolone group at 24 weeks and BASDAI50 was higher in that group, more robust measures like achieving ASAS20 and ASAS40 response was not significantly different between the groups,” they add.
The authors also say that “the lack of significant benefit in functional status [BASFI] was disappointing, as that is a crucial goal of therapy in axSpA.”
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