OP0108 RANDOMIZED CONTROLLED TRIAL OF ORAL CORTICOSTEROIDS IN AXIAL SPONDYLOARTHROPATHY: MODIFIED COBRA REGIME

Abstract

Background: There is an unmet need of anti‐inflammatory agents in axSpA after NSAID failure in patients with persisting high disease activity and not having access to recommended biologics. In this regard, corticosteroids may be helpful as a short‐term measure. It is unclear whether starting with a high dose followed by rapid taper would be effective (like the COBRA regime in RA). Objectives: To evaluate the efficacy and safety of a step‐down regimen of oral prednisolone over 24 weeks in patients of axial spondyloarthritis (axSpA). Methods: This proof‐of‐concept double‐blind randomized controlled trial enrolled patients with active axSpA (BASDAI ≥ 4), having predominantly axial disease (≤1 active joint currently) and inadequate response to NSAIDs. They were randomized to receive either oral prednisolone (n = 32) or placebo (n = 33) at a dose of 60 mg, 40 mg, 30 mg, 20 mg, 15 mg and 10 mg daily for one‐week each, following which they received 5 mg prednisolone (or placebo) daily for 18 weeks. Primary end‐point was BASDAI 50 at week 24. Analysis was intention‐to‐treat. Results: BASDAI‐50 response at 24 weeks was achieved by 12 of 32 patients (37.5%) in the prednisolone arm and 3 of 33 patients (9.1%) in the placebo arm (difference 28.4%; 95% CI 7.9 to 46.7%; P = 0.007). Similarly, there were significant between group differences in ΔASDAS‐CRP (‐0.93, 95% CI‐1.53 to‐0.33, P = 0.0028) and ΔASDAS‐ESR (‐0.97, 95% CI‐1.51 to‐0.42, P = 0.0007) in favour of prednisolone arm (figure‐1). There were no significant changes in ΔBASFI (P = 0.28) or ΔBASMI (P = 0.23) (table‐1). No serious adverse events were noted. There was weight‐gain in first 12 weeks (0.9 ± 0.4 Kg, P = 0.02), but not at 24 weeks (P = 0.57). Figure 1 Change in the disease activity indices during the study period. (a) Change in median BASDAI (from baseline) in the two groups at 12 and 24 weeks (b) Proportion of patients who achieved the BASDAI 50 response at 24 weeks. (c) Change in ASDAS‐CRP at 24 weeks (d) Change in ASDAS‐ESR at 24 weeks (e) Number of patients who achieved major improvement in ASDAS‐ESR and ASDAS‐CRP at 24‐weeks (F) Number of patients who achieved clinically important improvement in ASDAS‐ESR and ASDAS‐CRP at 24‐weeks. ∗P < 0.05, ∗∗P < 0.01, ∗∗∗P < 0.001, ns not significant. Conclusions: In this small study, oral prednisolone was found to be efficacious in axial SpA over 24 weeks. However, its impact on bone‐loss was not studied.