Randomised Controlled trial to determine most appropriate prednisolone tapering protocol in management of pemphigus vulgaris

Pemphigus vulgaris (PV) is a chronic autoimmune blistering disease treated primarily with systemic corticosteroids. While effective, prolonged steroid use is associated with significant adverse effects, most notably osteoporosis. Current clinical guidelines lack robust evidence on the safest and most effective tapering strategies. This study aims to compare two commonly used tapering approaches: tapering of prednisolone at the time of disease control vs. at the end of the consolidation phase, to determine their impact on bone health and disease remission.

This is a single-centre, prospective, randomized, open-label, controlled trial involving 40 treatment-naïve (or recently initiated) adult patients with mild to moderate PV. Participants will be randomized 1:1 into two groups using computer-generated permuted block randomization with variable block sizes. Both groups will receive standard therapy with oral prednisolone and either azathioprine or rituximab. The primary outcomes are the incidence of osteoporosis (assessed by DEXA at 0, 6, and 12 months) and pemphigus remission rate at 12 months. Secondary outcomes include biochemical markers of bone turnover, quality of life assessments (ABQOL, POLIS), time to remission, disease flare/relapse rates, and cumulative steroid dose.

Due to the nature of the intervention, blinding of participants and treating physicians is not feasible, but outcome assessors will be blinded. The findings are expected to inform evidence-based tapering strategies that minimize steroid-induced complications while maintaining disease control in PV.