Therapeutic efficacy of ultra-low dose rituximab in pemphigus vulgaris: a pilot study

Patients with a confirmed diagnosis of pemphigus vulgaris (on biopsy or ELISA) will be recruited in the study as per the eligibility criteria after an informed consent (Annexures 1 and 2). Detailed clinical history and examination will be recorded in a pre-structured proforma (Annexure 3). Baseline pemphigus disease area index (Annexure 4) and ABQOL score (Annexure 5), will be recorded to assess the pemphigus severity and impact on quality-of-life. Patients will be treated with oral prednisolone and ultra-low dose rituximab protocol (200mg on day 0 and 14) after the standard pre-treatment evaluation. Patients will be followed up at 2 weeks, 1, 3, 6 and 12 months after the first dose of rituximab or until clinical relapse off treatment, whichever is earlier. A 5ml venous blood sample will be collected at day 0 (before rituximab administration) and at every follow-up visit for flow cytometric evaluation of peripheral B-cell counts. PDAI, ABQOL, scores will be recorded at day 0 and at all follow-up visits.

Treatment protocol

Patients will be premedicated with hydrocortisone (100 mg), pheniramine maleate (8 mg), and paracetamol (1 g) intravenously 30 minutes prior to infusion. Injection rituximab (200 mg) in 200 ml of normal saline solution will be given over 2 hours and a second dose after 2 weeks. Patients will also be started on prednisolone (doses as per severity). As per the S2K guidelines.

Mild pemphigus Prednisolone dose 0.5-1 mg/kg

Moderate to severe pemphigus Prednisolone 1mg/kg