IVIG With Rituximab vs Rituximab as First Line Treatment of Pemphigus
Status:
Recruiting
Trial end date:
2024-12-31
Target enrollment:
Participant gender:
Summary
Pemphigus is a rare acquired autoimmune disease in which immunoglobulin G (IgG) antibodies
target desmosomal proteins to produce intraepithelial, and mucocutaneous blisters. It is
potentially fatal and the average mortality of pemphigus vulgaris (PV) was 75% before the
introduction of corticosteroids in the early 1950s.
Traditionally, treatment of pemphigus included high dose systemic corticosteroids with or
without adjuvant immunosuppressants. However; the prolonged use of high dose steroids carries
significant side effects. A recent randomized trial has proved the efficacy of Rituximab, a
monoclonal anti-CD20 antibody against B-lymphocytes, as an efficacious therapy for pemphigus.
Early use of rituximab was associated with better clinical outcomes, hence combination
treatment of rituximab and intravenous immunoglobulins (IVIG) has shown to be effective for
refractory pemphigus cases and can potentially induce long-term complete remission and lower
risks infectious complications.
In this study, investigators will evaluate the efficacy and safety of early use of rituximab
with or without IVIG in patients with moderate to severe pemphigus using protocols that were
similar to those previously published, investigators will also aim to measure the impact of
health care economics and in doing so, assess the cost and benefits of both treatment arms.