Real world evidence: Patients with refractory pemphigus treated with Rituximab

BACKGROUND: Pemphigus is a group of autoimmune blistering diseases, potentially life-threatening. Rituximab received FDA approval in June 2018 for the treatment of moderate to severe pemphigus vulgaris. OBJECTIVES: To evaluate the efficacy and safety of rituximab in patients with pemphigus, resistant to previous therapies or unable to receive classic immunosuppressive treatment due to serious adverse events or comorbidities. MATERIALS AND METHODS: Twenty-five patients (9 men, 16 women), mean age 49.4 ± 15.9 years (range 21–74 years), mean disease duration 4 ± 2.7 years (range 0.25–10 years) were included in the study: 19 patients with pemphigus vulgaris and 6 with pemphigus foliaceous. The efficacy of rituximab was evaluated according to the control of disease, retention of remission, disease severity, previous treatments and adverse reactions. During COVID-19 pandemic patients are monitored closely through tele-dermatology. RESULTS: Twenty-three out of 25 patients had great improvement, 2 out of 25 ceased therapy due to adverse events (arthralgias and dyspnea). Sixteen out of 23 received additional course after 8 months (range 5–60 months). More aged patients presented more frequently adverse events and underwent additional courses (p = 0.002). Rituximab was found superior to classic immunosuppressive treatment in terms of efficacy and safety, with larger periods of remission and lower doses of corticosteroids and immunosuppressants. No major adverse events were noticed. CONCLUSIONS: Rituximab is a very effective treatment of pemphigus and, remarkably, superior to classic immunosuppressive treatment.