The New England Journal of Medicine published a letter to the editor reporting results of a 10-year study using Rituxan (rituximab) in combination with intravenous immune globulin for the treatment of pemphigus vulgaris (PV), a potentially fatal autoimmune blistering disease that affects the skin and mucous membranes.
Findings showed that, following the discontinuation of Rituxan, all patients continued to remain in remission without recurrence of the disease.
Results showed that:
- During the 10-year follow up period, there were no short-term or long-term adverse events observed, and there was no need for hospitalization.
- No other autoimmune disease, cancer, or deaths occurred after treatment with either Rituxan or intravenous immune globulin.
- Counts of CD19+ B-cells revealed normal levels in starting in 2006 and continuing on.
- Skin biopsy specimens obtained 5 years after the last dose of Rituxan was administered from sites that had previously been affected by the disease showed no indication of disease on direct immunofluorescence assay.
About This Study:
Eleven patients with refractory, widespread, and prolonged pemphigus vulgaris were selected as participants for the trial. Before treatment was initiated, all patients had limited or incomplete responses to conventional treatment and had numerous relapses and remissions with multiple side effects and hospitalizations. Participants were treated with a novel combination therapy of Rituxan, systemic glucocorticoids and immunosuppressive agents. All patients who participated in the trial were observed to have 10-year remission rates, and no adverse effects were associated with the use of Rituxan and intravenous immune globulin.
Facts about Pemphigus Vulgaris:
- Pemphigus vulgaris is the most common type of a group of autoimmune disorders collectively called pemphigus.
- It is a painful, disfiguring and potentially fatal disease characterized by progressive blistering of the skin and/or the mucous membranes.
- The cause of the disorder is uncertain, and there is currently no FDA-approved treatment.
- It occurs primarily in adults ages 30-60, and affects women and men equally.
- About 3 in every 100,000 people are diagnosed with the disease
- PV has a mortality rate between 5 and 10 percent, mostly due to complications of therapy.