Rituximab increases sustained complete remission in patients with pemphigus vulgaris
1. A higher sustained complete remission rate was shown with rituximab treatment compared to mycophenolate mofetil in patients with pemphigus vulgaris.
2. Patients treated with rituximab showed a larger reduction in glucocorticoid use but had more serious adverse events compared to patients treated with mycophenolate mofetil.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Pemphigus vulgaris is an autoimmune blistering skin disease treated with rituximab, the first-line therapy, or mycophenolate mofetil, a glucocorticoid-sparing agent. However, there is a gap in knowledge as to compare the efficacy of both treatments in clinical trials. This study evaluated the effects of rituximab and mycophenolate mofetil in patients with moderate-to-severe pemphigus vulgaris over a 52-week treatment period. This study found that there was significantly increased sustained complete remission in patients treated with rituximab compared to those treated with mycophenolate mofetil. Additionally, there was significantly lower use of oral glucocorticoids in the rituximab group compared to the mycophenolate mofetil group. This study was limited by a small number of enrolled patients with severe pemphigus vulgaris, along with an imbalance in the study groups as more patients in the mycophenolate mofetil group did not complete the full 52-week treatment period. Nonetheless, the study’s findings are significant, as they demonstrate rituximab increased complete remission compared to mycophenolate mofetil over 52 weeks.
Click to read the study in NEJM
In-Depth [randomized control trial]: This randomized control trial studied 135 patients with moderate to severe pemphigus vulgaris. Patients who were of age 18 to 75 years, with a confirmed diagnosis of pemphigus vulgaris, and moderately to severely active disease were included in this study. Patients with pemphigus foliaceus, evidence of paraneoplastic pemphigus or other non-pemphigus vulgaris autoimmune blistering diseases were excluded from this study. The patients were randomized in a 1:1 ratio to receive either rituximab or mycophenolate mofetil treatment, respectively. The primary outcome measured was sustained complete remission at week 52. Sustained complete remission was defined as healing of lesions with no new active lesions and no use of an oral glucocorticoid and maintaining this status for at least 16 consecutive weeks during the 52-week treatment period. Among the two groups, sustained complete remission at week 52 was seen in 40% of patients in the rituximab group and 10% of patients in the mycophenolate mofetil group (difference, 31 percentage points; 95% confidence interval [CI], 15 to 45; P<0.001). The mean cumulative dose of oral glucocorticoids throughout the 52-week period was also lower in the rituximab group (3545 mg) compared to the mycophenolate mofetil group (5140 mg) (difference, -1595 mg; 95% CI, -2838 to -353; P<0.001). There was also a lower incidence of disease flares in the rituximab group (6 flares) compared to the mycophenolate mofetil group (44 flares) (adjusted rate ratio, 0.12; 95% CI, 0.05 to 0.29; P<0.001). However, there were higher rates of serious adverse events in the rituximab group (22%) compared to the mycophenolate mofetil group (15%), with examples including pneumonia, cellulitis, and pyelonephritis. Overall, the study determined that for patients with moderate to severe pemphigus vulgaris, treatment of rituximab increased sustained complete remission compared to mycophenolate mofetil treatment over a 52-week period.
Image: PD
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