HealthDay News — For patients with pemphigus vulgaris, rituximab is superior to mycophenolate mofetil for producing sustained complete remission at 52 weeks, according to a study published online May 19 in the New England Journal of Medicine to coincide with the annual meeting of the International Society for Pharmacoeconomics and Outcomes Research, held virtually from May 17 to 20.
Victoria P. Werth, M.D., from the University of Pennsylvania in Philadelphia, and colleagues randomly assigned patients with moderate-to-severe pemphigus vulgaris to receive either intravenous rituximab or oral mycophenolate mofetil in a 1:1 ratio (67 and 68 patients, respectively) in addition to an oral glucocorticoid administered on the same tapering schedule in the two groups.
The researchers found that at baseline, the median Pemphigus Disease Area Index activity scores were 22.9 and 18.3 in the rituximab and mycophenolate mofetil groups, respectively. Sustained complete remission was seen in 40 and 10 percent of patients in the rituximab and mycophenolate mofetil groups, respectively, at week 52. During the 52-week treatment period, the mean cumulative glucocorticoid dose was 3,545 and 5,140 mg in the rituximab and mycophenolate mofetil groups, respectively. Six disease flares occurred in the rituximab group compared with 44 in the mycophenolate mofetil group (adjusted rate ratio, 0.12). The mean change in the Dermatology Life Quality Index score was −8.87 and −6.00, respectively. More patients had serious adverse events in the rituximab group (22 percent) than in the mycophenolate mofetil group (15 percent).
“Further trials are needed to determine the comparative efficacy and safety of these drugs beyond 52 weeks of treatment,” the authors write.
The study was funded by F. Hoffmann-La Roche, the manufacturer of rituximab.