You are here

Rituximab Proves Superior for Rare, Deadly Skin Disease

Study Data Indicate Drug May Provide Complete Remission in PV

Positive topline results from PEMPHIX, a phase 3 trial evaluating rituximab compared to mycophenolate mofetil (MMF), demonstrated rituximab’s superiority in patients with pemphigus vulgaris (PV).

Pemphigus vulgaris is a rare autoimmune disease that causes blistering on the skin and mucous membranes. Treatment is usually with corticosteroids that suppress the immune system. Left untreated, PV can be fatal. The disease can affect all races, genders, and ages, but is common in people of Mediterranean descent and middle-aged to older adults.

In PEMPHIX, a randomized, double-blind, double-dummy, active-comparator, parallel-arm, multicenter study, patients with moderate to severe, active PV requiring 60–120 mg/day oral prednisone or equivalent received either rituximab plus MMF placebo or rituximab placebo plus MMF. The primary endpoint was the proportion of patients who had sustained complete remission for at least 16 consecutive weeks at Week 52.

The secondary endpoints, cumulative corticosteroid dose, number of flares, time to sustained remission, and time to disease flare, were also met by rituximab.

Study data also indicated that rituximab may provide complete remission and a successful tapering of corticosteroid therapy that is superior to MMF in adults with PV.

Source: BioSpace, June 13, 2019

Recent Headlines

Despite older, sicker patients, mortality rate fell by a third in 10 years
Study finds fewer than half of trials followed the law
WHO to meet tomorrow to decide on international public heath emergency declaration
Study of posted prices finds wild variations and missing data
Potential contamination could lead to supply chain disruptions
Mortality nearly doubled when patients stopped using their drugs
Acasti reports disappointing results for a second Omega-3-based drug
Declining lung cancer mortality helped fuel the progress
Kinase inhibitor targets tumors with a PDGFRA exon 18 mutation