Roche’s MabThera/Rituxan (rituximab) superior to mycophenolate mofetil in patients with pemphigus vulgaris
40% of patients with pemphigus vulgaris (PV) achieved sustained complete remission, without the use of steroids for 16 weeks or more, when treated with MabThera/Rituxan compared to 9.5% of patients on mycophenolate mofetil Study reinforces efficacy and safety of MabThera/Rituxan for treatment of PV, a rare autoimmune condition characterised by blistering of the skin and mucous membranes Full data of the 52-week treatment period presented at 28th Congress of the European Academy of Dermatology and Venereology (EADV) in Madrid - Roche today announced data from the Phase III PEMPHIX study evaluating the efficacy and safety of MabThera /Rituxan (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV).1 The study met the primary endpoint at Week 52 and demonstrated that MabThera/Rituxan is superior to MMF, with 40.3% of patients treated with MabThera/Rituxan achieving sustained complete remission (CR) without the use of steroids for 16 consecutive weeks or more, compared to 9.5% in the MMF arm (p<0. All secondary endpoints were statistically significant in favour of MabThera/Rituxan: lower cumulative oral corticosteroid dose (mean difference: 1595 mg; p=0.0005), fewer flares (6 vs 44, p<0.0001), a greater likelihood of sustained CR (hazard ratio [HR]=4.83; p=0.0003), a lesser likelihood of flare (HR=0.15; p<0.0001) and a greater improvement in the Dermatology Life Quality Index (DLQI) at week 52 (estimated mean change from baseline -8.87 vs -6.00, p=0.0012) compared to the MMF arm.
