Roche Reports Results of MabThera/Rituxan (rituximab) in P-III PEMPHIX Study for Pemphigus Vulgaris

Shots:

• The P-III PEMPHIX study involves assessing of MabThera/Rituxan vs Mycophenolate Mofetil (MMF) in patients with moderate to severe active PV, requiring 60-120 mg/day oral prednisone (or equivalent) for 52wks.
• The P-III PEMPHIX study results: met its 1EPs i.e, superior to MMF in achieving sustained CR without using steroids for 16+ consecutive wks. (40.3% vs 9.5%); met its 2EPs i.e, low cumulative oral corticosteroid dose, fewer flares, greater sustained CR, the lesser likelihood of flare, improvement in DLQI
• MabThera/Rituxan targets CD20, indicated to treat GPA & MPA in combination with glucocorticoids in adults & children & used to treat RA in combination with MTX and has received FDA & EMA’s approval for PV in Jun’18 & Mar’19 respectively

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