Wednesday, Jun 12, 2019
South San Francisco, CA -- June 12, 2019 --
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced positive top line results from the Roche-sponsored Phase III PEMPHIX study evaluating the efficacy and safety of Rituxan® (rituximab) compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV). The study met the primary endpoint, and demonstrated that Rituxan is superior to MMF in achieving sustained complete remission.
“The PEMPHIX study provides additional clinical evidence for the use of Rituxan for the treatment of pemphigus vulgaris,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “These data also demonstrated that Rituxan may provide complete remission rates and successful tapering of corticosteroid therapy that is superior to MMF in adults with pemphigus vulgaris.”
The primary endpoint was the percentage of participants who achieved sustained complete remission off corticosteroid therapy (no disease activity, as evaluated by Pemphigus Disease Area Index, without the use of steroids for 16 consecutive weeks or more) at Week 52. Rituxan also met the secondary endpoints, including cumulative corticosteroid dose, number of flares, time to sustained remission and time to disease flare. Adverse events were generally consistent with those seen in previous Rituxan clinical studies for other autoimmune indications.
PV is a rare, serious and potentially life-threatening condition characterized by progressive painful blistering of the skin and mucous membranes.1 MMF is an unapproved treatment for PV that is accepted as standard of care. In June 2018, Rituxan became the first biologic therapy approved by the FDA for PV and the first major advancement in the treatment of the disease in more than 60 years. This approval was based on the Ritux 3 clinical trial.2 This PEMPHIX trial provided additional clinical evidence on the effectiveness of Rituxan for PV. Complete data from the PEMPHIX study will be presented at an upcoming medical congress.
About the PEMPHIX study
PEMPHIX is a Phase III, randomized, double-blind, double-dummy, active-comparator, parallel-arm multicenter study (NCT02383589) designed to evaluate the efficacy and safety of Rituxan compared with mycophenolate mofetil (MMF) in patients with moderate to severe active pemphigus vulgaris requiring 60-120 mg/day oral prednisone (or equivalent). Participants were randomly assigned to receive Rituxan plus MMF placebo or Rituxan placebo plus MMF. Rituxan was administered at a dose of 1000 mg via IV infusion on day 1 and 15, with a repeat administration on days 168 and 182. MMF was administered at a dose of 2 grams orally daily from day 1 to week 52. The primary endpoint is the percentage of participants who achieved sustained complete remission, evaluated by the Pemphigus Disease Area Index (PDAI) Activity Score, for at least 16 consecutive weeks at Week 52. Secondary endpoints include cumulative oral corticosteroid dose, number of disease flares, time to sustained complete remission, time to disease flare and health-related quality of life, as measured by the Dermatology Life Quality Index.
About Pemphigus Vulgaris
Pemphigus vulgaris is an autoimmune blistering disease affecting the skin and mucous membranes.1 This rare, potentially life-threatening condition accounts for up to 80 percent of cases of pemphigus, a group of autoimmune disorders which affect 30,000 to 40,000 people in the United States. 3
What autoimmune diseases does Rituxan treat?
Rheumatoid arthritis (RA): with another prescription medicine called methotrexate, to reduce the signs and symptoms of moderate to severe active RA in adults, after treatment with at least one other medicine called a tumor necrosis factor (TNF) antagonist has been used and did not work well enough.
Granulomatosis with Polyangiitis (GPA) (Wegener’s Granulomatosis) and Microscopic Polyangiitis (MPA): with glucocorticoids, to treat GPA and MPA.
Pemphigus vulgaris (PV): to treat adults with moderate to severe PV.
It is not known if Rituxan is safe or effective in children.
Important Side Effect Information
What is the most important information patients should know about Rituxan?
Rituxan can cause serious side effects that can lead to death, including:
Before receiving Rituxan, patients should tell their healthcare provider if they:
What are the possible side effects of Rituxan?
Rituxan can cause serious and life‐threatening side effects, including:
What are the most common side effects during treatment with Rituxan?
The most common side effects of Rituxan include:
In patients with GPA or MPA, the most common side effects of Rituxan also include:
Other side effects include:
These are not all of the possible side effects with Rituxan. For more information, ask a doctor or pharmacist.
Contact a doctor for medical advice about side effects. Report side effects to the FDA at (800) FDA ‐ 1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at (888) 835 ‐ 2555.
Please see the Rituxan Prescribing Information and Medication Guide including Most Serious Side Effects for additional Important Side Effect Information at http://www.rituxan.com.
Genentech and Biogen collaborate on Rituxan in the United States, and Roche markets MabThera in the rest of the world, except Japan, where Rituxan is co-marketed by Chugai and Zenyaku Kogyo Co. Ltd.
Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.
1. Medscape. Pemphigus Vulgaris. Available at: http://emedicine.medscape.com/article/1064187-overview. [Last accessed: February 14, 2019]
2. Joly P, et al. First-Line Rituximab Combined with Short-Term Prednisone Versus Prednisone Alone for the Treatment of Pemphigus (Ritux 3): A Prospective, Multicentre, Parallel-Group, Open-Label Randomised Trial. The Lancet. March 22, 2017
3. International Pemphigus & Pemphigoid Foundation. Pemphigus. Available at: http://www.pemphigus.org/research/clinically-speaking/pemphigus/. [Last accessed: February 14, 2019]