Phase III PEMPHIX Study Showed That Genentech’s Rituxan (Rituximab) is Superior to Standard of Care in Achieving Sustained Remission in Patients with Pemphigus VulgarisSource: Business Wire
- Rituxan met the primary and secondary endpoints in the Phase III PEMPHIX study
Rituxan was the first and only biologic therapy approved by the
FDAin June 2018for the treatment of pemphigus vulgaris based on results from the Ritux 3 clinical trial
Results will be submitted to health authorities around the world,
U.S. Food and Drug Administration( FDA)
“The PEMPHIX study provides additional clinical evidence for the use of
Rituxan for the treatment of pemphigus vulgaris,” said
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
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
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:
- Infusion-Related Reactions : Infusion-related reactions are very common side effects of Rituxan treatment. Serious infusion-related reactions can happen during your infusion or within 24 hours after your infusion of Rituxan. Your healthcare provider should give you medicines before your infusion of Rituxan to decrease your chance of having a severe infusion-related reaction
- Severe Skin and Mouth Reactions : Tell your healthcare provider or get medical help right away if you get any of these symptoms at any time during your treatment with Rituxan: painful sores or ulcers on your skin, lips, or in your mouth; blisters; peeling skin; rash; or pustules
- Hepatitis B Virus (HBV) Reactivation : If you have had hepatitis B or are a carrier of hepatitis B virus, receiving Rituxan could cause the virus to become an active infection again. Hepatitis B reactivation may cause serious liver problems, including liver failure and death. You should not receive Rituxan if you have active hepatitis B liver disease. Your healthcare provider will monitor you for hepatitis B infection during and for several months after you stop receiving Rituxan
- Progressive Multifocal Leukoencephalopathy (PML) : PML is a rare, serious brain infection caused by a virus that can happen in people who receive Rituxan. People with weakened immune systems can get PML. PML can result in death or severe disability. There is no known treatment, prevention, or cure for PML
Before receiving Rituxan, patients should tell their healthcare provider if they:
- have had a severe reaction to Rituxan or a rituximab product
- currently have or have a history of other medical conditions, especially heart disease
- have had a severe infection, currently have an infection, or have a weakened immune system
- have had a recent vaccination or are scheduled to receive vaccinations
- are pregnant or planning to become pregnant. Females who are able to become pregnant should use effective birth control (contraception) during treatment with Rituxan and for 12 months after the last dose of Rituxan
- are breastfeeding or plan to breastfeed. Patients should not breastfeed during treatment and for at least 6 months after the last dose of Rituxan
- are taking any medications, including prescription and over-the-counter medicines, vitamins, and herbal supplements
What are the possible side effects of Rituxan?
Rituxan can cause serious and life‐threatening side effects, including:
- Tumor Lysis Syndrome (TLS): TLS is caused by the fast breakdown of cancer cells. TLS can cause you to have kidney failure and the need for dialysis treatment or may cause an abnormal heart rhythm. Tell your healthcare provider right away if you have any of the following signs or symptoms of TLS: nausea, vomiting, diarrhea, or lack of energy
- Serious Infections: Serious infections can happen during and after treatment with Rituxan and can lead to death. Rituxan can increase your risk of getting infections and can lower the ability of your immune system to fight infections. People with serious infections should not receive Rituxan
- Heart Problems: Rituxan may cause chest pain, irregular heartbeats, and heart attack. Your healthcare provider may monitor your heart during and after treatment with Rituxan if you have symptoms of heart problems or have a history of heart problems
Kidney Problems: especially if you are receiving Rituxan
for non–Hodgkin’s lymphoma (
NHL). Your healthcare provider should do blood tests to check how well your kidneys are working
- Stomach and Serious Bowel Problems That Can Sometimes Lead to Death: Tell your healthcare provider right away if you have any stomach-area pain during treatment with Rituxan
What are the most common side effects during treatment with Rituxan?
The most common side effects of Rituxan include:
- infusion-related reactions
- infections (may include fever, chills)
- body aches
In patients with GPA or MPA, the most common side effects of Rituxan also include:
- low white and red blood cells
- muscle spasms
Other side effects include:
- aching joints during or within hours of receiving an infusion
- more frequent upper respiratory tract infections
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
Genentech and Biogen collaborate on Rituxan in
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
1. Medscape. Pemphigus Vulgaris. Available at: http://emedicine.medscape.com/article/1064187-overview.
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,
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