Tuesday, Nov 1, 2016

Genentech to Present New Data on Medicines for Autoimmune Diseases and Severe Inflammatory Disorders at the 2016 ACR/ARHP Annual Meeting

  • 15 oral presentations from 17 abstracts across six autoimmune conditions
  • First presentation of Actemra data from GiACTA - the largest ever clinical trial in people with giant cell arteritis (GCA), a condition for which there has been no approved therapy in more than 50 years
  • New data from two studies investigating cardiovascular outcomes for people with rheumatoid arthritis (RA) treated with Actemra

South San Francisco, CA -- November 1, 2016 --

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that new data from Actemra® (tocilizumab) and Rituxan® (rituximab) will be presented during the 2016 American College of Rheumatology (ACR) and Association for Rheumatology Health Professionals (ARHP) Annual Meeting, November 11-16, Washington, D.C. These data add to the significant body of evidence for Actemra and Rituxan in RA and other serious immune-mediated conditions including GCA, systemic sclerosis (SSc), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA).

“Advances in our scientific understanding behind immune pathways are guiding the development of potential new treatments for severe autoimmune conditions,” said Sandra Horning, M.D., chief medical officer and head of Global Product Development. “Building on our more than a decade of experience in providing treatment options for people suffering from rheumatologic conditions, we look forward to sharing new data at this year’s ACR/ARHP meeting.”

At this meeting, key presentations from Genentech will include: the first efficacy and safety results from GiACTA – a study investigating Actemra in GCA, an often chronic, potentially life-threatening autoimmune condition; ENTRACTE, a Phase IV study in patients with RA evaluating the risk of cardiovascular (CV) events with Actemra in comparison to etanercept; a real world data analysis of CV outcomes in RA patients who switched from another biologic agent to either Actemra or a tumor necrosis factor inhibitor (TNFi); plus further insights into the use of Actemra in SSc. Additionally, treatment insights from Rituxan in RA and GPA/MPA will also be presented.

Overview of key oral and poster presentations featuring Genentech medicines at the 2016 ACR/ARHP Annual Meeting. Please note that in accordance with the meeting’s policy, all abstract data is strictly embargoed until November 12, 2016, 4:30 PM ET.

Presentation title

Abstract number / presentation times

(all times listed are Eastern Standard Time)

Tocilizumab studies

Efficacy and Safety of Tocilizumab in Patients with Giant Cell Arteritis: Primary and Secondary Outcomes from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Trial

(Stone J, et al.)

Oral presentation

Abstract ID: 911

Sunday, November 13

11:00 a.m. – 12:30 p.m.

Safety and Efficacy of Subcutaneous Tocilizumab in Early Systemic Sclerosis: Results from the Open-Label Period of a Phase 2 Randomized, Controlled Trial

(Khanna D, et al.)

Oral presentation

Abstract ID: 969

Sunday, November 13

2:30 – 4:00 p.m.

Comparative Cardiovascular Safety of Tocilizumab vs. Etanercept in Rheumatoid Arthritis: Results of a Randomized, Parallel-Group, Multicenter, Noninferiority, Phase 4 Clinical Trial

(Giles JT, et al.)

Oral presentation

Abstract ID: 3L

Tuesday, November 15

4:30 – 6:00 p.m.

Comparative Effectiveness of Tocilizumab Monotherapy with Tumor Necrosis Factor Inhibitors in Combination with Methotrexate in Patients with Rheumatoid Arthritis and Prior Exposure to Tumor Necrosis Factor Inhibitors

(Harrold L, et al.)

Poster presentation

Abstract ID: 1596

Monday, November 14

9:00 – 11:00 a.m.

Cardiovascular Safety of Tocilizumab Versus Tumor Necrosis Factor Inhibitors in Patients with Rheumatoid Arthritis

(Kim SC, et al.)

Poster presentation

Abstract ID: 2611

Tuesday, November 15

9:00 – 11:00 a.m.

Methotrexate Adherence in an Online Network of Patients with Rheumatoid Arthritis

(Katic B, et al.)

Poster presentation

Abstract ID: 2532

Tuesday, November 15

9:00 – 11:00 a.m.

Patient-Reported Outcomes in Two Randomized, Controlled Trials (RCTs) in Patients with Rheumatoid Arthritis (RA) Treated with Tocilizumab (TCZ) Monotherapy Compared with Methotrexate (MTX) or Adalimumab (ADA)

(Strand V, et al.)

Poster presentation

Abstract ID: 2515

Tuesday, November 15

9:00 – 11:00 a.m.

Rituximab studies

Factors Associated with Glucocorticoid Exposure in ANCA-Associated Vasculitis

(Cascino MD, et al.)

Poster presentation

Abstract ID: 1930

Monday, November 14

9:00 – 11:00 a.m.

Impact of Rituximab on Patient-Reported Outcomes in Patients with Rheumatoid Arthritis from the U.S. Corrona Registry

(Harrold L, et al.)

Poster presentation

Abstract ID: 1580

Monday, November 14

9:00 – 11:00 a.m.

Follow Genentech on Twitter via @genentech. Keep up with ACR 2016 news and updates by following the event’s hashtag #ACR16.

About Actemra
Actemra is the first humanized interleukin-6 (IL-6) receptor antagonist approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have used one or more disease-modifying antirheumatic drugs (DMARDs), such as methotrexate (MTX), that did not provide enough relief. The extensive Actemra RA IV clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries. The Actemra RA subcutaneous clinical development program included two Phase III clinical studies and enrolled more than 1,800 people with RA in 33 countries. In addition, Actemra is also used as an IV formulation for patients with active polyarticular juvenile idiopathic arthritis (PJIA) or systemic juvenile idiopathic arthritis (SJIA) two years of age and older. Actemra is not approved for subcutaneous use in people with PJIA or SJIA.

Actemra is intended for use under the guidance of a healthcare practitioner. 

Important Safety Information

Actemra can cause serious side effects. Actemra changes the way a patient’s immune system works. This can make a patient more likely to get infections or make any current infection worse. Some people taking Actemra have died from these infections.

Actemra can cause other serious side effects. These include:

  • Stomach tears

· Changes in blood test results, including low neutrophil (white blood cells) and platelet (platelets help the blood to clot) counts, and increases in certain liver function test levels and blood cholesterol levels

· An increased risk of certain cancers by changing the way a patient’s immune system works

  • Hepatitis B infection

· Serious allergic reactions, including death. These may happen with Actemra infusions or injections, even if they did not occur with an earlier infusion or injection.

  • Nervous system problems


Patients should tell their doctor if they are allergic to Actemra or if they have had a bad reaction to Actemra previously.

Common side effects in patients with RA treated with Actemra:

Patients should tell their doctor if they have these or any other side effect that bothers them or does not go away:

· Upper respiratory tract infections (like common cold and sinus infections)

  • Headache
  • Increased blood pressure (also called hypertension)
  • Injection site reactions

Common side effects in patients with PJIA or SJIA treated with Actemra:

· Upper respiratory tract infections (like common cold and sinus infections)

  • Headache

· Diarrhea

Actemra & pregnancy:

Patients should tell their doctor if they are planning to become pregnant, are pregnant, plan to breastfeed, or are breastfeeding. The patient and their doctor should decide if the patient will take Actemra or breastfeed. Patients should not do both. If a patient is pregnant and taking Actemra, they should join the pregnancy registry. To learn more, patients should call 1-877-311-8972 or talk to their doctor to register.

Patients should tell their doctor right away if they are experiencing any side effects. Report side effects to the FDA at 1-800-FDA-1088 or http:// www.fda.gov/medwatch . Call Genentech at 1-888-835-2555.

Please visit http://www.actemra.com for the full Prescribing Information, including Boxed Warning and Medication Guide, for additional Important Safety Information or call 1-800-ACTEMRA (228-3672).

Actemra is part of a co-development agreement with Chugai Pharmaceutical Co. and has been approved in Japan since June 2005. Actemra is approved in the European Union, where it is known as RoActemra, and several other countries, including China, India, Brazil, Switzerland and Australia.

What 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.

People with serious infections should not receive Rituxan. It is not known if Rituxan is safe or effective in children.

Important Side Effect Information

What is the most important information I should know about Rituxan?

Rituxan can cause serious side effects that can lead to death, including:

  • Infusion Reactions: Infusion reactions are the most common side effect of Rituxan treatment. Serious infusion reactions can happen during your infusion or within 24 hours after your infusion
  • Severe Skin and Mouth Reactions: 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
  • Progressive Multifocal Leukoencephalopathy (PML): a rare, serious brain infection caused by the JC virus

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
  • Serious Infections: Serious infections can happen during and after treatment with Rituxan and can lead to death
  • Heart Problems: Rituxan may cause chest pain and irregular heartbeats, which may need treatment, or your doctor may decide to stop your treatment with Rituxan
  • Kidney Problems: especially if you are receiving Rituxan for non-Hodgkin’s lymphoma (NHL). Your doctor 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 doctor right away if you have any stomach area pain during treatment with Rituxan
  • Low Blood Cell Counts: Your doctor may do blood tests during treatment with Rituxan to check your blood cell counts

What are common side effects during treatment with Rituxan?

  • Infusion reactions
  • Chills
  • Infections
  • Body aches
  • Tiredness
  • Low white blood cell counts

Other side effects include:

  • Aching joints during or within hours of receiving an infusion
  • More frequent upper respiratory tract infections

Tell your doctor about any side effect that bothers you or does not go away.

These are not all of the possible side effects with Rituxan. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at (800) FDA 1088 or http://www.fda.gov/medwatch . You may also report side effects to Genentech at (888) 835 2555.

Please see the Rituxan Full Prescribing Information and Medication Guide including Most Serious Side Effects for additional Important Side Effect Information.

About Genentech
Founded 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious or 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.