- OPTION (T Ocilizumab Pivotal Trial in methotrexate Inadequate resp ONders) trial:
- 59 percent and 48 percent of patients who received ACTEMRA 8 mg/kg and 4 mg/kg plus MTX, respectively, achieved ACR20 at Week 24, compared with 27 percent of patients who received placebo plus MTX
- TOWARD ( Tocilizumab in c Ombination With traditional DM ARD therapy) trial:
- 61 percent of patients who received ACTEMRA 8 mg/kg plus DMARD(s) achieved ACR20 at Week 24, compared with 25 percent of patients treated with DMARDs plus placebo
- LITHE (Toci LIzumab safety and THE prevention of structural joint damage) trial:
- 56 percent and 51 percent of patients who received ACTEMRA 8 mg/kg or 4 mg/kg plus MTX, respectively, achieved ACR20 at Week 24 compared with 27 percent of patients who received placebo plus MTX. In addition, ACTEMRA 4 mg/kg slowed (less than 75 percent inhibition compared to the control group) and ACTEMRA 8 mg/kg inhibited (at least 75 percent inhibition compared to the control group) the progression of structural damage compared to placebo plus MTX at week 52, as measured by change in total Sharp-Genant score.
About Rheumatoid ArthritisRheumatoid arthritis (RA) is an autoimmune disease estimated to affect up to 70 million people worldwide, including children. Joints become chronically inflamed, painful and swollen, and patients can become increasingly disabled as cartilage and bone is damaged. About ACTEMRA ® (tocilizumab) ACTEMRA is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active RA who have had an inadequate response to one or more disease-modifying antirheumatic drugs (DMARDs). The extensive ACTEMRA clinical development program included five Phase III clinical studies and enrolled more than 4,000 people with RA in 41 countries, including the United States. In addition, ACTEMRA is also approved for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older. Important Safety Information Some people have serious infections while taking ACTEMRA, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses that can spread throughout the body. Some people have died from these infections. Other serious side effects of ACTEMRA include tears (perforation) of the stomach and intestines, changes in blood test results, hepatitis B infection becoming an active infection again, and nervous system problems. Serious allergic reactions, including death, can happen with ACTEMRA. These reactions may happen with any infusion of ACTEMRA even if they did not occur with an earlier infusion. Patients must tell their doctor if they have had a previous reaction to ACTEMRA. Patients should not take ACTEMRA if they are allergic to it or any of its ingredients. Common side effects with ACTEMRA in rheumatoid arthritis include upper respiratory tract infections (common cold, sinus infections), headache, and increased blood pressure (hypertension). Common side effects with ACTEMRA in SJIA include upper respiratory tract infections (common cold, sinus infections), headache, and diarrhea.
Patients must tell their healthcare providers if they plan to become pregnant or are pregnant. It is not known if ACTEMRA will harm an unborn baby. Genentech has a registry for pregnant women who take ACTEMRA. Patients who are pregnant or become pregnant while taking ACTEMRA must contact the registry at 1-877-311-8972 and talk to their healthcare provider.Patients must call their healthcare provider for medical advice about any side effects. Patients or caregivers may report side effects to the FDA at 1-800-FDA-1088. Patients or caregivers may also report side effects to Genentech at 1-888-835-2555. For additional important safety information, including Boxed WARNINGS and Medication Guide, please visit http://www.actemra.com 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 India, Brazil, Switzerland, and Australia. About Genentech Founded more than 30 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.