In the study, 326 patients were randomized (1:1) to receive ACTEMRA 8 mg/kg intravenously (IV) every four weeks (plus placebo adalimumab) or adalimumab 40 mg subcutaneously (SC) every two weeks (plus placebo ACTEMRA) for 24 weeks.The study met its primary endpoint of a significantly greater reduction in the mean change from baseline in the DAS28 score in patients receiving ACTEMRA as a single-agent therapy compared to those receiving adalimumab as a single-agent therapy at 24 weeks. Specifically:
- Patients achieved a significantly greater DAS28 score reduction of 3.3 with ACTEMRA compared to 1.8 with adalimumab and also had a significantly greater proportion of patients achieving DAS28 low disease activity with a rate (DAS28 < 2.6) of 40 percent versus 11 percent, at 24 weeks respectively.
- Patients also achieved significant responses in favor of ACTEMRA with ACR20, 50 and 70 responses of 65 percent, 47 percent and 33 percent with ACTEMRA versus 49 percent, 28 percent and 18 percent with adalimumab at 24 weeks.
About ACR 20, 50, 70American College of Rheumatology (ACR) scores represent the percentage of reduction (20 percent, 50 percent, 70 percent) in tender and swollen joint counts, in addition to a corresponding improvement in three of the following five parameters:
- Acute phase reactant (such as erythrocyte sedimentation rate)
- Patients Global Assessment of Disease Activity
- Physicians Global Assessment of Disease Activity
- Pain scale
- Health Assessment Questionnaire (HAQ)
Important Safety InformationSome 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 GenentechFounded 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, Calif. For additional information about the company, please visit http://www.gene.com.