Genentech’s subcutaneous (SC) formulation of Actemra (tocilizumab) has met the primary endpoints of the Summacta study in adult patients with moderately to severely active rheumatoid arthritis (RA).

Actemra is the first humanised 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 tumour necrosis factor (TNF) antagonist therapies.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Summacta is a double-blind active-controlled parallel group multicentre two-year study that randomised 1,262 patients with RA to compare the efficacy of the SC formulation of Actemra 162mg weekly, compared to Actemra 8mg/kg intravenous (IV) formulation every four weeks.

The study’s secondary endpoints include assessments at week 24 of the proportion of patients in each group with an ACR50 response, an ACR70 response, DAS 28 low disease activity and decrease of = 0.3 in the Health Assessment Questionnaire Disability Index (HAQ-DI) from baseline to week 24.

"Actemra is the first humanised antibody approved for the treatment of adult patients with RA."

The study will also evaluate long-term safety profile and efficacy, pharmacokinetics (PK) and pharmacodynamics (PD) of Actemra SC, immunogenicity of Actemra SC and the effect of switching from one formulation to another on the safety, efficacy, PK and PD of the drug candidate.

See Also:

Patients in group A received Actemra 162mg SC weekly and those in group B received Actemra 8mg/kg IV. In each group, a similar proportion of RA patients achieved an ACR20 response at week 24, a measure indicating improvement in the number of tender and swollen joints, pain scale, patients and physicians’ assessment of improvement and certain laboratory markers.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The results of Brevacta, a second study investigating Actemra SC formulation administered every two weeks compared to placebo SC, are expected in late 2012.

Upon completion of the two studies, the company plans to submit Summacta and Brevacta data to health authorities in the US.