Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the SUMMACTA study met its primary endpoint, showing comparable efficacy (non-inferiority) of the subcutaneous (SC) formulation of ACTEMRA (tocilizumab) 162mg weekly compared to 8 mg/kg ACTEMRA intravenous (IV) formulation every four weeks. A similar proportion of rheumatoid arthritis (RA) patients in each group 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.
"We are very pleased with these data showing that subcutaneous administration of ACTEMRA provides clinically meaningful and comparable results to the IV infusion," said Hal Barron, M.D., chief medical officer and head, Global Product Development. "This may provide patients and their doctors with an important additional treatment option."
Preliminary safety analysis showed that the adverse event profiles of the SC and IV groups were comparable with no new clinically meaningful safety signals identified. Data from SUMMACTA will be submitted for presentation at an upcoming medical meeting. The results of BREVACTA, a second study assessing ACTEMRA SC formulation administered every two weeks versus placebo SC, are anticipated later in 2012. Following completion of the two studies Genentech will evaluate plans to submit SUMMACTA and BREVACTA data to health authorities in the U.S.
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