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.
About SUMMACTASUMMACTA is a randomized, double-blind, active controlled, parallel group , multicenter, two-year study with a double-blind period of 24 weeks with two treatment arms, followed by an open-label period of 72 weeks with some SC and IV switching. The trial is a non-inferiority design and randomized 1,262 patients with moderately to severely active RA who have had an inadequate response to disease-modifying antirheumatic drug (DMARD) therapies that may have included (in up to 20 percent of patients) one or more tumor necrosis factor (TNF) antagonist therapies into two treatment arms. Patients in group A received ACTEMRA 162 mg SC weekly and those in group B received ACTEMRA 8 mg/kg IV every four weeks. 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; decrease of ≥ 0.3 in the Health Assessment Questionnaire Disability Index (HAQ-DI) from baseline to Week 24 and the proportion of patients who withdrew due to lack of therapeutic response. Further analysis will assess 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 ACTEMRA.
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