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news.Genentech has announced that the Summacta study met its primary endpoint, showing comparable efficacy of the subcutaneous (SC) formulation of Actemra (tocilizumab) to Actemra intravenous (IV) formulation.
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Actemra is the first humanized IL-6 receptor-inhibiting monoclonal antibody approved for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.
The two-year double-blind active controlled parallel group multicenter Summacta study randomized 1,262 patients to receive the SC formulation of Actemra 162mg weekly (Group A) and Actemra 8 mg/kg intravenous (IV) formulation every four weeks (Group B).
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.
The data reported that similar proportion of patients in both the groups 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.