Genentech, a member of the Roche Group, has reported the preliminary results from its Adalimumab Actemra (ADACTA) study conducted in patients with rheumatoid arthritis (RA) who received Actemra (tocilizumab) as monotherapy.
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.
ADACTA is a Phase IV multi-centre randomised double-blinded parallel group trial, designed to compare the reduction in signs and symptoms during monotherapy treatment with Actemra versus adalimumab in adult patients with moderately to severely active RA who either have an intolerance to methotrexate (MTX) or in whom continued MTX treatment is inappropriate.
The study randomised 326 patients to receive Actemra 8mg/kg intravenously (IV) every four weeks (plus placebo adalimumab) or adalimumab 40mg subcutaneously (SC) every two weeks (plus placebo ACTEMRA) for 24 weeks.
In the trial, the primary endpoint was the mean change from baseline in the DAS28 score at 24 weeks, while the secondary endpoints included DAS28 remission and low disease activity, ACR20, 50 and 702 (standard criteria to assess effectiveness of treatments for RA).
Following 24 weeks, Actemra monotherapy was found to show greater reduction in disease activity when compared to adalimumab monotherapy.
Chief medical officer and head of Genentech Global Product Development Hal Barron said the findings from the study add to the growing body of evidence supporting the benefit of Actemra alone when methotrexate is not appropriate.
"Now that there are several therapies approved to treat patients with rheumatoid arthritis, trials comparing two active agents are critical as they provide important information to help healthcare professionals choose the right drug for their patients," Barron added.
Actemra is also approved for the treatment of active Systemic Juvenile Idiopathic Arthritis (SJIA) in patients two years of age and older, the company said.
Genentech discovers, develops, manufactures and commercialises medicines to treat patients with serious or life-threatening medical conditions.
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