Date: 2012-06-06
Type of information:
phase: 4
Announcement: results
Company: Roche (Switzerland) Chugai (Japan)
Product: RoACTEMRA®/ACTEMRA® outside Europe (tocilizumab)
Action mechanism:
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial
details: ADACTA is a phase IV multicentre, randomised, double blinded, parallel group study designed to compare the reduction in signs and symptoms during monotherapy (single-agent) treatment with RoACTEMRA® versus adalimumab in adult patients with severe active RA who either have intolerance to MTX or in whom continued MTX treatment is inappropriate. Also, patients participating in the trial had not previously received a biologic medicine for RA.
326 patients were randomised (1:1) to receive RoACTEMRA® 8 mg/kg IV every 4 weeks (plus placebo adalimumab) or adalimumab 40 mg subcutaneously (SC) every 2 weeks (plus placebo RoACTEMRA) for 24 weeks. The study met its primary endpoint of a significantly greater reduction in the mean change from baseline in the DAS28 score at 24 weeks in patients receiving RoACTEMRA® monotherapy compared to those receiving adalimumab monotherapy. Adverse event profiles in the two treatment groups were comparable and the safety profile of RoACTEMRA® in ADACTA was consistent with previous RoACTEMRA® RA clinical trials.
Latest
news: Rochehas announced data from the ADACTA study which showed that adult rheumatoid arthritis (RA) patients who received RoACTEMRA® (tocilizumab) as single-agent therapy (without other DMARDs) experienced a significantly greater improvement in disease activity (DAS28 score reduction1) after 24 weeks compared to patients who received adalimumab as single-agent therapy. The results of ADACTA will be presented on Friday at the annual European League Against Rheumatism (EULAR) conference in Berlin.
RA patients are often treated with a number of medicines, combining protein-based biologic therapies with methotrexate (MTX). However, about 1 in 3 patients on a biologic treatment such as RoACTEMRA® or adalimumab receive it as a single agent, also known as biologic monotherapy, largely due to intolerance to MTX.
Results from ADACTA showed that after 24 weeks of treatment patients with severe active RA and intolerance or inadequate response to MTX:
- achieved a mean improvement in disease activity (DAS28 score reduction) of 3.3 with RoACTEMRA® versus 1.8 with adalimumab
- had a DAS28 remission rate of 40% with RoACTEMRA® versus 11% with adalimumab (DAS28 <2.6)
achieved ACR20, 50 and 702 responses of 65%, 47% and 33% with RoACTEMRA versus 49%, 28% and 18% with adalimumab.
Differences on all of these endpoints were statistically significant. Adverse event profiles in the two treatment groups were comparable and RoACTEMRA® safety data in ADACTA was consistent with previous RoACTEMRA® RA clinical trials.
DAS28 is a measure of disease activity in RA. The score is calculated by a complex mathematical formula, which includes the number of tender and swollen joints (out of a total of 28), the erythrocyte sedimentation rate (a marker of systemic inflammation), and the patient’s ‘global assessment of global health’ (indicated by marking a 10 cm line between ‘very good’ and ‘very bad’). A DAS28 score greater than 5.1 indicates severe active disease, less than 3.2 low disease activity, and less than 2.6 DAS28 remission.
American College of Rheumatology (ACR) scores represent the percentage of reduction (20%, 50%, 70%) in tender and swollen joint counts, in addition to a corresponding improvement in three of the following five parameters: acute phase reactant (such as erythrocyte sedimentation rate); Patients Global Assessment of Disease Activity; Physicians Global Assessment of Disease Activity; pain scale; Health Assessment Questionnaire (HAQ).
