Date: 2012-05-07
Type of information:
phase:
Announcement:
Company: Roche (Switzerland)
Product: RoACTEMRA®/ACTEMRA® outside Europe (tocilizumab)
Action mechanism: RoACTEMRA® (tocilizumab, known as ACTEMRA outside Europe) is the result of research collaboration by Chugai and is also being co-developed globally with Chugai. This is the first humanized interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial
details: SUMMACTA is a randomized, double-blind, active controlled, parallel group, multicentre 2-year study with a double-blind period of 24 weeks with 2 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 1262 patients with moderate to severe, active RA who have had an inadequate response to DMARD therapy that may have included (in up to 20% of patients) one or more anti-TNFs into 2 treatment arms. Patients in group A received RoACTEMRA® 162 mg SC weekly and those in group B received RoACTEMRA® 8 mg/kg IV every 4 weeks.
Secondary endpoints include assessments at Week 24 of the proportion of patients in each group with an ACR50 response; an ACR70 response; DAS28 remission; a decrease of ? 0.3 in 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 and efficacy; pharmacokinetics (PK) and pharmacodynamics (PD); immunogenicity; and the effect of switching from one formulation to another on the safety, efficacy, PK and PD of RoACTEMRA®.
Latest
news: Roche has announced that the SUMMACTA study met its primary endpoint, showing comparable efficacy of the subcutaneous (SC) formulation of RoACTEMRA® 162 mg weekly compared to 8 mg/kg RoACTEMRA® intravenous (IV) formulation every 4 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.
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 RoACTEMRA SC administered every two weeks versus placebo SC, are anticipated later in 2012.
Following completion of the two studies Roche will evaluate plans to file SUMMACTA and BREVACTA data with the health authorities globally.
