Roche announced new data from the ACT-RAY study, presented at the European League Against Rheumatism congress. The results demonstrated that in people with rheumatoid arthritis (RA), RoACTEMRA (tocilizumab, known as ACTEMRA outside Europe) alone had comparable clinical efficacy to RoACTEMRA plus methotrexate (MTX). The safety profile of RoACTEMRA was consistent with previous clinical trials.

Methotrexate, a disease modifying anti-rheumatic drug (DMARD), is widely prescribed for people with RA. However, up to 40% of people given MTX do not adequately respond to treatment or experience adverse events and require other drugs to help control their inflammation.  Data from the ACT-RAY study demonstrated that RoACTEMRA provided clinical benefit, regardless of whether it was given in combination with MTX or as a monotherapy.

“The findings of the ACT-RAY study provide further evidence of the meaningful benefits of RoACTEMRA monotherapy. RoACTEMRA is approved for people with rheumatoid arthritis who do not respond to, or are unable to tolerate the side effects associated with methotrexate, a commonly used treatment for the disease,” said Hal Barron, M.D., Head of Global Development and Chief Medical Officer for Roche.

RA is a chronic, progressive inflammatory disease of the joints and surrounding tissues that is associated with intense pain, irreversible joint destruction and systemic complications such as fatigue and anaemia. RoACTEMRA is the first in a new class of treatments for rheumatoid arthritis which target interleukin-6 receptors. It is currently approved in Europe for the treatment of RA in people who have either responded inadequately to, or who were intolerant to, previous therapy with one or more DMARDs or tumour necrosis factor (TNF) inhibitors. Results from the ACT-RAY study build on a previous phase III study (AMBITION) which showed that compared to MTX, patients receiving RoACTEMRA alone achieved a greater reduction of signs and symptoms of RA (e.g. swollen and tender joints) at six months and nearly three times as many patients achieved DAS28 disease remission.RoACTEMRA is the first and only biologic to have demonstrated superiority as monotherapy treatment over MTX.

ACT-RAY is a phase IIIb double-blind two year study designed to evaluate the efficacy and safety of adding RoACTEMRA to MTX versus switching from MTX to RoACTEMRA monotherapy in MTX inadequate responder (IR), biologic naïve, adult patients with moderate to severe active RA.

556 patients with inadequate response to MTX received RoACTEMRA (8mg/kg every four weeks) and were randomised to either remain on stable dose of MTX (combination therapy, n=279), or receive a matching dose of placebo (monotherapy, n=277) with 92 per cent (n=512) completing the initial 24 week period. The primary endpoint of this study was to achieve DAS28 remission (DAS28<2.6) at week 24.

Results (at week 24) showed that RoACTEMRA monotherapy had comparable clinical efficacy to RoACTEMRA with MTX in RA patients who had an inadequate response to MTX.

Remission rates were consistent with previous clinical studies. DAS28 remission rate was 35 per cent for RoACTEMRA plus placebo and 40 per cent for RoACTEMRA plus MTX (p=0.19; 95% CI -2.4%, 13.7%).

The fast onset of action of RoACTEMRA was maintained.1 18.1 per cent and 15.2 per cent of patients achieved remission at week eight in the combination and monotherapy groups respectively.

No overt differences in the safety profile were observed between the two treatments.1 Rates of adverse events, serious adverse events and serious infections per 100 patient years were 491, 21 and 6 for RoACTEMRA plus MTX and 467, 18 and 6 for RoACTEMRA plus placebo.

RoACTEMRA (tocilizumab, known as ACTEMRA outside Europe) is the result of research collaboration by Chugai and is also being co-developed globally with Chugai. RoACTEMRA is the first humanised interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody.