Roche's RoActemra is as effective as a treatment for rheumatoid arthritis whether used on its own or in combination with methotrexate, according to data the Swiss major has presented at the European League Against Rheumatism congress in London.
At the moment, RoActemra (tocilizumab) is approved in Europe for use in combination with MTX to treat adults with moderate to severe rheumatoid arthritis who respond inadequately to one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor (TNF) inhibitors. However, Roche notes that 40% of people on widely-prescribed MTX, a DMARD, do not adequately respond to treatment or experience adverse events and require other drugs to help control their inflammation.
In the two-year Phase IIIb ACT-RAY study, 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% (n=512) completing the initial 24 -week period.
The primary endpoint of this study was to achieve DAS28 remission at week 24and the results showed that monotherapy (35%) had comparable clinical efficacy to the RoActemra/MTX combo (40%), consistent with previous clinical studies. Also 18.1% and 15.2% of patients achieved remission at week eight in the combination and monotherapy groups respectively.
RoActemra, which is known elsewhere as Actemra and blocks the action of the inflammatory interleukin IL-6, is becoming a big earner for Roche and first-quarter sales rocketed 111% to 129 million francs. Sales would soar further if the drug gets approved as a first-line treatment for RA.