Ahead of the European League Against Rheumatism conference in Berlin. Roche has unveiled Phase IV data which showed that its rheumatoid arthritis drug RoActemra is more effective than Abbott Laboratories' blockbuster Humira.
The Swiss major is set to report the full data set from the Adacta study (top-line results were released in March) which showed that adult RA patients who received RoActemra (tocilizumab) as single-agent therapy without any other disease-modifying anti-rheumatic drug (DMARD) experienced a significantly greater improvement in disease activity after 24 weeks compared to patients who received Humira (adalimumab). Specifically, the humanised interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody achieved a mean improvement in disease activity (using the DAS28 measure) of 3.3 versus 1.8 with Humira.
Furthermore, RoActemra had a DAS28 remission rate of 40% versus 11% with Humira and achieved ACR20, 50 and 70 responses of 65%, 47% and 33% with versus 49%, 28% and 18% with adalimumab; American College of Rheumatology (ACR) scores represent the percentage of reduction in tender and swollen joint counts.
Most RA patients are initially treated with combining protein-based biologic therapies with methotrexate (MTX), Roche said, although about one in three on a biologic such as RoActemra or Humira receive it as a single agent,largely due to intolerance to MTX. This latest data could provide a boost to sales of RoActemra, which is already doing well as turnover last year was just shy of $700 million, but the drug is only approved in the USA for adults with moderately to severely active RA who have had an inadequate response to one or more TNF inhibitors.
B-MS' Orencia demonstrates comparable efficacy to Humira
Meantime, also at the EULAR meeting, Bristol-Myers Squibb unveiled results from its own head-to-head trial of Orencia with Humira.
The data from the 646-patient Ample trial demonstrated that Orencia(abatacept) plus MTX achieved comparable rates of efficacy for ACR20 response at one year of 64.8% versus 63.4% for Humira plus MTX. B-MS added that ACR50, 70 and major clinical response (ACR70 for six consecutive months), "considered to be more stringent measures of efficacy", as well as DAS-28, were also assessed at one year "and found to be generally comparable for the two arms".