ACTEMRA Reduces Rheumatoid Arthritis Signs

Patients who suffer the chronic and debilitating effects of rheumatoid arthritis (RA) -- despite treatment with current therapies -- achieved significant improvements in signs and symptoms when treated with Roche's ACTEMRA (tocilizumab) alone or in combination with methotrexate compared with methotrexate alone, according to two international Phase III studies presented by researchers at the European Congress of Rheumatology (ECR) held by the European League Against Rheumatism (EULAR) in Paris.

Data from two new Phase III studies -- RADIATE and AMBITION trials -- will be highlighted as oral presentations at the congress, along with 21 additional abstracts involving ACTEMRA, a novel interleukin-6 (IL-6) receptor inhibitor being studied for the treatment of moderate to severe RA. Importantly, findings from the RADIATE study were also published online this week in the Annals of the Rheumatic Diseases.

In the RADIATE study, which evaluated difficult-to-treat patients who failed to respond to prior anti-TNF therapies, 50 percent of ACTEMRA-treated patients achieved a 20 percent (ACR20(1)) reduction in signs and symptoms. The AMBITION study showed that significantly more patients receiving ACTEMRA achieved a 20 percent improvement in their signs and symptoms [ACR20: 70%]. No previous biologic therapy has demonstrated statistically significant superiority compared to methotrexate in this important clinical parameter at week 24. In addition, nearly one-third of all ACTEMRA patients from both studies reached disease remission (as defined by DAS28 <2.6(2)).

"We are very encouraged by the results of the AMBITION study that shows for the first time that treatment with a single biologic agent is superior to methotrexate at six months of therapy," said Graeme Jones, M.D., lead investigator of the AMBITION trial and Associate Professor at the University of Tasmania in Hobart, Australia. "Overall, these compelling results further establish the efficacy and safety of ACTEMRA in treating the chronic signs and symptoms of RA that dramatically affect the lives of patients."

About AMBITION Study

The main AMBITION (Actemra versus Methotrexate double-Blind Investigative Trial In mONotherapy) study, a two-arm, randomized, double-blind, placebo-controlled study, was designed to evaluate the non-inferiority and subsequent superiority of ACTEMRA monotherapy in patients with RA compared with methotrexate alone at 24 weeks. Patients who had not received methotrexate for at least six months beforehand were randomized to receive either ACTEMRA (8 mg/kg) intravenously every four weeks plus placebo capsules weekly or placebo infusions every four weeks plus methotrexate weekly. The study evaluated 673 patients from 252 trial sites in 18 countries, including the United States.

In the AMBITION study, 70 percent, 44 percent and 28 percent of patients in the ACTEMRA (8 mg/kg) arm achieved ACR20, ACR50 and ACR70 compared, respectively, with 53 percent, 34 percent and 15 percent, respectively, of patients treated with methotrexate alone. Disease remission (DAS28 <2.6) was demonstrated in 34 percent of ACTEMRA patients compared with 12 percent of patients in the control group. A higher proportion of ACTEMRA (8 mg/kg) patients achieved a significant EULAR response(3) as early as the second week in the trial.

ACTEMRA was generally well tolerated; the most common adverse reactions reported more frequently in the ACTEMRA arm of the AMBITION trial were upper respiratory tract infections, headache and nasopharyngitis.