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ACTEMRA(R) (tocilizumab) Significantly Reduces Rheumatoid Arthritis Signs and Symptoms Regardless of Previous Therapy in Two New Global Studies

Friday, June 13, 2008 General News J E 4
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PARIS, June 13 Patients who suffer the chronic anddebilitating effects of rheumatoid arthritis (RA) -- despite treatment withcurrent therapies -- achieved significant improvements in signs and symptomswhen treated with Roche's ACTEMRA(R) (tocilizumab) alone or in combinationwith methotrexate compared with methotrexate alone, according to twointernational Phase III studies presented by researchers at the EuropeanCongress of Rheumatology (ECR) held by the European League Against Rheumatism(EULAR) in Paris.

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

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

"We are very encouraged by the results of the AMBITION study that showsfor the first time that treatment with a single biologic agent is superior tomethotrexate at six months of therapy," said Graeme Jones, M.D., leadinvestigator of the AMBITION trial and Associate Professor at the Universityof Tasmania in Hobart, Australia. "Overall, these compelling results furtherestablish the efficacy and safety of ACTEMRA in treating the chronic signs andsymptoms of RA that dramatically affect the lives of patients."

About AMBITION Study

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

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

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

About RADIATE Study

The RADIATE (RheumAtoiD ArthritIs Study in Anti-TNF FailurEs) trial, athree-arm, randomized, double-blind, placebo-controlled study, was designed toevaluate the safety and efficacy of ACTEMRA plus methotrexate compared withplacebo plus methotrexate in patients who failed to adequately respond toanti-TNF medications alone.
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