Certolizumab Pegol+Methotrexate and Tocilizumab: New Rheumatoid Arthritis Therapies in the Oven

November 14, 2007 by  
Filed under ARTHRITIS

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In lieu of the recent of the American College of Rheumatology Annual Meeting in Boston, all research on arthritis takes center stage this past couple of days.

However, I would like to give focus on two new rheumatoid arthritis drug or therapies that are currently under works by respective research teams.

First is tocilizumab which has been found safe and effective in the treatment of rheumatoid arthritis (RA) in its Phase III clinical trials.

Researchers tested the effectiveness and safety of tocilizumab, a new humanized, anti-human IL-6 receptor antibody, in patients with moderate to severe active RA despite being treated with methotrexate. Tocilizumab blocks the function of interleukin-6, a molecule that plays a fundamental role in maintaining the inflammation that affects patients with RA.

623 participants in this double-blind, placebo-controlled, phase three trial were randomly given 8 mg/kg of tocilizumab, 4 mg/kg of tocilizumab, or placebo intravenously every four weeks for twenty-four weeks. All participants received weekly doses of methotrexate throughout the study. No other disease-modifying anti-rheumatic drugs, or DMARDS, were allowed.

Researchers found that a significantly higher proportion of patients treated with tocilizumab showed improvements in the primary endpoint (ACR 20 at 24 weeks). The ACR 20 response was achieved by 59 and 48 percent of patients receiving tocilizumab at 8 and 4mg/kg, respectively, compared to 27 percent on placebo.

The more stringent ACR 70 response was achieved by 22 percent of patients treated with 8mg/kg tocilizumab, but only two percent of patients receiving placebo.

This particular study was led by Josef Smolen, MD from the Medical University of Vienna and Hietzing Hospital (Vienna, Austria).

Second is the potential new therapy called certolizumab pegol, when used in combination with methotrexate, may be safe and effective at treating active rheumatoid arthritis (RA).

Investigators followed 982 adult patients in a Phase III, multicenter, double-blind, placebo-controlled, 52-week study. Primary endpoints were clinical improvement according to a composite measure of disease activity, the ACR20, at week 24 and an improvement in the radiographic findings in joint x-rays (Sharp score) from the start to the end of the study.

Secondary endpoints included ACR20 at week 52 and the more demanding ACR 50/ACR70 response rates at weeks 24 and 52. The ACR 20/50/70 scoring criteria measures improvement in tender and swollen joint count and improvement in at least three of the following five criteria: pain; level of disability; overall self-assessment; overall physician assessment; and acute phase reactant (e.g., C-reactive protein).

Patients received certolizumab pegol in three 400 mg doses given every two weeks, followed by doses of 200 mg or 400 mg every two weeks, or placebo. All patients were taking methotrexate therapy.

Patients receiving certolizumab at either dose combined with methotrexate had significant improvement compared to patients taking only methotrexate, with up to 60% an ACR20 response and at least 20% an ACR70 response at weeks 24 and 52. Adverse events, including injection site reactions, were reported in both groups, the majority of which were considered mild to moderate.

This particular study was led by Gurkirpal Singh, MD from the Stanford University School of Medicine and the Institute of Clinical Outcomes Research and Education.

Indeed, it is great to know that new therapies or treatments are being explored by experts against rheumatoid arthritis (RA).

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