Sufferers crippled with arthritis were offered new hope last week with a new wonder drug that makes conventional treatment three times more effective.

After intense trials Roche Pharmaceuticals has hailed Actemra "Tocilizumab" as a major breakthrough in halting the progression of rheumatoid arthritis.

The disease attacks joints leaving sufferers crippled and unable to walk around or lift objects.

Professor Paul Emery, a Rheumatologist at Leeds Hospital as quoted the UK's Daily Mail Newspaper said: "It is true to say that this drug will literally transform lives." The drug also known as Tocilizumab, is an antibody developed by pharmaceutical giant Roche with Japanese company Chugai Pharma. It could save thousands of patients from years of worsening disability. Details of Actemra's success were recently presented at the Paris meeting of the European League Against Rheumatism.

The drug can work alone. But trials also showed patients who combined it with methotrexate, a conventional treatment, were three times as likely to get relief.

Rheumatologists hope early use of the drug, which is injected via a drip, will halt major and often irreversible damage to sufferer's joints.

Actemra is expected to be launched here in the UK within six months.

Phase 3 Study Results.

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.

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 level of acute phase reactants (including the C-reactive protein or sedimentation rate).

Adverse events were similar across all groups of participants. Of 41 serious adverse events affecting approximately six percent of participants in each group, 15 were considered related to the study treatment and 11 led to discontinuation of treatment. Serious infections were observed more often in the participants treated with tocilizumab than the placebo group (2.9 percent in the 8 mg/kg group, 1.4 percent in the 4 mg/kg group, and 1 percent in the placebo group).

"The data prove that IL-6 is importantly involved in the inflammatory response of RA, and that targeting the IL-6 receptor with tocilizumab is a useful novel treatment modality," said Josef Smolen, MD; professor of medicine; chairman, department of internal Medicine III and division of rheumatology; Medical University of Vienna; Chairman, 2nd department of medicine, Hietzing Hospital; Vienna, Austria; and an investigator in the study.

"Rheumatoid Arthritis is a chronic, progressive autoimmune disease for which patients often require long-term therapy. Biological response modifiers offer the prospect of not only providing symptom relief but also the potential to stop disease progression, the ultimate goal of therapy."

Terry O'Brien

Back Trouble UK.