A team of researchers funded by Arthritis Research UK and GlaxoSmithKline are setting up a multicenter Phase I study of a targeted T-cell anti-CD3 monoclonal antibody therapy known as otelixizumab as a treatment for rheumatoid arthritis. And the scientists hope that the therapy, which also is in Phase III testing for autoimmune Type 1 diabetes, will be able to “switch off” the debilitating disease.

CD3 is a molecule found on the surface of T-cells and is important in stimulating the them into action. Otelixuzumab works by latching onto the T-cells, potentially switching them off and increasing regulatory cells that control inflammation. Researchers are betting that otelixizumab will be as effective in reducing symptoms as the current standard therapy for severe RA, but will have a more sustained effect from just a one-off one course of treatment.

“Everything we know about this drug suggests that it has the potential to be a powerful treatment,” Professor John Isaacs from Newcastle University’s Musculoskeletal Research Group who will lead the study says in an Arthritis UK statement. He adds that the researchers hope to demonstrate the safety of the drug with the study. If the drug was shown to be safe and effective in subsequent Phase II and III trials, it could be available for RA patients in eight to 10 years, Isaacs says.

In an important aspect of the study, researchers from Newcastle University and King’s College London, will also be performing laboratory studies aimed at identifying and analyzing potential biomarkers in the blood that might predict whether or not a patient will have a sustained response to the therapy.

Source: FierceBiotech

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A drug reserved for advanced rheumatoid arthritis (RA) could save thousands of people with early stage disease from disability, say researchers.

Trials show rituximab, marketed as MabThera, almost completely halts the deterioration of the joints in people showing the first signs of the disease.

In Britain alone nearly 18,000 people are diagnosed with RA each year.

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The findings presented at the EULAR conference could lead to a shift in recommended treatment, experts said.

The National Institute for Health and Clinical Excellence currently says rituximab should be used only if other arthritis drugs called TNF treatments have failed.

But the latest study on 755 patients shows the drug, when used with the gold standard treatment for early RA methotrexate for a year, not only reduces symptoms but slows joint damage to almost a complete stop if used early enough.

About 70% of patients treated within six months of their first symptoms developed no joint damage over the first 12 months of therapy, and after only six months of treatment joint damaged stopped almost completely.

Cost-effective

In comparison, many patients on methotrexate alone will develop continuous joint damage.

Although expensive, a course of rituximab treatment costs nearly £3,500, the therapy could ultimately save the NHS money, say campaigners.

The direct and indirect costs of RA in the UK are estimated to be £3.8-£4.75 billion every year, much of this is due to people becoming too debilitated to work.

And a course of anti-TNF therapy costs around £12,000.

Leading rheumatologist Professor John Isaacs, of the Institute of Cellular Medicine at Newcastle University, said: “The emphasis should be on the early stage of disease. When patients first develop the disease there is no joint damage and the aim is to prevent that happening. That’s essentially what this combination is doing.

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“There are many trials going on around the world now looking at these sorts of drugs very early…and the results do look very good.”

He said ultimately it would be up to NICE to decide if rituximab should now be used earlier. However, the drug is not yet licensed for use in early RA.

Rituximab works by targeting the immune system which causes the damage in RA.

Ailsa Bosworth, chief executive of the National Rheumatoid Arthritis Society, said: “The findings are very exciting.

“Hopefully this can form part of the evidence base we need to convince NICE that these drugs should be used earlier in RA.

“At the moment we are not allowed to use this at early stage disease when patients would benefit the most and instead have to wait until they are sicker.

“These drugs are expensive and we understand that they have to be used judiciously. But we could look at targeting therapy to patients with the most aggressive disease.”

This would equate to about 10% of the half a million people with RA, she said.

A spokeswoman from NICE said rituximab would need to get its licence and then be referred to them by the Department of Health before they could consider it for use in early RA.

Source: BBC NEWS

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