Another biologic makes the grade – but will NASTY sanction it?

October 6, 2009 at 7:23 pm | Posted in rheumatoid arthritis (RA) | 2 Comments
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Cimzia (certolizumab pegol), a biologic produced by UCB and administered by injection under the skin, has got the OK from the European Commission for use in rheumatoid arthritis. (It was approved by the FDA in the US in May.) It has been approved both as a combination therapy with MTX for those with moderate to severe active RA who haven’t responded to treatment with DMARDs, AND as a treatment on its own where a patient can’t use methotrexate.

Trials showed that Cimzia brought significant benefits to patients that lasted for more than two years. Clinical data also indicates that Cimzia stops disease progression – or did for the length of the trial, which was around two years.

Of course the big question for the UK (and it’s a big question for UCB as well since the UK market is quite a significant one) is will ‘NICE’ approve it for use on the NHS? I wouldn’t like to try and guess but it’ll be an interesting story to follow.

A ‘one injection’ cure for Arthritis within five years … well, let’s hope so!

August 15, 2008 at 1:02 pm | Posted in rheumatoid arthritis (RA) | 5 Comments
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Some great news was widely reported yesterday – there might be a cure for rheumatoid arthritis and it could be tested and available within five years. No disputing it, that is great news! But a word or two of caution …

Unlike a drug, this treatment involves taking cells from a patient’s immune system, altering them in the lab and injection them back in to a joint affected by rheumatoid arthritis. However, not only have there been no human trials yet, there have actually been no trials at all. The only work that’s been done so far is on the cells in the laboratory.

The announcement seems a little premature to me because they don’t even know yet whether the re-injection of the cells will cause the ‘fixed’ immune system cells to spread through the body or not.

The injection is likely to cost in the region of £25,000 according to press reports. The cynic in me wonders whether that’s why it’s being billed as a ‘one injection cure’. Because if all it did was halt the disease in one joint, and most RA patients have many joints affected, the cost would be totally prohibitive and perhaps the research would be stopped. According to the Daily Telegraph : ‘The team also hope to find out if the vaccine is effective only in the joints it is injected into, or whether the new cells spread throughout the body.’ So as yet they really have no idea whether it’s a cure or something to help one badly affected joint. And if it affects one joint for £25,000, the ‘National Institute for Clinical Excellence,’ in the UK, (who are the folks that decide whether medication is too expensive to give to patients, and who are often known as NASTY for obvious acronym reasons) certainly won’t be letting us UK folk have this on the NHS!

The BBC’s report quotes Professor Alan Silman, from the Arthritis Research Campaign, who are a charity I hold in great esteem and who are funding this research, as saying that the cells should be ‘reset’ to normal activity, rather than attacking the joints and that ‘The presumption is that they will stay this way, unless the same trigger which is thought to cause the problem in the first place is encountered again. Aye, there’s the rub!!

Not only is this currently nothing more than a presumption, but more importantly we don’t actually know what the trigger is – or I should probably say what the triggers are, as it’s thought that there are many different triggers. So let’s suppose, as has been suggested in the scientific literature, that one of the many triggers is consumption of decaffeinated coffee. If the cell ‘resetting’ is a success and NASTY decides the treatment will be made available an the NHS, then I toddle off for my injection, it works, I feel fantastic for a day or two (and that’s assuming, of course, that it doesn’t have some horrible side effects) and then I have a nice cup of decaffeinated coffee … if that’s my trigger, Wham – flare up – back to square one? I don’t know, but maybe. There isn’t even a comprehensive list of known triggers, so it’s not possible to even avoid them after the injection!

Then there’s the side effect thing – this is, like the current DMARDS and anti-TNFs, something that affects the immune system, stopping it from attacking the joints in error. Again according to the Telegraph article, and they may have got the wrong end of the stick slightly, or I may have, and I haven’t read any scientific paper on this, ‘Using chemicals, steroids and Vitamin D, the team has devised a way to manipulate a patient’s white blood cells so they suppress, rather than activate, the immune system.’ So …where does the immune system go? Is one cured of RA but suddenly unable to leave a big plastic bubble for fear of getting a common cold and dying from it due to lack of immune system? Probably not, because it’s probably very specific cells they’re targeting, but I’d like to understand this a bit better.

Don’t get me wrong, I’m delighted that RA, and cures for it, are being thoroughly researched, and even more glad that there might be a light at the end of the tunnel. As someone said on the NRAS forum yesterday, hope is a good medicine in itself. I’d just have appreciated some slightly more balanced and less gungho reporting.

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