AIN 457 Study - my personal experience

AIN 457 Study – my personal experience

P1250053Could this be the answer?

From a personal perspective, Nick tells his story about his experience on the Phase 3 Novartis AIN457 Study

“I’m really happy to bring some good news. I’ve been taking part in the Study of a new treatment for the last 6 months and it seems to be working. I’ve been off all other meds for 2 months now without any sign of a flair-up and my doctors agree that the new treatment seems to be controlling the disease.

AIN457 is a new drug in the final stage of trials to treat a number of different inflammatory conditions. It has been created by the Swiss company Novartis and is a fully human antibody to Interleukin 17a – a messenger in the immune system which is thought to be responsible for a number of auto-immune conditions including Birdshot.

In July this year I joined the phase 3 Study of this new drug which is also being tested on other uveitus patients as well as birdshotters. It’s a double blind trial which means that neither the doctors nor the patients know who is receiving the medication or who is getting the placebo and is being tested at different levels of dosage.

I had been taking prednislone and cellcept for nearly 3 years, with a number of unpleasant side effects so I was glad to try something else. Since 2008 I have been treated by Professor Murray’s team at the Birmingham (UK) Eye Centre where the Study is being run, so I’m familiar with the staff there who are great, although the hospital is a long way from home and each visit involves a day off work.

I have previously reported good results with dietary supplements – in particular saffron and turmeric. I also eat an organic diet as far as possible, I try to avoid inflammatory foods and eat lots of anti inflammatory foods (google “inflammatory foods” and “anti-inflammatory foods” for details. However, no one’s perfect and my doctor says I drink too much, but only red wine – anti-inflammatory!) All these things have helped me to avoid new inflammation with my birdshot while continuing with low doses of pred and cellcept.

I also believe that a positive attitude is crucial in fighting this disease and my mental battle with it is based on my daily practise of Nichiren Buddhism. I chant twice a day, every day to bring out my inner ‘Buddha’ strength and I’m convinced that this is helping my body to heal itself.

The procedure with the Study has involved me going to the hospital fortnightly where I have a check up, have blood samples taken and receive the study medication (or placebo) as an injection. All results are sent to Novartis HQ in Switzerland and added to data from other centres around the world. They are expected to report the results this summer.

After joining the Study at the beginning of August, I came off Cellcept a month later. With no sign of inflammation, I began tapering off the Pred and by the middle of November had stopped that too, so for the past two months, I have only been on the Study medication. I have been back for 3 more visits since then with no sign of new inflammation, and I’m feeling good!

This raises a number of possibilities – all of them positive. Firstly, it may be that the new drug is indeed keeping my Birdshot under control without any other treatment being necessary. Alternatively, I may be on the placebo and simply ‘healing’ myself as an act of faith: my doctors feel this is very unlikely. It’s also possible that I’ve only had a mild case of Birdshot, but when I stopped taking Pred in 2008 out of desperation, I very quickly suffered a flair up so I don’t think my condition is passive. I’m convinced that I am getting the Study drug and that it’s controlling my Birdshot, in concert with all the lifestyle stuff I’ve mentioned.

I’ve talked to my doctors about this result and they are also very optimistic. I finish the first part of the trial at the end of this month and I’ve signed up for a a further six months. It’s hoped that the new treatment will be available in the US by the end of 2011 and some time after that in the UK, although it may be available sooner off label. In the meantime, I will continue to post reports on my progress and will happily answer any questions about my experience.

Keep the faith and believe that you can beat Birdshot.”

Nick

12 thoughts on “AIN 457 Study – my personal experience

  1. Thanks Nick, this is very positive and uplifting news, please keep us posted on any further developments, any hope of getting off of Prednisolone and Cellcept is welcome.

    Carole

  2. Nick,

    Thanks for the posting the article I’ll raise it when I next visit my consultant. I must start the saffron treatment and will be googling for anti-inflammatory info. Nothing for me has been as effective as the prednisilone, thankfully I’m not too bad at the moment but would love to be in a position where I don’t notice or think about birdshot daily.

    Thanks,

    Will

  3. Nick,
    I was very interested to read your article about AIN 457 and of course am curious to know more. From a personal point of view I think that a lot of PIC sufferers would be also very interested and with your permission I would like to post this article (either directly quoting or via link) over on my site. As Carole has said the thought of getting off Prednisolone/Cellcept would (from what I’ve heard from others – I don’t take it myself) be extremely welcome.
    Kind Regards,
    Dave.

  4. I am also on this trial and have had a positive result.
    I have continued on to the next 6 month phase and continue to hope that no side effects appear like with LX211 My history is that I had birdshot for 6 years with medication for 4 and am willing to try the trials in order to hopefully not be on steriods for ever.

  5. Marilyn,
    This is great news, if two of us are getting a positive result then that greatly increases the chances of this treatment being beneficial for others. Are you still on other meds apart from the new one? Re LX211 – my understanding is that this one is related to cyclosporine so it’s not surprising it produced side effects – did you do a trial on that as well?
    all the best, Nick

  6. I googled and found a study published in November 2011 It involved people with Ankylosing Spondylitis. AIN457 showed Good Safety and Efficacy in the Treatment of Active Ankylosing Spondylitis. Conclusion: The primary endpoint of this study was met, as secukinumab( (AIN457) induced significantly higher ASAS20 responses than placebo at week 6. No early safety signal was noted in this study population. Interim data presented here suggest that secukinumab may be useful for the treatment of moderate to severe active ankylosing spondylitis and thereby warrant larger long-term studies on safety and efficacy.

    http://www.abstracts2view.com/acr/view.php?nu=4350&type=abstract&sesId=541&num=APS&trk=

    also see http://www.rheumatology-congress.co.uk/2010Videolisting/tabid/218/xmid/241/Default.aspx?&cat=cat39&rec=yes talking about this drugs possiblies in relation to rheumatoid arthritis.

  7. Nick,
    It seems you are having a really positive experience. I hope it keeps going well and keep us updated. Its great to read good news stories.

    All the best

    Adrian

  8. I have only just registered on this site and the first item I read is yours. fantastic good news. Keep us all updated and I do hope you will be completely cured and off all type of medication. (which is the wish from everyone with birdshot. )If chanting twice a day will cure me then I will need to find out more info!!!!!

  9. Hi Cheryl, I went in for another hospital visit last week including full medical and slit lamp exam – still no sign of new imflammation so I’m now more than 2 months without pred or cellcept and still no problems – fingers crossed!
    I chant Nam-Myoho-Renge-Kyo which is profound both in meaning and in it’s effects in everyday life. If you would like more info feel free to contact me directly at nick (at) bucknall (dot) entadsl (dot) co (dot) uk Nick

  10. Nick I amended your email address to make it less obvious. As it stood, you will be hit by all sorts of unwelcome email spam from robots crawling around. Hope you don’t mind. Perhaps we should post your chanting instructions? Is there a good you tube video link to help get the rhythm? The ones I found all seemed incredibly fast, but they did help me get an idea of how it should be done. Annie

  11. Thanks for your protection Annie. It’s best if the process of learning to chant is done on a one-to-one basis and for that reason, I’d prefer to deal with individuals, so I will repeat my earlier suggestion that questions can be sent to my email address – nick(at)bucknall(dot)entadsl(dot)co(dot)uk.
    Generally the easiest way to learn is to chant with someone else and this comes down to finding someone who chants Nam Myoho Renger Kyo and lives near you. With that in mind, anyone interested may also like to call the organisation that supports people who chant. SGI-UK has its national centre near Maidenhead and their number is 01628 773163.
    I have been part of this for 40 years and can vouch for the sincerity of the people involved – there are no obligations and you will definitely not be asked for money!

  12. Nick,
    I have been in this study for almost a year now with some “ok” results. I tapered my pred down to alternating 10/5 mill., however when I went lower…I flared. I was set to begin the new extension where we all received the max. dose 2xmonth…but was notified last week that the study is being discontinued. Is this the case with you? I was so looking forward to getting the “full” dose to determine the results.

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