Clinical Trial

[SudsSuds]

Did anyone else take part in the Abbie-154 clinical trial as a patient?

[Koalajane]

No sorry

[Bridge31]

I googled it and after a short research found it’s actually named ABBV-154. Interesting trial.

[PMRpro Ambassador in reply to Bridge31]

It has been discontinued

fiercebiotech.com/biotech/a....

"AbbVie also announced that it is scrapping ABBV-154, an antibody drug conjugate that was being studied in polymyalgia rheumatica and Crohn's disease. The investigational immunology treatment, once thought of as a potential Humira successor, has been axed due to its risk profile."

I was briefly involved in a group on the study design - I was very sceptical that it would work even at that point! Reading that - I don't think they understood much about PMR.

[SudsSuds in reply to PMRpro]

Yes, the study was stopped a little after half way. I was given two reasons. The risk factor and its (lack of) efficacy. I was also told that it was a prospective steroid replacement which was a major factor in my deciding to participate in the study.

I was hoping that others on the group might have participated so we could share experiences.

[PMRpro Ambassador in reply to SudsSuds]

It wasn't a steroid replaccement though from what it says - the adverse effects experienced were those of high steroids.

[SudsSuds in reply to PMRpro]

I have re-read the study documentation. Forgive me if you know this but ABBV-154 is composed of adalimumab and a glucocorticoid receptor modulator (the new/secret bit) which is designed to work like a steroid but with fewer side effects. Google tells me that adalimumab and humira are the same thing so ABBV-154 is seemingly humira with a GRM bolted on. So it seems to me that ABBV-154 is designed both to replace humira and steroids. But I could be wrong as I am very much a novice in this sort of stuff.

Do you have more details on the adverse effects as I have not seen any resulting from the trial. In fact Abbvie have gone a bit quiet about offering reasons for the study being stopped.

[PMRpro Ambassador in reply to SudsSuds]

I'm sure they have - the whole thing seems a bit embarrassing to me, especially in combo with the cystic fibrosis failure. No, we weren't told anything as PMR patient experts and I got the impression the medical expert hadn't been told a lot either. The company said the Humira (which I know is out of patent and now very cheap) was being used as the transport medium for the new bolted-on bit which they wouldn't say anything about. I had asked how a TNF-inhibitor could achieve much with PMR - they are specifically warned against in the 2015 Recommendations. But it now appears that the modulator caused the same sort of steroid effects as the real deal - that was all that was said.

Were you actually on the stuff - have they told you that?

[SudsSuds in reply to PMRpro]

Wow that is a lot of interesting information and thank you. I wish I found this group three years ago.

I have not been told yet whether I was on the placebo or on the drug and what dosage. I asked the Study Team for an update a few days ago both on the placebo point and the reason(s) the study was curtailed. They had no new information. I therefore asked if they would reach out to Abbvie on the placebo point as that should be a really simple question to answer. That was only a couple of days ago but no answer yet. I reminded the Study Team that my participating in the study was conditional upon me being given that information after the study stopped. I really hope they come up with it soon as I really feel I am entitled to know.

[PMRpro Ambassador in reply to SudsSuds]

You are - but I suppose they need to get their ducks in a row!!

[SudsSuds in reply to PMRpro]

Quite so. I'll post an update when I know. Thanks again.

[SudsSuds in reply to SudsSuds]

I have now received some information about the study. Firstly I was on the "double" standard dose of 340mg of the trial drug every 2 weeks. The other doses were standard, half standard and placebo. I had no ill effects apart from occasional minor irritation at the injection sites and I bruised very easily.

Unfortunately that was not the case for everyone and the study was stopped early because too many participants had serious infections and the perceived benefits were not good enough. Abbvie will conduct a closure meeting with the hospital I attended in November and if anything new comes out the consultant will get in touch.

I went on the study with the main aim of getting off steroids after having had four attempts at tapering which all ended badly at about 5mg of pred. Personally speaking I think the study helped me as my last dose of pred was in January this year. My last dose of study drug was in July. Since then I have symptoms that feel like mild pmr but at least I can get out of bed without falling out, get my socks on fairly easily and I don't have to drag myself up the stairs.

So life is fairly normal now but I have been left with osteopenia in my lower back. I am taking Calcium D3 for that. Also I have lost a lot of muscle mass and feel ridiculously weak. I am trying to exercise gently and tried swimming which seems good.

Do you have any more ideas/advice that might help me in this stage of recovery please?

[PMRpro Ambassador in reply to SudsSuds]

"the main aim of getting off steroids after having had four attempts at tapering which all ended badly at about 5mg of pred"

Now you see I would not call that "ending badly" - you are never reducing relentlessly to zero, as long as the underlying autoimmune disorder is active you will need some pred and at any given time you are looking for the lowest effective dose - and about 5mg is not bad at all. You will get lower, maybe even off pred, but not yet.

[SudsSuds in reply to Bridge31]

Yes you are right of course - the perils of autocomplete and a bit of tiredness and brain fog.