Long-term safety of single-agent ibrutinib in ... - CLL Support

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Long-term safety of single-agent ibrutinib in patients with chronic lymphocytic leukemia in 3 pivotal studies

Jm954 profile image

I have checked but apologies if this has been posted before.

Published online June 13, 2019.

Key Points

* In 424 patients with CLL on long-term ibrutinib, AEs were primarily grade 1/2 and manageable; the majority of patients continued therapy.

* AE management requiring dose modification most commonly occurs in the first year of ibrutinib and does not preclude extended therapy.

Lots to read here: bloodadvances.org/content/3...


12 Replies

Seems like the side-effects are worse in year 1?

Jm954 profile image
Jm954Administrator in reply to deveritt

Yep, so stick with it as much as you can unless your doctor advises otherwise because of something like AF.


That’s a cool study Jackie. The drawback to ibrutinib for some is the thought of people on a pill forever.

I think eventually that for most people, some drug will be added to get a remission and take them off ibrutinib.

Buyback let’s say that doesn’t happen. With data like this showing most ibrutinib side effects diminishing over time, is being on an oral pill to control your cancer indefinitely a bad thing?

If you could guarantee for me ibrutinib would work forever, I would sign a deal today agreeing to take it forever.

Jm954 profile image
Jm954Administrator in reply to cajunjeff


I don't mind taking the pill but I do mind the side effects.. Ibrutinib has been very good for me but 4 years on I still get arthralgia and cramps that are debilitating, so I would welcome the chance to stop. If someone offered me venetoclax for 12 months then stop both I would jump at the chance. Now, that is a trial that is worth doing and would probably recruit well.


mrsjsmith profile image
mrsjsmith in reply to Jm954

Thanks very interesting Jackie,

After about 18 months I still have only minor side effects 🤞. Taking the pills doesn’t bother me either. When you get to a certain age most of us are taking a pill for something or other.


cajunjeff profile image
cajunjeff in reply to Jm954

We are on the same page Jackie. My main side effects are elevated blood pressure and diarrhea. I am writing in a relative sense, that is, if ibrutinib could allow me to live a normal life span instead of a dying an early, uncomfortable death from cancer, I'll take it along with the side effects. I don't know that any drug gives us a free ride.

My doc wants to add venetoclax and get me off all drugs. I thought that would happen on my last visit, but he wants to wait until venetoclax is approved for that. He could have prescribed it for me off-label, but I think he was worried about doing that when I was otherwise doing okay on ibrutinib.

He did express a concern that diarrhea is a problem with venetoclax and could make it worse for me. I hope the chart you posted holds true for me and that over the next year the diarrhea side effect gets better or goes away. I dont know how they classify side effects, its kind of a mild to moderate problem for me.

They have a trial like you describe at md anderson where venetoclax is added. I was all set to enroll and then flunked out, this time for a good reason. You had to be high risk. My high risk category to get in would have been a beta 2 microglobulin result that was still elevated after a year on ibrutinib. Wouldn't you know that right at my one year anniversary my beta2 tested in the normal range for the first time. I was set to enroll that day. :)

Pooldude05 profile image
Pooldude05 in reply to cajunjeff

Hi Jeff I am new to this forum and reall like it, that being said I will be starting Ibrutinib and I am so great full for it also ,and like you said if it could keep this cancer in check for the rest of my life I would sign up to, cll can be very dangerous for some of us mine has not been the so called indolent type ,I did chemoimmuno BR and was blessed with a 6 year remmision,but it has come back with-a bad attitude unfortunately

cllady01 profile image
cllady01Volunteer in reply to cajunjeff


I do believe a "bad" thing about a life-long pill is that it is not affordable for some patients. It is easy to see there is efficacy in Ibrutinib.

It is just as easy to see the financial cost being beyond the realm of reality for some. There is no foundation that can help enough for some people to be able to avoid the consequences of rising cost of living with fewer-to no raises in income.

And, as others have noted, a "bad" thing about this treatment is the side effects for some can be debilitating.

The trials that are ongoing to include Ibrutinib in combinations seem to be quite hopeful. There again, despite the efficacy and hope, there will be 2 or 3 pills to financially impact CLL patients.

The reality is that we are not all on the same playing field--whether we speak of CLL profiles, co-morbidities, age, or financial security, or availability in our given countries.

cajunjeff profile image
cajunjeff in reply to cllady01

I feel I am being lectured here for reasons not clear. Did my post imply I am not aware of or insensitive to the fact we face different challenges? I have had my fair share of them for sure. I think I’ll take a break from the forum for a while.

cllady01 profile image
cllady01Volunteer in reply to cajunjeff

Sorry, Jeff, I didn't mean to lecture, just wanted to state the obvious as far as "bad" in regard to treatment and why the benefits and attractiveness of Ibrutinib may not be the same for all who have CLL.

I apologize if my way of stating it came across as too direct and pedantic.

mrsjsmith profile image
mrsjsmith in reply to cajunjeff

Please don’t.


johnl profile image
johnl in reply to cajunjeff

Hang in there Jeff, I always make a point to read your posts


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