New Humira formulation being used in the US yet?

[pdx]

Does anyone know if the new, less-painful Humira formulation is now being used in the US? I haven't heard anything about it for a while. My daughter is still doing OK on Remicade, but I'm always thinking about the future...

 

[Maya142]

I heard on a JIA Facebook group that AbbVie now says it will be introduced in mid-2018.

But they said it would be introduced last summer at the 2016 Juvenile Arthritis Conference so I suppose the date could change again.

I know there are a LOT of parents really hoping it is introduced soon.

 

[pdx]

Thanks, Maya. I wonder why it's taking such a long time? At first, I was thinking that they were just using up old stock, but now it seems like more than that. Maybe an issue getting it approved?

 

[Maya142]

I honestly don't know. In 2016, when we talked to the Abbvie reps at the conference (my older daughter was on Humira at the time and very eager to get the new pain-free version), they said after the old stock was used up they would introduce the new one.

But I have no idea now why it's taking so long.

There are definitely tips and tricks to help your daughter get through the shots should she have to use Humira.

My girls were around your daughter's age when they were put on Humira (younger one was 13, older one 15) and though both hated it at first, they both got used to it quickly once they realized it was helping. They even did their own shots.

 

[kimmidwife]

I keep asking our doctors and the pharmacy about it. My daughter really suffers with the shots praying it is here soon!!!

 

[Maya142]

I wish they would at least give it to pediatric patients, especially the little ones. I know many parents in the JIA community are very frustrated because it has been used in Europe for over a year now, maybe even 2 years.

It is used a lot in JIA, in kids as young as 2 years old.

I will see what I can find out - in case anyone knows more in the JIA groups.

I have heard from multiple parents of kids with JIA that adding Lidocaine to the shot REALLY helps. Many say it really changes the experience - they have kids who used to scream and cry and even hide who now tolerate the shot.

 

[kimmidwife]

Our doctor won’t. I asked about it. He feels adding lidocaine is not safe.

 

[my little penguin]

Sorry to hear that
GI don’t tend to use lidocaine and are not comfortable with it
But most GI don’t use humira as much

Rheumo use humira a ton and are extremely comfortable with lidocaine
Risk vs benefit
Ds used it for over 5 years with lidocaine
Never had a single issue

That said Ds now takes another daily biologic for a different issue which burns worse than humira per DS
The difference now is he knows what to do to distract and lessen the pain
Daily shots stink

 

[Pilgrim]

We're in Canada and have asked about the pain free formula. The (biologics only) pharmacy first pretended they didn't know what I was talking about! Later talked to another person who had heard about it but not for several months. They aren't talking.

 

[Maya142]

Kimmidwife, there are studies on adding Lidocaine I believe. They were done by rheumatologists I think, but they show that it is safe.

I would expect most pediatric GIs to be using Humira a lot now since it is approved for pediatric Crohn's now. At our children's hospital, our GI was very comfortable with Humira even 5-6 years ago when it hadn't yet been approved for pediatric Crohn's.

However, the ped. GI dept. does not add Lidocaine to the injections as far as we know. Or at least, they didn't in 2013 which is when I last asked.

 

[crohnsinct]

Hmm Maya123, do you know if the Humira biosimilars hurt as much as Humira? With all the insurance changes etc, if you are switching biologics, they may only approve the Humira biosimilar. I wonder if they use a formula that doesn't hurt as much.

Insurance will generally not ask you to change to the biosimilar of a biologic you are already on but when switching to a new biologic they may.

 

[Maya142]

I don't know honestly. I have heard the cost won't be reduced by much though. I do think there are some patent issues and if I am remembering correctly the Humira biosimilar won't hit the market till 2021 or later. I believe that biosimilar is produced by Amgen, the company that makes Enbrel (which is also an anti-TNF, just doesn't work for IBD).

My older daughter just switched from Humira to a different biologic so I am following Humira new less carefully now!

 

[Maya142]

The pain in Humira comes from the citric acid I think, which lowers the pH of the shot. But if the biosimilar does not use citric acid then I would assume the shot would hurt a lot less.

There are other anti-TNFs on the market, many of which you all have heard about - Cimzia, Simponi, which hurt a LOT less. Simponi is basically painless according to both my girls. Cimzia hurts, but much less that Humira. My daughter said it stings and it's very thick and the injection (only a syringe, no pen) takes a long time. But it still hurts a lot less than Humira.

But anyway, the point is that clearly they can be formulated without citric acid or whatever it is that lowers the pH and makes the shot really burn.

My daughter is now on daily shots of a different medication but they are basically painless and she does not mind them at all. So it really depends on the medication - the poke is easy to deal with, even when it's every day.

 

[crohnsinct]

Right Maya. It was the Amjevita I was thinking of. Wow! That got FDA approval back in Fall of 2016. That is a long time to market.

Interestingly, I am hearing there are a few biosimilars for Infliximab and the problem there is your hospital may not stock the one that your insurance approves. So people are having to find other infusion centers. Just more hoops for people to jump through. Hopefully the insurance company continue to approve the biologics for the peds kiddies.