Contemplating Enbrel during pregnancy

[Petdoc]

Hi all! This is my first post even though I have been reading the message boards for a while. I am 30 and was diagnosed with PA (and mild P on scalp) 6 months ago. I have several swollen toes, two sausage digits on the left hand plus minor aches and pains elsewhere. I started Enbrel in September and feel significantly better. The swelling has come down quite a bit and the morning stiffness is completely gone. I am finally starting to feel almost normal again. So...to get to my question. I have been married for 5 years and want to start a family. I know that Enbrel is category B but I am still very hesitant due to the inadequate testing on pregnant women. However, I am VERY scared that I will become permanently disabled if I stay off of the Enbrel for the entire pregnancy. My rheumatologist says that pregnancy-induced remission is much less common in PA than in RA. So, has anyone out there stayed on ENbrel (or Humira or Remicade) while pregnant??

Megan

[jennab711]

Everything changes so much when u r pregnant. SOOOOOO much, right girls!? I wouldn't take the chance. I am not arthritic, but my psoriasis went into remission for over 4 years during my 2nd trimester. Gone. Maybe you are one of lucky ones, and the same would happen for you. That is much more worth the risk than giving your baby life long battles due to side effects/effects of untested materials. Rather, would you want to be a ginea pig for the drug companies? I wouldnt. Just my thought, good luck to you, it is an extremly difficult decision to make. Maybe now would be a good time to make ALL those sacrifices we make for our kids.......Jenna

[ouchyk]

Hi Megan,

Welcome. I found a study, it is below, and it's tiny...I hope that you can read thru it and get a sense of what the possiblities might be of being pregnant on Enbrel. I know there are a few posters here who have been thru this.

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12563675&itool=iconabstr&query_hl=14&itool=pubmed_docsum

The drug is only 12 years old and the studies are far from completed. I'm glad that it works so well on you.

Here is another study about pregnancy and PA; it's old but has some good info, it states that 80% of PSA goes into remission during pregnancy. Maybe you'll be one of them looks like the stats are in your favor!

http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=1285888&itool=iconabstr&query_hl=19&itool=pubmed_docsum

Such a tough personal decision, good luck with it.

Karen

[sabsmako]

My pregnancy wasn't exactly planned. I had actually been pregnant for a little over a month until I found out I was pregnant...and was taking Enbrel the whole time. Of course I stopped as soon as I found out...but there are a lot of different opinions out there. My OB said that I should be able to take it, and I guess did some extensive research into it. I don't remember exactly what he said, but I'm sure I could find out again. On the other hand...my derm told me to stop the meds right away and didn't want me to take it at all until I was done breastfeeding. I went with option B since I wasn't so sure. Now I'm a part of this whole survey thing with Amgen and they ask me a million questions every few months to see how the baby's doing and stuff like that.

[Petdoc]

Thanks everyone! It's nice to know I'm not alone here. Any information about pregnancy studies is very appreciated.

Megan

[Dulane]

When I was first diagnosed with PA, I was doing research and I met a lady on another health forum. I had asked if anyone had any experience with PA. She answered and said she had ankalosing spondlyitis, which she said was a 'cousin' to what I had.

For her, it was fusing her lower vertabrae. I began to tell her about my natureopath...and she told me that she was about to start taking MTX, but it was a very difficult decision, because she had just discovered she was pregnant.

Her doctor pretty much specified that she make a decision, so she had an abortion. She felt that she would try again, after they got her under control. I told her about my elimination diet (for P and PA), and sent her my doctor's diet documents that I had received via email.

She wrote back and told me it was nearly the same diet that she had received, called an anti-arthritis diet.

**

I worked as an occupational therapist's assistant in a public school setting, and I got to work with lots of kids with different birth defects. And I got to know their parents. I'm sure if those parents could have taken their child's disability upon themselves, they would have.

Since you have the time to plan, it seems to me that you would plan to create the best possible situation for pregnancy. You might want to look at using gradual dietary changes to see if it helps with swelling, and reduce your need for medication, so you could plan a time for pregnancy. That way you'd know you'd made every effort to ensure a healthy outcome.

Good luck with your planning.

[ouchyk]

Megan,

The Arthritis foundation puts out a brochure that you might find helpful. If you go to www.arthritis.org and type in pregnancy you will find it, also 100+ other hits.

It might take you a while to go thru each and every publication but it would be worth it.

The Human Genome: Advances in the field of genetics hold promise for the treatment -- and possible cure -- of arthritis. Researchers share what's in store for the years to come. Also in this issue: Pregnancy Prognosis: Here's what you need to know if you're expecting a baby or just thinking about it.

I think it's 3.99 and most likely RA related ( were kinda ignored over there lol ) but it might offer some insight.

Today I feel lucky that I am not faced with such a decision, I honestly don't know how people who are of child bearing age or who have small children at home do it.

I was going to tell you my personal opinion but that wouldn't be right as it's your decision to make along with your husband and doctor.

I'll keep looking for you, medscape might have some articles and studies as well.

Good luck,
Karen

[RichJ]

hi megan,
sorry i can't help much but welcome to the p family. you have met some of the wonderful people on here and will find alot of great info. welcome and nice to meet you.

have a good night all

richard

[Petdoc]

Hi all,

Thank you for the info. My OBGYN wants me to be in complete remission prior to stopping the Enbrel and starting to try and conceive. Has anyone out there gone into spontaneous remission and stayed in remission after coming off of all meds??

[crazyme]

I don't know if I will be of much help because I haven't been officially diagnosed with PA by a Rheumy yet... However, I have had p for as long as I can remember. Slight case but it is on my elbow, ears, toenails, sometimes scalp, and various other places.

Anyway, I noticed 2 fingers on my left hand swelling (ring and middle) about 20 months ago. I got pregnant maybe 2 months after. While the swelling didn't go down 100% during pregnancy, it was definitely no longer 'sausage like'.

When the baby was about 4 months old, I started falling apart. Toe swelling on rt foot, severe back pain, and now I have 2 'sausage' digits; both index fingers.

My doc recently ran tests with the following results: sed rate is low, white blood count is low, no signs of RF, and x-rays are normal. Having said all of that, my doc still believes I have early onset of pa and is referring me to a Rheumy.

If I do have pa, it clearly went into 'remission' for me during the pregnancy but came back much worse after the birth.

It may indicate that you would be able to try some alternatives during pregnancy. You may have to forego breastfeeding to get you back on the meds right after birth, but the pregnancy may be OK.

My friend is a PharmD and she specifically would not let me take any class B meds while pregnant. Simply stated, they are not tested on pregnant woman and, therefore, can be potentially unsafe.

I don't know if this helped you but I wish you a lot of luck. I'm sure you will make the right decision for you.

Dawn

[traceyo]

hi
my advice is to carry out lots of research. i am also trying for a baby and have come of mtx and my nsaids. you cans till have steriod shots and i an relying on that. it's not alwyas fun but i decidied to give it 12 mnths if it was not too bad.

i'm not sure how safe enbrel is and we don;t have much access here in the uk but from what i have read is that intitial studies suggest it is ok.

good luck

tracey

[kate7047]

While I agree that it's better to stop drugs if you can, sometimes you can't. I have had 2 friends with severe crohn's disease on Remicade who took Remicade through the entire pregnancy with no trouble. The gastro was afraid to let them flare because that too is risky for the pregnancy, so choices had to be made.

The manufacturers are collecting data on these people because of course you can NEVER get approval to do a randomized, placebo-controlled, double blinded study on pregnant women! And unless the aforementioned randomized etc etc studies have been done you can't get a category A. (That's why there are almost no Category A drugs!) The best you can get is a category B. You might be able to get some information from the manufacturers about how many preggos they have had in their registry and outcomes. It's not a "real" study, but it might give you some pointers.

[Petdoc]

Hi all,

Thank you for all of the information and advice. I am collecting as much as possible before making the big decision. I will definately contact the Ebrel manufacturers to see if they will share any info.

Thanks again.

Megan

[lulu'smom]

I'd reccomend asking Dr. Hale

Here is his bio:

http://neonatal.ttuhsc.edu/lact/html/drhale_bio.html

He is PHD in Pediatrics, and has done some of the leading research in drugs & breastfeeding. I think he might have an opinion on pregnancy.

Here is the forum where he discusses enbrel & other TNF Inhibitors & breastfeeding. I imagine he'd give you an answer. Good luck:


http://66.230.33.248/discus/messages/48/295.html?1109696927


I found his information very useful when I made the decision to breastfeed while on Enbrel.I also found that my Pediatrician and OBGYN also deferred to his book when advising me.

Nancy

[Petdoc]

Nancy,

That is a great reference. I may try to contact him to see if he has any new studies on Enbrel in addition to the studies on Remicade.

Thanks

Megan

[Petdoc]

Hi everyone,

I just wanted to move this post to the top again and see if there were any new opinions about pregnancy and the biologics. My husband and I have decided to wait and hope for a drug induced remission prior to trying to conceive. My rheumatologist says that if I am in a drug induced remission prior to pregnancy and then stop the medication, I only have a 30% chance of flaring during pregnancy. Now I just need to go into remission!!

Megan

[Allie]

Megan,

THANK YOU!!! For posting this thread, and even more for bumping it. I went Enbrel in Jan '04 during a severe p flare, and was dx'd with mild pa the previous fall. March '06, after you originally posted this... my Derm discontinued my treatment for me to prepare for conception this fall. He wanted me off at least 6 weeks prior to trying, and the longer the better. The concern I personally had was regarding my immune system being suppressed. I mean how can it only target my immune system and NOT target the developing immune system of my future little one?

Couple things, I was one of the fastest into remission my Derm had ever seen - asking me what else I was using... In reality a locarb diet and lots of shea butter were my only two rabbits out of the hat. I know locarb dieting is NOT healthy for conception, but if it helps you get to remission - then I say "GO FOR IT"!!!

Post Enbrel.... I have maintained fairly well.... Once I stopped intaking sugar as a primary part of my diet. In general I avoid eating refined carbs, opting more the for the complex ones. (I did the locarb diet for two weeks, and found instant relief from all PA pain, but I cannot stick with it, knowing I am going off the pill later this summer.... I want my body as healthy as I can have it, even if that means I have to deal with pain and spots.) I am hoping my limited intake of refined carbs will help prolong the re-appearance of my health issues....

Also, I would like to add... I believe (but need to wait for my new insurance to kick in to confirm, as I changed jobs the first of May) a new auto-immune has spiked its ugly head in my stomach, as a result of me coming off Enbrel. It was probably always there, as my mom has it, but never affected me. I started noticing signs around the early part of May, but reducing my sugar intake & yeast intake, combined with Acidflourous I have found tons of relief.

My Derm provided me reports stating post-Enbrel spots and pain should be lessoned from prior-Enbrel flares. The statistics state, our body does not seem to rebound to be as vicious to our bodies. He also informed Enliven is collecting data for anyone on or has used Enbrel for its data gathering toward pregnancy and Enbrel.

Good Luck!!! I hope you find your remission soon, so you can join me in the fall for a TTC thread. :D (we need a "happy dance" face)

[Allie]

Nancy,

Thanks so much for the information!!! I am going to back-pocket it in case I flare during pregnancy... instead of the ever so dreamed of remission.

[makeitgoaway]

Good Luck!!! I hope you find your remission soon, so you can join me in the fall for a TTC thread. :D (we need a "happy dance" face)


I keep seeing this. What is TTC?

[Petdoc]

Allie - keep us posted on your success. I may need to try a low carb diet, but I am not very good at denying myself sweets! I am excited to hear of how successful your remission has been so far.

Makeitgoaway - TTC means "trying to conceive". Now someone just needs to tell me what PPPP means.

Megan

[Petdoc]

I actually emailed Dr. Hale (the breastfeeding specialist) and he sent me the following exerpt from his new MMM book:

"Etanercept is a dimeric fusion protein consisting of the extracellular ligand-binding portion of tumor necrosis factor bound to human IgG1. Etanercept binds specifically to tumor necrosis factor (TNF) and blocks its inflammatory and immune activity in rheumatoid arthritis patients.[1] Elevated levels of TNF are found in the synovial fluid of arthritis patients.

In a recent study of a non-breastfeeding mother who received 25 mg twice weekly, etanercept was measured in the milk retained in the breast.[2] This mother was not breastfeeding but retained some milk in the breast after 30 days. The author reported milk levels of 75 ng/mL on the day after injection. While this data is interesting, measuring drug transfer in residual breast milk following involution of alveolar tissues is simply not clinically relevant. After involution, the alveolar system would be totally open to drug transfer due to the breakdown of the tight intercellular junctions between lactocytes.

Due to its enormous molecular weight (150,000 daltons), I still believe it is extremely unlikely clinically relevant amounts would transfer into milk in breastfeeding mothers. In addition, due to its protein structure, it would not be orally bioavailable in an infant. Infliximab is somewhat similar and is apparently not secreted into human milk (see infliximab).

1.Pharmaceutical Manufacturer Prescribing Information. 1999.

2.Ostensen M, Eigenmann GO. Etanercept in breast milk. J Rheumatol 2004 May;31(5):1017-8.
"

I found this interesting and thought you might too!

Megan

[Allie]

Thanks Megan!

Sorry for confusing you Steve.... Being on baby boards as well as here, I forgot not everyone knows the short words here....

[stonemi82]

Hi Everyone

I am 24 yrs old and thinking about using Enbrel. I dont plan on having kids for awhile (don't even have a boyfriend) but that's not the point. I am worried if there will side effects from this product, that might effect unborn children. I went to a seminar about the drug and when I asked, they completely moved to another topic. Not exactly reassuring.

[RichJ]

hi stonemi82,
sorry i can't help much but welcome to the p family. you have will meet some of the wonderful people on here and will find alot of great info. welcome and nice to meet you.

have a good night all

richard

[baldwin123]

Hi Megan,
That article was interesting... but since I don't know all the lingo, I just wanted to check, it was talking only about how the medicine passes through breastmilk, right? While pregnant, there really is not way to monitor the effects a med might have... I guess future studies will monitor the development of children who were exposed in utero to biologics- but of course the results of those will take more time than I have left :)...I am sure no-one wishes to have their child be the guinnea pig in a study, and women who become pregnant while on biologics would give anything to guarantee health and happiness for the child- my rheumatologist has told me that humira (which I am on) is safe during pregnancy, but of course he is basing that on the limited info out there as compared to other drugs such as mtx... guess for me the decision will be whether I want to come off my meds to ttc, or be happy with the family I have- up until now, I have really been in limbo, not making a decision about this... I have been on humira for 15 months, with only one break... during that break, I had a really bad flare, and I am a little afraid to go off the humira again (not just because I am afraid of the pain but because its hard to be patient and upbeat when you feel that way, and how good would I be to my hubby and kids not to mention how would I handle my job if I DON'T go into remission with pregnancy)... thank you though to this board for helping me think about it in clearer terms...it is definitely one of those issues I just haven't been able to face since I was diagnosed... Oh well!
Take care everybody!
Jen

[Petdoc]

Hi Jen,

Yes, the article was only referring to breast feeding. Unfortunately for all of us, studies simply haven't been conducted on pregnant women. I know that Amgen and other drug companies are constantly collecting data about the effects of the biologics on the developing fetus, but nothing is published yet. Animal studies apparently have shown no detrimental affects on fetal development....but of course you cannot study or evaluate mental development, learning disorders, behavioral disorders, etc. in animals. So...that leaves us all making a tough decision. I did read about one woman (who has Rheumatoid Arthritis) who stayed on Enbrel throughout pregnancy and had a great pregnancy and a healthy baby. If you google Enbrel and pregnancy the RA forum will come up with her story.

I am basically going to wait until I am at a point in my life when I can afford to be on disability for 9 months (worst case scenerio). I am going to stay on Enbrel as long as possible prior to conception. My rheumatogist believes that during the first week or so of pregnancy, the egg is basically implanting in the uterus (not a lot of development). So....when I get a positive pregnancy test, I will stop the Enbrel. Enbrel leaves the body pretty quickly so, hopefully, if I don't miscarry, I should be in the clear as far as Enbrel is concerned. Then, I will just cross my fingers that I don't flare and become so permantly disabled that I can't ever use my hands normally again.

Maybe if there is anyone else out there who wants to try going off the meds during pregnancy around Spring '07 we could be email buddies and commiserate. How far in the future are you thinking, Jen? I guess we'll just have to wait and see.

Megan

[SandraJean]

Welcome stonemi82,

I saw where you went to a seminar the other night about Enbrel. Were you at the seminar in Buffulo, New York? I was at that the other night.

Welcome to the boards. Hope you are able to find the right kind of meds that will work for you. Everyone is so different and everyone responses to different treatment.

Take care,

Sandy

[magnetik]

Hello all! Some of you might remember me from my recent post on Pregnancy and PA. I've been doing the rounds with my doctors and trying to get everything situated before TTC. I had my last Remicade infusion on June 7th and told my rheumy at that time that I wanted to get pregnant. We discussed my options again and she is going to do more research for me. She has had patients on Enbrel who have had pregnancies with no complications and healthy babies. She's heard of patients with Crohn's Disease that stayed on Remicade while they were pregnant, but she doesn't actually have experience with that so she's not quite comfortable with it. Our basic plan is to use Prednisone as needed during the pregnancy if I don't go into remission or if I flare during pregnancy. That and keeping all fingers crossed!

I'm getting my IUD (internal birth control) taken out next month and then we will start TTC. My rheumy says 4 weeks off of the Remicade will be fine. I'll be doing 6 just to be sure.

I've read about a lot of miscarriages when someone has been on a lot of medications and has pa, but who knows? I'm just going to be praying that all will work out. The worst is the whole unknown factor.

Good luck with whatever you choose! I will be keeping everyone updated on my situation.

As I said before, you all are awesome!

Jennifer

[Petdoc]

Jennifer,

Have you used Prednisone in the past, and if so, did it help with your P or PA? Prior to being on Enbrel, I has a short course of high dose Prednisone and it did absolutely nothing for my PA. Unfortunately I only got the increased appetite, increased need to drink and go to the bathroom, and facial swelling. It is possible that I did not give it enough of a try. I have heard that during pregnancy, they will use a lower dose of Prednisone. I am curious if it has been helpful for you in the past. Good luck TTC!

Megan