Kickas.org Forums Treatments, Drugs and Alternatives Anti TNF and other biological medications Enbrel and pregnancy

Hi everyone, i posted a while ago about whether anyone has had any advice/info on when to stop enbrel before trying to conceive as my current rheumy/anti TNF clinic were very vague.

I've since transferred to a hospital nearer to home and have had my first consultation with my new rheumy and new anti TNF nurse and i asked the same question. They said that they stick to a hard line of you must be off it for 6 months before trying to conceive and if a patient of theirs fell pregnant whilst taking enbrel or in the 6 months after stopping they would be offered and encouraged to have a termination.

I just thought this was interesting information to impart, as other advice i've been given has been quite vague. I don't take a full dose so i'd be comfortable to stick to the drug company advice which is 4 months. Such a difficult decision to make that i though the more info the better.

Hi Sarah,
I think I'm replying to you.... again on the same topic... hehe... ah well...I'll reply again in case anyone else missed the first.
The idea of terminating a pregnancy because you took enbrel less than six months prior, is positively shocking to me.
I've had this conversation with a few doctors over the years, and they've all agreed it's safe (as far as we know) to continue with enbrel if I ever became pregnant. I've researched this like mad, and there are quite a few reports stating that anti-TNFs can be safely tolerated through pregnancy, but of course, if you can go without them during pregnancy, that's probably the way to go. Why take a drug if you don't have to, right? And who knows - many women tend to go into remission during pregnancy too - we can always hope! And by the way, you're able to clear enbrel in a matter of a couple of weeks, so I'm not sure where the 6 month deadline came from.
There are a ton of women who have severe Crohn's or other autoimmune disease who choose to stay on anti-TNF drugs during their whole pregnancy, after weighing the pros and cons for themselves, and they end up having healthy babies.
It's a tough call.... because we don't really know for sure, and medical professionals of course like to err on the side of caution. Nonetheless, good luck with everything, and I'm sure you'll end up with a healthy, beautiful little one no matter what you choose!

the first time i read it, i thought it was "termination of the pregnancy" and thought, that can't possibly be. then i reread it a few more times and though its ambiguous, was hoping it was terminating the drugs during the pregnancy. maybe that is what was meant, because otherwise i agree with megan that the other option seems awful drastic.

sue

Hi Sue, no i really meant that a termination of the pregnancy would be offered. They take a really hard line on it which i was quite surprised about as well. BUT, at least it actually gave me a definitive answer rather than expecting me to make my own conclusions. I don't think we'll wait 6 months, i'd be happy to wait 4, my fiance says he'd be happy with 3 as i take a half dose, so we'll see!

Apparently but not surprisingly there seems to be much disagreement among doctors. I have been through careful discussions with my rheumatologist on this topic recently.

There are two main issues with TNF-α inhibitors and pregnancy. I am taking Adalimumab/Humira, a pregnancy class B. I am able to stretch my intervals to six instead of two weeks between injections. Does Humira (big dose or my small dose) interfere with implantation since in theory TNF is important for this process? According to my doctor, there are no studies that support this, and in fact there are many case reports that report normal conception on therapy.

Second, are there increased birth defects in fetuses born to mothers on biologics? In recent studies the rate of both spontaneous abortions and congenital anomalies parallels the normal population. There is a presentation from the OTIS registry (looking at pregnancy outcomes in patients with autoimmune disease) supporting no additional risk.

I agree with Megan. 6 months seems like an overly cautious recommendation. Recommending termination of pregnancy is outright irresponsible. Lots of women have conceived, gone to term and given birth to healthy babies while ON the biologics. While surely not the ideal scenario, it might in some cases (severe cases of AS) constitute the lesser of two evils and on that basis constitute the more sound recommendation. There will in these cases of severe disease be a high risk of uncontrolled systemic inflammation if biologics therapy is discontinued prior to conception or during pregnancy. The two rheumatologists in two countries that I consult with have both given me the green light to make my own informed decision weighing the two evils. Together we have formulated an agreement that sounds like this: I can stay on Humira UNTIL conception happens. I would stay off it during organogenesis and the whole first trimester. If necessary, I would resume and stay on Humira until end of term.

As my doctor says, even though this is still a relatively new drug in terms of pregnancy, there is no good evidence to suggest that harm outweighs benefit. It might be blue-eyed but I do take comfort in this. And no, I am not yet pregnant.

All the best,
N

Interesting. It is a very personal choice.

You may be able to find out more specifics b/c I believe that companies do follow women who become pregnant and give birth while on anti-tnfs. I'm not sure if this info is published.

I was told that some women choose to take throughout pregnancy (though not endorsed), not sure if that is a difference in how it is recommended for use in the US vs. UK? If you are interested, you may want to go to the enbrel.com website and read the US prescribing info.

Good luck to you. Jessica

Good luck to you Nattush,

A pregnancy category B is pretty good! Most docs feel comfortable prescribing a category B during pregnancy and you don't just get a category B for no reason... It's not a default - you would have to supply data to FDA to support that the claim. The claims are listed below.

Jessica

United States FDA Pharmaceutical Pregnancy Categories

Pregnancy
Category A
Adequate and well-controlled studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Pregnancy Category B
Animal reproduction studies have failed to demonstrate a risk to the fetus and there are no adequate and well-controlled studies in pregnant women OR Animal studies which have shown an adverse effect, but adequate and well-controlled studies in pregnant women have failed to demonstrate a risk to the fetus in any trimester.

Pregnancy Category C
Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Pregnancy Category D
There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Pregnancy Category X
Studies in animals or humans have demonstrated fetal abnormalities and/or there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience, and the risks involved in use of the drug in pregnant women clearly outweigh potential benefits.

Also, mig provided a very helpful bit of info in a message called Remicade on 8/10/08 with links.
Jessica

Just thought I'd post this. It was the latest journal article I could find on the topic:

Nat Clin Pract Rheumatol. 2007 Mar;3(3):156-64.

Drug insight: Anti-tumor necrosis factor therapy for inflammatory arthropathies during reproduction, pregnancy and lactation.

Skomsvoll JF, Wallenius M, Koksvik HS, Rødevand E, Salvesen KA, Spigset O, Kvien TK.

Department of Obstetrics, Trondheim University Hospital, Trondheim, Norway. johan.skomsvoll(at)ntnu(dot)no

Tumor necrosis factor (TNF) antagonists are widely used to reduce disease activity and joint damage, and to improve health-related quality of life in patients suffering from rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis. To date, no increased risk of embryotoxicity or teratogenicity, or adverse pregnancy outcome (such as birth defects, premature birth, and low birth weight) has been reported in patients with inflammatory arthropathies treated with anti-TNF therapy, compared with the general population. However, the available data are limited, and methotrexate, which is commonly used in combination with anti-TNF drugs, is teratogenic. Until more data are available, no firm conclusions can be reached regarding the safety of anti-TNF therapy in pregnancy. Nevertheless, in selected cases where there is high disease activity, anti-TNF therapy might be recommended, depending on the results of individual risk-benefit analyses. Fully informed consent from the mother is needed in such cases. Anti-TNF agents are not usually used during lactation, although the risk of toxicity is probably negligible.

PMID: 17334338 [PubMed - indexed for MEDLINE