Patient Selection and Safety With TNF Inhibitors - Episode 15
Megan E.B. Clowse, MD: A lot of patients ask what they can do beyond take medications to control their inflammatory disease. Medical doctors don’t always have the best answers for that. All of our data that have been collected over the years have really been driven by medications, so that’s what we know the most about: which medications can control inflammation, which are best at it, which work best for different diagnoses, how long to use them, etc. There is a lot of interest from patients, however, about dietary changes that can be made to influence inflammation. There’s a lot of information out there on the internet about people claiming that they have diets that control inflammation and can really improve the outcomes and the feelings that people with autoimmune diseases have.
I’ll be honest—there’s really very little scientific data showing that any of those diets make a real, lasting difference for patients. So my feeling and the advice that I give to patients is, if they have found a food that really seems to bother them or have found an activity that really makes them feel better, as long as it’s not going to interfere with their health in any other way, then great. Don’t eat that food that bothers you, and go do that alternative medicine approach that really helps you feel better. But there are really no data to support doing that instead of treating your autoimmune disease with medications. All of our data suggest that if you’re not on medications to control your inflammatory disease over the long term, you will do worse. You are likely to have more disability 10, 20 years down the line. So I think it’s important to do what you can to be healthy but not do that instead of working with your rheumatologist closely to manage the inflammation that’s going on.
The vast majority of studies for inflammatory arthritis are performed on both men and women pretty equally. Actually, there are usually more women in the studies just because there are more women with autoimmune diseases than men—in particular, rheumatoid arthritis. But there doesn’t appear to be a difference in how men and women respond to different medications, so we don’t generally pick different medications for men versus different medications for women based on how well they’re going to make you feel. We do, however, need to make some considerations for how we pick medications for women if they want to go on and get pregnant, particularly if they want to get pregnant in the near future.
So for patients with inflammatory arthritis who are female and don’t really want to get pregnant in the near future, they can really use any medication that’s currently approved for inflammatory arthritis. As far as we know, at this time, our studies all show us that none of our current medications affect fertility negatively. None of them will cause you to have birth defects later if you’re on it outside of pregnancy, so you can take whatever it is that you need to control your disease if you’re not trying to get pregnant.
Some of our medicines, however, do cause birth defects. If you were to get pregnant while taking methotrexate, which is really for patients with inflammatory arthritis, it’s important to know that there is a much higher rate of pregnancy loss—about 40%—and a higher rate of the baby having a birth defect. It goes up to almost 10%.
So we really strongly recommend that if you’re taking methotrexate and you are a female, that you strongly avoid getting pregnant. And for most women who are sexually active, that means using some sort of contraception or birth control. I really recommend that it be a highly effective birth control method that really prevents pregnancy, like an intrauterine device—which is also called an IUD)—or birth control pills that are taken regularly. So we definitely have to think about the risks of medications to the pregnancy if a women is trying to get pregnant.
We also have a lot of medications for rheumatoid arthritis and other inflammatory arthritides for which we really don’t have great pregnancy data. In fact, we don’t really have any pregnancy data for some of these—none that would be considered reliable. The pregnancies that we know about are a small handful of pregnancies that happened by accident during a clinical trial, and so we don’t really know the impact of getting pregnant on a lot of our newer medications. At this point, we don’t know if they increase the risk of birth defects or pregnancy loss. We have no idea. For women who fall pregnant on one of these medications, it can be really stressful because you just don’t know. You don’t know if you’ve just put your potential infant at risk or yourself. So I really strongly recommend not using medications that don’t have any kind of pregnancy safety data in women who are either considering getting pregnant right now or are not using birth control.
Methotrexate can cause a range of birth defects, most often abnormalities in the face. The good news with methotrexate is that it’s not as bad as we thought. I was certainly trained to think that methotrexate caused birth defects in the vast majority of infants, and that’s actually not true at all. Ninety percent of infants who are born after methotrexate exposure are actually normal. So methotrexate can be really problematic, and it causes a lot of stress for women in pregnancy, but it’s not as terrible as we thought it was. It’s not as bad as some of the other medications, to be honest, but we certainly would like to avoid pregnancies on it.