Navigating Allergy, Asthma and Biologics in Pregnancy

Join us as Monica Kraft, MD, FAAAAI, provides an evidence-based framework for managing allergic conditions during pregnancy, focusing on the safety of commonly used medications, from inhaled corticosteroids and antihistamines to biologics. We address the risks of undertreated asthma and explore the latest recommendations for penicillin allergy delabeling to optimize maternal-fetal outcomes. The discussion offers practical strategies for collaborating with OB-GYN colleagues to ensure safe, effective treatment throughout every trimester.

View the Work Group Report: Penicillin Allergy Delabeling Can and Should Be Performed in Pregnant Patients: A Work Group Report of the AAAAI Women’s Health in Allergy and Immunology and Adverse Reaction to Drugs, Biologics and Vaccines Committees

Transcript

Rebecca Saff, MD, PhD, FAAAAI 0:10

Hello, welcome to Conversations in the World of Allergy, the podcast of the American Academy of Allergy, Asthma & Immunology. I'm your host, Dr. Rebecca Staff. Allergy and Immunology is a field that's evolving at an incredible pace, and staying print isn't just important, it's essential. This podcast brings you conversations with leading experts to explore the latest advances, challenge how we think about core topics, and ultimately help us deliver the best care for our patients. Pregnancy introduces unique challenges in the management of allergic disease, where clinicians must carefully balance the health of the mother and the baby. In this episode, we explore the evidence and clinical decision making behind treating asthma and allergic conditions during pregnancy, including the use of standard therapies and emerging biologics. We also discussed the importance of penicillin allergy delabeling in pregnancy. Today we welcome Dr. Monica Kraft. Dr. Kraft is an associate professor in the clinical decision of allergy and immunology at the Ohio State College of Medicine and the Associate Program Director for the Allergy and Immunology Fellowship. She has an interest in allergy and pregnancy and was the lead author on a recent work group report entitled Penicillin Allergy to Labeling Can and Should Be Performed in Pregnant Patients. Dr. Kraft, thank you so much for taking the time to join us today and welcome to the podcast.

Monica Kraft, MD, FAAAAI 1:22

Thank you so much for having me. I'm so excited to be here today and to talk about this really important topic.

Rebecca Saff, MD, PhD, FAAAAI 1:27

I'd like to start by getting to know you a little better. Can you tell us a little bit about yourself?

Monica Kraft, MD, FAAAAI 1:32

Yeah, so I um am, as you mentioned, an allergen immunologist at the Ohio State University. Um I am not a Buckeye originally. I uh kind of grew up on the East Coast and came out here for my residency training and have been here ever since and have really grown to call it home. And um I particularly enjoy working with kind of pregnant patients and multidisciplinary care between how allergy interacts with other specialties. And that has kind of led to the interest on this project. Um, and outside of work, I have two little girls and spend most of my time keeping up with them.

Rebecca Saff, MD, PhD, FAAAAI 2:07

Fair enough. It can keep you busy.

Monica Kraft, MD, FAAAAI 2:09

Mm-hmm.

Rebecca Saff, MD, PhD, FAAAAI 2:10

What made you choose allergy immunology as a field?

Monica Kraft, MD, FAAAAI 2:13

Well, I always told my parents that I had to become an allergist because they never took me to one and I needed to figure out why my mouth itched so much when I ate fresh apples. And um once I found out that I wasn't going to die from that allergy, um, I it was very reassuring. But in all seriousness, when um I was in medical school, I initially thought I was going to be a dermatologist. And I found that the thing that interested me the most about the dermatologic conditions was kind of how different immune manifestations were coming up on this skin. Um, I vividly remember seeing this case of pyodermic gangrinosum and going to staff at the attending and saying, I think this is something, some horrible infection. And then he kind of showed me how it was their Crohn's disease and IBD kind of manifesting on the skin. And then I'd done some reviews on kind of side effects of biologic therapies and dermatologic conditions, and realized that it was really more the immune system that was interesting me than just what you were seeing on the skin. And around that same time, I had rotated with an allergist during my pediatrics rotation and found that they were all about the history and trying to figure out what was going on behind the scenes there. Um, and so I really got hooked and fell in love. So as I was spending more time with uh kind of the allergy side of things, I decided, okay, I'm gonna pivot and went into pediatrics residency with kind of the goal that I would hopefully um go into allergy fellowship after that. I also learned that procedures were not for me after nearly passing out during a most procedure. So I feel like it was the match made in heaven once I realized dermatology was not it.

Rebecca Saff, MD, PhD, FAAAAI 3:40

And it's perfect. One of our medderm physicians always tells us that the window or the skin is a window into the inside of the body. And so I think that um combining that love of dermatology and allergies sounds perfect.

Monica Kraft, MD, FAAAAI 3:52

Absolutely.

Rebecca Saff, MD, PhD, FAAAAI 3:54

So today the topic is discussing allergy and pregnancy. Can you tell us a little bit about how pregnancy affects common allergic conditions that we see in the clinic?

Monica Kraft, MD, FAAAAI 4:04

Allergy and kind of pregnancy definitely um are something that there's a relationship back and forth in terms of whether they are getting worse or um you have existing prior to pregnancy versus being identified during pregnancy. And pregnancy is such kind of a unique physiologic condition for the patient that there's just so much happening and so much changing in this kind of finite period of time that there can be a lot of questions of like how the allergic diseases are manifesting. And there's sort of the adage that we may have all kind of heard in training of the third rule of thirds. So extrapolating from kind of um some papers from the 80s where in asthma patients and then kind of looked at cohorts of patients with asthma who became pregnant, a third kind of got better during pregnancy, a third seemed to worsen, and a third stayed about the same. But kind of as we've gotten more data, it seems like that may be a little bit too general, and there may be more patients that worsen or at least stay the same during pregnancy. So up to 40 to 60 percent of patients with asthma may actually have worsening flare-ups during pregnancy. So probably that third getting better may be a little bit less than we um would hope for. But it's kind of been extrapolated to other conditions as well. So we see things like allergic rhinitis and nasal symptoms that can happen during pregnancy that can be worsening of underlying allergic rhinitis, or it can be mimicked by other pregnancy-specific conditions like pregnancy rhinitis, where patients can have kind of chronic nasal congestion, drainage, and really refractory nasal symptoms for more than six weeks, but it's actually not due to any underlying allergic mechanism. That usually gets better after delivery. And even things like atopic dermatitis or eczema may be existing prior to pregnancy, and then all of the immune changes and hormonal changes that are happening during pregnancy may trigger flare-ups in existing AD, or in some people it may get better, kind of stay stable, and in rare cases kind of identify or present for the first time during pregnancy. So there's a lot of different ways that pregnancy can affect allergic conditions, and it's probably not the same for every patient.

Rebecca Saff, MD, PhD, FAAAAI 6:08

And 40, 60% having possible we're saying in asthma is quite a large number. Um, what are the concerns about having uncontrolled asthma in pregnancy?

Monica Kraft, MD, FAAAAI 6:17

So we know that uncontrolled asthma and uncontrolled severe asthma in particular can have outcomes for both mother and baby. So there can be a significant proportion, so up to 5% of all pregnant patients who have some asthma, and of those, up to 20% may be severe or uncontrolled asthma. And that comes, the more uncontrolled phenotype is the one that comes with the risk for kind of mother and baby in particular. So there's been increased risk of preterm delivery, of low birth weight for the baby, increased perinatal mortality, increased preoclampsia and some other kind of conditions for the mother. So with the more severe asthma, with uncontrolled asthma, there's definitely some risk for both the mom and the fetus.

Rebecca Saff, MD, PhD, FAAAAI 7:01

And do we know anything about why asthma worsens during pregnancy?

Monica Kraft, MD, FAAAAI 7:06

So there may be a lot of different physiologic reasons for that. So in terms of kind of like hormonal changes and risk factors, but also in terms of people stopping medications. So sometimes it's not physiologic, it's more of patients who are worried about whether their medications are safe during pregnancy. So when people find out they're pregnant, they want to do everything that's best for their baby. So there's a lot of misunderstanding about what they can or cannot take during pregnancy.

Rebecca Saff, MD, PhD, FAAAAI 7:33

And given the concern that women rightfully have about medications, what do we know about medication management during pregnancy?

Monica Kraft, MD, FAAAAI 7:41

So the first and one of the most important things to kind of get across to patients is that their standard therapies like inhaled corticosteroids, kind of the baseline maintenance therapy we have for asthma, is safe. And so I think that is what I have a patient who's pregnant and who's one or who's about to become pregnant and they're wondering, you know, what can I take? We always try to talk about what is the worst thing that we can do, which is just to stop everything cold turkey. We're finally in a spot that is in controlling their asthma and that um has them comfortable. So we want to make sure that they understand that the risk is when they have exacerbations, when they have um kind of severe respiratory symptoms, that is going to have much more long-term impacts on their health and their the fetus health as opposed to the medications. But I also think it's important to know what's been reported with different medications that patients may be on, because they're gonna ask and they're gonna be looking up what are the potential risks here. Um so, with things like steroids, most of the concern for steroids affecting babies and affecting during pregnancy and kind of the fetal development is coming from kind of systemic steroids, so kind of oral steroids and kind of early animal studies that suggested that when you have high dose systemic glucocorticoids, there may be some increased risk for fetal abnormalities. So facial abnormalities have been reported like cleft palate and things like that. And human studies seem to be less suggestive, but you can't rule it out. And so when you think about early in pregnancy in those first 12 weeks when the fetus is developing and it's the highest risk for kind of malformations, thinking about what exposures are there. Now, inhaled steroids are not considered to have that same sort of increased risk. And the ones that have the best safety data would be things like butestinide, um, baclamathasone, fluticazone, all have really strong, really robust safety data. So we always kind of talk about steroids is not a catch-all term. Inhaled steroids to the kind of the lowest dose needed to control asthma symptoms is safe, is effective, even in the first trimester. Now, even if a patient has been well controlled on a different inhaled steroid prior to pregnancy, I typically will have them continue it. It does seem that there's not a significant need to change to a brand new controller inhaler or something like that during pregnancy. We talk about the potential increased risk with very high dose inhaled corticosteroids if you get some of that kind of systemic absorption. But I really try to make the distinction for patients between keeping their bodies healthy and preventing exacerbations that could need sort of systemic steroids, is going to keep them in a better spot than trying to stop all medications.

Rebecca Saff, MD, PhD, FAAAAI 10:24

And does the same hold true for nasal steroids or and then talk a little bit about anahistamines? Because many of these patients with asthma also have allergic conditions that can worsen their asthma if they stop those.

Monica Kraft, MD, FAAAAI 10:34

Yeah, absolutely. So um nasal steroids are considered safe in pregnancy as well. So when we think about kind of the same principles of we have topical treatment or inhaled treatment of the steroids, you have a way less dose of sort of systemic leucocorticoids. Um, and most uh inhaled steroids like bedesinide, fluticosone for nasal steroids have been well studied. The categories for pregnancy safety are kind of being phased out, but I think a lot of people still think about what was category B. So things like bedesinide and fluticosone were former category B drugs. The only nasal steroid I uh caution patients about is triamcinolone, which was a former category C, and there's probably just not enough safety data, but there's been some suggestion of whether triamolone could have a slight increase risk in some respiratory tract malformations. And then other ones that have less evidence. So nasal antihistamine sprays, acelastine, olpatidine are probably safe, but have less data. What we'll find every time we're talking with patients is that we don't have a lot of studies that specifically study pregnant patients with these medications. So we always try to use the best information we have in controlling symptoms. But intranasal steroids absolutely are a mainstay of treatment. Chromalin nasal spray has been extrapolated from inhaled chromalin for asthma and seems to be safe, although dosing tends to be pretty frequent, so may not be a first choice for a lot of people. And oral antihistamines are generally safe in pregnancy. What's funny is that because we go based off of the most data that we have, when I see recommendations from the OBGYN that my patients are seeing, oftentimes they have the first generation or older antihistamines like chlorphenuriamine or diphenhydramine listed there as safe to take, which as allergists we have not been typically prescribing as first line for allergic rhinitis for a long time. Those ones have the most robust safety data, but other second-generation antihistamines like thoratidine and cetirazine have great long track records of safety data. Um, and so when I talk with patients, we talk about use the medications that are controlling your symptoms. Here's the ones that we have the best data for. And importantly, we talk about what things they need to be cautious about. So I do recommend they avoid uh decongestants. So things like pseudophedrin have been linked to small but perceptible risks of um malformation, so things like abdominal wall defects in developing fetuses. So we always kind of talk about what is the risk benefit, what are the symptoms that they're having, and non-pharmacologic measures too. So sometimes using things like nasal strips, if you have um the nasal congestion and just kind of need to open up um your nose for things like rhinitis of pregnancy, where it's not really the allergies driving it, that can actually work better than medications in some cases.

Rebecca Saff, MD, PhD, FAAAAI 13:16

And so definitely, and all our allergy management recommendations for you know keeping the house clean, deskite precautions, all of those can be really good things for patients to consider as well. Absolutely. And so most of our data in pregnancy comes not from direct studies of pregnant patients, but more from the retrospective world.

Monica Kraft, MD, FAAAAI 13:35

Yes, and so we have had a lot of um great sort of meta-analyses and things that have come out and kind of summarized like what data do we have, sometimes some cohort studies. Um, but it's hard because we don't specifically uh study pregnant patients in some of the clinical trials. Um, so it's it all of these things are important to have tracking, and there's great sort of registries and resources for people who are on medications, but it is definitely hard when you don't have that specific data to talk with patients and and the meta-analyses are what we kind of rely on, which are really helpful.

Rebecca Saff, MD, PhD, FAAAAI 14:11

So many of our patients as they go into pregnancy may be on immunotherapy. So, what are your recommendations to patients when they're pregnant or who are anticipating pregnancy about immunotherapy?

Monica Kraft, MD, FAAAAI 14:22

I think that it is really important to talk about where somebody might be interested in pregnancy at the time that you're starting immunotherapy. So I always have that conversation with people of childbearing age of what are the general rules of thumb when it comes to subcutaneous immunotherapy and allergen immunotherapy. For things like aeroallergen immunotherapy, we usually talk about we're not going to start or initiate skit during pregnancy. During the buildup phase tends to be the highest risk of allergic reaction, but we will continue at a maintenance phase whatever they have been previously tolerating. It does appear that subcutaneous immunotherapy is safe during pregnancy. But we really want to just do as many things as we can to try to mitigate the risk for allergic reaction. So if somebody is planning to become pregnant and also considering starting immunotherapy, we may defer until after delivery to kind of start that buildup process. For somebody who is on maintenance immunotherapy and still has a reaction, as we know, can happen. I think it's also important to know that epinephrine remains first line. So the risk of allergic reaction during pregnancy, there's sort of the theoretical risk of could you decompromise blood supply to the uterus or cause contractions or things like that. But epinephrine is still first line, is still safe during pregnancy, and it's still important to be able to be treating patients who do experience anaphylaxis in the clinic. And there may be other reasons that are mitigating factors, so venom in immunotherapy or something like that, where the risk of an anaphylaxis to a sting may outweigh the risk of the immunotherapy. Those are all things to kind of consider during pregnancy. The other thing is in terms of blood pressure changes, patients maybe started on a beta blocker newly in pregnancy. And so, with regards to kind of safety with immunotherapy, having that conversation of how those things could interact with their immunotherapy is really important if the patient were to become pregnant so that you were aware kind of as they're they're treating allergists.

Rebecca Saff, MD, PhD, FAAAAI 16:18

So biologics and asthma have become much more commonplace, particularly a more severe asthma. What do we know about the safety of biologics in pregnancy?

Monica Kraft, MD, FAAAAI 16:27

Biologics are fascinating because they have totally revolutionized how we practice allergy immunology, how we care for patients with asthma. Um, and you are seeing patients on these younger and younger. And so it's really a consideration because there are people who may have not even thought about sort of trying to conceive or what future pregnancy was going to be about when they got their allergic and atopic diseases under control. And now they're on this medication and they're asking you, what do we do about it? Is it safe? What's the recommendation here? I think the most important thing to think about is as we go back to what are the potential other risks, we are using way less steroids for patients who have achieved control for uh with biologic therapy. But because women who are pregnant were not included in those initial trials, we don't necessarily have dedicated data for biologics in pregnancy. We know that IgG-based antibodies cross the placenta. So it's a reasonable thing to wonder is sort of like what are the potential effects here? And the data that we do have for biologics comes from kind of case reports and then registries. So the kind of early pharmacovigilance studies and registries that were saying, hey, here's this person that became pregnant, they were on a biologic therapy, what was the outcome? All look very reassuring for these biologics that we use in allergy immunology. And we have the most data for the ones that have been on the market the longest. So for things like omalizumab, where we have more than 20 years of use now in asthma, we can rely on things like the expect registry. So that was established back in 2006 to kind of look at perinatal outcomes for patients with severe asthma who were on omalizumab during pregnancy and kind of compared it to a matched, uh age-matched cohort that was not on omalizumab from another pregnancy registry in Canada. And in general, it was really reassuring to see the outcomes of patients on omalizumab did not seem to have a significant impact on the like fetus or the mother. There was a small but statistically significant difference in low birth weight infants among patients on omalizumab versus on those without, but those were also patients who had higher severity asthma than the other cohorts. So whether it was the severity of the asthma or being on the biologic therapy is sort of kind of out for debate. And it's also important that there were no sort of congenital malformations that were identified from either group or from the homeless map group. So we have used data like that, which is so great to have kind of a large registry, and then we've looked for similar things with other biologic therapies. And as the case series kind of come out, it appears that a lot of these medications are safe. But it's hard. It's a conversation to have with the patient and kind of like what to do next.

Rebecca Saff, MD, PhD, FAAAAI 19:16

Absolutely. I often find that I will mention it to my young female patients as well before they're thinking about pregnancy, but just kind of talking through if you become pregnant, these are the things that we consider because it sometimes you don't know what's going to come up in the future. And so it's good to address that early.

Monica Kraft, MD, FAAAAI 19:34

Absolutely.

Rebecca Saff, MD, PhD, FAAAAI 19:35

And there is that question because we know that asthma, severe asthma in pregnancy has complications. And so are the people that we're putting on biologics just when we're having to rely on this registry, they are they just have more severe asthma, and that's really what we're seeing.

Monica Kraft, MD, FAAAAI 19:50

Right, exactly. And I think that that's such an important thing. And it also, you know, we think about these biologics, they're not just used for asthma, they're used in a lot of conditions we treat. And sometimes the condition may help guide of sort of what do we do regarding the biologic around pregnancy.

Rebecca Saff, MD, PhD, FAAAAI 20:04

Yeah, absolutely. And some women will decide they want to stop regardless, and so then we have to figure out how we can best manage them since it's a shared decision making.

Monica Kraft, MD, FAAAAI 20:14

Absolutely. And some of the resources that I'll kind of bring up for patients are things like the Mother-to-Baby kind of fact sheet on different medications, and that can be a great resource whether it's the biologic medication or their inhaler and kind of summarizing it in very approachable terms. Um, I also think even just as a clinician, it's helpful to have something to go back to and say, where what is the data that we have? How robust is the data there? And if the patient decides that they are going to stop their biologic, um, how can you make sure, whether it's more frequent office visits, really monitoring their symptom control, making sure that you're seeing them regularly, of how do we make sure you don't lose control the control that we had during pregnancy or prior to pregnancy while you are pregnant.

Rebecca Saff, MD, PhD, FAAAAI 20:55

And Mother- to- Baby also has a registry, I think, for biologics that I often encourage women to go online and register for if they're interested to contribute to the body of data that we have.

Monica Kraft, MD, FAAAAI 21:05

Exactly. I talk about the same thing with patients too, is that we only find out about um how about this safety data because people like them will kind of put in their experiences and things can be monitored. So the more data we have, the better.

Rebecca Saff, MD, PhD, FAAAAI 21:18

So penicillin allergy and pregnancy has been a really important area of research, and you were recently involved in a work group that looked at penicillin allergy delaying in pregnancy. What were the recommendations that came out of that work?

Monica Kraft, MD, FAAAAI 21:29

I think the key recommendation comes from the title. So we we tried to make it pretty clear from the beginning, which penicillin allergy testing can and should be done during pregnancy. Uh, and I think that that was our biggest takeaway is that we wanted everybody kind of in allergy immunology or practicing allergists to realize that pregnancy is not a reason to defer penicillin allergy testing. And in fact, it may be a reason to proactively test because it has such far reaching implications for the outcomes for both mother and baby.

Rebecca Saff, MD, PhD, FAAAAI 22:00

And why is it so important to delabel in pregnancy?

Monica Kraft, MD, FAAAAI 22:04

So when it comes to penicillin allergy, there we know that similar to the general population, pregnant patients are going to have sort of the inappropriate penicillin allergy labels. So up to 8 to 10% of pregnant women are going to walk in with penicillin allergy label, and the vast majority of those, 90% plus, are going to be not allergic to it. What is important to know is that the use of beta-lactams and penicillin-based antibiotics in particular are first line for a lot of pregnancy-specific conditions. So group B strep, first line prophylaxis is ampicillin or penicillin. And up to a third of women will have GBS colonization during pregnancy. So that's not an insignificant number of people that, if they had a penicillin allergy on their list, are not getting first-line antibiotics. And the alternatives, if you're not getting penicillin, are kind of much broader-reaching antibiotics, so things like gentomycin and vincomycin. And so you're getting a lot more broad spectrum than needed in those cases. And things like syphilis during pregnancy to prevent congenital syphilis, penicillin is the first-line antibiotic. And so knowing if a patient can take it safely is important to help prevent delays of care and sort of long-term outcomes. And we know that people who have penicillin allergy labels have higher length of hospital stays, higher risk of infectious complications for both mother and baby. And so it's really important to kind of get it figured out right from the beginning.

Rebecca Saff, MD, PhD, FAAAAI 23:26

And do you feel that obstetricians are more aware of this and kind of readily sending their patients for delabeling?

Monica Kraft, MD, FAAAAI 23:33

It probably depends on where you are and who the obstetricians are. So I have found in my experience, the obstetricians in our group are really proactive about wanting patients to have this allergy delabeled. The American College of Obstetrics and Gynecology, or ACOC, has had a statement out since 2020 that encourages penicillin testing during pregnancy as part of their kind of treatment and algorithm for groupie strep evaluation and prevention in the newborn. And so they their National Society has definitely recommended penicillin allergy testing and evaluation. And that was part of the impetus for this work group report, which had started from a leadership institute project that I was a part of, which was really looking at why is it that the OB-GYNs are so familiar and comfortable with penicillin allergy testing, but the practice variety is all over the place when it comes to getting to the allergy clinic. We had noticed even in our own group. So one of the co-authors on this work group report was one of my former fellows and now colleagues on Dr. Vicky Wen. We looked at just within our own group how are people doing allergy testing for penicillin when a pregnant patient came in. And some were doing direct oral challenges, some were skin testing everybody first, some said come back after you know if your group be strep positive, some said come back after delivery. And that was just within one institution. And so, you know, I really raised the question of is there a lot of confusion about what we should be doing for pregnant patients when they make it to the allergy clinic, even if the OB-GYN team realizes that this is important, what happens when they get to us? And so that's where we really wanted to provide some clarity.

Rebecca Saff, MD, PhD, FAAAAI 25:10

So what are the recommendations of the work group, particularly in practices maybe that aren't penicillin allergy testing?

Monica Kraft, MD, FAAAAI 25:17

So our recommendation is that penicillin allergy testing absolutely should be done during pregnancy for patients who are considered low risk, regardless of whether they have an existing clinical indication. And the reason that we came to that recommendation is that we know that if you wait until group B strep status is known, which is typically close to 37 weeks, you will miss a large proportion of patients who are just not able to come back in in time prior to delivery for testing. And we know that penicillin allergy testing is safe. And so what we tried to do with this work group report was to summarize the existing literature. Over the last 20 years, there's been a lot of kind of individual institution reports of how people are testing pregnant patients. And we kind of summarized some of those studies in the work group report that represents over 2,000 individually tested pregnant patients, some who initially were tested with skin testing only and then challenged at the time of delivery if they needed it. And now, more recently, looking at large groups of cohorts that did direct oral challenge to penicillin or amoxicillin at any trimester that the patient was evaluated and had no increased risk of allergic reaction or positive testing than those who had empiric skin testing first. So while we did not say that there's one particular best way to test, the idea that having the conversation with the patient and making sure they understand the importance of testing and doing that definitive testing during pregnancy is really, really important.

Rebecca Saff, MD, PhD, FAAAAI 26:50

So it sounds like there's no specific recommendation of when in pregnancy to proceed with the testing, but the overall data shows that it's pretty safe no matter which trimester you're in.

Monica Kraft, MD, FAAAAI 26:59

Exactly. So the least amount of data is in the first trimester for a couple of different reasons. So, number one, by the time that patients have their first gynecology obstetrician visit, oftentimes they're eight to ten weeks along, and then by the time they're coming into an allergy clinic, most of these studies just did not have a lot of patients tested in the first trimester, although the ones that did have no had no adverse outcomes. The majority of the studies showed second or third trimester. The other reason why the first trimester is tricky is because there's some other symptoms of early pregnancy that can sometimes either mimic reactions during a challenge, like kind of nausea or upset kind of stomach or just kind of feeling a little unwell, that it can be hard if you're doing a direct oral challenge to help with some of those subjective symptoms. But in terms of safety, there was no kind of adverse outcomes, even in those that were tested in the first trimester. When we looked at the studies, the majority were second or third trimester testing. And whether it was skin testing first or direct oral challenge did not have a significant difference. And a lot of times, because of the potential for a false positive skin test, more people were delabeled if they went through the direct oral challenge cohort compared to those who had empiric penicillin skin testing first.

Rebecca Saff, MD, PhD, FAAAAI 28:12

And how can we involve our OB colleagues or even other healthcare professionals? It's a large population to try to test to get in in a very timely manner. So are there ways we can involve outside groups in helping to clear the penicillin allergy?

Monica Kraft, MD, FAAAAI 28:26

Absolutely. So one of the things that would be great is to try to figure out from the OB-GYN community what is the need and what is the process to sort of identify patients. Because it's great if we all kind of have this shared goal of trying to do the delabeling and do the definitive testing for patients, but if we can't identify the patients or get them in in a timely fashion, that's going to be really challenging. So the other thing in the work group report that we tried to highlight is how different institutions have successfully implemented kind of a streamlined process. And so that could be through an e-consult system, if that is already in existence, where a referring provider can ask sort of initial screening questions or get some characteristics, and then an allergist immunologist reviews it electronically. And then if they're eligible for definitive testing, skin testing and/or challenge, then kind of having them scheduled directly into that spot. Best practice alerts, where it kind of flags to identify in pregnant patients if their penicillin allergy is there, that kind of defaults to a referral program. Sometimes having a dedicated drug allergy clinic was practiced. Having a nurse triage sometimes was practiced where the either on the OB-GYN side or on the allergy side, if a patient was sort of identified as pregnant and having a penicillin allergy, the nurse could call and ask questions and utilizing some type of a standardized scale like PenFast can really help to stratify those patients early before coming in for a visit. The other thing is working with the OB-GYN colleagues is just setting up the expectation for why it's important and why it's yet one more appointment that patients will need during their pregnancy early on, so that you have sort of that full nine months of talking with the patient to try to get them into the allergy clinic for definitive testing. There's some places that are looking into doing kind of e-or teleconsults for more remote areas and then seeing if sort of the oral challenge can be done locally with the either the obstetrician's office. So those ones I haven't seen done quite as frequently, but it's there's a lot of different ways, depending on what the community needs, to talk about what are the successful ways to delabel a patient. And then finally, partnering with the people who are seeing these patients before they become pregnant is another really good opportunity to try to get this figured out. So when we think about primary care and the number of kind of direct oral challenges that we've seen working with the primary care communities to help delabel low-risk patients even before they ever make it to an allergy specialty clinic could be another great way to try to partner with the community and kind of decrease the burden of people with a penicillin allergy label long before they ever become pregnant.

Rebecca Saff, MD, PhD, FAAAAI 30:59

Well, certainly us being on the lookout for it, just like we can have conversations about asthma management and biologics well before a patient becomes pregnant, seeing that penicillin allergy label in someone who has the potential to be pregnant in the near future saying, you know, this is a really important thing we address now so that way it doesn't become an issue in pregnancy because it really allows you to get the best care.

Monica Kraft, MD, FAAAAI 31:21

Absolutely. So, and I am guilty of it myself. Sometimes you forget, you know, you have so many things you discussed in that first visit that you forget about the drug allergy list there that's uh alerting on the side of your screen and your electronic medical record. But it's an important reminder to come back, and that may be a way to launch that conversation of also if you were to become to, you know, where are you in the family pre-leaning process? If you were to become pregnant, do you feel comfortable with what you would be taking from your allergy management, your asthma management? And hey, did you know that this penicillin allergy is something that we might want to get addressed beforehand? And here's why.

Rebecca Saff, MD, PhD, FAAAAI 31:56

Have you find wet ways to successfully work with the your OB colleagues in order to really provide the best care for patients who are pregnant?

Monica Kraft, MD, FAAAAI 32:04

We are constantly trying to improve our process. I think the best advice that I have for anybody who's trying to get this up and started is to try to figure out who within the OB-GYN group may have a special interest in this area. Because I think you'd be surprised that some there are some people that really have have found that this is a particular passion area for them. So for me, finding those individuals, and one of them, because sort of at our institution is a co-author on our work group report, Dr. Catherine Stratford, has been for a long time advocating to the rest of her group about why this is important. And so you need somebody on the inside who is gonna say, rather than coming in from an allergy perspective and kind of preaching to another group of, hey, we're here, this is why you should refer to us. I think making sure that there is buy-in on both sides is important. I also think that the misperceptions on both sides is something that means we need more communication than ever. Because I have found that I've talked with allergists who said, oh no, the OB-GYNs don't want us to test the pregnant patients, they're not going to refer to us. And I've talked with OB-GYNs that said, why would I keep referring to allergy? Last time they didn't even test my patient when I wanted them for a penicillin allergy. So there's definitely a room for communication on both sides here. So having somebody who's interested and can kind of share that with the colleagues is a huge key step. And then we found that there's different ways that we can do it. So we've talked about trying to do e-consults first, where we can try to identify the um the patients and then get them in directly for same-day evaluations and doing kind of a new patient visit and a challenge at the same time if possible. And we've tried to put a flag on with sort of central scheduling for us, where when our wait lists get long, so if we're in a several month wait list, we want to make sure that that's not somebody who's gonna miss their window for delabeling. So one of the standard questions on our intake now is whether or not the patient is pregnant who is referred for the penicillin allergy. And if so, it gets routed directly to our clinic schedulers for kind of more first priority visits. And it's a work in progress. I think that in an ideal world, I would love to see something where we have sort of a dedicated half day where we can just group a bunch of patients. I know there's some other institutions that have dedicated challenge days or drug allergy clinics, and they could have kind of a focus on pregnant patients being evaluated. And I wouldn't pretend to say that we our group has figured out the best way to do it, but it's a great area for quality improvement. It's a great area to see what is working, what is the holdup, are there specific groups that are referring consistently and then other groups or providers that are not? How do we kind of promote education there?

Rebecca Saff, MD, PhD, FAAAAI 34:37

I love having a champion within the field because it's so important that the OBs within the group know who they can kind of turn to for questions and concerns, and that person can really promote within for delabeling. And remembering that these patients have so many, the patients who are pregnant have so many visits, and as much as we can stream that in the process for them, the more likely they are to be delabeled.

Monica Kraft, MD, FAAAAI 34:59

Absolutely. I also think it's really important to realize this is not something that is owned by academic groups. So all pregnant patients that have a penicillin allergy are gonna need to be assessed. And this does not need to be those within an academic OB-GYN practice and an academic allergy immunology practice. We know that so many of our colleagues in allergy immunology are practicing out in the community and they're gonna be the first line, and that penicillin allergy evaluations are a staple of our visit. And being pregnant does not empirically increase the risk of challenging or testing the patient for penicillin allergy. So getting back to the fundamentals of how do you risk stratify low-risk patients, how do you do, you know, kind of your direct oral challenge and telling local private OB-GYN practices that you are available, you are a resource, is going to be really important to create that partnership in the community no matter what the practice setting is.

Rebecca Saff, MD, PhD, FAAAAI 35:49

Well, what are some take-home points that you would like allergists to remember as they care for patients during pregnancy?

Monica Kraft, MD, FAAAAI 35:55

I think the biggest take-home point is that pregnancy should not mean pause in anything that we are doing as allergist immunologists. It uh does not mean we stop our care. And our existing patients may become pregnant, and we they're gonna ask us what to do about their asthma, about their allergies. And they also are gonna rely on our expertise for where we can help them. So being educated ourselves is gonna help us maintain that kind of doctor-patient relationship where we can then really promote comfort with the things that we are doing. Patients are nervous at this time when they're growing a new life and they want to do everything that's best for their baby. And so, for us to be able to speak confidently to how we can help them manage their allergies, their asthma, and their drug allergy, it's gonna really help them with the confidence that they need kind of going forward. So I think the biggest takeaway from me would be just to familiarize yourself as the allergist immunologist of like where is the overlap of our field and pregnancy so that you can best help your patients.

Rebecca Saff, MD, PhD, FAAAAI 36:59

That's fantastic. Well, thank you so much, and thank you for taking care of patients throughout all stages of life. Um, and thank you for your involvement in the work group. This is great.

Monica Kraft, MD, FAAAAI 37:08

Wonderful. Thank you so much for having me. I really appreciate it.

Rebecca Saff, MD, PhD, FAAAAI 37:12

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