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Biologics in Psoriasis and Pregnancy: What Dermatologists Need to Know
When discussing psoriasis in women of child-bearing age with other physicians and providers, I often hear comments like “I just do not often see pregnant women who have psoriasis” or “most of my patients with psoriasis are men.” I often wonder if this is actually true, or if we just simply forget to recall this population because many of us, for a lot of our career, have felt uncomfortable treating pregnant women with any systemic psoriasis drugs. Traditionally, our go-to conversation with our patient with psoriasis who gets pregnant goes a little something like “unfortunately, we don’t have much data on these medications and since this isn’t life-threatening, here are some topicals and/or a light booth. Call me when you’re done breastfeeding.” At least that’s how the conversation used to occur in my practice.
This was never a discussion I enjoyed. I felt horrible kicking my newly pregnant patient with psoriasis aside and essentially abandoning them for 10 months while they had to endure this strange new physiological state. And, we all remember the old myth that women who get pregnant will have relief from psoriasis since pregnancy is a “form of immunosuppression.” However, this is not the case for everyone. Approximately 23% of patients worsen during pregnancy, and 21% remain the same.1 Moreover, up to 90% of patients worsen in the immediate postpartum period.2
So, what are the chances we are going to even see this in our clinic, and why do we care? On average, there are 7.2 million people affected by psoriasis in the US alone, and about half of these cases are women.3 For females, the average age at the time of disease onset is 28 years, which means that many of these patients with psoriasis are of child-bearing potential.2 According to a 2008 article in the Journal of American Academy of Dermatology, it was estimated that 65,000 to 107,000 deliveries occur annually in women with psoriasis.4 Studies repeatedly demonstrate that pregnancy outcomes are poorer in patients with psoriasis, and women aged 35 years and older with psoriasis have significantly lower pregnancy rates and live birth rates compared with disease-free control patients.5 In addition, it is known that psoriasis comorbidities such as diabetes, metabolic syndrome, cardiovascular disease, and depression may also increase the risk of negative birth outcomes. This patient population is also more likely to smoke, suffer from depression, be overweight or obese, and are less likely to take prenatal vitamins.6
In my practice, this is enough to treat my pregnant women with psoriasis and those of child-bearing age aggressively. The caveat is: we do not have any evidence (yet) to support that biologics can actually improve these negative pregnancy outcomes, but we do know that biologics improve overall quality of life and are now being shown to improve cardiovascular outcomes.7,8 In addition, the body of literature regarding biologics in pregnancy continues to increase and suggests that biologics may be used safely during pregnancy. This is especially true of the tumor necrosis factor (TNF)-α agents as there is longer-term data available.
I, personally, feel even more at ease using certolizumab pegol (Cimzia), a pegylated TNF-α agent approved for psoriasis and psoriatic arthritis, in this population. Certolizumab has clinical data that demonstrates that the drug has little to no transportation to the fetus.9 This can be reassuring to both the prescriber and the mother when choosing a biologic for a woman who is considering becoming or is pregnant.
For breastfeeding, the data supports the idea that biologics are likely safe. Biologics are injected subcutaneously because they cannot pass through gastric acid and still be bioavailable. This is also likely to occur in infants.10 Regardless, certolizumab also has breastfeeding data that demonstrates that there is negligible to low transfer of drug into the breast milk.11
As with any patient, there are several considerations to make when deciding treatment options for this population. The first step is to attempt to keep the conversation fair and balanced. I present the real fact that having psoriasis while being pregnant does inherently come with its own risks, and then review the risks of being on a biologic. Certolizumab, with its placental and breast milk transfer data, brings me the most peace when choosing a systemic medication. Regardless of the minimal transfer of this drug, newborns who have been exposed to any biologic in utero should not receive live vaccines for 6 months following birth. Be sure to enroll your pregnant patients in registries so that the community can continue to collect helpful information, and direct your pregnant patients to https://mothertobaby.org so that they can stay informed.
Dr Hawley is with the Derm Institute of West Michigan and an associate clinical professor at Michigan State University College of Osteopathic Medicine in East Lansing, MI.
Disclosures: Dr Hawley served as consultant and/or national speaker for AbbVie, Celgene, Novartis, Ortho Dermatologics, and UCB.
References
1. Horn EJ, Chambers CD, Menter A, Kimball AB, International Psoriasis Council. Pregnancy outcomes in psoriasis: Why do we know so little? J Am Acad Dermatol. 2009;61(2):e5-8. doi:10.1016/j.jaad.2009.05.004
2. Tauscher AE, Fleischer AB Jr, Phelps KC, Feldman SR. Psoriasis and pregnancy. J Cutan Med Surg. 2002;6(6):561-570. doi:10.1007/s10227-001-0147-1
3. Jacobson CC, Kumar S, Kimball AB. Latitude and psoriasis prevalence. J Am Acad Dermatol. 2011;65(4):870-873. doi:10.1016/j.jaad.2009.05.047
4. Lam J, Polifka JE, Dohil MA. Safety of dermatologic drugs used in pregnant patients with psoriasis and other inflammatory skin diseases. J Am Acad Dermatol. 2008; 59(2):295-315. doi:10.1016/j.jaad.2008.03.018
5. Powers J. Psoriasis is significantly associated with lower rates of pregnancy and live births. Presented at: 21st Congress of European Academy of Dermatology and Venereology; September 27-30, 2012; Prague, Czech Republic. Abstract P921.
6. Bandoli G, Johnson DL, Jones KL, et al. Potentially modifiable risk factors for adverse pregnancy outcomes in women with psoriasis. Br J Dermatol. 2010;163(2):334-339. doi:10.1111/j.1365-2133.2010.09899.x
7. Jungo P, Maul JT, Djamei V, et al. Superiority in quality of life improvement of biologics over conventional systemic drugs in a Swiss real-life psoriasis registry. Dermatology. 2016;232(6):655-663. doi:10.1159/000455042
8. Mehta NN, Shin DB, Joshi AA, et al. Effect of 2 psoriasis treatments on vascular inflammation and novel inflammatory cardiovascular biomarkers: A randomized placebo-controlled trial. Circ Cardiovasc Imaging. 2018;11(6):e007394. doi:10.1161/CIRCIMAGING.117.007394
9. Mariette X, Förger F, Abraham B, et al. Lack of placental transfer of certolizumab pegol during pregnancy: results from CRIB, a prospective, postmarketing, pharmacokinetic study. Ann Rheum Dis. 2018;77(2):228-233. doi:10.1136/annrheumdis-2017-212196
10. Clowse MEB. The use of anti-TNFα medications for rheumatologic disease in pregnancy. Int J Womens Health.2010;2:199-209.
11. Clowse M, Förger F, Hwang C, et al. Minimal to no transfer of certolizumab pegol into breast milk: results from cradle, a prospective, postmarketing, multicenter, pharmacokinetic study. Ann Rheum Dis. 2017;76(11):1890-1896. doi:10.1136/annrheumdis-2017-21138