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      Pregnancy Outcomes in Women With Moderate-to-Severe Psoriasis From the Psoriasis Longitudinal Assessment and Registry (PSOLAR)

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          Key Points

          Question

          Is there an association between pregnancy outcomes and psoriasis or exposure to systemic therapies for moderate-to-severe psoriasis?

          Findings

          This cohort study used data from the Psoriasis Longitudinal Assessment and Registry (PSOLAR) for 220 women with 298 pregnancies, of which 244 (81.9%) resulted in live births. Rates of spontaneous abortion, neonatal problems, and congenital anomalies were similar to rates in the general US population, and pregnancy outcomes for women exposed to biologics were similar to those for women with exposure to nonbiologics.

          Meaning

          Pregnancy outcomes among women with moderate-to-severe psoriasis within PSOLAR appeared to be consistent with previously reported data; pregnancy-specific registries are needed to more fully characterize the effect of psoriasis and its treatment on birth outcomes.

          Abstract

          This cohort study reports pregnancy outcomes observed among women enrolled in the Psoriasis Longitudinal Assessment and Registry.

          Abstract

          Importance

          Prospective data are limited on pregnancy outcomes among women with psoriasis who may be receiving biologic or conventional systemic therapy.

          Objective

          To report pregnancy outcomes observed in the Psoriasis Longitudinal Assessment and Registry (PSOLAR).

          Design, Setting, and Participants

          This cohort study used data from PSOLAR, a multicenter, disease-based, observational registry evaluating long-term safety and clinical outcomes for patients receiving or eligible to receive treatment for psoriasis with biologics and/or conventional systemic therapies. Of 12 090 enrollees, 5456 were women (45.1%), and 2224 women were of childbearing age (18-45 years). Participants had a total of 12 929 patient-years of follow-up (median, 7.2 [range, 3.3-8.0] years per patient). Data were collected from June 20, 2007, to August 23, 2019, and analyzed from April 23 to June 23, 2020.

          Exposures

          Exposure to biologics within the prenatal period (≤1 year before birth or ≤6 months before spontaneous abortion) or at any other time.

          Main Outcomes and Measures

          Descriptive summaries of pregnancies and pregnancy-related outcomes were self-reported in PSOLAR, including births, stillbirths, spontaneous abortions, and elective terminations. Live birth characteristics collected in PSOLAR include whether a birth was full-term (≥37 weeks) or premature (<37 weeks) and whether neonatal adverse events or congenital anomalies occurred.

          Results

          A total of 298 pregnancies occurred among 220 women (mean [SD] age, 27.8 [5.2] years), and the general fertility rate was 18.9 per 1000 women aged 18 to 45 years. Of the 298 pregnancies, 244 (81.9%) resulted in birth, 41 (13.8%) ended in spontaneous abortion, and 13 (4.4%) were electively terminated. Gestational age was available for 243 births; 221 infants (90.9%) were full-term, and 22 (9.1%) were born prematurely. Birth outcomes included 231 healthy newborns, 10 infants with a neonatal problem, 2 infants with a congenital anomaly, and 1 stillbirth. Of the 298 pregnancies, 252 were associated with biologic exposure before or during pregnancy. Pregnancy outcomes for women exposed to biologics were similar to those for women exposed to nonbiologics. Among women who became pregnant, mean (SD) age at the time of pregnancy outcome was 30.9 (4.8) years; at enrollment into the registry, 74 of 219 (33.8%) had obesity, and 121 of 220 (55.0%) were past or current smokers.

          Conclusions and Relevance

          The findings of this cohort study suggest that pregnancy outcomes in PSOLAR have remained consistent with previous reports. Overall and live birth outcomes were similar to those for the general population.

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          Most cited references22

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          Psoriasis prevalence among adults in the United States.

          Psoriasis is a chronic inflammatory disorder associated with significant morbidity and mortality. Up-to-date prevalence data on psoriasis provide the foundation for informing population research, education, and health policy. We sought to determine the prevalence of psoriasis among US adults. We performed a cross-sectional study using National Health and Nutrition Examination Survey 2009 through 2010 data to determine psoriasis prevalence rates. From 6218 participants older than 20 years of age, 6216 respondents provided complete information regarding a psoriasis diagnosis. The prevalence of psoriasis among US adults ages 20 years and older is 3.2% (95% confidence interval [CI] 2.6%-3.7%). A total of 7.2 million US adults had psoriasis in 2010; an estimated 7.4 million US adults were affected in 2013. When stratifying the sample by race among those between ages 20 and 59 years, the psoriasis prevalence was highest in Caucasians at 3.6% (95% CI 2.7%-4.4%), followed by African Americans (1.9%; 95% CI 1.0%-2.8%), Hispanics (1.6%; 95% CI 0.5%-2.8%), and others (1.4%; 95% CI 0.3%-2.6%). The prevalence of psoriasis among US adults has not changed significantly since 2003 to 2004 (P > .05). Dermatologist evaluation and skin photographs were unavailable for the 2009 through 2010 surveys. In the United States, psoriasis remains a common, immune-mediated disease, affecting 7.4 million adults. Its prevalence has remained stable since the mid-2000s. Copyright © 2013 American Academy of Dermatology, Inc. Published by Mosby, Inc. All rights reserved.
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            ACOG Practice Bulletin No. 200

            (2018)
            Early pregnancy loss, or loss of an intrauterine pregnancy within the first trimester, is encountered commonly in clinical practice. Obstetricians and gynecologists should understand the use of various diagnostic tools to differentiate between viable and nonviable pregnancies and offer the full range of therapeutic options to patients, including expectant, medical, and surgical management. The purpose of this Practice Bulletin is to review diagnostic approaches and describe options for the management of early pregnancy loss.
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              Pregnancy Outcomes After Exposure to Certolizumab Pegol

              Objective Anti–tumor necrosis factor (anti‐TNF) medications are effective in controlling chronic inflammatory diseases, but information about their use and safety in pregnancy is limited. Consequently, anti‐TNF agents are often discontinued early in gestation. Certolizumab pegol (CZP), a PEGylated, Fc‐free anti‐TNF agent approved for the treatment of rheumatic diseases and/or Crohn's disease, has minimal to no active placental transfer. This analysis was undertaken to evaluate pregnancy outcomes in women receiving CZP, especially those exposed during early pregnancy. Methods Prospective and retrospective data on maternal CZP exposure were extracted from the UCB Pharma safety database through March 6, 2017. Analysis was limited to prospective reports to avoid potential bias associated with retrospective submissions. The numbers of live births, miscarriages, elective abortions, stillbirths, and major congenital malformations were ascertained. Results Of 1,137 prospectively reported pregnancies with maternal exposure to CZP, 528 (including 10 twin pregnancies) had 538 known outcomes: 459 live births (85.3%), 47 miscarriages (8.7%), 27 elective abortions (5.0%), and 5 stillbirths (0.9%). There were 8 major congenital malformations (1.7%) among the 459 infants. First trimester exposure occurred in 367 (81.2%) of 452 pregnancies resulting in 459 live births. Exposure during all 3 trimesters occurred in 201 (44.5%) of 452 pregnancies. Conclusion This analysis represents the largest cohort of pregnant women exposed to an anti‐TNF agent for management of chronic inflammatory diseases. Analysis of pregnancy outcomes does not indicate a teratogenic effect of CZP, compared to the general population, nor an increased risk of fetal death. The data are reassuring for women of childbearing age considering treatment with CZP.
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                Author and article information

                Journal
                JAMA Dermatol
                JAMA Dermatol
                JAMA Dermatology
                American Medical Association
                2168-6068
                2168-6084
                3 February 2021
                March 2021
                3 February 2021
                : 157
                : 3
                : 1-6
                Affiliations
                [1 ]Department of Dermatology, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts
                [2 ]The Guenther Dermatology Research Centre, London, Ontario, Canada
                [3 ]Department of Dermatology and Skin Science, University of British Columbia, Vancouver, British Columbia, Canada
                [4 ]Department of Dermatology, Radboud University Medical Center, Nijmegen, the Netherlands
                [5 ]Janssen Scientific Affairs, LLC, Horsham, Pennsylvania
                [6 ]Janssen Research and Development, LLC, Horsham, Pennsylvania
                [7 ]Department of Dermatology, University of Toronto, Toronto, Ontario, Canada
                Author notes
                Article Information
                Accepted for Publication: December 8, 2020.
                Published Online: February 3, 2021. doi:10.1001/jamadermatol.2020.5595
                Open Access: This is an open access article distributed under the terms of the CC-BY-NC-ND License. © 2021 Kimball AB et al. JAMA Dermatology.
                Corresponding Author: Alexa B. Kimball, MD, MPH, Beth Israel Deaconess Medical Center, 330 Brookline Ave, Shapiro 2nd Floor, Boston, MA 02215 ( clears@ 123456bidmc.harvard.edu ).
                Author Contributions: Dr Kimball had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
                Concept and design: All authors.
                Acquisition, analysis, or interpretation of data: Kimball, Guenther, Kalia, de Jong, Lafferty, Chen, Langholff.
                Drafting of the manuscript: Lafferty, Chen, Langholff.
                Critical revision of the manuscript for important intellectual content: Kimball, Guenther, Kalia, de Jong, Lafferty, Langholff, Shear.
                Statistical analysis: Kalia, Lafferty, Chen, Langholff.
                Administrative, technical, or material support: Kalia, Lafferty.
                Supervision: Kimball, Kalia, Lafferty.
                Conflict of Interest Disclosures: Dr Kimball reported consulting and serving as an investigator for AbbVie, Bristol Myers Squibb, Janssen Pharmaceutica, Eli Lilly and Company, Novartis International AG, UCB, and Pfizer, Inc; serving on the Board of Directors for Almirall, SA, and the International Psoriasis Council; receiving fellowship funding from Janssen Pharamceutica and AbbVie; serving as past president of the International Psoriasis Council; and serving on the OTIS (Organization of Teratology Information Specialists) Pregnancy Registry Board for Stelara, Cimzia, and Otezla. Dr Guenther reported consulting and serving as investigator and speaker for AbbVie, Amgen, Inc, Bausch Health Companies, Inc, Celgene Corporation, Eli Lilly and Company, GlaxoSmithKline, Janssen Pharmaceutica, Leo Pharma A/S, Merck & Co, Novartis International AG, and Pfizer, Inc, and serving as an investigator for Boehringer Ingelheim, UCB, and Sun Pharmaceuticals Industries Limited. Dr Kalia reported consulting for Amgen, Inc, AbbVie, Aralez Pharmaceuticals Canada Inc, Celgene Corporation, Galderma SA, Eli Lilly and Company, La Roche–Posay, Bausch Health, Johnson & Johnson, Novartis International AG, Pfizer, Inc, Sanofi Genzyme, and UCB; conducting clinical trials that have received funding from AbbVie, Corbus Pharmaceuticals Holdings, Inc, Merck & Co, Bausch Health, Janssen Pharmaceutica, Amgen, Inc, Eli Lilly and Company, Leo Pharma, Novartis, Pfizer, Inc, and UCB; receiving grant funding from Leo Pharma A/S, and Novartis International AG; and serving as co-chair of the Canadian PSOLAR steering committee. Dr de Jong reported receiving research grants from AbbVie, Novartis International AG, Janssen Pharmaceutica, and Leo Pharma A/S and consulting, serving as a paid speaker, and/or participating in research sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Janssen Pharmaceutica, Novartis International AG, Eli Lilly and Company, Celgene Corporation, Leo Pharma A/S, UCB, and Almirall, SA, with funding going to the independent research fund of the Department of Dermatology of the Radboud University Medical Centre Nijmegen. Dr Lafferty reported owning stock in Johnson & Johnson, of which Janssen Pharmaceutica is a subsidiary. Dr Langholff reported owning stock in Johnson & Johnson, of which Janssen Pharmaceutica is a subsidiary. Dr Shear reported consulting for AbbVie, Amgen, Inc, Bausch Medicine, Novartis International AG, Sanofi Genzyme, UCB, Leo Pharma A/S, Ostuka Pharmaceutical Co, Ltd, Janssen Pharmaceutica, Alpha Laboratories, Eli Lilly and Company, ChemoCentryx, Inc, Vivoryon Therapeutics NV, Galderma SA, Innovaderm, Chromocell Corporation, and Daiichi Sankyo Company, Limited. No other disclosures were reported.
                Funding/Support: This study was supported by Janssen Scientific Affairs, LLC.
                Role of the Funder/Sponsor: The study sponsor was involved in the design and conduct of the study, and in the collection and analysis of the data. The authors provided the interpretation of the results and made the decision to submit the manuscript for publication.
                Additional Contributions: Editorial and writing support was provided by Cherie Koch, PhD, Synchrogenix, and Cynthia Arnold, BSc, CMPP, Janssen Scientific Affairs, LLC. Joel Gelfand, MD, MSCE, Hospital of the University of Pennsylvania, and the PSOLAR Scientific Advisory Committee provided critical review of the analytical plan. This support was funded by Janssen Scientific Affairs, LLC.
                Article
                doi200077
                10.1001/jamadermatol.2020.5595
                7859871
                33533924
                3413f020-23c3-439d-ae3d-1500c0ed56c8
                Copyright 2021 Kimball AB et al. JAMA Dermatology.

                This is an open access article distributed under the terms of the CC-BY-NC-ND License.

                History
                : 15 October 2020
                : 8 December 2020
                Categories
                Research
                Research
                Original Investigation
                Online First
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