839 Inflamm Bowel Dis • Volume 24, Number 4, April 2018 ORIGINAL RESEARCH CLINIC Fecal Calprotectin During Pregnancy in Women With Moderate-Severe Infammatory Bowel Disease Heidi Kammerlander, MD,* Jan Nielsen, PhD,* Jens Kjeldsen, PhD, † Torben Knudsen, DMCs, ‡ Kim Oren Gradel, PhD,* Sonia Friedman, MD,* ,§ and Bente Mertz Nørgård, DMCs* ,§ Background: Fecal calprotectin (FC) is a biomarker used for assessing disease activity among IBD patients. Sparse knowledge exists as to whether FC correlates with clinical disease activity during pregnancy. Our aim was to assess FC and selected biomarkers in women with moder- ate-severe IBD and correlate them with clinical disease activity scores in pregnant women. Methods: We identifed a nationwide cohort of 219 singleton pregnancies in women with moderate-severe disease (all treated with anti–tumor recrosis factor–α [anti-TNF-α] therapy during pregnancy), and we reviewed the medical records to extract clinical details and information on biomarkers. FC, C-reactive protein (CRP), hemoglobin, and albumin were collected according to each trimester. Results: A total of 346 FC measurements were obtained throughout the gestational periods. FC values were between 80–120, 259–349, and 778–1277 mg/kg in women with clinically inactive, mild, and moderate-severe disease activity, respectively, and were signifcantly higher among the women with clinical disease activity. ROC curves for disease activity were computed according to the preconception period: 0.81 (95% confdence interval [CI], 0.69–0.93), frst trimester: 0.73 (95% CI, 0.60–0.86), second trimester: 0.74 (95% CI, 0.62–0.86), and third trimester: 0.76 (95% CI, 0.64–0.88), respectively. We found a sensitivity of 69.7%–80.0%, a specifcity of 66.7%–73.3%, and a positive predictive value of 66.7%–74.4% over the 4 gestational periods when a cutoff of 200 mg/kg was used. We found no clinically signifcant differences in CRP, albumin, or hemoglobin. Conclusions: FC in pregnant women with moderate-severe IBD treated with anti-TNF-α therapy was signifcantly higher in women with clinical disease activity compared with the women without. FC correlated with the level of clinical disease activity in all gestational periods. Key Words: fecal calprotectin, pregnancy, inflammatory bowel disease P regnancy in women with infammatory bowel disease (IBD) may be challenging due an alteration of the typical symptoms of IBD mixed with symptoms from the pregnancy. Furthermore, the impact of medical treatment and disease relapse and their impact on pregnancy and the fetal develop- ment must be addressed. Recent studies have suggested that active IBD in pregnant women is associated with lower birth weight, lower gestational age, and inadequate gestational weight gain. 1–8 Therefore, frequent outpatient visits and close observation of pregnant women with IBD may be necessary to detect and treat disease relapse. Endoscopies are the best diagnostic tool and the “gold standard” to determine pres- ence of mucosal infammation in the bowel. Yet physicians are reluctant to perform endoscopies during pregnancy for fear of inducing adverse pregnancy outcomes. 9,10 No other diagnos- tic method is recommended to determine disease activity dur- ing a pregnancy besides ultrasound and magnetic resonance imaging (MRI), but ultrasound may be less accurate during the third trimester, and the intravenous contrast gadolinium used in MRI is contraindicated during the frst trimester. Thus, a noninvasive “gold standard” diagnostic tool to mon- itor the degree of disease activity and response to treatment is warranted. Clinical disease activity scores are frequently evaluated during outpatient visits to monitor the disease course, occa- sionally by an overall physician assessment and occasionally by a scoring system such as the Harvey Bradshaw Index (HBI) for Crohn’s disease (CD) or the Simple Clinical Colitis Activity Index (SCCAI) for ulcerative colitis (UC). Clinical scoring systems have not been validated for use during pregnancy. Received for publication August 2, 2017; Editorial Decision September 19, 2017 From the *Center for Clinical Epidemiology, Odense University Hospital, and Research Unit of Clinical Epidemiology, Institute of Clinical Research, University of Southern Denmark, Odense, Denmark; † Department of Medical Gastroenterology, Odense University Hospital, Odense, Denmark; ‡ Department of Medical Gastroenterology, Hospital of Southwest Jutland, Esbjerg, Denmark; § Crohn’s and Colitis Center, Brigham and Women’s Hospital, Boston, Massachusetts and Harvard Medical School, Boston, Massachusetts. © 2018 Crohn’s & Colitis Foundation. Published by Oxford University Press on behalf of Crohn’s & Colitis Foundation. Conficts of interest: The authors declare no confict of interest. Supported by: The study is supported by the region of Southern Denmark (jour- nal nr: 13/25954 & 13/27667), the Hospital of Southwest Jutland, the University of Southern Denmark, the Danish Colitis-Crohn Association, the Karola Jørgensen Foundation, and the Jacob and Olga Madsens Foundation. Address correspondence to: Heidi Kammerlander, MD, Center for Clinical Epidemiology, Odense University Hospital, Kløvervænget 30, entrance 216, 5000 Odense C, Denmark (heidi.kammerlander@rsyd.dk). doi: 10.1093/ibd/izx055 Published online 28 February 2018 Downloaded from https://academic.oup.com/ibdjournal/article/24/4/839/4913664 by guest on 14 May 2023