Outcomes of Continuation vs Discontinuation of Adalimumab Therapy During Third Trimester of Pregnancy in Inflammatory Bowel Disease
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ABSTRACT:
SUBMITTER: Truta B
PROVIDER: S-EPMC11307739 | biostudies-literature | 2022 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundBowel-related disorders are common conditions associated with pregnancy and are a cause of significant distress and healthcare burden. However, there is a lack of data in the literature about these disorders.ObjectiveThis study aimed to investigate bowel dysfunctions during the third trimester of pregnancy in a large cohort of women using the validated bowel domain of the Italian version of the Pelvic Floor Questionnaire for Pregnant and Postpartum Women.Study designThis was a secondary analysis of a multicenter cross-sectional study conducted in hospitals in Italy and Italian-speaking Switzerland. Women in the third trimester of pregnancy were asked to complete the Italian Pelvic Floor Questionnaire for Pregnant and Postpartum Women.ResultsDuring the study period, 927 pregnant women in the third trimester of pregnancy responded to the questionnaire and were included in the analysis. Overall bowel dysfunctions were reported by 29.6% of patients. Constipation was reported by 66.6% of pregnant women, whereas symptoms of obstructed defecation were reported by 49.9% of patients. In contrast, urgency was reported by 41.1% of patients. Incontinence to flatus and incontinence to stool were reported by 45.1% and 2.8% of patients, respectively. Moreover, age >35 years, familiarity with pelvic floor disorders, nicotine abuse, and pelvic floor contraction inability were identified as independent risk factors for at least 1 bowel symptom.ConclusionBowel symptoms are extremely common in the third trimester of pregnancy and can greatly affect a patient's quality of life; therefore, bowel symptoms deserve to be investigated and managed properly. The use of validated questionnaires represents a precious tool to investigate functional symptoms that could be very frequent and disabling in this particular period of life for women.
| S-EPMC10461240 | biostudies-literature
Project description:Intestinal obstruction complicating pregnancy is a surgical emergency associated with a high incidence of morbidity and mortality for both the mother and fetus. This case report discusses the presentation and treatment of a young female in her third trimester of pregnancy at a repeat visit to the emergency department (ED) with right-sided abdominal pain. She was diagnosed with ileal intussusception secondary to a Meckel's diverticulum with associated small bowel obstruction (SBO) seen on computerized tomography (CT) imaging. She underwent surgical reduction of the invaginated bowel and diverticulectomy. Making a diagnosis of intestinal intussusception during pregnancy is particularly difficult because common symptoms of intestinal obstruction such as anorexia, nausea, vomiting and abdominal pain are encountered frequently during a normal pregnancy.1 Diagnosis is often delayed during pregnancy due to physician hesitancy over the radiation risk to the fetus. While the gold standard for diagnosis is a barium enema, it is often identified on CT scan in adults, and it is regularly managed with surgery.2.TopicsIntussusception, small bowel obstruction, pregnancy, Meckel's diverticulum.
| S-EPMC10332542 | biostudies-literature
Project description:Henoch-Schönlein purpura (HSP) is an IgA-mediated small vessels' vasculitis that affects the skin, intestines and kidneys. Pregnancy has been reported as an exacerbating factor. We present the case of a 24-year-old primigravida with HSP that occurred in the third trimester and lasted up to the end of the successful delivery. She had pruritic maculopapular exanthema on her legs. Biopsy of a cutaneous lesion was performed for histopathologic features and direct immunofluorescence (DIF) for the presence of perivascular IgA deposition. Histopathology of the cutaneous lesion confirmed leukocytoclastic vasculitis. A DIF examination of the skin lesion confirmed deposits of fibrinogen in the small blood vessel walls. Six weeks following delivery, the skin lesions almost completely disappeared. Control laboratory findings were normal. This case of HSP might have been primarily associated with a preceding respiratory infection but this should first be carefully investigated due to a possible severe immunological disease in the patient's background requiring special attention since nephrotic symptoms may occur.
| S-EPMC5806616 | biostudies-literature
Project description:The rapidly expanding cases of the coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have exposed vulnerable populations, including pregnant women to an unprecedented public health crisis. Recent data show that pregnancy in COVID-19 patients is associated with increased hospitalization, admission of the intensive care unit, and intubation. However, very few resources exist to guide the multidisciplinary team in managing critically ill pregnant women with COVID-19. We report our experience with managing a morbidly obese pregnant woman at 36 weeks' gestation with history of asthma and malignancy who presented with persistent respiratory symptoms at an outside hospital after being tested positive for SARS-CoV-2 polymerase chain reaction (PCR). Early in the course of the hospitalization, patient received remdesivir, convalescent plasma, bronchodilator, systemic steroids, and IV heparin for COVID-19 and concomitant asthma exacerbation and pulmonary embolism. Due to increasing oxygen requirements, she was eventually intubated and transferred to our institution for higher level of care. Respiratory acidosis, severe hypoxemia, and vent asynchrony were managed with vent setting adjustment and paralytics. After 12 hours from spontaneous rupture of her membranes and with stabilization of maternal status, patient underwent a term cesarean delivery for nonreassuring fetal heart tracing. The neonate was discharged on the 2nd day of life, while the patient was extubated on the 6th postpartum day and was discharged to acute inpatient rehabilitation facility on the 19th hospital day. This report highlights the disease progression of COVID-19 in a pregnant woman, the clinical challenges in the critical care aspect of patient management, and the proposed multidisciplinary strategies utilizing an algorithmic approach to optimize maternal and neonatal outcomes.
| S-EPMC7563040 | biostudies-literature
Project description:Background and objectivesExisting data on pregnancy complications in inflammatory bowel disease (IBD) are inconsistent. To address these inconsistencies, we investigated potential associations between IBD, IBD-related medication use during pregnancy, and pregnancy loss, pre-eclampsia, preterm delivery, Apgar score, and congenital abnormalities.MethodsWe conducted a cohort study in >85,000 Danish National Birth Cohort women who were pregnant in the period 1996-2002 and had information on IBD, IBD-related medication use (systemic or local corticosteroids, 5-aminosalicylates), pregnancy outcomes and potential confounders. We evaluated associations between IBD and adverse pregnancy/birth outcomes using Cox regression and log-linear binomial regression.ResultsIBD was strongly and significantly associated with severe pre-eclampsia, preterm premature rupture of membranes and medically indicated preterm delivery in women using systemic corticosteroids during pregnancy (hazard ratios [HRs] >7). IBD was also associated with premature preterm rupture of membranes in women using local corticosteroid medications (HR 3.30, 95% confidence interval [CI] 1.33-8.20) and with medically indicated preterm delivery (HR 1.91, 95% CI 0.99-3.68) in non-medicated women. Furthermore, IBD was associated with low 5-minute Apgar score in term infants (risk ratio [RR] 2.19, 95% CI 1.03-4.66). Finally, Crohn's disease (but not ulcerative colitis) was associated with major congenital abnormalities in the offspring (RR 1.85, 95% CI 1.06-3.21). No child with a congenital abnormality born to a woman with IBD was exposed to systemic corticosteroids in utero.ConclusionWomen with IBD are at increased risk of severe pre-eclampsia, medically indicated preterm delivery, preterm premature rupture of membranes, and delivering infants with low Apgar score and major congenital malformations. These associations are only partly explained by severe disease as reflected by systemic corticosteroid use.
| S-EPMC4471220 | biostudies-literature
Project description:ObjectiveThis systematic search and review aimed to evaluate the available literature on discontinuation of adalimumab and other tumor necrosis factor inhibitors (TNFi) for patients with well-controlled chronic inflammatory arthritides.MethodsWe conducted a publication search on adalimumab discontinuation from 2000-2023 using PubMed, CINAHL, EMBASE, and Cochrane Library. Included studies evaluated adalimumab discontinuation approaches, tapering schemes, and outcomes including successful discontinuation and recapture after flare, in patients with well-controlled disease. Studies included evaluated rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and juvenile idiopathic arthritis (JIA).ResultsForty-nine studies were included. Studies evaluating adalimumab alone were limited, and many reported TNFi outcomes as a single entity. Studies on rheumatoid arthritis (RA) (32, 8 RCTs) reported flare rates from 33-87%. Flares with medication tapering were slightly lower than with abrupt stop, and successful recapture was generally high (80-100%). Studies on spondyloarthropathy (12, 4 RCTs), focused on tapering, noting lower flare rates in tapering rather than abruptly stopping, and high recapture rates (~ 90%). Studies on JIA (5) were observational and demonstrated modestly lower flare rates with tapering (17-63%) versus abrupt stopping (28-82%). There was notable variability in study design, follow-up duration, specificity for TNFi results, and controlled pediatric studies.ConclusionThe literature evaluating adalimumab and other TNFi discontinuation, flare rates, and recapture success within the inflammatory arthritis population demonstrated less flare when medications were tapered, over abrupt stop in the RA, spondyloarthropathy, and JIA populations. When medications were restarted after flare, recapture of well-controlled disease was generally high in RA and spondyloarthropathy, and generally favorable in JIA.
| S-EPMC11684048 | biostudies-literature
Project description:BackgroundThe impact of pregnancy on efavirenz (EFV) pharmacokinetics is unknown.MethodsInternational Maternal Pediatric Adolescent AIDS Clinical Trials P1026s is an on-going, prospective, nonblinded study of antiretroviral pharmacokinetics in HIV-infected pregnant women that included a cohort receiving 600 mg EFV once daily as part of combination antiretroviral therapy. Intensive steady-state 24-hour blood sampling was performed during the third trimester and at 6-12 weeks postpartum. Maternal and umbilical cord blood samples were drawn at delivery. Pharmacokinetics targets were the estimated 10th percentile EFV area under the curve (AUC) in nonpregnant historical controls (40.0 mcg·hr(-1)·mL(-1)) and a trough concentration of 1 mcg/mL.ResultsTwenty-five women were enrolled during the third trimester: median (range) age was 29.3 (18.9-42.9) years, weight 69.0 (40-130) kg, and gestational age 32.9 (30.1-38.7) weeks. Median (range) EFV AUC(0-24), C(max), and C(24 hours) were 55.4 mcg·hr(-1)·mL(-1) (13.5-220.3), 5.4 mcg/mL (1.9-12.2), and 1.6 mcg/mL (0.23-8.13), respectively. EFV AUC and C(max) did not differ during pregnancy and postpartum but C(24 hours) was lower during the third trimester (1.6 vs. 2.1 mcg/mL, P = 0.01). During the third trimester, 5 of 25 (20%) women had an EFV AUC below the target and 3 of 25 (12%) had a trough concentration below 1 mcg/mL. EFV cord blood/maternal concentration ratio was 0.49 (0.37-0.74). All women had a HIV-1 RNA viral load less than 400 copies per milliliter at delivery and 19 (76%) had a viral load below 50 copies per milliliter. One child was perinatally HIV infected. Three women were exposed to EFV throughout the first 6 weeks of pregnancy. EFV was well tolerated, and among the 25 infants, no congenital anomalies or newborn complications were reported.ConclusionsChanges in EFV pharmacokinetics during pregnancy compared with postpartum are not sufficiently large enough to warrant a dose adjustment during pregnancy.
| S-EPMC3288559 | biostudies-literature
Project description:Background and aimsHaemodynamic instability is associated with peri-operative myocardial injury, particularly in patients receiving renin-angiotensin system (RAS) inhibitors (angiotensin-converting-enzyme inhibitors/angiotensin II receptor blockers). Whether stopping RAS inhibitors to minimise hypotension, or continuing RAS inhibitors to avoid hypertension, reduces peri-operative myocardial injury remains unclear.MethodsFrom 31 July 2017 to 1 October 2021, patients aged ≥60 years undergoing elective non-cardiac surgery were randomly assigned to either discontinue or continue RAS inhibitors prescribed for existing medical conditions in six UK centres. Renin-angiotensin system inhibitors were withheld for different durations (2-3 days) before surgery, according to their pharmacokinetic profile. The primary outcome, masked to investigators, clinicians, and patients, was myocardial injury [plasma high-sensitivity troponin-T (hs-TnT) ≥ 15 ng/L within 48 h after surgery, or ≥5 ng/L increase when pre-operative hs-TnT ≥15 ng/L]. Pre-specified adverse haemodynamic events occurring within 48 h of surgery included acute hypertension (>180 mmHg) and hypotension requiring vasoactive therapy.ResultsTwo hundred and sixty-two participants were randomized to continue (n = 132) or stop (n = 130) RAS inhibitors. Myocardial injury occurred in 58 (48.3%) patients randomized to discontinue, compared with 50 (41.3%) patients who continued, RAS inhibitors [odds ratio (for continuing): 0.77; 95% confidence interval (CI) 0.45-1.31]. Hypertensive adverse events were more frequent when RAS inhibitors were stopped [16 (12.4%)], compared with 7 (5.3%) who continued RAS inhibitors [odds ratio (for continuing): 0.4; 95% CI 0.16-1.00]. Hypotension rates were similar when RAS inhibitors were stopped [12 (9.3%)] or continued [11 (8.4%)].ConclusionsDiscontinuing RAS inhibitors before non-cardiac surgery did not reduce myocardial injury, and could increase the risk of clinically significant acute hypertension. These findings require confirmation in future studies.
| S-EPMC10984566 | biostudies-literature
Project description:BackgroundInfliximab therapy during pregnancy in inflammatory bowel disease is challenged by a dilemma between maintaining adequate maternal disease control while minimizing fetal infliximab exposure. We investigated the effects of pregnancy on infliximab pharmacokinetics.MethodsThe study population comprised 23 retrospectively identified pregnancies. Patients with inflammatory bowel disease were generally in clinical remission at pregnancy conception (74%) and received steady infliximab maintenance therapy (5 mg/kg q8w n = 17; q6w n = 4; q10w n = 1; 10 mg/kg q8w n = 1). Trough blood samples had been obtained in the same patients prior to pregnancy (n = 119), the first trimester (n = 16), second trimester (n = 18), third trimester (n = 7), and postpregnancy (n = 12). Data were analyzed using nonlinear mixed-effects population pharmacokinetic modeling.ResultsDose-normalized infliximab concentrations were significantly higher during the second trimester (median 15 mg/ml/kg, interquartile range 10-21) compared to prepregnancy (7, 2-12; p = 0.003), the first trimester (9, 1-12; p = 0.04), or postpregnancy (6, interquartile range 3-11; p > 0.05) in patients with inflammatory bowel disease. Similar trends were observed in the third trimester (13, 7-36; p > 0.05). A one-compartment model with linear elimination described the pharmacokinetics of infliximab (volume of distribution n = 18.2 L; clearance 0.61 L/day). Maternal infliximab exposure was influenced by the second and third trimester of pregnancy and anti-infliximab antibodies, and not by pregnancy-imposed physiological changes in, for example, body weight or albumin. Infliximab clearance decreased significantly during the second and third trimesters by up to 15% as compared to pre- and postpregnancy and the first trimester. The increased maternal infliximab exposure was weakly associated with lowered clinical disease activity. Pharmacokinetic model simulations of virtual patients indicated the increased maternal infliximab trough concentrations imposed by pregnancy will not completely counteract the decrease in infliximab concentration if therapy is paused in the third trimester.ConclusionInfliximab clearance decreases significantly in the second and third trimesters, leading to increasing maternal infliximab concentrations in any given regimen. Maternal infliximab levels may thus be maintained as constant in a de-intensified regimen by therapeutic drug monitoring guidance in inflammatory bowel disease.
| S-EPMC8259366 | biostudies-literature
Project description:IntroductionPain during pregnancy affects women's well-being, causes worry and is a risk factor for the child and the mother during labor. The aim was to investigate the relative importance of an extensive set of pregnancy-related physiological symptoms and psychosocial factors assessed in the first trimester compared with the occurrence of pregnancy-related pain symptoms later in the pregnancy.Material and methodsIncluded were all women who booked an appointment for a first prenatal visit in one of 125 randomly selected general practitioner practices in Eastern Denmark from April 2015 to August 2016. These women answered an electronic questionnaire containing questions on the occurrence of five pregnancy-related pain symptoms: back pain, leg cramps, pelvic cavity pain, pelvic girdle pain and uterine contractions. The questionnaire also included sociodemographic questions and questions on chronic diseases, physical symptoms, mental health symptoms, lifestyle and reproductive background. The questionnaire was repeated in each trimester. The relative importance of this set of factors from the first trimester on the five pregnancy-related pain symptoms compared with the second and third trimesters was assessed in a dominance analysis.ResultsA total of 1491 women were included. The most important factor for pregnancy-related pain in the second trimester and third trimester is the presence of the corresponding pain in the first trimester. Parity was associated with pelvic cavity pain and uterine contractions in the following pregnancies. For back pain and pelvic cavity pain, the odds increased as the women's estimated low self-assessed fitness decreased and had low WHO-5 wellbeing scores.ConclusionsWhen including physical risk factors, sociodemographic factors, psychological factors and clinical risk factors, women's experiences of pregnancy-related pain in the first trimester are the most important predictors for pain later in pregnancy. Beyond the expected positive effects of pregnancy-related pain, notably self-assessed fitness, age and parity were predictive for pain later in pregnancy.
| S-EPMC10541159 | biostudies-literature