Sumona Saha

Nausea and vomiting of pregnancy.

Nausea and vomiting are common experiences in pregnancy, affecting 70% to 80% of all pregnant women. Various metabolic and neuromuscular factors have been implicated in the pathogenesis of nausea and vomiting of pregnancy (NVP) and hyperemesis gravidarum (HG), an entity distinct from NVP. However, their exact cause is unknown. Consequently, treatment of NVP and HG can be difficult, as neither the optimal targets for treatment nor the full effects of potential treatments on the developing fetus are known. This article reviews the epidemiology, pathology, diagnosis, outcomes, and treatment of NVP and HG.

2017 American College of Rheumatology Guideline for the Prevention and Treatment of Glucocorticoid-Induced Osteoporosis

To develop recommendations for prevention and treatment of glucocorticoid‐induced osteoporosis (GIOP).

Feeding jejunostomy for the treatment of severe hyperemesis gravidarum: a case series.

BACKGROUNDnHyperemesis gravidarum is severe nausea and vomiting during pregnancy leading to dehydration, nutrition deficiency, and fetal morbidity and mortality. Treatment must maintain fluid and electrolyte balance and caloric intake. Parenteral nutrition is often attempted; however, complication rates are high. Nutrition via nasoenteric and percutaneous endoscopic gastrostomy tubes is limited by poor patient tolerance, tube dislodgement, and altered anatomy in pregnancy.nnnMETHODSnWomen with hyperemesis gravidarum who failed standard therapy were offered jejunostomy. All patients underwent surgical jejunostomy in the second trimester. Isotonic tube feeds were administered to a goal caloric factor calculated by the Harris-Benedict equation with a correction added for pregnancy. Patients were monitored until delivery.nnnRESULTSnFive women underwent jejunostomy placement at our institution between 1998 and 2005. One patient underwent jejunostomy placement twice for consecutive pregnancies. The mean body weight loss from prepregnancy was 7.9% (range, 4.0%-15.9%). Patients underwent jejunostomy placement between 12 and 26 weeks of gestation (median 14 weeks). Twelve to 16 Fr catheters were placed in the proximal jejunum. Maternal weight gain occured in 5 of 6 pregnancies. The mean duration of tube placement was 19 weeks (range, 8-28 weeks). All pregnancies ended with term deliveries (range, 36-40 weeks of gestation). The mean infant birth weight was 2885 g (range, 2270-4000 g). Tube-related complications were limited to dislodgement in 2 patients in the third trimester. No cases of infection, bleeding, or preterm labor occured.nnnCONCLUSIONSnFeeding via jejunostomy is a potentially safe, effective, and well-tolerated mode of nutrition support therapy in hyperemesis gravidarum.

Stability of infliximab in polyvinyl chloride bags.

PURPOSEnThe stability of prepared infusions of the tumor necrosis factor (TNF)-α agent infliximab after storage for up to two weeks was investigated.nnnMETHODSnTo determine the feasibility of liberalized expiration dating of infliximab (current recommendations call for the infusion of prepared doses within three hours), the stability of diluted infliximab stored in polyvinyl chloride (PVC) bags at 4 °C for up to 14 days was evaluated. A known quantity of TNF-α was combined with infliximab test samples in PVC bags for one hour; immediately after the reaction period and after 7 and 14 days of storage, the residual amount of TNF-α (an indirect measure of the drugs biological activity) was analyzed via a validated enzyme-linked immunosorbent assay (ELISA).nnnRESULTSnThe mean ± S.D. amount of TNF-α consumed by infliximab was calculated to be 24.5 ± 5.6 pg/mL at baseline, 29.0 ± 4.4 pg/mL at 7 days, and 24.8 ± 17.3 pg/mL at 14 days. At all evaluated time points, ELISA results indicated that 19-24% of the original TNF-α had been consumed by infliximab (mean ± S.D. consumption: 19.6% ± 4.5% at baseline, 23.2% ± 3.5% at 7 days, and 19.8% ± 13.8% at 14 days).nnnCONCLUSIONnInfliximab, when prepared at a concentration of 400 μg/mL in 0.9% sodium chloride injection, incurred no loss of biological activity when stored for up to 14 days at 4 °C in PVC bags. Changing infliximab preparation practices may improve clinic efficiency by reducing patient dissatisfaction with long wait times for infusions and avoiding costly waste.

Body image dissatisfaction in patients with inflammatory bowel disease.

Background:Despite the fact that the inflammatory bowel diseases (IBD) and their treatments may affect physical appearance, the effect of IBD on body image is poorly understood. The aims of this study were to determine whether body image dissatisfaction (BID) changes over time in patients with IBD and to examine the demographic and disease-related variables associated with decreased body image. Methods:Adults aged 18 and above in the Ocean State Crohns and Colitis Area Registry with at least 2 years of follow-up were eligible for this study. All patients were enrolled within 6 months of IBD diagnosis and followed prospectively. BID was assessed using a modified version of the Adapted Satisfaction With Appearance questionnaire. Total Adapted Satisfaction With Appearance scores and 2 subscores were calculated. To assess for changes over time, general linear models for correlated data were used for continuous outcomes, and generalized estimating equations were used for discrete outcomes. Results:Two hundred seventy-four patients were studied. BID was found to be stable over time among men and women with IBD despite overall improvements in disease activity. No differences were found in BID according to IBD subtype. Female gender, greater disease activity, higher symptom burden, longer duration of steroid use, dermatologic and musculoskeletal manifestations of IBD, and ileocolonic disease location among patients with Crohns disease were associated with greater BID. Greater BID was associated with lower health-related quality of life. Conclusions:BID remains stable in an incident cohort of IBD despite improved disease activity and is associated with lower health-related quality of life.

Women's health training in gastroenterology fellowship: a national survey of fellows and program directors.

Background and AimsThe Gastroenterology Core Curriculum requires training in women’s digestive disorders; however, requirements do not necessarily produce knowledge and competence. Our study goals were: (1) to compare perceptions of education, fellow-reported levels of competence, and attitudes towards training in women’s gastrointestinal (GI) health issues during fellowship between gastroenterology fellows and program directors, and (2) to determine the barriers for meeting training requirements.MethodsA national survey assessing four domains of training was conducted. All GI program directors in the United States (nxa0=xa0153) and a random sample of gastroenterology fellows (nxa0=xa0769) were mailed surveys. Mixed effects linear modeling was used to estimate all mean scores and to assess differences between the groups. Cronbach’s alpha was used to assess the consistency of the measures which make up the means.ResultsResponses were received from 61% of program directors and 31% of fellows. Mean scores in perceived didactic education, clinical experiences, and competence in women’s GI health were low and significantly differed between the groups (Pxa0<xa00.0001). Fellows’ attitudes towards women’s GI health issues were more positive compared to program directors’ (Pxa0=xa00.004). Barriers to training were: continuity clinic at a Veteran’s Administration hospital, low number of pregnant patients treated, low number of referrals from obstetrics and gynecology, and lack of faculty interest in women’s health.Conclusions(1) Fellows more so than program directors perceive training in women’s GI health issues to be low. (2) Program directors more so than fellows rate fellows to be competent in women’s GI health. (3) Multiple barriers to women’s health training exist.

Safety and efficacy of immunomodulators and biologics during pregnancy and lactation for the treatment of inflammatory bowel disease

Introduction: The inflammatory bowel diseases (IBD) are chronic, idiopathic, inflammatory conditions of the gastrointestinal tract, that peak in incidence during the reproductive years. Therefore, the safety of IBD medications during pregnancy and lactation is of significant interest to patients. Unfortunately, the current pregnancy labeling used by the United States Food and Drug Association (FDA) is often misinterpreted and may mislead healthcare providers and their patients to believe that risk increases from Category A to B to C to D to X, which in fact, is not the case. In addition, the FDA categories do not always distinguish between risks based on human versus animal data, or between differences in frequency, severity, and type of fetal developmental toxicities. Areas covered: This article provides an in-depth review of the available safety data during pregnancy and lactation for the more potent immunosuppressants used to treat IBD: the immunomodulators and biologics. It also includes the authors expert opinions on the use of these medications during these critical periods. Expert opinion: The benefit-to-risk ratio for most immunomodulators and biologics used in the treatment of IBD favors medication continuation during pregnancy. Certain immunomodulators, however, can cause extreme fetal harm and should be used with caution. While human safety data regarding teratogenesis and some data on pregnancy outcomes exist for most IBD medications, long-term follow-up studies of children and young adults exposed to these drugs in utero are lacking. These studies are needed to determine if these drugs are of sufficiently low risk to be considered safe.

The role of integrin antagonists in the treatment of inflammatory bowel disease

Introduction: Ulcerative colitis (UC) and Crohn’s disease are chronic inflammatory diseases of the bowel associated with complex inflammatory cascades within the mucosal lining of the gut. Areas covered: INTEGRINS and their use as therapies in UC and Crohn’s. Expert Opinion: The anti-adhesion molecules are a welcome addition to the armamentarium of medical therapies for inflammatory bowel disease.

Lower Sustained Diphtheria and Pertussis Antibody Concentrations in Inflammatory Bowel Disease Patients

BackgroundPatients with inflammatory bowel disease (IBD) are often immunosuppressed, and those patients receiving anti-tumor necrosis factor α (TNF) therapy can have lower antibody responses to vaccines. Pertussis cases are at their highest levels in the post-vaccine era. There is little data regarding responses to the Tdap (tetanus, diphtheria, and acellular pertussis) vaccine in IBD patients.AimsThe aim of this study was to compare sustained vaccine-induced Tdap antibody concentrations in a cohort of IBD patients stratified by medication regimens with healthy controls (HC) who had received an adult Tdap booster.MethodsWe performed a cross-sectional study evaluating antibody responses to Tdap vaccine among IBD patients compared to HC. Our study consisted of three patient groups: adults with IBD stratified by maintenance medication regimen: (1) thiopurine monotherapy; (2) anti-TNF monotherapy; and (3) combination therapy (anti-TNF and immunomodulator (thiopurine or methotrexate)).ResultsNinety IBD patients and 20 HC participated. Pertussis pertactin antibody concentrations were significantly lower in IBD patients (pu2009=u20090.021) compared to HC, and those on anti-TNF agents (monotherapy or combination) had lower antibody concentrations compared to those on thiopurine monotherapy (pu2009=u20090.028). Diphtheria antibody concentrations were also lower in IBD patients (pu2009<u20090.001), and those on anti-TNF agents (monotherapy or combination) had lower antibody concentrations compared to the thiopurine monotherapy group (pu2009<u20090.001).ConclusionIBD patients on anti-TNF agents had lower antibody concentrations to diphtheria and pertussis. These findings suggest a need for different Tdap booster schedules for IBD patients on anti-TNF therapy.Clinical Trials Registry NCT02434133.

Methotrexate Is Not Superior to Placebo in Maintaining Steroid-Free Response or Remission in Ulcerative Colitis

BACKGROUND & AIMSnParenteral methotrexate induces clinical remission but not endoscopic improvement of mucosal inflammation in patients with ulcerative colitis (UC). We performed a randomized, placebo-controlled trial to assess the efficacy of parenteral methotrexate in maintaining steroid-free response or remission in patients with UC after induction therapy with methotrexate and steroids.nnnMETHODSnWe performed a 48-week trial, from February 2012 through May 2016, of 179 patients with active UC (Mayo score of 6-12 with endoscopy subscore ≥ 2) despite previous conventional or biological therapy. The study comprised a 16-week open label methotrexate induction period followed by a 32-week double-blind, placebo-controlled maintenance period. Patients were given subcutaneous methotrexate (25 mg/wk) and a 12-week steroid taper. At week 16, steroid-free responders were randomly assigned to groups that either continued methotrexate (25 mg/wk, nxa0= 44) or were given placebo (nxa0= 40) until week 48. We compared the efficacy of treatment by analyzing the proportion of patients who remained relapse free and were in remission at week 48 without use of steroids or other medications to control disease activity.nnnRESULTSnNinety-one patients (51%) achieved response at week 16, and 84 patients were included in the maintenance period study. During this period, 60% of patients in the placebo group (24/40) and 66% in the methotrexate group (29/44) had a relapse of UC (Pxa0= .75). At week 48, 30% of patients in the placebo group (12/40) and 27% of patients in the methotrexate group (12/44) were in steroid-free clinical remission without need for additional therapies (Pxa0= .86). No new safety signals for methotrexate were detected.nnnCONCLUSIONSnParenteral methotrexate (25 mg/wk) was not superior to placebo in preventing relapses of UC in patients who achieved steroid-free response during induction therapy. ClinicalTrials.gov, Number: NCT01393405.