Anti-TNF Therapy in Pregnant Women With Inflammatory Bowel Disease: Effects of Therapeutic Strategies on Disease Behavior and Birth Outcomes.

BACKGROUND: Active inflammatory bowel disease (IBD) adversely affects pregnancy outcomes. Little is known about the risk of relapse after stopping anti-tumor necrosis factor (anti-TNF) treatment during pregnancy. We assessed the risk of relapse before delivery in women who discontinued anti-TNF treatment before gestational week (GW) 30, predictors of reduced infant birth weight, a marker associated with long-term adverse outcomes, and rates and satisfaction with counseling. METHODS: Pregnant women with IBD receiving anti-TNF treatment were prospectively invited to participate in an electronic questionnaire carried out in 22 hospitals in Denmark, Australia, and New Zealand from 2011 to 2015. Risk estimates were calculated, and birth weight was investigated using t tests and linear regression. RESULTS: Of 175 women invited, 153 (87%) responded. In women in remission, the relapse rate did not differ significantly between those who discontinued anti-TNF before GW 30 (1/46, 2%) compared with those who continued treatment (8/74, 11%; relative risk, 0.20; 95% confidence interval [CI], 0.02 to 1.56; P = 0.08). Relapse (P = 0.001) and continuation of anti-TNF therapy after GW 30 (P = 0.007) were independently associated with reduced mean birth weight by 367 g (95% CI, 145 to 589 g; relapse) and 274 g (95% CI, 77 to 471 g; anti-TNF exposure after GW 30). Of 134 (88%) women who received counseling, 116 (87%) were satisfied with the information provided. CONCLUSIONS: To minimize fetal exposure in women in remission, discontinuation of anti-TNF before GW 30 seems safe. Relapse and continuation of anti-TNF therapy after GW 30 were each independently associated with lower birth weight, although without an increased risk for birth weight <2500 g. Most women received and were satisfied with counseling.

Home parenteral nutrition increases fat free mass in patients with incurable gastrointestinal cancer. Results of a randomized controlled trial.

OBJECTIVE: Preventing loss of muscle mass and function is an enduring challenge in malnourished patients with incurable cancer. The benefit of supplemental home parenteral nutrition has not been firmly established. Our aim was to evaluate the effects of supplemental home parenteral nutrition, the primary endpoint being fat free mass (FFM) and secondary: muscle function, quality of life and overall survival. DESIGN AND METHODS: In a single centre open-label randomised controlled trial, patients with incurable gastrointestinal cancer, nutritionally at risk, were randomly assigned to either; a) best practice nutritional care and dietetic counselling (non-sHPN) or b) dietetic counselling and supplemental home parenteral nutrition (sHPN group). Treatment duration was 24 weeks with visits every six weeks for five scheduled visits. Main outcome was gain in bioelectrical impedance analyses (BIA) estimated FFM. Secondary outcomes were muscle strength, quality of life and survival. RESULTS: Eligible for inclusion were 234 patients, 47 of these accepted enrolment; 25 were randomized to non-sHPN and 22 to sHPN according to performance status, age and diagnoses. Median age was 66.9 (41.5-88.2), BMI 21.3 (14.8-35.7) and (91%) were receiving palliative chemotherapy. Median FFM and fat free mass index increased in the sHPN group. At 12 weeks a significant difference (p < 0.01) was found between the groups; in the sHPN group 69% of the patients (versus 40%) increased their FFM. Handgrip strength increased in both groups but without significance between the two. Quality of life at 12 weeks was significantly better (p < 0.05) in the sHPN group. No difference was noticed in survival, median 169 (CI 88-295) days versus 168 (CI 80-268) days. Study completion was accomplished by 36%; 60% died before end of study. CONCLUSIONS: Providing supplemental home parenteral nutrition may prevent loss of FFM, and it is even possible to increase FFM in patients with incurable gastrointestinal cancer. Supplementation with parenteral nutrition might have a temporarily positive impact on quality of life. TRIAL REGISTRATION: (NCT02066363) www.clinicaltrials.gov.

Home parenteral support in patients with incurable cancer. Patient characteristics of importance for catheter related complications and overall survival.

PURPOSE: It is uncertain if home parenteral support (HPS) is of advantage in patients with incurable cancer and intestinal failure, functional obstruction or severe malabsorption. From a single centre cohort we present characteristics of patients with incurable cancer treated with HPS. METHODS: Over a ten year period (2005-2015) data were retrospectively collected on patients with incurable cancer discharged on HPS from a Danish tertiary referral centre. Data on socio-demographics, catheters and parenteral nutrition, catheter related complications, re-admissions and mortality were analysed. The inflammation based score; modified Glasgow prognostic score (mGPS) was investigated as a prognostic score by Cox proportional hazard regression analyses adjusted for sex, age, diagnosis, and pathophysiological conditions. RESULTS: Eighty patients with incurable cancer, aged 25.1-83.6 (median 63.8) were identified. Patients with gynaecologic cancer accounted for 25% of the cohort, thus women predominated. Short bowel syndrome was more prevalent in the patients with gynaecologic or lower gastrointestinal cancer compared to the upper gastrointestinal cancer. Catheter related complications occurred in a minority of patients (31%); most frequent was catheter related bloodstream infection (CRBSI). CRBSI rate was overall 0.97 pr 1000 catheter days, depending on diagnosis. Eleven percent had several infections, and 75% did not have any. Patients self-administering the catheter were younger, less frail and had fewer CRBSI events. Re-admissions were prevalent, and only one fifth of the patients had no re-admissions after initiation of HPS. Patients with mGPS 0 or 1 survived significantly longer, median 372 (CI 39-2006) days versus patients scoring 2 in mGPS, median 43 (CI 6-578) (p < 0.01). In patients with mGPS 0 or 1 survival at six months was 75% and in patients with mGPS 2, 20%. In multivariate cox regression analyses mGPS 2 was a significant predictor of mortality (HR 4.66, 95% CI 2.65-8.20, p < 0.01). CONCLUSIONS: It is feasible to offer HPS to patients with incurable cancer. Frequency of catheter related infections is acceptable but most patients will be re-readmitted after initiation of HPS. Predictors of survival in patients with incurable cancer on HPS may include mGPS. However, our study does not give a clear answer; when to prescribe HPS and who might possible benefit from the treatment in patients with incurable cancer.

Models with Men and Women: Representing Gender in Dynamic Modeling of Social Systems.

Dynamic engineering models have yet to be evaluated in the context of feminist engineering ethics. Decision-making concerning gender in dynamic modeling design is a gender and ethical issue that is important to address regardless of the system in which the dynamic modeling is applied. There are many dynamic modeling tools that operationally include the female population, however, there is an important distinction between females and women; it is the difference between biological sex and the social construct of gender, which is fluid and changes over time and geography. The ethical oversight in failing to represent or misrepresenting gender in model design when it is relevant to the model purpose can have implications for model validity and policy model development. This paper highlights this gender issue in the context of feminist engineering ethics using a dynamic population model. Women are often represented in this type of model only in their biological capacity, while lacking their gender identity. This illustrative example also highlights how language, including the naming of variables and communication with decision-makers, plays a role in this gender issue.

Randomized crossover study in patients with neuroendocrine tumors to assess patient preference for lanreotide Autogel(®) given by either self/partner or a health care professional.

BACKGROUND: Lanreotide Autogel(®) is supplied in prefilled syringes. Therefore, it is possible for patients with neuroendocrine tumors to use self-/partner-administered injections. The primary objective of this study was to assess the proportion of patients preferring self/partner injections over injections administered by health care professionals, and to describe the impact of self/partner administration on efficacy, safety, and costs. METHODS: Of 62 eligible patients, 26 (42%) patients with neuroendocrine tumors treated with a stable dose of lanreotide Autogel 90 mg or 120 mg every 4 weeks agreed to participate in this Phase IV, international, open-label, crossover study, conducted at hospitals in Sweden, Norway, and Denmark. Patients were randomized to two blocks, starting with administration of lanreotide Autogel by either self/partner or a health care professional. Preference for injections administered by self/partner or health care professionals was measured, as well as efficacy, safety, and health care resource utilization (both direct and indirect costs). RESULTS: Of 25 evaluable patients, 22 (88%) preferred self/partner injections, mainly because they experienced increased independence. Based on all patients asked to participate (n = 62), 35% preferred self/partner injections on a regular basis. There was no difference in efficacy or safety between the two administration blocks. CONCLUSION: Many patients with neuroendocrine tumors prefer self/partner injection of lanreotide Autogel, and are able to self/partner inject without any impact on efficacy or safety. This administration method seems to provide a good alternative for suitable patients to increase patient independence and reduce the number of clinic visits.