Vulvovaginal erosive lichen planus refractory to topical therapies: What's next? A case report.

A 60-year-old woman was referred for progressive and severe vulvovaginal pain characterized by erosions and Wickham's stria for the past 7 months. Her condition had not responded to oral fluconazole, topical estrogen cream, and topical clobetasol cream. Vulvar and vaginal biopsies were obtained under general anesthesia to verify the diagnosis of erosive lichen planus given the failed response to ultrapotent topical steroids. Tacrolimus cream was added but not tolerated. Oral and cutaneous lesions of lichen planus also developed. In the absence of evidence-based guidelines, three different systemic treatments were administered sequentially (hydroxychloroquine, mycophenolate, and finally cyclosporin) before a satisfactory, well-tolerated, and sustained clinical response was obtained. Topical betamethasone ointment in a taper was continued to assist in sustaining a vulvovaginal response after cyclosporin was discontinued.

Human Milk and Plasma Pharmacokinetics of Single-Dose Rimegepant 75 mg in Healthy Lactating Women.

Objective: Investigate whether rimegepant-an oral small molecule calcitonin gene-related peptide receptor antagonist for the treatment of migraine-is excreted in human milk after a single 75 mg dose and characterize its concentration-time profile in the plasma and milk of healthy lactating women to determine the relative infant dose (RID). Methods: This open-label, single-center study enrolled healthy lactating women aged 18-40 years with a gestation of 37-42 weeks and uncomplicated delivery of a single healthy child ≥2 weeks (14 days) and ≤6 months before study drug administration. Plasma samples were collected 0, 1, 2, 4, and 8 hours postdose; human milk samples were collected at 0, 1, 2, 4, 8, 12, 16, 24, 32, and 36 hours. The milk:plasma drug concentration ratio was estimated as the ratio of the human milk:plasma areas under the curve. The RID (%) was calculated as 100 times the quotient of the body weight-normalized infant and maternal doses. Results: Subjects (N = 12) were enrolled between 25 January and 15 September 2020. The mean (standard deviation [SD]) age was 29.8 (3.6) years; mean (SD) body mass index was 26.8 (4.9) kg/m2. The mean (SD) RID of rimegepant was 0.51% (0.14). The mean (SD) body-weight normalized infant dose was 0.005 (0.001) mg/kg/day, the mean (SD) body-weight normalized maternal dose was 1.04 (0.18) mg/kg/day, and mean (SD) maternal body weight was 74.0 (13.3) kg. Conclusion: On a weight-adjusted basis, the mean RID of rimegepant was <1% of the maternal dose.

Endocrine factors associated with non-alcoholic fatty liver disease in women with polycystic ovary syndrome: do androgens play a role?

OBJECTIVE: To characterise the metabolic profile of women with polycystic ovary syndrome (PCOS) and non-alcoholic fatty liver disease (NAFLD) and to determine whether circulating androgens differ in PCOS women with NAFLD compared to PCOS subjects without NAFLD. METHODS: Retrospective study of 21 women with PCOS, elevated liver enzymes and ultrasound evidence of hepatic steatosis matched with 32 PCOS women with normal liver enzymes. Extensive demographic, endocrine and metabolic data were compared. Pearson's correlation coefficients were calculated to assess for potential relationships between the free androgen index (FAI) and other dependent variables. RESULTS: PCOS subjects with NAFLD demonstrate greater insulin resistance but have similar circulating androgen levels. CONCLUSION: In this pilot study, insulin resistance was the most prominent feature characterising NAFLD complicating PCOS. Total testosterone, FAI, DHEAS and 17-hydroxyprogesterone levels were similar between patients with PCOS and without NAFLD.

Endocrine and metabolic differences among phenotypic expressions of polycystic ovary syndrome according to the 2003 Rotterdam consensus criteria.

OBJECTIVE: The Rotterdam criteria extend the phenotypic spectrum of polycystic ovary syndrome (PCOS). We characterized endocrine and metabolic differences among women meeting the National Institutes of Health (NIH) definition for PCOS vs two novel phenotypes established by the European Society of Human Reproduction and Embryology/American Society for Reproductive Medicine definition. STUDY DESIGN: Endocrine and metabolic data from a retrospective analysis of 160 age- and weight-matched women with PCOS and 23 controls were compared. Insulin sensitivity indices were correlated with androgens, gonadotropins, and lipids within each phenotype. RESULTS: Ovarian and adrenal androgens were highest in the NIH-defined PCOS group, lowest in the nonhyperandrogenic PCOS group, and intermediate in the hyperandrogenic ovulatory PCOS population. Insulin sensitivity indices, gonadotropins, and lipids were similar across all PCOS phenotypes. The magnitude of insulin resistance correlated with free testosterone only in the NIH-defined group. CONCLUSION: Androgen levels are the major distinguishing endocrine feature differentiating phenotypic expressions of PCOS. Hyperinsulinemia correlates with free testosterone levels only in traditional NIH-defined women with PCOS.

Detection of gestational diabetes mellitus by homeostatic indices of insulin sensitivity: a preliminary study.

OBJECTIVE: We investigated whether homeostatic indices of insulin sensitivity might suitably screen for gestational diabetes mellitus. STUDY DESIGN: One hundred twenty-three pregnant women who were between 24 and 28 weeks of gestation completed a 3-hour 100-g oral glucose challenge test and fasting insulin level in a nested case-control study design. Insulin sensitivity indices were calculated and tested for their ability to detect gestational diabetes mellitus. RESULTS: Fasting glucose demonstrated the best overall accuracy, but the homeostasis model assessment and quick insulin sensitivity check index were also sensitive screening techniques for gestational diabetes mellitus when either the National Diabetes Data Group or Carpenter-Coustan criteria were used. CONCLUSION: Homeostasis model assessment, quick insulin sensitivity check index, and fasting glucose are sensitive screening tests for gestational diabetes mellitus and can avoid oral administration of glucose-containing solutions.

Transfer of natalizumab into breast milk in a mother with multiple sclerosis.

Natalizumab (Tysabri) is a recombinant humanized antibody to α4-integrin that is approved by the Food and Drug Administration for the treatment of multiple sclerosis (MS) and Crohn disease. This is a case report of a 28-year-old woman with MS who was taking natalizumab (300 mg intravenously infused over 1 hour every 4 weeks) while breastfeeding her 11.5-month-old daughter 3 times a day. Breast milk samples were collected over a 50-day period after the patient's first drug infusion. The average concentration of natalizumab was 0.93 µg/mL/d, and the relative infant dose was 1.74% of the weight-adjusted maternal dose. Transfer of natalizumab into human milk increased over time and with subsequent injections, with the highest concentration of 2.83 µg/mL at day 50 with a relative infant dose of 5.3%. Because these data suggest continued accumulation of natalizumab in milk, and because we cannot provide an accurate assessment of levels of this drug at 24 weeks (steady state), we are unable to determine safety at this time.

Transfer of methylprednisolone into breast milk in a mother with multiple sclerosis.

High-dose intravenous methylprednisolone, a glucocorticoid with powerful anti-inflammatory activities, has become increasingly important in treating acute relapses of multiple sclerosis (MS). This is a case report of a 36-year-old lactating female who was receiving a 3-day course of high-dose methylprednisolone (1000 mg IV) to treat MS. Breast milk samples were obtained at 1, 2, 4, 8, and 12 hours following a 2-hour intravenous infusion on days 1, 2, and 3. The relative infant dose was found to be 1.45%, 1.35%, and 1.15% for days 1, 2, and 3, respectively. Using the average measured concentrations (C(avg)) for days 1, 2, and 3, the estimated infant exposure was 0.207, 0.194, and 0.164 mg/kg/day, respectively, which is below the recommended dose given to neonates requiring methylprednisolone drug therapy. Infant exposure is low and mothers could continue to breastfeed if treatment with IV methylprednisolone is very brief. However, if the mother wishes to limit infant exposure further, she could wait 2 to 4 hours after IV methylprednisolone administration, thus significantly limiting the amount of drug in the breast milk.

Transfer of interferon ß-1a into human breastmilk.

AIM: This study determined the transfer of intramuscular interferon ß-1a into human milk and provides an estimate of infant exposure to this antiviral in six women chronically receiving intramuscular interferon ß-1a (Avonex(®), Biogen Idec, Research Triangle Park, NC). METHODS: Interferon ß-1a was measured at various times at steady state in milk samples collected from women receiving interferon ß-1a at 30 µg/week. RESULTS: Average milk concentrations were 46.7, 97.4, 66.4, 77.5, 103.1, 108.3, 124, and 87.9 pg/mL at 0, 1, 4, 8, 12, 24, 48, and 72 hours, respectively, after dosing. Using the highest value measured (179 pg/mL), the estimated relative infant dose would be 0.006% of the maternal dose. CONCLUSIONS: These data clearly suggest that interferon ß-1a does not penetrate the milk compartment significantly and that levels in milk are far subclinical. No side effects were noted in any of the breastfed infants.

Transfer of carboplatin and paclitaxel into breast milk.

Carboplatin is an alkylating agent that is FDA approved for the treatment of advanced ovarian cancer. Paclitaxel is a plant taxane mitotic inhibitor approved for primary or salvage treatment of ovarian and breast cancer. This is a case report of a 40-year-old woman who was exclusively breastfeeding prior to being treated for papillary thyroid cancer with intravenous carboplatin (233 mg) and intravenous paclitaxel (30 mg/m(2)) for 6 consecutive weeks. Breast milk samples were collected during the sixth chemotherapy session. Carboplatin had a relative infant dose of 2.0% and remained measurable after 316 hours. Paclitaxel had a relative infant dose of 16.7% but was eliminated before 316 hours. The potential side effects of infant exposure of these medications include myelosuppression, hypersensitivity reactions, nephrotoxicity, and neurotoxicity. It would be inadvisable for a mother to breastfeed while undergoing therapy with these 2 medications.

Lipoprotein profiles in Mexican American and non-Hispanic white women with polycystic ovary syndrome.

OBJECTIVE: To compare lipid profiles between Mexican American and non-Hispanic white women with polycystic ovary syndrome (PCOS). DESIGN: Cross-sectional analysis using the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guidelines. SETTING: University gynecology service. PATIENT(S): Self-identified Mexican Americans (n = 71) and non-Hispanic whites (n = 120) with PCOS defined by the 2003 European Society of Human Reproduction and Embryology and American Society of Reproductive Medicine consensus. INTERVENTION(S): Serum drawn from fasting state followed by oral glucose tolerance test. MAIN OUTCOME MEASURE(S): Age, body mass index (BMI), androgens, cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, fasting, and minimal model analyses of insulin sensitivity. RESULT(S): Mexican American women were more insulin resistant than non-Hispanic whites, but cholesterol, triglycerides, HDL cholesterol, LDL cholesterol, and calculated non-HDL cholesterol levels were similar. BMI inversely correlated with HDL cholesterol and positively with triglycerides. Approximately half of both ethnic groups had at least one lipid level in the low (HDL) or high (cholesterol, triglycerides, and LDL cholesterol) range according to National Cholesterol Education Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults guidelines. CONCLUSION(S): Despite greater insulin resistance among Mexican Americans with PCOS, lipid levels were similar to those of age- and weight-matched non-Hispanic whites. Obesity adversely affected lipid levels-primarily HDL cholesterol and triglycerides-in both groups. The prevalence of dyslipidemia was approximately 50% in each ethnic group.

Infant feeding and contraceptive practices among adolescents with a high teen pregnancy rate: a 3-year retrospective study.

BACKGROUND: Adolescents consistently demonstrate the lowest rates of breastfeeding among women of reproductive age despite well-documented benefits of breastfeeding. In Amarillo, Texas, a medium-sized community with a perennially high teen pregnancy rate, we sought (1) to determine breastfeedings practices among adolescent females immediately after delivery and again at 6 weeks and (2) to identify contraceptive choices among the same teen population. METHODS: This was a retrospective chart review focused on adolescents between the ages of 13 and 18 coming to a university-based obstetrical service between January 1, 2006, and December 31, 2008. Data on breastfeeding and contraceptive practices were analyzed. RESULTS: Five hundred forty-three cases were analyzed. At hospital discharge, 59.3% initiated breastfeeding, but this dropped to 22.2% at the 6-week postpartum appointment. Over 27% of all study subjects failed to appear for postpartum evaluation. Multiparity was the only outcome variable associated with failure to initiate breastfeeding. Depot-medroxyprogesterone acetate, the levonorgestrel intrauterine device (IUD), and combination oral contraceptives were the most popular contraceptive choices, but 16% elected to forego any form of contraception at the postpartum visit. CONCLUSIONS: Adolescent women living in an area of Texas with a high teen pregnancy rate reported relatively low breastfeeding rates immediately postpartum, with a >50% decrease in breastfeeding in any form by 6 weeks postpartum. A substantial number failed to initiate any form of contraception at the postpartum visit. These findings support the critical need for additional breastfeeding support and contraceptive education in this at-risk adolescent population.