Ferring Pharmaceuticals (Switzerland)

BackgroundFecal microbiota, live-jslm (RBL) is FDA-approved for prevention of recurrent Clostridioides difficile infection (rCDI) in adults following completion of antibiotic treatment. The safety and efficacy of RBL have been demonstrated in trials, but few studies have evaluated outcomes in real-world populations. The primary objective of ROAR (NCT05835219) is to assess RBL effectiveness in reducing rCDI through 8 weeks in clinical practice.Table 1.Treatment success rates by subgroupMethodsROAR is an ongoing, prospective, multicenter, open-label, non-interventional registry of patients receiving RBL for rCDI prevention in the United States. Adults who completed antibiotics for rCDI and are not in an interventional trial are eligible. The primary endpoint assesses the proportion of patients who experience treatment success (no CDI recurrence through 8 weeks). Other objectives describe rCDI management in real-world clinical practice and adverse events (AEs) after RBL administration. This analysis includes patients who received RBL within 30 days of completing antibiotics for rCDI.ResultsAs of September 18, 2024, 76 patients received RBL within 30 days of completing antibiotics and completed 8 weeks of follow-up. Patients were mostly White (93.4%) and female (76.3%), with a median age of 69 years (range, 19-96 years) and a median body mass index of 24.4 (range, 16.5-49.4). Through 8 weeks, 82.9% of patients (63/76; 95% CI, 72.5%-90.6%) experienced treatment success. Similarly, the rate of treatment success was 87.8% (36/41) in the subgroup of patients who received RBL after an antibiotic washout period > 72 hours. Treatment success rates ranged from 77-100% across patient subgroups, including those stratified by age and number of previous CDI episodes within the past 3 years (Table). Overall, 18 (23.7%) patients experienced an AE, 6 (7.9%) experienced a serious AE, and 1 (1.3%) experienced an AE of special interest (large bowel obstruction). AEs assessed as related to RBL occurred in 3 patients (3.9%). There was 1 fatal AE during the study, considered unrelated to RBL.ConclusionInitial results from ROAR are consistent with previous RBL trial results, indicating that RBL is effective and safe for preventing rCDI through 8 weeks after administration in real-world practice.DisclosuresNicholas W. Van Hise, PharmD, Ferring: Advisor/Consultant|Ferring: Grant/Research Support|Innoviva: Advisor/Consultant Teena Chopra, MD, MPH, Cepheid: Advisor/Consultant|Ferring Pharmaceuticals, Inc: Advisor/Consultant|Melinta: Speaker|Pfizer: Advisor/Consultant|Pfizer: Speaker|Shinogi: Speaker Kelly R. Reveles, PharmD, PhD, AstraZeneca: Advisor/Consultant|Ferring Pharmaceuticals: Advisor/Consultant Sahil Khanna, MBBS, MS, Ferring Pharmaceuticals, Inc: Grant/Research Support|ProbioTech Inc: Advisor/Consultant|Rise: Advisor/Consultant|Takeda: Advisor/Consultant|Vedanta: Grant/Research Support Lasse Nielsen, MS, Ferring: Employee Lorien E. Urban, PhD, Ferring Pharmaceuticals Inc: Employee

Endocrine dysfunctions refer to alterations in hormone production, release, or regulation that can significantly impact health. In pregnant women or those planning pregnancy, these conditions may manifest as disorders such as polycystic ovary syndrome, hypothyroidism, endometriosis, gestational diabetes mellitus, and other metabolic issues, which could potentially cause infertility or pregnancy complications. Research and clinical experience indicate that hormones play a crucial role in basic physiology and are essential for overall health and well-being. At the same time, lifestyle—defined as daily habits related to nutrition, exercise, sleep, stress management, and other factors—directly influences microbial composition and hormonal regulation. The human microbiome, a diverse community of microorganisms residing within the human body, plays essential roles in supporting overall health. The increasing prevalence of hormonal disorders, especially in urban populations, has heightened interest in how modern lifestyles—characterised by sedentary habits, chronic stress, imbalanced diets, and inadequate sleep—may contribute to the development or aggravation of these conditions, leading to higher infertility rates or pregnancy complications if untreated. This review investigates the interaction between hormonal dysfunction, the human microbiome, and lifestyle factors, with a focus on their effects on pregnant women and those seeking to conceive. Its purpose is to provide a comprehensive overview of the underlying pathophysiological mechanisms and to examine preventative and therapeutic approaches that could alter these patterns.

BackgroundLumbar disc herniation (LDH) affects approximately 1% to 3% of the population annually and leads to substantial physical burden, quality-of-life burden, and productivity loss. Commonly used interventions, including pharmacological and epidural steroid injections (ESIs), have limited high-quality evidence to support their effectiveness in the long-term for treating LDH beyond symptom relief. In general, there is a lack of consensus for timing of treatment after LDH onset and limited data on real-world treatment of LDH. The objective of this study was to describe current real-world treatment patterns and inform gaps in clinical management of patients with LDH.MethodsA retrospective analysis was performed using data from January 01, 2018 through March 31, 2023 of a United States commercial health insurance claims database (IQVIA PharMetrics Plus). Patients aged 30–70 years with newly-diagnosed LDH and continuous insurance enrollment for ≥6 months before and ≥12 months after index (first) LDH diagnosis were included. Relevant billing codes were used to identify LDH, related treatments (nonpharmacologic, pharmacologic, invasive), and comorbidities. Demographic and clinical characteristics were summarized for the baseline (preindex) period. Treatment patterns were described over the follow-up period, up to 3 years after LDH diagnosis. Time from LDH diagnosis to ESI(s) and surgery(ies) were calculated.ResultsA total of 1,086,552 patients with LDH were included, with a mean age of 50.8 years. Patients had a mean follow-up of 27 months after LDH diagnosis. Nearly 20% of patients with LDH underwent ESI, with half of this group undergoing multiple ESIs. Multiple ESIs were associated with a greater likelihood of surgical intervention and repeat surgical intervention compared to those who only underwent single ESI. LDH surgery was performed on 7.2% of patients, approximately 10% of whom had multiple surgeries during follow-up. A large subset (44.1%) of patients who underwent LDH surgery did not have any ESI prior to surgery. General limitations of claims data analyses can include data misclassification, missing claims for diagnoses and procedures that were conducted, missing clinical information (severity of condition, insights into clinical decision making), and some missing patient demographics and characteristics.ConclusionsIn this study, approximately one quarter of patients with LDH underwent ESI and/or surgery after conservative treatment. Opportunities exist to provide more guideline-concordant care to patients with LDH. In addition, unmet needs exist in the current treatment options for patients with LDH, potentially including the need for other nonsurgical treatment options for patients who do not fully respond to conservative treatment.

Hemophagocytic lymphohistiocytosis is a rare life-threatening condition, with a high mortality rate, characterized by a dysfunctional immune response resulting in multi-organ damage. The secondary or sporadic form of the disease can be triggered by a multitude of infections, malignancies, and autoimmune disorders. Tuberculosis is commonly involved as a trigger for hemophagocytic lymphohistiocytosis. In a rare case, a 52-year-old gentleman with advanced human immunodeficiency virus (HIV) and disseminated tuberculosis (TB) developed secondary hemophagocytic lymphohistiocytosis. This patient was successfully treated with the 1994 hemophagocytic lymphohistiocytosis treatment protocol at a hospital in a rural province in South Africa. TB, a treatable condition,remains the most lethal disease in South Africa. This case highlights another severe complication of TB. Despite the widespread rollout of antiretroviral treatment, HIV still remains South Africa's largest epidemic. This case emphasizes the need for physicians, treating people living with HIV infection and TB, to have a high index of suspicion in the appropriate clinical situation for hemophagocytic lymphohistiocytosis.Improved outcomes are possible for these cases when diagnosed and treated timely and correctly.

This article compares and explores vacuum foam-drying as an alternative drying technology to freeze-drying and spray drying for a recombinant human lipase as the model protein. Materials characteristics such as structure, surface composition and the solid-state properties of the dry materials were compared and investigated. Moreover, the technical functionality in terms of reconstitution characteristics and the lipase stability were also investigated. The stability of the lipase was evaluated through activity measurements. Sucrose and dextran D40 (40 kDa) were used as matrix former and the surfactant α-dodecyl maltoside was used as surface active additive. The study demonstrated that the drying technique greatly influenced the material structure and composition which in turn affected the reconstitution characteristics. The lipase was overrepresented at the material surface in declining order spray-dried > vacuum foam-dried > freeze-dried. The lipase activity was retained up to 10 % lipase content in solids, but at 20 % lipase a loss of activity was observed for all drying techniques. Phase separation in the solid material may be an explanation. Vacuum foam-drying shows promise as an alternative drying technique for the lipase, and potentially other proteins.

To evaluate the outcomes and complications of video-assisted thoracoscopic (VATS) treatment of chylothorax in cats. Multi-institutional retrospective study. Fifteen client-owned cats. The medical records of cats undergoing thoracoscopic thoracic duct ligation (TDL) for treatment of idiopathic chylothorax were reviewed. Cats undergoing additional procedures including thoracoscopic pericardectomy and/or laparoscopic cisterna chyli ablation (CCA)_were included. Follow up was obtained through communication with the referring veterinarian or owner. All cats underwent thoracoscopic TDL. Thirteen cats underwent simultaneous pericardectomy and two cats underwent laparoscopic CCA without pericardectomy. Conversion from a thoracoscopic to open approach was necessary in 2/15 (13%) of thoracic duct ligations and 1/11 (9%) of pericardectomies. The most common postoperative complication was persistent pleural effusion in five cats (33%). Four of 15 cats (27%) died or were euthanized prior to hospital discharge following surgery. Recurrence of effusion occurred in 1/7 (14%) of cats that sustained resolution of the effusion at the time of surgery with a median follow up of 8 months. The overall mortality attributed to chylothorax was 47%. Thoracoscopic treatment of idiopathic chylothorax resulted in a low incidence of intraoperative complications or conversion in the study population; however, mortality related to feline idiopathic chylothorax remained high. While VATS treatment of idiopathic chylothorax is technically feasible, further consideration of the underlying pathology and current treatment algorithm is needed to improve outcomes as this remains a frustrating disease to treat in the feline population.