Repository corticotropin injection in patients with advanced symptomatic sarcoidosis: retrospective analysis of medical records.

BACKGROUND: Repository corticotropin injection (RCI) has regulatory approval for many indications, including symptomatic sarcoidosis. This large case series of patients with advanced symptomatic sarcoidosis treated with RCI describes patient characteristics, RCI utilization patterns, concomitant therapies, and physicians' assessments of treatment response. METHODS: Patients ⩾18 years with symptomatic sarcoidosis, treated with RCI in the previous 36 months, who had completed a course of RCI or received RCI for ⩾6 months at the time of data collection were included. RESULTS: The study included 302 patients (mean age, 51 years; 52%, women) with a mean 4.8 years since initial diagnosis of sarcoidosis. Most patients (76%) had extrapulmonary involvement, primarily in the skin (28%), joints (25%), heart (22%), and eyes (22%); 34% had multiple (⩾2) organ involvement. The mean duration of RCI treatment was 32.5 weeks, with 61.6% of patients continuing RCI therapy for ⩾6 months. The RCI utilization pattern indicated an individualized approach to therapy, with a higher starting dose associated with a shorter duration of therapy compared with a lower starting dose. The percentage of patients who used corticosteroids decreased from 61.3% during the 3 months before initiation of RCI to 12.9% 3 months after RCI therapy; the mean daily dose of corticosteroid decreased from 18.2 mg to 9.9 mg. The proportion of patients given <10 mg/day of prednisone increased from 21% before RCI use to 47% 3 months after RCI use. According to physicians' assessments of change in patients' health status after RCI therapy, overall status improved in 95% of patients, overall symptoms in 73%, lung function in 38%, and inflammation in 33%. CONCLUSIONS: The findings suggest that RCI is a viable treatment option for patients with advanced symptomatic sarcoidosis and provide insights on patient characteristics and practice patterns to help clinicians determine appropriate use. The reviews of this paper are available via the supplemental material section.

Real-world adverse events with niraparib 200 mg/day maintenance therapy in ovarian cancer: a retrospective study.

Aim: To assess real-world occurrence of common clinical trial-reported adverse events (AE) among patients with recurrent ovarian cancer initiating niraparib 200 mg/day. Materials & methods: This retrospective observational study used physician-extracted anonymized medical record data of eligible patients initiating niraparib 200 mg/day after platinum-based chemotherapy. Results: Of 153 patients, 57 (37%) experienced ≥1 of the three most common all-grade AEs within 3 months after niraparib initiation: nausea (16%; grade 3/4: 2%), thrombocytopenia (14%; grade 3/4: 3%) and fatigue (24%; grade 3/4: 3%). In the ENGOT-OV16/NOVA trial, these respective AEs occurred in 74, 61 and 59% of patients. Conclusion: Incidence of common clinical trial-reported AEs was lower among patients initiating niraparib 200 mg/day in real-world practice versus patients initiating niraparib 300 mg/day in ENGOT-OV16/NOVA.

Retrospective Medical Record Review to Describe Use of Repository Corticotropin Injection Among Patients with Uveitis in the United States.

INTRODUCTION: Repository corticotropin injection (RCI) has immune-modulatory and anti-inflammatory effects and is approved for multiple indications, including severe and acute chronic allergic and inflammatory processes involving the eye and adnexa. This study describes patient characteristics, treatment patterns, and physicians' assessments of patients with uveitis treated with RCI. METHODS: This was a retrospective medical record review of US patients. Eligible patients had a diagnosis of uveitis, received RCI in the past 12 months, and had completed or were receiving RCI treatment at the time of data collection. Baseline characteristics and after-treatment clinical data are descriptively reported. RESULTS: The study included 91 patients (mean age 41 years, 62% female, and mean time since diagnosis 3.98 years). Most patients had moderate (n = 48, 53%) to severe (n = 21, 23%) visual impairment, and none was blind before RCI therapy. Patients used an average of 2.5 medications before RCI. Initial RCI dosing regimens, dose adjustments, and treatment durations were different for each patient. Concomitant medication use and dosages were reduced during RCI; 76 patients (84%) improved, 15 patients (16%) stayed the same, and none worsened; 86% of patients had improvements in vision. CONCLUSIONS: Physicians individualized RCI therapy among patients who suffered uveitis for several years and when previous therapies were inadequate. Most patients improved after initiating RCI, most commonly in vision. The findings support use of RCI for uveitis and provide a better understanding of patient characteristics and practice patterns to guide appropriate use.

Understanding if, How, and Why Women with Prior Spontaneous Preterm Births are Treated with Progestogens: A National Survey of Obstetrician Practice Patterns.

Objective In 2017, the Society for Maternal-Fetal Medicine (SMFM) Guideline Committee reaffirmed that 17 α -hydroxyprogesterone caproate (17-OHPC) to prevent preterm birth (PTB) is underutilized. We sought to determine what drove progestogen treatment choice of obstetricians managing pregnant women with histories of 1+ singleton spontaneous PTBs (< 37 weeks) who then delivered singleton gestations within the previous 12 months. Subjects We recruited a nationally representative random sample of obstetricians to abstract medical records of study-qualified patients. Of the 423 study-qualified physicians contacted, 358 (85%) participated; 56 (16%) maternal fetal medicine specialists and 302 (84%) general obstetrician/gynecologists (OB/GYNs) extracted data from 991 eligible patient charts. Results Almost three-fourths of patients (73.6%) were treated with 17-OHPC; 18.6% received vaginal progesterone, and 11.8% were not treated. Key drivers of physicians' choice to (1) prescribe branded 17-OHPC were "FDA (Food and Drug Administration) approval" (52% relative influence [RI]) and "SMFM guidelines" (24% RI); (2) prescribe vaginal progesterone were "ease of administration" (32% RI) and "shortened cervix" (16% RI); and (3) not provide prophylaxis were "patient not informed of risk" (35% RI) and "no shortened cervix" (29% RI). Conclusion Study findings support SMFM's contention of continued 17-OHPC underutilization to prevent PTB. Need for additional physician education merits assessment along with appropriate follow-up actions.

A Retrospective Medical Record Review of Utilization Patterns and Medical Resource Use Associated with Repository Corticotropin Injection among Patients with Rheumatologic Diseases in the United States.

INTRODUCTION: Repository corticotropin injection (RCI) has anti-inflammatory and immune-modulatory effects and is approved for multiple indications, including several rheumatologic conditions. The aims of this nationally representative, retrospective, observational study were to describe patient characteristics, RCI treatment patterns, and barriers to RCI use in patients with rheumatologic disease, and to compare medical resource use (MRU) before and after RCI therapy. METHODS: A random sample of US physicians was recruited to abstract the medical records of deidentified patients with a diagnosis of rheumatoid arthritis (RA), psoriatic arthritis (PsA), dermatomyositis/polymyositis (DM/PM), or systemic lupus erythematosus (SLE) who had been treated with RCI in the previous 24 months. Patient characteristics and patterns of RCI use were identified. Mean MRU in the 3 months before and after RCI therapy was compared using paired-samples t tests. RESULTS: A total of 449 physicians abstracted the medical records of 217 RA, 190 PsA, 254 DM/PM, and 95 SLE patients. In all groups combined, patients had received a mean of 3.3 treatment medications before initiating RCI. Most patients (75%-94%) were receiving RCI for the first time, indicating that repeated courses of RCI were uncommon. RCI was used as bridge therapy in 18% of patients. Approximately 24% of patients encountered an obstacle in accessing RCI, primarily insurance-related. After RCI therapy, the number of hospitalizations and hospital days were significantly reduced for all cohorts (all P < 0.05), and the number of outpatient visits was significantly lower for all cohorts (P < 0.05) except the SLE cohort (P = 0.3230). Study limitations include potentially incomplete data in the medical records and a relatively short duration for capturing MRU changes. CONCLUSIONS: RCI was used primarily as late-line therapy in patients with rheumatologic diseases. Medical resource use was significantly lower in the 3 months after therapy compared with 3 months prior. This finding suggests that RCI may improve disease control and warrants further evaluation. FUNDING: Mallinckrodt Pharmaceuticals.

Lack of adherence to evidence-based treatment guidelines for nontuberculous mycobacterial lung disease.

RATIONALE: The 2007 American Thoracic Society (ATS) and Infectious Diseases Society of America (IDSA) recommend that patients with pulmonary nontuberculous mycobacterial (PNTM) disease caused by Mycobacterium avium complex (MAC) or M. abscessus be treated with a macrolide-based multidrug antibiotic regimen until sputum culture negative for 1 year. After 6 years, the degree of adherence to recommended guidelines among physicians remains unknown. OBJECTIVE: To describe antibiotic treatment practices among physicians treating patients with PNTM in the United States. METHODS: A nationally representative sample of 1,286 U.S. physicians was contacted in December 2011 through January 2012; 582 of the responding physicians were treating patients with PNTM and were eligible to participate. Physicians were asked to extract medical record data on the last four patients they treated in the past year with PNTM disease from either MAC or M. abscessus. Treatment patterns were assessed for all patients by NTM species and physician specialty, and compared with the 2007 recommended ATS/IDSA guidelines. MAIN RESULTS: Questionnaires were completed by 349 physicians on 915 patients with PNTM, including 744 (81%) with MAC and 174 (19%) with M. abscessus; 3 patients were positive for both. Physicians treated 76 (44%) patients with M. abscessus and 411 (55%) patients with MAC. Only 13% of antibiotic regimens prescribed to patients with MAC met ATS/IDSA guidelines, 56% did not include a macrolide, and 16% were for macrolide monotherapy. Among patients with M. abscessus, 64% of regimens prescribed did not include a macrolide. CONCLUSIONS: Adherence to the 2007 ATS/IDSA guidelines for treating PNTM disease is poor. Across all physician specialties evaluated, suboptimal or potentially harmful antibiotic regimens were commonly prescribed.

The use of immediate postoperative instillations of intravesical chemotherapy after TURBT of NMIBC among European countries.

PURPOSE: The aim of this study was to assess the use of immediate postoperative instillation of intravesical chemotherapy (IPOIC) after transurethral resection of bladder tumour (TURBT) of nonmuscle invasive bladder cancer (NMIBC) in Europe. METHODS: Urologists based in five European Union nations were asked to extract information from the records of patients with NMIBC-urothelial carcinoma who received at least one TURBT. Multivariate logistic regression models were developed to determine the significant predictors of IPOIC usage. Data were weighted to control for country-to-country and other differences. RESULTS: Overall, 324 urologists (58 France, 72 Germany, 62 Italy, 65 Spain, 67 United Kingdom) were involved; the participation rate was 55 %. Overall, 771 patients received 954 TURBTs (mean-1.2/patient), of which 413 of the TURBTs (43.3 %) were administered IPOIC . Sixty-six of the 413 IPOICs (16.0 %) were for a recurrent tumour. Five of the tested variables were significantly associated with a patient's likelihood of receiving IPOIC after TURBT. Variables in the order of significance are as follows: (1) country (United Kingdom, patients most likely to receive IPOIC; France, least likely); (2) progression risk (physician assessed) [lower-risk conditions (no CIS, tumour < 3 cm) or intermediate risk-more likely]; (3) whether urologist completed a uro-oncology fellowship (completed-more likely); (4) recurrence risk (physician assessed) [higher-risk conditions (≥T2, ≥3 cm, CIS)-more likely]; and (5) physician's NMIBC patients volume (higher volume-more likely). CONCLUSIONS: This study revealed wide practice variation and substantial noncompliance with European Association of Urology Guidelines on the use of IPOIC after TURBT for NMIBC.

National practice patterns for immediate postoperative instillation of chemotherapy in nonmuscle invasive bladder cancer.

PURPOSE: We assessed the use of intravesical postoperative chemotherapy among United States urologists in patients with nonmuscle invasive bladder cancer. MATERIALS AND METHODS: A national sample of United States based urologists (259) retrospectively assessed their practice patterns involving intravesical postoperative chemotherapy after transurethral resection in patients with nonmuscle invasive bladder cancer. These urologists reviewed the medical records of their last 4 patients with nonmuscle invasive bladder cancer, and completed a case report form for specific demographic, pathological and treatment information. Selection criteria included the pathological and patient factors of histologically confirmed diagnosis of nonmuscle invasive bladder cancer-transitional cell carcinoma, completion of initial treatment plan with ongoing observation, candidate for or recipient of intravesical therapy, and no ongoing initial intravesical induction therapy. RESULTS: Overall the participation rate among those sampled was 61%. Of the 1,010 eligible patients with nonmuscle invasive bladder cancer 59.6% received instillation therapy during the initial treatment, of whom 28.4% (16.9% of patients overall) received intravesical postoperative chemotherapy. Primary, low risk patients most often received intravesical postoperative chemotherapy and 90.4% of the time patients received immediate instillation within 12 hours of surgery. However, of the urologists surveyed 66% never used intravesical postoperative chemotherapy, 17% used intravesical postoperative chemotherapy half (50%) of the time and only 2% used intravesical postoperative chemotherapy all (100%) of the time. CONCLUSIONS: Wide variation in the use of intravesical postoperative chemotherapy exists among urologists in the United States. The reason for the great diversity in the use of intravesical postoperative chemotherapy is speculative. However, physician awareness, physician bias, recurrence risk, and local pharmacy and hospital practice factors are all likely contributing factors.