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BACKGROUND: Elotuzumab plus lenalidomide and dexamethasone has shown improved progression-free and overall survival versus lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. We aimed to assess these regimens in patients with newly diagnosed multiple myeloma who are ineligible for haematopoietic stem-cell transplantation (HSCT). METHODS: ELOQUENT-1 is an open-label, multicentre, randomised, phase 3 trial conducted at 185 hospitals, oncology practices, and research centres in 19 countries. Eligible patients were aged 18 years or older with newly diagnosed, untreated, symptomatic myeloma and not candidates for high-dose therapy plus HSCT, and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower. Patients were randomly assigned (1:1) to receive elotuzumab plus lenalidomide and dexamethasone or lenalidomide and dexamethasone using an interactive voice response system, stratified by the International Staging System (ISS; stage I-II vs III), age (

Novel strategies for initiation and continuation of buprenorphine are critical, especially during a pandemic when traditional opioid use disorder treatment pathways may be disrupted. We describe an innovative outpatient to inpatient reallocation initiative for extended-release buprenorphine (XR-BUP) designed to repurpose an expensive medication for use in hospitalized patients facing treatment barriers upon discharge and pilot the feasibility of XR-BUP use in the inpatient setting.We collaborated with our institution's inpatient pharmacy and a New Jersey Medicaid managed care organization to create an alternate pathway to make XR-BUP available to hospitalized patients insured by the same payor. In this process, XR-BUP doses were deidentified and transferred to the inpatient controlled substance inventory for administration to hospitalized patients at no charge by our Addiction Medicine Consult Service after a period of sublingual buprenorphine stabilization. Our reallocation pathway bypassed several existing XR-BUP regulatory barriers to allow for inpatient administration.To date, we have transferred approximately 85 XR-BUP 300 mg doses to the inpatient controlled substance inventory. This equates to a cost savings of nearly $145,000.Reallocation of XR-BUP from an outpatient to inpatient setting increased postdischarge buprenorphine treatment access while also reducing health care costs by repurposing an expensive medication that would otherwise go to waste. Use of reallocated XR-BUP in the inpatient setting may pave the way for addition of XR-BUP to the hospital's formulary to minimize treatment gaps after discharge.

Patients undergoing haploidentical or mismatched unrelated donor (haplo/MMUD) allogeneic hematopoietic cell transplantation (alloHCT) receiving post-transplant cyclophosphamide (PTCy) are at high risk of cytomegalovirus (CMV) infection. Experience with letermovir (LET) in this population is limited. This single center retrospective cohort study compared CMV and transplant outcomes between LET and a historical control with high-dose valacyclovir (HDV) prophylaxis in adults undergoing haplo/MMUD alloHCT. Thirty-eight CMV seropositive patients were included, 19 in each arm. LET reduced the incidence of CMV infection (5% vs. 53%, RR 0.01, 95% CI 0.014-0.71

BACKGROUND: Prescription drug monitoring programs (PDMPs) exist in 49 states to guide opioid prescribing. In 40 states, clinicians must check the PDMP prior to prescribing an opioid. Data on mandated PDMP checks show mixed results on opioid prescribing. OBJECTIVES: This study sought to examine the impact of the Massachusetts mandatory PDMP check on opioid prescribing for discharges from an urban tertiary emergency department (ED). METHODS: This was a retrospective cohort study of discharges from one ED from 7/1/2010–10/15/2018. The primary outcome was the monthly percentage of patients discharged from the ED with an opioid prescription. The intervention was Massachusetts mandating a PDMP check for all opioid prescriptions. Prescribing was compared pre- and post-mandate. Interrupted time series (ITS) analysis accounted for known declining trends in opioid prescribing. RESULTS: Of 273,512 ED discharges, 35,050 (12.8%) received opioid prescriptions. Mean monthly opioid prescribing decreased post-intervention from 15.1% (SD ± 3.5%) to 5.1% (SD ± 0.9%; p < 0.001). ITS showed equal pre and post-intervention slopes (−0.002, p = 0.819). A small immediate decrease occurred in prescribing around the mandated check: a 3-month level effect decrease of 0.018 (p = 0.039), 6-month level effect 0.019 (p = 0.023), and a 12-month level effect of 0.020 (p = 0.019). The 24-month level effect was not decreased. CONCLUSION: Prior to the mandated PDMP check, ED opioid prescribing was declining. The mandate did not change the rate of decline but was associated with a non-sustained drop in opioid prescribing immediately following enactment. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13181-021-00837-4.

The COVID-19 pandemic has triggered outbreaks of unanticipated toxicities, including methanol toxicity. Multiple methanol outbreaks have been described, including contaminated hand sanitizer in the southwest USA. In this case, we describe a fatal case of methanol toxicity from hand sanitizer ingestion, geographically separated from the outbreak in the southwest USA and prior to the announcement of nationwide warnings by the Food and Drug Administration (FDA). The product was identified as one later recalled by the FDA for methanol contamination. Additionally, the consumption in this case was related to a desire to conceal alcohol consumption from family members. This case of methanol toxicity should increase awareness of the ease of which contaminated products can be widely distributed and of the use of alternative ethanol-containing products to obscure relapse in alcohol use disorder.

Pegaspargase (PEG) increases venous thromboembolism (VTE) in acute lymphoblastic leukemia (ALL) potentially due to depletion of anticoagulation factors, including antithrombin (AT). The benefit and cost of AT supplementation in adults is unclear. We aimed to characterize VTE incidence and risk factors following AT and determine the characteristics and costs of supplementation. Fifty-three adults received PEG and AT. VTE occurred in 21% (grade ≥3 8%). T cell ALL and patients receiving prednisone during induction were at highest risk. Repeat AT levels post supplementation were subtherapeutic forty-four percent of the time. A median of 18 days elapsed between PEG and two sequential therapeutic AT levels despite supplementation. Patients received a median of 2 AT doses per PEG dose at a median cost of $11,145. VTE remains common in adults despite AT supplementation. More aggressive AT supplementation may reduce VTE but warrant prospective evaluation given the significant cost.

The purpose of this study was to evaluate barriers and facilitators to glycemic control and diabetes shared medical appointment (SMA) engagement in underserved patients with type 2 diabetes.Semi-structured focus groups were conducted in 50 patients using an interview script guided by a social determinants of health (SDOH) conceptual framework.Patients positively perceived the social support and access to care benefits of the SMA. While barriers related to self-care behaviors (particularly diet), financial issues, and unreliable transportation were common, notable differences among the four groups existed. Controlled patients were motivated by fear of diabetic complications. Poorly-controlled patients discussed comorbidities and negative influence of family as barriers to glycemic control. Diabetes distress and fatalism were endorsed by poorlycontrolled, non-engaged patients.Overcoming SDOH including transportation barriers, food insecurity, and diabetes distress and fatalism are promising areas of intervention for SMA models to improve care for underserved populations.

BACKGROUND: Elotuzumab plus lenalidomide and dexamethasone has shown improved progression-free and overall survival versus lenalidomide and dexamethasone in patients with relapsed or refractory multiple myeloma. We aimed to assess these regimens in patients with newly diagnosed multiple myeloma who are ineligible for haematopoietic stem-cell transplantation (HSCT). METHODS: ELOQUENT-1 is an open-label, multicentre, randomised, phase 3 trial conducted at 185 hospitals, oncology practices, and research centres in 19 countries. Eligible patients were aged 18 years or older with newly diagnosed, untreated, symptomatic myeloma and not candidates for high-dose therapy plus HSCT, and an Eastern Cooperative Oncology Group (ECOG) performance status of 2 or lower. Patients were randomly assigned (1:1) to receive elotuzumab plus lenalidomide and dexamethasone or lenalidomide and dexamethasone using an interactive voice response system, stratified by the International Staging System (ISS; stage I-II vs III), age (

Objectives We describe retention in care, medication for opioid use disorder (MOUD) prescribing, and urine toxicology outcomes of a comprehensive perinatal shared medical appointment model that combined medication, group-based counseling, and recovery supports. Methods We conducted a retrospective study of program retention between 11/1/16 and 3/31/20 in pregnant and postpartum women with substance dependence or use disorder. Disengagement reasons, MOUD prescribing, and urine toxicology were abstracted from medical records. A Cox proportional hazards model was used to evaluate risk factors for program disengagement. Results Approximately 87% of patients had OUD and 80% were pregnant at the initial visit (N = 140). Retention at 3 months, 6 months, 1 year, and 2 years was approximately 86%, 78%, 66%, and 48%, respectively. Over 97% of patients were prescribed MOUD and 88% of all urine toxicology results were negative for non-prescribed opioids. Patients enrolled after initiation of wraparound services (HR 0.52, 95% CI 0.28-0.96) and those attending more shared medical appointments (HR 0.90, 95% CI 0.87-0.93) had a lower hazard of disengagement after controlling for other covariates. Loss to follow-up was the most common disengagement reason. Conclusions A low-threshold, comprehensive perinatal shared medical appointment program had high retention rates, increased access to evidence-based MOUD, and high rates of opioid-negative urine toxicology. Participants enrolled after wraparound services began had a lower hazard of disengagement. Future research in perinatal substance use should evaluate the most optimal and cost-effective components of comprehensive programs to inform standard of care.

Purpose The purpose of this study was to explore the mentor-mentee relationship in veterans with type 2 diabetes and gain insight into successful pairings. Methods Qualitative semistructured interviews were conducted as part of a peer mentoring randomized controlled trial to understand participants’ experiences, their relationship with their partner, and how the intervention affected self-care behaviors. Purposive sampling was done to ensure adequate representation of mentees who made large strides in reaching their glycemic targets, those who made marginal improvements toward their glycemic goals, and those who got worse. All interviews were audio-recorded, transcribed, and analyzed for salient themes. Results The intervention was well received, with most participants describing it as valuable. Participants perceived the intervention to have a number of benefits, including accessible support, enhanced self-confidence, increased accountability, better self-efficacy, improved glycemic management, and a fulfilled sense of altruism. Participants did encounter barriers, including logistical, interpersonal, and individual obstacles. The more successful mentees tended to be more effusive in their description of their mentors, endorsed a stronger sense of connection to their mentor, described a more structured interaction with their mentor, and tended to be more complimentary of the intervention. Conclusions Large peer support programs are appealing and well received. These programs can be optimized by selecting naturally inclined mentors, providing additional training to introduce more structure into mentorship interactions, and targeting mentees who are not struggling with overwhelming comorbidities.

Direct oral anticoagulants are now commonplace, and reversal agents are recently becoming available. Andexanet alfa (AnXa), approved by the United States Food and Drug Administration in 2018, is a novel decoy molecule that reverses factor Xa inhibitors in patients with major hemorrhage. We present a case of a 70-year-old man taking rivaroxaban with hemodynamic instability from a ruptured abdominal aortic aneurysm. He received AnXa prior to endovascular surgery, and intraoperatively he could not be heparinized for graft placement. Consideration should be given to the risks and benefits of AnXa administration in patients who require anticoagulation after hemorrhage has been controlled.

Graft-versus-host disease (GVHD) remains the most common treatment-related complication after allogeneic hematopoietic cell transplantation (allo-HCT). Lymphocyte migration plays a critical role in the pathogenesis of GVHD. A previous phase I/II trial demonstrated that CCR5 blockade with maraviroc in the first 30days after allo-HCT resulted in a low incidence of early acute GVHD, primarily in visceral organs, but with no impact on late acute or chronic GVHD. We conducted a phase II trial to examine the efficacy of an extended course of maraviroc, administered through post-transplantation day +90 in addition to standard prophylaxis in 37 recipients of reduced-intensity-conditioned unrelated donor allo-HCT performed to treat hematologic malignancies. Extended maraviroc treatment was safe and feasible. The primary study endpoint, day +180 rate of grade II-IV acute GVHD, was 22 ± 7%, liver GVHD was not observed, and gut GVHD was uncommon. The day +180 rate of grade III-IV acute GVHD was 5 ± 4%. The 1-year rate of moderate to severe chronic GVHD was 8 ± 5% and that of disease relapse was 30 ± 8%. Overall survival at 1 year was 70 ± 8%. Compared with the previously studied short course of maraviroc, the extended course resulted in a significantly higher GVHD-free, relapse-free survival (adjusted hazard ratio [HR], .45; 95% confidence interval [CI], .25 to .82; P = .009) and overall survival (adjusted HR, .48; 95% CI, .24 to .96; P = .037). A combined analysis of both trials showed that high maraviroc trough concentrations on the day of hematopoietic cell infusion were associated with lower rates of acute GVHD. An extended course of maraviroc after reduced-intensity-conditioned unrelated donor allo-HCT is safe and effective in preventing acute and chronic GVHD and is associated with favorable survival.