Publications by authors named "Justin R Arnall"

16 Publications

  • Page 1 of 1

Comparative Utilization and Efficacy of Thrombopoietin Receptor Agonists in Relapsed/Refractory Immune Thrombocytopenia.

Am J Ther 2021 Jan 8. Epub 2021 Jan 8.

Atrium Health, Specialty Pharmacy Service, Charlotte, NC; and Department of Pharmacy, Atrium Health, Levine Cancer Institute, Concord, NC.

Background: The thrombopoietin (TPO) agonists, eltrombopag and romiplostim, stimulate the production of platelets and offer an effective treatment option in relapsed/refractory immune thrombocytopenia (ITP). Recently published 2019 ITP guidelines recommend the TPO agonists as second-line therapy following corticosteroids; however, little data offer insights into comparative efficacy and tolerability.

Study Question: Is there a difference in the efficacy between romiplostim and eltrombopag in relapsed/refractory ITP?

Study Design: We conducted a single-center, retrospective chart review of patients with ITP treated with romiplostim or eltrombopag.

Measures And Outcomes: The primary objective was a sustained platelet response, defined as platelets greater than 50,000/μL in more than 66% of clinic visits over a 6-month period. Secondary objectives sought to evaluate response to and tolerability of TPO agonists.

Results: The study included 107 consecutive patients, 67 (63%) on romiplostim and 40 (37%) on eltrombopag. Previous corticosteroids and rituximab were used in 95% and 50% of patients, respectively. There was no difference identified in platelet responses between the TPO-RAs, 72% romiplostim versus 65% eltrombopag (P = 0.520). In addition, no differences were identified in secondary measures of response.

Conclusions: In our experience with romiplostim and eltrombopag for ITP, we did not identify a difference in the efficacy of these agents. Further larger and prospective evaluations should be considered.
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http://dx.doi.org/10.1097/MJT.0000000000001335DOI Listing
January 2021

Ibrutinib treatment via alternative administration in a patient with chronic lymphocytic leukemia and dysphagia.

J Oncol Pharm Pract 2020 Oct 27:1078155220967440. Epub 2020 Oct 27.

Atrium Health, Levine Cancer Institute, Concord, NC, USA.

Introduction: Ibrutinib is a small molecule inhibitor of Bruton's tyrosine kinase indicated for the treatment of a variety of B-cell malignancies including chronic lymphocytic leukemia, mantle cell lymphoma, marginal zone lymphoma, and Waldenstrom's macroglobulinemia. These indolent hematologic malignancies are considered diseases of the elderly, a population that may have dysphagia leading to difficulty swallowing tablets and capsules. Ibrutinib is currently not available in a liquid oral dosage form. We report the utilization and clinical outcomes associated with alternative administration of ibrutinib capsules in a patient with chronic lymphocytic leukemia and significant dysphagia.

Case Report: An 86-year old female requiring chronic lymphocytic leukemia-directed therapy due to a rising absolute lymphocyte count and worsening, transfusion-dependent anemia with a past medical history of dementia and dysphagia, was initiated on ibrutinib.

Management & Outcome: Due to the patient's significant inability to swallow, ibrutinib capsules were administered via an alternative method by opening them and sprinkling onto soft food or applesauce. With ibrutinib therapy, the patient has had a significant clinical response in her chronic lymphocytic leukemia as evidenced by her decreased absolute lymphocyte count and achieving transfusion independence with improvements in hemoglobin.

Discussion: Ibrutinib administration via this alternative method resulted in an initial clinical response in the treatment of our patient's chronic lymphocytic leukemia as evidenced by a decreasing absolute lymphocyte count and improved anemia that achieved transfusion independence. The patient has maintained this response to therapy after approximately 1 year at the time of manuscript preparation.
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http://dx.doi.org/10.1177/1078155220967440DOI Listing
October 2020

Evaluation of Montelukast for the Prevention of Infusion-related Reactions With Daratumumab.

Clin Lymphoma Myeloma Leuk 2020 10 7;20(10):e777-e781. Epub 2020 Jun 7.

Department of Hematologic Oncology and Blood Disorders, Atrium Health, Levine Cancer Institute, Charlotte, NC.

Background: Daratumumab is an anti-CD38 monoclonal antibody indicated for the treatment of multiple myeloma. Infusion-related reactions (IRRs) are among the most common adverse events associated with daratumumab. IRRs are most common with the first infusion of daratumumab. Recommended premedications to be given prior to the daratumumab dose include acetaminophen, diphenhydramine, and a corticosteroid. There is emerging data to suggest that the addition of montelukast to this premedication regimen can lower the incidence of daratumumab-related IRRs.

Patients And Methods: This was a single-center, retrospective chart review conducted at a large, multistate health system with several different hematology/oncology practice sites. Eligible patients included those with a primary diagnosis of a plasma cell disorder who received at least 1 dose of daratumumab. The primary outcome was the incidence of IRRs with the first daratumumab infusion.

Results: A total of 141 patients receiving daratumumab-based therapy were included in this study. All patients received acetaminophen, diphenhydramine, and a corticosteroid as premedications prior to the first infusion of daratumumab. Overall, 46 (33%) patients experienced an IRR with the first infusion of daratumumab. The incidence of IRR was lower in patients that received montelukast as a premedication compared with those that did not (montelukast, n = 25 [27%]; no montelukast, n = 21 [45%]; P = .0371). Patients in each arm experienced similar rates of overall, composite pulmonary, gastrointestinal, and systemic IRR manifestations.

Conclusion: The use of montelukast prior to the first daratumumab infusion led to a reduction in the incidence of IRRs in our experience.
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http://dx.doi.org/10.1016/j.clml.2020.05.024DOI Listing
October 2020

Caplacizumab: an anti-von Willebrand factor antibody for the treatment of thrombotic thrombocytopenic purpura.

Am J Health Syst Pharm 2020 07;77(15):1201-1207

Department of Pharmacy, Levine Cancer Institute, Atrium Health, Concord, NC.

Purpose: The pharmacology, pharmacokinetics, efficacy, safety, dosing and administration, and place in therapy of caplacizumab, a novel antibody fragment that inhibits von Willebrand factor, for the treatment of acquired thrombotic thrombocytopenic purpura (TTP) are summarized.

Summary: Caplacizumab is a humanized anti-von Willebrand factor monoclonal antibody fragment that inhibits the interaction between ultralarge von Willebrand factor multimers and platelets. Caplacizumab is indicated for use in combination with standard-of-care modalities such as plasma exchange and immunosuppressive therapy for the treatment of adults with acquired TTP. By inhibiting von Willebrand factor, caplacizumab offers a new approach to the management of TTP by preventing the development of potentially life-threatening microvascular thrombosis that can occur in the disease process. In a randomized, placebo-controlled phase 3 trial, patients with acquired TTP treated with caplacizumab had more rapid platelet level normalization than placebo users; caplacizumab use also resulted in lower rates of disease recurrence and TTP-related death. The most common adverse events associated with caplacizumab use are bleeding-related events. In a phase 3 trial, serious bleeding-related adverse events were reported in 8 patients (11%) in the caplacizumab group and 1 patient (1%) in the placebo group. Caplacizumab is administered as an 11-mg intravenous loading dose 15 minutes prior to plasma exchange, followed by administration of 11 mg subcutaneously daily after plasma exchange. Once-daily caplacizumab administration can be continued for 30 days after the last plasma exchange. The medication and supplies for administration are provided as a single-use kit; patients should be trained on proper reconstitution and self-administration technique prior to the use of caplacizumab in the ambulatory setting.

Conclusion: Caplacizumab is a first-in-class von Willebrand factor inhibitor approved for the treatment of adults with acquired TTP.
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http://dx.doi.org/10.1093/ajhp/zxaa151DOI Listing
July 2020

Necessity of pharmacist-driven nonprescription telehealth consult services in the era of COVID-19.

Am J Health Syst Pharm 2020 07;77(15):1188

Specialty Pharmacy Service at Atrium Health Charlotte, NC.

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http://dx.doi.org/10.1093/ajhp/zxaa162DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7239252PMC
July 2020

Dialysis Independence Following Combination Daratumumab, Thalidomide, Bortezomib, Cyclophosphamide, and Dexamethasone in Multiple Myeloma With Severe Renal Failure.

Clin Lymphoma Myeloma Leuk 2020 07 7;20(7):e395-e398. Epub 2020 Apr 7.

Levine Cancer Institute, Concord, NC.

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http://dx.doi.org/10.1016/j.clml.2020.03.014DOI Listing
July 2020

Safety and Cost Benefits of the Rapid Daratumumab Infusion Protocol.

Clin Lymphoma Myeloma Leuk 2020 08 7;20(8):526-532.e1. Epub 2020 Mar 7.

Plasma Cell Disorders Division, Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute/Atrium Health, Charlotte, NC. Electronic address:

Introduction: Daratumumab is approved for the treatment of multiple myeloma in both frontline and relapsed/refractory settings. Its major limitation is the long infusion time, especially with the first dose. Recent data demonstrated the feasibility of infusing daratumumab at an accelerated rate of 90 minutes starting from cycle 1 on day 15. Herein, we report the safety profile and cost associated with rapid daratumumab infusion protocol.

Patients And Methods: A chart review was performed to identify patients who completed at least 1 cycle of daratumumab (single agent or in combination) from April 2016 to October 2018. Patients were divided into 2 cohorts: cohort 1 received rapid daratumumab infusion after its implementation in March 2018, whereas cohort 2 included patients treated with daratumumab administered at the standard rate. The primary endpoint was to compare differences in rates of infusion-related reactions (IRRs). An Excel (Microsoft)-based model was developed to estimate cost and productivity.

Results: A total of 100 patients with relapsed/refractory disease were included in this study (53 in cohort 1 and 47 in cohort 2). Of the 53 patients in cohort 1, 18 (34%) received rapid daratumumab infusion starting with cycle 1. Overall, there was no statistically significant difference in rates of IRRs between cohort 1 and 2 (1.9% vs. 4.3%, P = .59); 1 patient in cohort 1 developed an IRR. The total costs estimated for a 52-week regimen of daratumumab infused at standard and rapid rates were $137,200 and $122,200 (P < .001), respectively.

Conclusion: Our findings indicate that rapid daratumumab infusion is safe and tolerable and provides cost savings for patients with relapsed/refractory disease.
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http://dx.doi.org/10.1016/j.clml.2020.02.014DOI Listing
August 2020

A Review of Growth Factor Support in Bloodless Autologous Hematopoietic Stem Cell Transplant.

Biol Blood Marrow Transplant 2019 10 8;25(10):e305-e309. Epub 2019 Jul 8.

Pennsylvania Hospital, Center for Bloodless Medicine and Surgery, Philadelphia, , Pennsylvania.

Bloodless autologous hematopoietic cell transplantation is associated with risks of severe bleeding and profound anemia. RBC or platelet transfusions are often used to prevent these hematologic complications. However, in patients such as Jehovah's Witnesses who refuse major blood components, the lack of transfusion support is not an absolute contraindication to an autologous hematopoietic cell transplant. Pennsylvania Hospital performed the world's first bloodless hematopoietic cell transplant more than 15 years ago and has gradually improved its technique with a sizable patient population. Erythropoiesis-stimulating agents were successfully employed as part of their pretransplant regimen to prevent severe anemia. Thrombopoietin agonists' potential role in bloodless transplant is also currently being explored. Although there is limited literature, available reports in combination with physiologic reasoning may support the use of these growth factors to promote transplant success. These agents offer potential benefit and may be of utility in minimizing complications of a bloodless transplant. In this review, we summarize the available literature and offer insight into how we may incorporate growth factors to allow bloodless autologous hematopoietic cell transplantation to be an available option to patients who may otherwise be denied.
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http://dx.doi.org/10.1016/j.bbmt.2019.07.003DOI Listing
October 2019

Enhancing the feasibility of outpatient daratumumab administration via a split-dosing strategy with initial doses.

Leuk Lymphoma 2019 09 8;60(9):2295-2298. Epub 2019 Mar 8.

Department of Hematologic Oncology and Blood Disorders, Atrium Health, Levine Cancer Institute , Charlotte , NC , USA.

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http://dx.doi.org/10.1080/10428194.2019.1576871DOI Listing
September 2019

Ibrutinib for the treatment of Bing-Neel syndrome, a complication of Waldenström macroglobulinemia: Patient case report.

J Oncol Pharm Pract 2019 Sep 13;25(6):1534-1539. Epub 2019 Feb 13.

2 Department of Oncology, Carolinas Healthcare System NorthEast, Levine Cancer Institute, Concord, NC, USA.

Bing-Neel syndrome is a rare complication of Waldenström macroglobulinemia, characterized by infiltration of lymphoplasmacytic cells to the central nervous system. Multiple treatment modalities exist including purine analogs, bendamustine, high-dose methotrexate, or high-dose cytarabine. Of interest, ibrutinib, a Bruton tyrosine kinase inhibitor has also displayed efficacy in Bing-Neel syndrome. Current literature is limited for the treatment of Bing-Neel syndrome considering its rarity, and while ibrutinib is indicated for the treatment of Waldenström macroglobulinemia, it is utilized off-label for treatment of Bing-Neel syndrome. Additionally, debate exists regarding the recommended dosing strategy for ibrutinib for this indication with disease remission demonstrated at 560 mg and 420 mg. We present a case report that provides additional evidence for this debate with a patient who received 560 mg of ibrutinib initially and maintained disease control despite a dose reduction to 420 mg for tolerability. Ultimately, more data are needed to develop standardized Bing-Neel syndrome treatment strategies with specific consideration to the use of ibrutinib in this condition.
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http://dx.doi.org/10.1177/1078155219830162DOI Listing
September 2019

Daratumumab, pomalidomide, and dexamethasone as a bridging therapy to autologous stem cell transplantation in a case of systemic light-chain amyloidosis with advanced cardiac involvement.

J Oncol Pharm Pract 2019 Jun 26;25(4):1021-1025. Epub 2018 Nov 26.

2 Department of Hematologic Oncology and Blood Disorders, Levine Cancer Institute, Atrium Health, Charlotte, NC, USA.

Systemic light-chain (AL) amyloidosis is a rare hematologic disorder where proteins infiltrate tissues leading to organ failure and death. Cardiac involvement, present in ∼70% of patients, determines stage and prognosis of the disease, with advanced involvement having a median survival of six months. The treatment of light-chain amyloidosis is directed at recovering organ function with therapeutic strategies following those of multiple myeloma with plasma cell-directed therapies. The use of single agent daratumumab has been reported in light-chain amyloidosis achieving rapid and deep responses. The combination of daratumumab, pomalidomide, and dexamethasone (DaraPomD) is particularly interesting for severe AL based on success in multiple myeloma. A 43-year-old female with light-chain amyloidosis and concomitant multiple myeloma presented with severe bowel dysmotility causing abdominal pain, anemia, and a 100-pound unintentional weight loss. A combination of cyclophosphamide, bortezomib, and dexamethasone was initiated but after five cycles her symptoms were progressing and therapy was switched to DaraPomD to optimize response. At the conclusion of two cycles she had achieved an amyloid complete-hematologic response, with her recurring ileus and abdominal pain significantly improved. Additionally, cardiac markers also suggested a rapid response without a common paradoxical worsening of congestive heart failure, and was overall well tolerated. Given the severe symptoms and refractory nature of our patient's disease DaraPomD was reasonable. With the tolerability and response seen, this patient experience supports a formal clinical trial evaluating the safety and efficacy of DaraPomD in light-chain amyloidosis.
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http://dx.doi.org/10.1177/1078155218815305DOI Listing
June 2019

Transitioning historically inpatient chemotherapy regimens for hematologic malignancies to the ambulatory care setting.

Am J Health Syst Pharm 2018 Nov 21;75(22):1824-1830. Epub 2018 Aug 21.

Department of Pharmacy, Levine Cancer Institute, Atrium Health, Charlotte, NC.

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http://dx.doi.org/10.2146/ajhp180060DOI Listing
November 2018

Incidence and management of adverse events associated with panobinostat in the treatment of relapsed/refractory multiple myeloma.

J Oncol Pharm Pract 2019 Apr 31;25(3):613-622. Epub 2018 Jul 31.

2 Emory University School of Medicine, Winship Cancer Institute of Emory University, Atlanta, GA, USA.

Multiple myeloma is a plasma cell neoplasm that has seen impressive improvements in outcomes in recent years with combination therapies, such as proteasome inhibitors and immunomodulatory drugs. Histone deacetylase inhibition is an additional unique mechanism of action with established biological relevance in multiple myeloma. Panobinostat is the first histone deacetylase inhibitor indicated for the treatment of relapsed/refractory multiple myeloma in patients who have received at least two prior regimens, including bortezomib and an immunomodulatory agent. While the addition of panobinostat to bortezomib and dexamethasone has demonstrated response and progression-free survival benefits, the incidence and severity of adverse events associated with it can create a challenge for clinicians and patients. Specifically, diarrhea, myelosuppression, an increased risk for infectious complications, cardiotoxicity, and nausea/vomiting may be seen with use. The frequency and grade of adverse event occurrence may differ between doses and schedule of panobinostat as well as with different companion therapies and routes. Herein we discuss the incidence, severity, and practical management of adverse events associated with panobinostat in the treatment of relapsed/refractory multiple myeloma.
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http://dx.doi.org/10.1177/1078155218788706DOI Listing
April 2019

Implementation of a longitudinal early immersion student pharmacist health system internship program.

Curr Pharm Teach Learn 2017 05 12;9(3):421-426. Epub 2017 Apr 12.

University of North Carolina Medical Center and Chatham Hospital, Division of PACE, UNC Eshelman School of Pharmacy, 101 Manning Dr., CB #7600, Chapel Hill, NC 27514, United States. Electronic address:

Purpose: The initiation, implementation, and benefits of a longitudinal early immersion student pharmacist health system internship are described.

Educational Activity: A two-year longitudinal internship experience was implemented to provide exposure into distributional operations, direct patient care activities, and health-system pharmacy administration. The intent of the program was to create an opportunity for student pharmacists to enhance the quality of their education with practical experience by immersing them early in their careers within the healthcare system. Early in their academic training the student interns were exposed to a broad range of services and programs while contributing longitudinally to the service line through quality improvement projects and distributional operations. The first year primarily focuses on distributional operations with direct patient care shadowing, while the second year targets intern involvement in hematology/oncology direct patient care activities. In this role, they are able to serve as pharmacist extenders.

Summary: Our comprehensive, longitudinal two-year health-system pharmacy internship program offers student pharmacists a unique early immersion experience that builds upon itself throughout their didactic training but is outside of the academic requirements. Students are exposed to distributional operations, direct patient care activities, and health system pharmacy administration prior to APPE rotations.
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http://dx.doi.org/10.1016/j.cptl.2017.01.011DOI Listing
May 2017

A clinical pharmacy pilot within a Precision Medicine Program for cancer patients and review of related pharmacist clinical practice.

J Oncol Pharm Pract 2019 Jan 27;25(1):179-186. Epub 2017 Oct 27.

3 Bone Marrow Transplantation, Wake Forest Baptist Medical Center, Winston-Salem, USA.

Purpose: The implementation, benefits, and challenges of clinical pharmacist services within a Precision Medicine Program for cancer patients are described. By relating the practice model that was developed, this report may further encourage pharmacists at cancer centers nationally to be involved and lead precision-based care in the oncology setting.

Summary: A clinical pharmacist was integrated into a Precision Medicine Program for oncology patients using somatic testing to identify actionable mutations and apply targeted therapy to malignancies. This pharmacist served as a drug resource for the program's molecular tumor board and oncologists seeking precision-based oncologic strategies. The pharmacist was a facilitator of drug assistance and dispensing in collaboration with the specialty pharmacy and provided care to 14 oncology patients receiving precision-based therapies. The clinical pharmacist was readily accepted as an addition to the team by both oncologists and patients and the experience served as an important learning opportunity.

Conclusion: The success of integrating this precision medicine pharmacist into a newly formed Precision Medicine Program and the model it can serve as may be considered for other cancer centers that may or may not have easily accessible pharmacogenomic experts and resources. This service highlights the importance of pharmacist care in such a program and the various opportunities for integration. Oncology clinical pharmacists should seek to integrate into Precision Medicine Programs and systems directing this care and develop their knowledge and understanding of genomics to continue providing the highest level of cancer care as a pivotal member of the cancer care team.
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http://dx.doi.org/10.1177/1078155217738324DOI Listing
January 2019