scholarly journals A Retrospective Database Analysis of Treatment Pathways in US Medicare Patients with Multiple Myeloma Following Sequential Treatment with Lenalidomide and a Proteasome Inhibitor

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4963-4963
Author(s):  
Natalie Boytsov ◽  
Anissa Cyhaniuk ◽  
Gary Leung ◽  
Feng Wang ◽  
Cosmina Hogea ◽  
...  

Abstract Introduction: Although multiple myeloma (MM) is currently incurable, the survival rate has improved over the past decade. Despite advances in treatment, most patients will become refractory to treatment. Lenalidomide and proteasome inhibitors (PI) are frequently used in early MM treatment regimens; however, there is a need to further understand how follow-up treatments affect patient outcomes. The aim of this retrospective database analysis was to examine the demographics, clinical characteristics, treatment sequencing, and overall survival in US Medicare patients with MM who initiated any MM treatment after observed treatment with lenalidomide and a PI. Methods: Claims data from the Centers for Medicare and Medicaid Services (CMS) were assessed during the study period of January 1, 2016, through December 31, 2018. Medicare patients who were diagnosed with MM and had any MM therapy at least 28 days following treatment with lenalidomide and PI were eligible. The index date (ID) was the date of the first observed claim for any MM therapy as a next line of therapy (LOT) following treatment with lenalidomide and a PI. Patients were required to have ≥6 months of continuous enrollment prior to ID (baseline period). Patient data were assessed until health plan disenrollment, death, or end of study period (whichever occurred first). Results: This study identified a cohort of 6590 eligible Medicare patients with MM exposed to lenalidomide and a PI. The mean age (standard deviation) was 72 (8.0) years, and 53.0% of patients were male. The Southern United States showed the largest representation of patients in this population (37.0%). The top baseline comorbidities included osteoarthritis (83.0%), hypertension (76.9%), anemia (76.7%), and respiratory infections (75.7%). PIs used in the lenalidomide/PI combination in the baseline period included bortezomib (67%), carfilzomib (30%), and ixazomib (29%). A patient could have received one or more of these PIs. Of the 6590 patients who received index therapy, 51% had triplet therapy, 35% had doublet therapy, 10% had monotherapy, 3% had quad therapy, and <1% had another combination. Among the 78% patients with a post-index LOT, 37% had triplet therapy, 37% had doublet therapy, 22% had monotherapy, 4% had quad therapy, and <1% had another combination. The most common therapies during the follow-up were dexamethasone (88%), lenalidomide (73%), bortezomib (45%), pomalidomide (31%), and daratumumab (31%). Patients could have received one or more of these therapies in the follow-up period. Overall, 4,788 (73%) patients were retreated with lenalidomide and 5,613 (85%) patients were retreated with a PI during the follow-up period. Between the ID and the end of study period, 24.4% of patients died. The median (range) time to death was 211 (1─890) days from ID. Conclusions: This study showed there was wide variation in subsequent treatment strategies following lenalidomide/PI exposure. After exposure, patients were most often treated with triplet therapies, and there was frequent re-treatment with previously used agents and/or classes. These results highlight the need for novel treatments/classes of therapy and sequencing strategies that may improve outcomes in patients with MM. Funding: GSK (Study 213462) Disclosures Boytsov: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Cyhaniuk: STATinMED Research: Current Employment. Leung: STATinMED Research: Current Employment. Wang: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Hogea: GlaxoSmithKline, paid employee: Current equity holder in publicly-traded company, Ended employment in the past 24 months. Mudumby: STATinMED Research: Current Employment.

Blood ◽  
2021 ◽  
Vol 138 (Supplement 1) ◽  
pp. 4019-4019
Author(s):  
Natalie Boytsov ◽  
Anissa Cyhaniuk ◽  
Gary Leung ◽  
Feng Wang ◽  
Cosmina Hogea ◽  
...  

Abstract Introduction: Recentreal-world data for multiple myeloma (MM) treatment patterns and outcomes are limited, particularly for patients with refractory or relapsed MM. As the MM treatment landscape evolves, it is important to understand how new treatments are integrated into patient treatment patterns. The aim of this study was to examine patient demographics, clinical characteristics, treatment patterns, and survival among Medicare patients with MM following exposure to daratumumab (DAR), an immunomodulatory agent, and a proteasome inhibitor (PI). Methods: This was a retrospective database analysis utilizing the Centers for Medicare and Medicaid Services claims data during the study period of January 1, 2016, through December 31, 2018. The start of the study period was chosen to align with DAR market entry in the United States (FDA approval November 2015). Medicare patients, diagnosed with MM, and with existing claims for DAR, an immunomodulatory agent, and a PI (tri-exposure) were eligible for inclusion. Index tri-exposure was achieved once a patient had been exposed to all 3 MM treatments, regardless of their sequence. The index date was the first observed claim for any MM regimen (index line of therapy [LOT]) following tri-exposure. Patients were required to have ≥6 months of continuous enrollment prior to the index date (baseline period). Therapies given after the index LOT were defined as post-index therapy. Patient data were assessed until health plan disenrollment, death, or end of study period, whichever occurred first. Results: There were 1336 Medicare patients with MM who met the inclusion criteria. Of these patients, the mean age (standard deviation [SD]) at the index date was 71 (8.5) years and 705 (52.8%) were male. The Southern United States showed the largest representation of patients in this population (n=471, 35.3%). The top baseline comorbidities included respiratory infections (98.3%), osteoarthritis (86.8%), anemia (86.9%), hypertension (78.1%), dyslipidemia (66.5%), chronic pain/fibromyalgia (51.9%), acute or chronic kidney disease (44.5%), cardiac arrhythmia (45.81%), and neutropenia (47.98%). The mean (SD) number of days from the index date until the end of index LOT was 48.7 days (12.0). Among 949 patients (71.0%) who had post-index therapy, the mean (SD) time from the last observed claim for index LOT to the beginning of the post-index therapy and duration of post-index therapy was 51.8 (44.2) days and 57.8 (16.0) days, respectively. The median (range) duration of follow-up time from the index date was 223 (3─886) days. During the study follow-up period, 571 patients (42.7%) died, and the median (range) number of days from the index date until death was 173 (3─873) days. While there was variation in treatment sequencing leading to tri-exposure, the most frequent tri-exposure sequence was an immunomodulatory agent < PI < DAR (33.2% [See Table for overview of treatment sequencing]). Among patients who received index LOT following tri-exposure, 49.4% had triplet therapy and 29.8% had doublet therapy. The most common index LOT regimens were triplet: DAR/pomalidomide/dexamethasone (DEX; 7.6%), elotuzumab/lenalidomide/DEX (5.2%), and DAR/bortezomib/DEX (4.9%). The most common post-index LOT regimens were triplet (39.9%): DAR/pomalidomide (6.1%), carfilzomib/cyclophosphamide/DEX (3.7%), DAR/bortezomib/DEX (3.5%), and DAR/lenalidomide/DEX (3.5%). During follow-up, 52.8% of patients were retreated with DAR, 79% with PI, and 77.3% with immunomodulatory drugs. Conclusions: This study suggests wide variation in treatment sequencing and regimens after tri-exposure to DAR, an immunomodulatory agent, and a PI. Triplet regimens were predominant treatment after the tri-exposure and following the index LOT. Retreatment with the same agents was common. Among those who died, survival was often less than 1 year following tri-exposure. These results highlight the need for new treatment options in triple-class refractory MM settings. Funding: GSK (Study 213462) Figure 1 Figure 1. Disclosures Boytsov: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Cyhaniuk: STATinMED Research: Current Employment. Leung: STATinMED Research: Current Employment. Wang: GlaxoSmithKline: Current Employment, Current equity holder in publicly-traded company. Hogea: GlaxoSmithKline, paid employee: Current equity holder in publicly-traded company, Ended employment in the past 24 months. Mudumby: STATinMED Research: Current Employment.


Blood ◽  
2020 ◽  
Vol 136 (Supplement 1) ◽  
pp. 17-18
Author(s):  
Fredrik Borgsten ◽  
Xenia Gatopoulou ◽  
Marta Pisini ◽  
Magnus Tambour ◽  
Frida Schain ◽  
...  

Background In the last decades the introduction of novel drugs has greatly improved the prognosis of multiple myeloma (MM) patients. We have investigated healthcare resource utilization and sickness absence-associated productivity loss over time in a population-wide, retrospective registry study in Sweden. Methods 8,693 patients were identified in the National Cancer Register with a MM diagnosis from July 2001 to December 2015 and followed until 2016. Specialized healthcare usage (inpatient admissions and outpatient visits) were obtained from the Patient Register and costs were estimated by weighted DRG codes. For patients under 66 years of age, sickness absence and salary information were obtained by linkage to the LISA Register. Analyses were performed separately on patients who underwent autologous stem cell transplantation (ASCT) (n=1,425) and on non-transplanted patients (n=7,012) and stratified by diagnosis periods 2001-2005, 2006-2010 and 2011-2015 to reflect increased introduction of effective drugs into clinical care. Median age was 60 years in the ASCT group and 75 years in the non-ASCT group. Results The number of MM patients that underwent ASCT increased over time (n= 282 in 2001-2006 to n= 592 in 2011-2015). MM patients diagnosed most recently had improved overall survival (OS), with five-year OS rate increasing from 52% to 58% to 62% for patients diagnosed in 2001-2005, 2006-2010 and 2011-2015, respectively (p<0.0001). Patients diagnosed during 2011-2015 spent on average 20% and 9% less total time in specialized healthcare than patients diagnosed during 2001-2005 and 2006-2010, respectively (adjusting for sex, age at ASCT, weighted comorbidity score at ASCT and per follow-up year and education at ASCT). This decrease was driven by less usage and time in both inpatient and outpatient care. Adjusted sickness absence time decreased by 41% and 38% in the third follow-up year for patients diagnosed during 2011-2015 compared to patients diagnosed during 2001-2005 and 2006-2010, respectively. Productivity loss costs represented about 45% of total costs (healthcare resource costs ~55%) in the first two follow-up years, but decreased over time. The cumulative median per person cost (healthcare- and productivity-related) over the three follow-up years post-diagnosis decreased by 21% in 2011-2015 (€52,273) compared to 2001-2005 (€66,182), despite an 8% increase in three-year OS over the same period. The number of non-ASCT MM patients also increased over time (n=2,053 in 2001-2005 to n= 2,587 in 2011-2015). Median survival increased from 2.5 years to 3.4 years for patients diagnosed during 2001-2005 compared to 2011-2015. Average total time spent in specialized healthcare was reduced by 29% and 12% for patients diagnosed during 2011-2015, compared to patients diagnosed during 2001-2005 and 2006-2010, respectively (adjusting for sex, age at diagnosis, weighted CCS at diagnosis, weighted CCS per follow-up year and education at diagnosis). This was associated with decreased need for inpatient care and a shift towards more outpatient usage. By the third follow-up year, the adjusted sickness absence time in patients diagnosed during 2011-2015 was reduced by 44% and 23% compared to patients diagnosed in 2001-2005 and 2006-2010, respectively. Productivity loss accounted for approximately 15% of total costs (healthcare resource costs ~85%) and was stable over follow-up years. The cumulative median per-person cost (healthcare- and productivity-related) over three follow-up years was similar for patients diagnosed in 2001-2005 (€25,621) and 2011-2015 (€26,592), despite a 12% increase in three-year OS over the same period. Conclusion The availability of new treatment options for MM patients in Sweden over time was associated with less healthcare usage, less time spent in healthcare and lower productivity loss due to sickness absence for both ASCT and non-ASCT-treated patients. These improved clinical and economic outcomes provide policy makers, healthcare providers and physicians with invaluable real-world insights for cost-benefit considerations in the continued development and introduction of effective treatments for MM. Figure 1 Disclosures Borgsten: Janssen: Current Employment. Gatopoulou:Janssen: Current Employment. Pisini:Janssen: Current Employment. Tambour:Janssen: Current Employment, Current equity holder in publicly-traded company. Schain:Schain Research: Current Employment, Current equity holder in private company, Membership on an entity's Board of Directors or advisory committees; Janssen: Consultancy, Divested equity in a private or publicly-traded company in the past 24 months, Ended employment in the past 24 months. Jones:Schain Research: Current Employment. Kwok:Schain Research: Other: Internship . Hjortsberg:Janssen: Current Employment.


2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Ian Matthews ◽  
Xiaoyan Lu ◽  
Qian Xia ◽  
Wynona Black ◽  
Bayad Nozad

Abstract Background In the UK certain groups with pre-disposing conditions are eligible for vaccination with the pneumococcal polysaccharide vaccine (PPV23). Uptake of the vaccine in these individuals has not been reported for 10 years. Hence this study investigated the rates of pneumococcal vaccination, the time to vaccination since diagnosis, and factors associated with vaccination in individuals aged 18–64 years with certain underlying medical conditions. Methods A retrospective database analysis was conducted using the Clinical Practice Research Datalink (CPRD). Individuals aged 18 to 64 years who had a diagnosis for underlying medical conditions of interest at the index date (January 1, 2011 to December 31, 2015) were included in this study. Both underlying conditions and pneumococcal vaccination were identified using Read codes. A multivariable logistic regression model was used to identify factors associated with pneumococcal vaccination. Results A total of 99,153 individuals with underlying medical conditions were included in this study. Within 1 year of follow-up, 13.6% had received pneumococcal vaccination. This figure rose to 32.0% after 4 years of follow-up. The mean time between diagnosis and vaccination was 148.7 days across the overall cohort. Based on multivariate analysis of results, individuals with chronic heart disease, chronic kidney disease, chronic liver disease, chronic respiratory disease or diabetes mellitus were significantly less likely (P < 0.0001) to be vaccinated than those with immunosuppression. Individuals were significantly more likely to receive a pneumococcal vaccination if they received an influenza vaccination in the first year of follow-up than those who did not (P < 0.001). Conclusions Despite the Joint Committee on Vaccination and Immunisation (JCVI) recommendations for pneumococcal vaccination in clinical risk groups, rates of pneumococcal vaccination are suboptimal in the UK for individuals aged 18–64 with underlying medical conditions. Further emphasis should be made on the importance of increased pneumococcal vaccination coverage in the UK, given the increased risk of morbidity and mortality associated with indicative underlying medical conditions.


Blood ◽  
2009 ◽  
Vol 114 (22) ◽  
pp. 4944-4944
Author(s):  
Donna Spencer ◽  
Satyin Kaura ◽  
Jose Ricardo Perez ◽  
Henry J Henk

Abstract Abstract 4944 Background MM patients with BM may be treated with a variety of anti-cancer and bone treatments. The purpose of this study was to examine the use of ZOL, a therapy administered intravenously to reduce or delay skeletal complications, in the real-world treatment of adult patients with MM and BM. Of special interest to the study was the use of ZOL in the context of bortezomib (BOR) and lenalidomide (LEN). Methods Claims-based analysis of commercial and Medicare data from a large US managed care plan and a 45-health plan database was conducted to examine the use of ZOL in the treatment of adult patients (18 years and older) with MM and BM. Patients with at least one claim for ZOL and evidence of MM diagnosis and BM diagnosis were included. The identification period was 7/1/03 – 7/31/08 for the large US commercial health plan, 7/1/03 – 12/31/07 for the Medicare plan, and 7/1/04 – 6/30/08 for the 45-health plan database. The sequencing, number, and duration of ZOL treatments were analyzed. Continuous enrollment in the health plan for six months before and three months following the index date was required. Patients were followed until they disenrolled from the plan (including due to death), or the end of the study's follow-up period. Results The study sample included 8,632 of which 4,260 patients were enrolled in their health plan for at least one year following ZOL initiation, with a median follow-up length of 21.2 months (range = 12 months to 5.3 years). Among the 4,260 patients, 38.7% were men, the mean age was 60.7 ± 11.9 years, and the average Charlson comorbidity index score was 5.4 (SD=2.2). Accounting for variable follow-up during the study period, patients had an average of 7.01 ZOL administrations per person year. Approximately 63.5% (n=2,707) patients were still receiving ZOL at the end of the first year following ZOL initiation. The majority of patients (90.2%, n=3,841) treated with ZOL were not treated with either BOR or LEN. Approximately 93.0% of these cases received other types of anti-cancer treatments (e.g., melphalan, thalidomide, prednisone, and other chemotherapies) at some point during the study period. For 345 (8.1%) patients, BOR or LEN initiation followed the start of ZOL, and 185 (53.6%) of these cases started BOR or LEN within the first year following initiation of ZOL. Among those initiating BOR or LEN, the median time from ZOL initiation was 337 days (range = 5 to 1,594 days). In 19 (0.4%) cases, ZOL was started at the same time as BOR or LEN, and in 55 (1.3%) cases, ZOL treatment followed BOR or LEN initiation. Conclusions According to this retrospective database analysis, the vast majority of patients with MM and BM who initiate ZOL do not go on to receive BOR or LEN within the year following ZOL initiation. Among patients enrolled in the health plan for at least one year following ZOL initiation, the majority of patients remained on ZOL treatment. As anticipated, this study showed that the overwhelming proportion of MM patients with BM using ZOL were being treated with anti-cancer therapies, but only approximately 10.0% with either BOR or LEN. Disclosures Kaura: Novartis: Employment, Equity Ownership. Perez:Novartis: Employment, Equity Ownership.


Author(s):  
Bader Hamza Shirah ◽  
Hamza Assad Shirah

<p class="abstract"><strong>Background:</strong> Graves' disease is an autoimmune disease that affects the thyroid gland and frequently results in hyperthyroidism and an enlarged thyroid. Treatment of Graves' disease includes antithyroid drugs, radioiodine (radioactive iodine I-131), and thyroidectomy, either total, or subtotal excision. In this paper, we aim to analyse the outcome of thyroidectomy performed on patients affected by Graves' disease in Medina – Saudi Arabia, and evaluate if thyroidectomy should be considered the first treatment option for all patients with Graves' disease.</p><p class="abstract"><strong>Methods:</strong> A retrospective database analysis of the surgical treatment outcome of 574 Saudi Arabian patients who were affected with Graves' disease between January 2003 and December 2012 was done. The computerized database medical records were reviewed and analysed for preoperative, intraoperative, and postoperative factors.  </p><p class="abstract"><strong>Results:</strong> 194 (33.8%) patients were males, and 380 (66.2%) were females. The average age of patients was 44 ± 2 years. 154 (26.8%) had subtotal thyroidectomy, and 420 (73.2%) had total thyroidectomy performed. There was (0%) recurrent laryngeal nerve injury, and (0%) intraoperative complication were recorded. With a follow up time of 2 years, 7 (1.22%) patients developed recurrent disease (all in subtotal thyroidectomy group). There were no recurrences in the total thyroidectomy patients, and 11 (1.9%) patients were found in histopathology to have papillary thyroid cancer (all in total thyroidectomy group).</p><p><strong>Conclusions:</strong> We conclude that total thyroidectomy is a safe and effective treatment modality for Graves' disease that offers rapid and long-lasting results, in addition to eliminating the risk of recurrence and malignancy. It should be offered to all confirmed Graves' disease patients during counselling.</p>


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