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Functional Disability Predicts Mortality in Older Adults With Newly Diagnosed Multiple Myeloma

Source: Myeloma – Hematology Advisor

Among older adults with multiple myeloma (MM) receiving home health services, functional disability is a predictor of early mortality, according to research published in JCO Clinical Cancer Informatics.

“The care of patients with MM is often challenging because of the higher prevalence of vulnerabilities observed with advancing age, a risk factor associated with MM incidence,” the authors wrote in their report.

The researchers retrospectively evaluated the relationships between disability, treatment receipt, and survival outcomes in older adults with newly diagnosed MM using the US nationwide Surveillance, Epidemiology, and End Results (SEER)-Medicare data set. 

The study included adults aged ≥66 years diagnosed with MM from 2010 to 2017 who used home health services the year before diagnosis. At home health assessment, patients’ degree of functional disability was assessed using a composite score derived from items related to ability to complete activities of daily living. The primary outcome was overall mortality, and secondary outcomes included receipt of any MM therapy in the year after diagnosis, treatment type, and health care utilization.

A total of 37,280 adults aged ≥66 years were diagnosed with MM from 2010 to 2017. Of those, 18.2% used home health services in the year before diagnosis. Those who used home health services were categorized as having mild disability (34.5%), moderate disability (32.1%), and severe disability (33.3%).

Patients with moderate disability at assessment had similar receipt of MM-directed therapy as those with mild disability and similar health care usage after diagnosis as patients with severe disability. 

These individuals have greater early mortality than older adults with MM who did not previously receive [home health] services, potentially highlighting the utility of [home health] service receipt as a marker of individuals who will need more intensive support when starting therapy.

Patients who used home health services had a higher comorbidity burden (3 vs 2) and higher mortality (adjusted risk ratio [RR] for 3-year mortality, 1.59; 95% CI, 1.55-1.64) than those who did not use these services. Postdiagnosis mortality was higher among those with more severe functional disability before diagnosis (adjusted RR at 6-months: severe vs mild, 2.30; 95% CI, 2.05-2.58; moderate vs mild, 1.32; 95% CI, 1.22-1.43).

“These individuals [requiring home health services] have greater early mortality than older adults with MM who did not previously receive [home health] services, potentially highlighting the utility of [home health] service receipt as a marker of individuals who will need more intensive support when starting therapy,” the authors wrote. 

Limitations of the study included its retrospective nature, lack of distinction between individuals with clinically overt MM and those with presymptomatic smoldering MM, and assessment of newly diagnosed patients potentially receiving first-line therapy.

Disclosure: Some study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.  

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FDA Approves Denosumab Biosimilars Jubbonti and Wyost

Source: Myeloma – Hematology Advisor

The Food and Drug Administration has approved Jubbonti® (denosumab-bbdz) and Wyost® (denosumab-bbdz), the first interchangeable biosimilars to Prolia (denosumab) and Xgeva (denosumab), respectively.

Jubbonti is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. The Jubbonti approval also includes a Risk Evaluation and Mitigation Strategy program designed to inform prescribers of the risk of severe hypocalcemia in patients with advanced kidney disease. 

Wyost is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

For this approval, the FDA reviewed a comprehensive clinical data package, which included data from the phase 3 ROSALIA trial (ClinicalTrials.gov Identifier: NCT03974100). The study compared denosumab-bbdz to the reference product (Prolia) in 527 postmenopausal women with osteoporosis. Study participants were randomly assigned to receive the biosimilar or the reference product for up to 78 weeks of treatment. Findings showed the biosimilar denosumab was comparable to the reference product with regard to pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity.

The availability of Jubbonti and Wyost is still unclear as ongoing patent litigation precludes Sandoz from launching the products at this time.

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Recent Publications

Thromboembolic risk of carfilzomib or bortezomib in combination with lenalidomide and dexamethasone for newly diagnosed multiple myeloma: A comparative systematic review and meta-analysis

Am J Hematol. 2024 Mar 15. doi: 10.1002/ajh.27288. Online ahead of print. ABSTRACT Thrombosis represents a frequent and potentially severe complication in individuals diagnosed with multiple myeloma (MM). These events can be driven by both the disease as well as the therapies themselves. Overall,...