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Clinical and Serologic Responses After a Two-dose Series of High-dose Influenza Vaccine in Plasma Cell Disorders: A Prospective, Single-arm Trial.

ABSTRACT: Patients with multiple myeloma (MM) and other plasma cell disorders are highly susceptible to influenza infections, which are major causes of morbidity in this population, despite the routine administration of a seasonal influenza vaccination. Existing data are limited by small and retrospective studies, which suggest poor seroprotection rates of < 20% after standard influenza vaccination in patients with MM.Patients with plasma cell dyscrasia (n = 51) were treated with a 2-dose series of high-dose inactivated trivalent influenza vaccine during the 2014 to 2015 influenza season. Laboratory-confirmed influenza infections were identified through seasonal surveillance, sera were collected for influenza hemagglutination antibody inhibition (HAI) titer assays, and logistic regression models were used to identify the clinical correlates to the HAI serologic responses.Influenza vaccine was well tolerated, without any vaccine-related grade ? 2 adverse events. Only 3 patients (6%) experienced laboratory-confirmed influenza. The rates of HAI seroprotection against all 3 vaccine strains (A/California/7/2009 [H1N1] pdm09-like virus; A/Texas/50/2012 [H3N2]-like virus; and a B/Massachusetts/2/2012-like virus) increased from 4% at baseline to 49% and 65% after 1 and 2 doses, respectively. The risk factors associated with a lower likelihood of HAI serologic response included plasma cell disorder requiring therapy, less than a partial response found on disease response assessment, and active conventional chemotherapy. Alternatively, active therapy with an immunomodulatory drug alone or with a proteasome inhibitor was associated with a greater likelihood of an HAI serologic response.These data have demonstrated that, in contrast to the historically poor results with standard influenza vaccination, this novel high-dose booster vaccination strategy leads to high rates of seroprotection. Randomized controlled studies are needed to compare this novel strategy to the standard vaccination strategy.

SUBMITTER: Branagan AR

PROVIDER: S-EPMC5413398 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Clinical and Serologic Responses After a Two-dose Series of High-dose Influenza Vaccine in Plasma Cell Disorders: A Prospective, Single-arm Trial.

Branagan Andrew R AR Duffy Eamon E Albrecht Randy A RA Cooper Dennis L DL Seropian Stuart S Parker Terri L TL Gan Geliang G Li Fangyong F Zelterman Daniel D Boddupalli Chandra Sekhar CS Zhang Lin L Verma Rakesh R Ferencz Thomas M TM Dhodapkar Madhav V MV

Clinical lymphoma, myeloma & leukemia 20170307 5

<h4>Background</h4>Patients with multiple myeloma (MM) and other plasma cell disorders are highly susceptible to influenza infections, which are major causes of morbidity in this population, despite the routine administration of a seasonal influenza vaccination. Existing data are limited by small and retrospective studies, which suggest poor seroprotection rates of < 20% after standard influenza vaccination in patients with MM.<h4>Patients and methods</h4>Patients with plasma cell dyscrasia (n = ...[more]

PMID: 28343904

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Project description:BackgroundAcute musculoskeletal (MSK) pain is very common and associated with impaired productivity and high economic burden. Access to timely and personalized, evidence-based care is key to improve outcomes while reducing healthcare expenditure. Digital interventions can facilitate access and ensure care scalability.ObjectivePresent the feasibility and results of a fully remote digital care program (DCP) for acute MSK conditions affecting several body areas.MethodsInterventional single-arm study of individuals applying for digital care programs for acute MSK pain. Primary outcome was the mean change between baseline and end-of-program in self-reported Numerical Pain Rating Scale (NPRS) score and secondary outcomes were change in analgesic consumption, intention to undergo surgery, anxiety (GAD-7), depression (PHQ-9), fear-avoidance beliefs (FABQ-PA), work productivity (WPAI-GH) and engagement.ResultsThree hundred forty-three patients started the program, of which 300 (87.5%) completed the program. Latent growth curve analysis (LGCA) revealed that changes in NPRS between baseline and end-of-program were both statistically (p < 0.001) and clinically significant: 64.3% reduction (mean - 2.9 points). Marked improvements were also noted in all secondary outcomes: 82% reduction in medication intake, 63% reduction in surgery intent, 40% in fear-avoidance beliefs, 54% in anxiety, 58% in depression and 79% recovery in overall productivity. All outcomes had steeper improvements in the first 4 weeks, which paralleled higher engagement in this period (3.6 vs 3.2 overall weekly sessions, p < 0.001). Mean patient satisfaction score was 8.7/10 (SD 1.26).Strengths and limitationsThis is the first longitudinal study demonstrating the feasibility of a DCP for patients with acute MSK conditions involving several body areas. Major strengths of this study are the large sample size, the wide range of MSK conditions studied, the breadth of outcomes measured, and the very high retention rate and adherence level. The major limitation regards to the absence of a control group.ConclusionsWe observed very high completion and engagement rates, as well as clinically relevant changes in all health-related outcomes and productivity recovery. We believe this DCP holds great potential in the delivery of effective and scalable MSK care.Trial registrationNCT, NCT04092946 . Registered 17/09/2019.

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Dataset Information

Clinical and Serologic Responses After a Two-dose Series of High-dose Influenza Vaccine in Plasma Cell Disorders: A Prospective, Single-arm Trial.

Publications

Clinical and Serologic Responses After a Two-dose Series of High-dose Influenza Vaccine in Plasma Cell Disorders: A Prospective, Single-arm Trial.

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