Your browser doesn't support javascript.
loading
Show: 20 | 50 | 100
Results 1 - 20 de 31
Filter
1.
J Prev Alzheimers Dis ; 11(3): 537-548, 2024.
Article in English | MEDLINE | ID: mdl-38706270

ABSTRACT

BACKGROUND: Monoclonal antibodies that target amyloid-beta and remove amyloid plaques can slow cognitive and functional decline in early Alzheimer's disease. Gantenerumab is a subcutaneously administered fully-human anti-amyloid-beta monoclonal antibody with highest affinity for aggregated amyloid-beta. Since the phase 3 GRADUATE trials did not meet the primary endpoint (change from baseline to Week 116 in Clinical Dementia Rating scale - Sum of Boxes), development of gantenerumab in sporadic Alzheimer's disease was stopped and all ongoing trials were terminated early due to sponsor decision. Subcutaneous administration at the clinic or at home by care partner would be an important option for other therapies in this class in order to increase flexibility and reduce overall burden. The insights obtained from the experience with gantenerumab home administration by care partner in the phase 2 GRADUATION trial will serve to guide the ongoing efforts with other anti-amyloid-beta antibodies. OBJECTIVES: To evaluate the pharmacodynamic effects on brain amyloid load of once weekly subcutaneous administration of gantenerumab and the safety and feasibility of home administration by care partners. DESIGN: Phase 2, open-label, single arm study. SETTING: Multicenter trial conducted in 33 sites in 8 countries from November 2020 to March 2023. PARTICIPANTS: Participants aged 50 to 90 with early symptomatic Alzheimer's disease (mild cognitive impairment/mild dementia due to Alzheimer's disease), and evidence of amyloid positron emission tomography positivity. INTERVENTION: Participants could receive up to 255 mg gantenerumab once-weekly, administered subcutaneously at site or at home by healthcare professionals or non-healthcare-professional care partners. MEASUREMENTS: The primary endpoint was the change from baseline to Week 52 and to Week 104 in brain amyloid load as measured by PET centiloid levels. The secondary endpoints were responses to the home administration questionnaire, plasma concentrations and safety. RESULTS: The overall number of participants enrolled was 192, with a mean (standard deviation) amyloid PET load at baseline of 101.80 (29.80) centiloids. At the time of early study termination by sponsor, 149 participants had valid Week 52 amyloid PET data (primary endpoint), and 12 participants had an early termination PET within the pre-defined time range of Week 104. The mean change in amyloid PET from baseline to Week 52 and Week 104 was -26.19 centiloids (range: -75.6-15.8; n=149) and -35.48 centiloids (range: -63.2--7.0; n=12), respectively. Responses to the home administration questionnaire at Week 52 (n=148) indicated that the majority of care partners (88-97%) considered administration of study drug at home easy (30.4%) or very easy (57.4%), and convenient (25.7%) or very convenient (70.9%). Care partners felt confident (31.1%) or very confident (62.2%) and satisfied (29.7%) or very satisfied (64.9%) with giving the injection at home. Responses by care partners at Week 36 (n=72), Week 76 (n=126) and Week 104 (n=29) and participant (patient) assessment of convenience and satisfaction at these time points were similar. There were no new safety findings associated with gantenerumab administered subcutaneously once weekly at 255 mg or safety issues associated with at-home injections by non-healthcare professional care partners. CONCLUSIONS: Once-weekly subcutaneous home administration of the anti-amyloid-beta antibody gantenerumab by non-healthcare-professional care partners to participants with early Alzheimer's disease was feasible, safe, well tolerated, and considered as a convenient option by both the care partners and participants with Alzheimer's disease. Although gantenerumab's development has been stopped due to lack of efficacy, this approach has the potential to reduce the frequency of hospital/outpatient clinic visits required for treatment with other anti-amyloid-ß antibodies and can increase flexibility of drug administration for people living with Alzheimer's disease and their families.


Subject(s)
Alzheimer Disease , Antibodies, Monoclonal, Humanized , Feasibility Studies , Humans , Alzheimer Disease/drug therapy , Antibodies, Monoclonal, Humanized/administration & dosage , Antibodies, Monoclonal, Humanized/therapeutic use , Aged , Female , Male , Caregivers , Positron-Emission Tomography , Amyloid beta-Peptides/metabolism , Injections, Subcutaneous , Brain/drug effects , Brain/metabolism , Brain/diagnostic imaging , Middle Aged , Aged, 80 and over
2.
Front Oncol ; 14: 1335344, 2024.
Article in English | MEDLINE | ID: mdl-38434688

ABSTRACT

The diagnosis and treatment of cancer impose a significant emotional and psychological burden on patients, families, and caregivers. Patients undergo several interventions in a hospital setting, and the increasing number of patients requiring extended care and follow-up is driving the demand for additional clinical resources to address their needs. Hospital at Home (HaH) teams have introduced home-administered oncologic therapies that represent a new model of patient-centered cancer care. This approach can be integrated with traditional models and offers benefits to both patients and healthcare professionals (HCPs). Home-administered treatment programs have been successfully piloted globally, demonstrated as a preferred option for most patients and a safe alternative that could reduce costs and hospital burden. The document aims to establish the minimum recommendations for the home administration of oncologic therapies (ODAH) based on a national expert agreement. The expert panel comprised seven leading members from diverse Spanish societies and three working areas: clinical and healthcare issues, logistical and administrative issues, and economic, social, and legal issues. The recommendations outlined in this article were obtained after a comprehensive literature review and thorough discussions. This document may serve as a basis for the future development of home-administered oncologic therapy programs in Spain. .

3.
J Appl Gerontol ; 43(6): 688-699, 2024 06.
Article in English | MEDLINE | ID: mdl-38173136

ABSTRACT

Objective: To explore skilled nursing facility (SNF) administrator retrospective perspectives on their preparation for and initial implementation of the Patient Driven Payment Model (PDPM), the new Medicare payment system for SNFs enacted on October 1, 2019. Methods: 156 interviews at 40 SNFs in eight U.S. markets were conducted and qualitatively analyzed. Results: Administrators retrospectively expressed feeling well-prepared for the PDPM implementation. Advance preparation focused on training staff regarding patient assessment and documentation. Administrators also recognized increased incentives for admitting patients with more complex needs and prepared accordingly. Therapy staffing reductions were concentrated in contract employees, while SNF-employed therapists were less affected. Conclusion: Policy makers and industry experts should consider the long-term impact of changing financial incentives through payment reform, and ensure that reimbursement best reflects the cost of providing services while prioritizing high-quality care. PDPM's effect on care quality and access to care should continue to be monitored.


Subject(s)
Medicare , Skilled Nursing Facilities , Humans , Skilled Nursing Facilities/economics , Skilled Nursing Facilities/organization & administration , United States , Medicare/economics , Retrospective Studies , Reimbursement Mechanisms , Qualitative Research , Interviews as Topic , Quality of Health Care
4.
J Appl Gerontol ; 43(6): 706-715, 2024 06.
Article in English | MEDLINE | ID: mdl-38102567

ABSTRACT

The COVID-19 pandemic created challenges for U. S. nursing home administrators (NHA) and staff. This study explored organizational and psychological factors associated with NHA stress, dissatisfaction, and turnover intent (TI) during the third year of the pandemic. Results from a nationwide, cross-sectional survey of 1139 NHAs were merged with Centers for Medicare and Medicaid Services nursing home survey deficiency, staffing, complaint, and other operations data. A hierarchical, generalized estimating equations model with ordered logit link found that NHAs with higher COVID stress (AOR = 1.65, 95% CI = 1.22, 2.23), higher use of agency/contract staff (AOR = 1.50, 95% CI = 1.08.2.09) and higher role conflict were more likely to indicate TI. NHAs with higher job satisfaction in workload, work content, and rewards were less likely to hold TI. Industry leaders should create strategies to reduce NHA's job stress and role conflicts and provide opportunities for improving staff recruitment and retention, reducing reliance on agency staffing.


Subject(s)
COVID-19 , Job Satisfaction , Nursing Homes , Personnel Turnover , Humans , COVID-19/epidemiology , COVID-19/psychology , Nursing Homes/organization & administration , Cross-Sectional Studies , United States , Male , Female , SARS-CoV-2 , Occupational Stress/epidemiology , Adult , Middle Aged , Pandemics , Workload/psychology , Intention , Surveys and Questionnaires
5.
J Appl Gerontol ; 42(11): 2179-2188, 2023 11.
Article in English | MEDLINE | ID: mdl-37409575

ABSTRACT

Post-acute and long-term care (PALTC) delivery is complex, and the COVID-19 pandemic created additional complexities. This qualitative study investigates how PALTC administrators responded to the pandemic, factors that impacted their leadership role and decision-making. Participants from North Carolina (N = 15) and Pennsylvania (N = 6) were interviewed using an interview guide containing open-ended questions. The results revealed three themes: (1) critical knowledge and competencies; (2) resources, supports and essential actions taken; and (3) psychosocial impact. The findings suggest communication and relationship building were the most useful competencies. Lack of staff was a primary stress point during and after the pandemic.


Subject(s)
COVID-19 , Long-Term Care , Humans , Pandemics , Leadership , Qualitative Research
6.
J Neuroendocrinol ; 35(6): e13281, 2023 06.
Article in English | MEDLINE | ID: mdl-37290479

ABSTRACT

Lanreotide autogel/depot (LAN) is a somatostatin analog used in first-line treatment for neuroendocrine tumors (NETs). The aim of HomeLAN was to evaluate the satisfaction with injection experience among patients with NETs receiving at-home LAN injection via patient support programs (PSPs). This was an international, non-interventional, cross-sectional, online survey in adults with NETs enrolled in PSPs, receiving LAN injections at home, administered by a healthcare professional (HCP) or administered independently (self or caregiver administering injection). The primary endpoint was satisfaction with the most recent LAN injection. Secondary endpoints included the level of anxiety prior to injection, impact on daily life, and the extents to which participants felt in control of their life and agreed that home administration met their medical needs. In total, 111 participants from Belgium, Greece, the Netherlands, and Spain completed the survey (50.5% male; mean age, 63.6 years; most common primary tumor site was intestine [47.7%]). For 99 participants, their most recent injection was administered by an HCP. Overall, 95.5% of all participants were satisfied with their most recent injection experience (95% confidence interval: 89.89%-98.06%); 67% reported experiencing no anxiety prior to injection, 91.0% reported that home injection had a "great deal" or "quite a bit" of positive impact on their daily life, and 85.6% strongly agreed that the PSP met their medical needs. In the HCP injection subgroup, 71.7% reported that this mode of administration helped them to feel in control of their lives. In this patient survey, satisfaction levels were high among patients with NETs receiving LAN injections at home via a LAN PSP. Most patients did not experience anxiety prior to their most recent injection and acknowledged that thanks to their treatment they had a good quality of life despite their disease. Most strongly agreed that the PSP met their medical needs, which highlights the valuable service that LAN PSPs provide for patients with NETs.


Subject(s)
Neuroendocrine Tumors , Adult , Humans , Male , Middle Aged , Female , Neuroendocrine Tumors/pathology , Cross-Sectional Studies , Quality of Life , Patient Satisfaction
7.
J Appl Gerontol ; 42(7): 1611-1619, 2023 07.
Article in English | MEDLINE | ID: mdl-36703571

ABSTRACT

This study explored nursing home social services directors' interest in pursuing trauma-informed care (TIC) training, and individual and organizational characteristics associated with their interest. Data from the 2019 National Nursing Home Social Services Directors Survey, a national cross-sectional survey, were used. Measures sought information on participants' interest in TIC training, sociodemographic characteristics, and characteristics of employing nursing homes. Descriptive statistics and multivariate binary logistic regression analyses were used. Of the 924 respondents, 880 (95.2%) were included in the analysis. Most (71.7%) expressed high interest in TIC training. Younger age, fewer years of nursing home social services experience, being degreed and licensed in social work, and being a person of color were associated with greater odds of high interest in TIC training. Neither nursing home ownership nor social services staffing ratio was significantly associated with interest in TIC training. As policy requires TIC in nursing homes, these findings present a first step towards understanding implementation.


Subject(s)
Nursing Homes , Social Work , Humans , Cross-Sectional Studies , Surveys and Questionnaires , Social Work/education , Skilled Nursing Facilities
8.
Eur Ann Allergy Clin Immunol ; 55(1): 35-40, 2023 01.
Article in English | MEDLINE | ID: mdl-35261225

ABSTRACT

Summary: Introduction. Several biological agents for the treatment of severe asthma have been approved for self-administration on an outpatient basis in the last years. However, data on the impact of home administration in outcomes such as asthma control and quality of life in real-life settings are sparse. Being this knowledge crucial for clinical practice, this study aimed to assess asthma control and quality of life in patients who transitioned from day hospital administration of biological therapy to home administration. Methods. A single-center prospective analysis of 33 patients treated with biologics for severe asthma, who switched from hospital to home treatment was performed. Asthma Control Test (ACT), Control of Allergic Rhinitis and Asthma Test (CARAT), Asthma Life Quality (ALQ) and the number of exacerbations were assessed 3 months before and 3 and 6 months after of home-use. Results. ACT and CARAT did not show statistical differences comparing to the baseline values (21.8 ± 2.7 and 23.8 ± 5.5) within 3 months (22.1 ± 2.4, p = 0.609; 23.2 ± 5.3, p = 0.572) or 6 months (23.4 ± 0.9, p = 0.553; 23.7 ± 6.2, p = 0.149) of home administration. Also, ALQ score did not show meaningful variations between baseline (9.5 ± 3.2) and after 3 months (11.2 ± 4.4, p = 0.275) and 6 months (10.3 ± 3.8, p = 0.209) of home-use. Regarding asthma exacerbations, we did not record a significant difference comparing to the baseline values of 3 months/patient exacerbations (0.2 ± 0.4) and after 3 months (0.2 ± 0.5, p = 0.786) or 6 months (0.2 ± 0.4, p = 1.000) of change in modality treatment. There was no cases of anaphylaxis or other serious adverse effects in those patients treated at home. Conclusions. Transition of day hospital administration of biologic treatment for severe asthma to home administration did not lead to any deterioration of asthma control or quality of life. Our results emphasized the efficacy and safety of home administration of biologic treatment and provide support on changing the paradigm of the administration of biological treatment in severe asthma.


Subject(s)
Anti-Asthmatic Agents , Asthma , Rhinitis, Allergic , Rhinitis , Humans , Quality of Life , Asthma/diagnosis , Asthma/drug therapy , Asthma/chemically induced , Rhinitis, Allergic/drug therapy , Anti-Asthmatic Agents/therapeutic use , Anti-Asthmatic Agents/adverse effects
9.
Rev Clin Esp (Barc) ; 223(3): 154-164, 2023 03.
Article in English | MEDLINE | ID: mdl-36549642

ABSTRACT

BACKGROUND AND OBJECTIVE: Biologic therapies are known to reduce exacerbations and improve severe uncontrolled asthma management. The at-home administration of biologics has increased during the COVID-19 pandemic, but the characteristics of severe uncontrolled asthma patients who may benefit from at-home administration of biologic therapy have yet to be identified. MATERIALS AND METHODS: This project is based on the Delphi method, designed to reach an expert consensus through a multidisciplinary scientific committee addressing the following questions: clinical characteristics, treatment adherence, patient or caregiver administration ability, patient self-care, relationship with the healthcare professional, patient preference, and access to the hospital. RESULTS: One hundred and thirty-one healthcare professionals (pulmonologists, allergists, nurses, and hospital pharmacists) completed two Delphi consensus questionnaires. Fourteen items were identified as priority characteristics, the first five being: 1. The patient follows the healthcare team's indications/recommendations to control their disease, 2. The patient is capable of detecting any deterioration in their disease and of identifying exacerbation triggers, 3. The patient receives biologic therapy and has stable disease with no vital risk, 4. The patient takes responsibility for their self-care, 5. The patient has occupational/educational obligations that prevent them from going to the hospital regularly. CONCLUSION: Disease stability and control plus the ability to identify exacerbation triggers are the most important characteristics when opting for at-home administration for a patient with severe uncontrolled asthma on biologic therapy. These recommendations could be applicable in clinical practice.


Subject(s)
Asthma , Biological Products , COVID-19 , Humans , Consensus , Pandemics , Asthma/diagnosis , Asthma/drug therapy , Biological Products/therapeutic use
10.
Int J Cardiol ; 365: 69-77, 2022 10 15.
Article in English | MEDLINE | ID: mdl-35853499

ABSTRACT

BACKGROUND: End-stage heart failure (ESHF) is characterized by severe cardiac dysfunction with persistent disabling symptoms and recurrent acute decompensated heart failure (ADHF), despite guideline-directed medical therapy. The aim of this study was to evaluate the efficacy and safety of intravenous diuretics administration at home through a peripherally inserted central venous catheter (PICC) in ESHF patients. METHODS AND RESULTS: Forty-one ESHF patients received PICC implantation for intravenous diuretic administration at home. The primary efficacy endpoint was the patient-level number of HF hospitalizations in the short (1-3 months), medium (six months), and long term (1 year), before and after PICC implantation. Pre- and post-PICC ADHF-free days were also evaluated as co-primary endpoint. Secondary endpoints comprised changes in clinical, laboratory and echocardiographic parameters, and device safety. A cost-effectiveness analysis was performed to estimate the economic impact of using PICC. For each time frame analyzed, a significant reduction in the number of hospitalizations due to ADHF was observed, resulting in a significant increase in ADHF-free days (71 ± 44 vs. 163 ± 136, p = 0.003). In matched patients' analysis, significant decrease in body weight (68 ± 16 kg vs. 63 ± 10 kg, p = 0.041) and mitral regurgitation grade 3/4 (55% vs. 18%, p < 0.001) were also observed. Freedom from PICC-related complications was observed in 61% of patients. A significant reduction in overall ADHF-hospitalizations cost was observed. CONCLUSIONS: This proof-of-concept study demonstrates the effectiveness and safety of home administration of intravenous diuretic therapy via PICC in ESHF patients. This palliative cost-effective strategy can be taken in consideration for selected end-stage patients no longer responsive to conventional therapies.


Subject(s)
Catheterization, Central Venous , Catheterization, Peripheral , Central Venous Catheters , Heart Failure , Catheterization, Central Venous/adverse effects , Catheterization, Peripheral/adverse effects , Central Venous Catheters/adverse effects , Cost-Benefit Analysis , Diuretics/therapeutic use , Heart Failure/diagnosis , Heart Failure/drug therapy , Humans
11.
J Allergy Clin Immunol Pract ; 10(9): 2312-2323.e2, 2022 09.
Article in English | MEDLINE | ID: mdl-35487370

ABSTRACT

BACKGROUND: Biologics are an effective therapy for severe asthma. Home administration of biologics by patients is likely to facilitate their accessibility. Yet little is known about patients' and health care providers' (HCPs) perceptions regarding home administration of biologics. OBJECTIVE: The aim of this study is to create more insight into the perceptions and experiences of patients and HCPs regarding home administration of biologics in the context of the treatment of severe asthma. METHODS: A qualitative international study was performed in the Netherlands, United States, Australia, and United Kingdom. In each country, 2 focus groups were held with potential/recent and long-term users of biologics at home. Prior to the focus groups, patients were prompted with themes on online forums. For triangulation purposes, interviews were held with HCPs to discuss salient findings from forums and focus groups. Data were analyzed with qualitative content analysis. RESULTS: In total, 75 patients participated in the forums, of which 40 participated in the focus groups. Furthermore, 12 HCPs were interviewed. The following overarching themes were identified: living with severe asthma; practical aspects of using biologics; the role of HCPs regarding biologics; social support from family, friends, and others; effectiveness of biologics and other treatments; side effects of biologics. CONCLUSIONS: This study showed that, for those using biologics for severe asthma, the benefits of home administration of biologics usually outweigh inconvenience and side effects. Guided practice, accessible support contact, and monitoring including social support should be central in the transition from hospital to home administration of asthma biologics.


Subject(s)
Asthma , Biological Products , Asthma/drug therapy , Biological Products/therapeutic use , Health Personnel , Humans , Qualitative Research , Social Support
12.
J Appl Gerontol ; 41(7): 1695-1701, 2022 07.
Article in English | MEDLINE | ID: mdl-35439093

ABSTRACT

Urinary tract infections (UTIs) are the most common infections among nursing home (NH) residents. Antibiotics are often misused when a UTI is suspected. Using sophisticated information technology (IT) could help in appropriate UTI prevention, diagnosis, and treatment. This repeated cross-sectional study explored relationships between IT maturity and UTI prevalence among long-stay NH residents. Data were from (1) four annual surveys 2013-2017 measuring IT maturity in a random sample of Medicare-certified NHs, (2) Minimum Data Set assessments for resident characteristics, and (3) Certification and Survey Provider Enhanced Reporting data for facility characteristics. In multivariate regressions using NH fixed effects, controlling for resident and NH characteristics, Administrative IT maturity in NHs was associated with decreased odds of UTI (AOR: 0.906, 95% CI: 0.843, 0.973). These results were robust in all sensitivity analyses. Using IT to relieve administrative burden may decrease UTIs.


Subject(s)
Information Technology , Urinary Tract Infections , Aged , Cross-Sectional Studies , Humans , Medicare , Nursing Homes , United States/epidemiology , Urinary Tract Infections/diagnosis , Urinary Tract Infections/drug therapy , Urinary Tract Infections/epidemiology
13.
Expert Rev Respir Med ; 16(4): 419-428, 2022 04.
Article in English | MEDLINE | ID: mdl-35324362

ABSTRACT

INTRODUCTION: The advent of biologic therapies for severe asthma has profoundly changed the management of this pathology. The introduction of home administration is therefore an important innovation to optimize the patients' management, even if there are many aspects that need to be clarified and pointed out. AREAS COVERED: This review summarizes the path that led to the possibility of self-administration of biologics, and what the pandemic has changed in the management of these patients. EXPERT OPINION: The growing understanding of asthma phenotypes and endotypes is enabling the careful selection of patients suitable for biologics. In this context, the availability of reliable and simple self-injection devices is important in implementing self-administration. The transition to self-injection is also possible thanks to the high safety profile of biologics. With attention, most patients may potentially be suitable for self-administration. The transition process from hospital to home administration can therefore be carried out correctly by clinicians with adequate expertise in the field of severe asthma and biologic therapies, with the support of other health professionals, pharmacists, and general practitioners. Home administration is probably the best way to guarantee high adherence and high-level satisfaction of patients, even in the long term.


Subject(s)
Anti-Asthmatic Agents , Asthma , Biological Products , Anti-Asthmatic Agents/adverse effects , Asthma/drug therapy , Biological Products/adverse effects , Humans , Phenotype
14.
Respir Med ; 194: 106776, 2022 04.
Article in English | MEDLINE | ID: mdl-35221150

ABSTRACT

The anti-IL-5 biologic reslizumab for the treatment of severe eosinophilic asthma is administered intravenously. In the current study home administration of intravenous reslizumab was evaluated in 24 patients included between 2019 (July) and 2020 (July). This is the first study to show that intravenous reslizumab can be administered safely and successfully in an outpatient setting. Notably, not all patients prefer home administration and severe asthma patients may have different needs when it comes to choosing treatment at home or in the hospital.


Subject(s)
Anti-Asthmatic Agents , Asthma , Anti-Asthmatic Agents/therapeutic use , Antibodies, Monoclonal, Humanized/therapeutic use , Asthma/drug therapy , Humans , Netherlands/epidemiology
15.
J Clin Med ; 11(4)2022 Feb 12.
Article in English | MEDLINE | ID: mdl-35207233

ABSTRACT

Severe asthma patients are at an increased risk of major complications and they need to be monitored regularly. The COVID-19 pandemic has notably impacted on the health care resources. The telemedicine approach applied to the follow-up of asthmatic patients has been proven to be effective in monitoring their disease and their adherence to the therapy. The aim of our study was to investigate the satisfaction of severe asthma patients before the activation of a telemedicine management, as well as their current experience with self-administration of injection therapy. An ad hoc questionnaire was developed and sent by e-mail to 180 severe asthma patients. Most of subjects, 82%, were confident with the idea of doing self-measurements and self-managing their disease. Further, 77% of subjects favoured to carry out virtual visits and telemedicine. Regarding the home treatment, 93% of patients considered the self-injection therapy easy, 94% of subjects felt safe, and 93% were not worried while self-administering. Only mild adverse events were reported in 22% of patients after self-administration. Our results showed an agreement between what is considered necessary and practicable by healthcare personnel and what is perceived by the severe asthma patients in terms of treatment and monitoring of the disease with Telehealth. Biologics have a safety profile and can be easily self-administred at home.

16.
J Asthma Allergy ; 14: 381-392, 2021.
Article in English | MEDLINE | ID: mdl-33907423

ABSTRACT

BACKGROUND: Tezepelumab is an anti-thymic stromal lymphopoietin monoclonal antibody in development for the treatment of severe asthma. This study assessed the functionality and performance of an accessorized pre-filled syringe (APFS) and an autoinjector (AI) for administration of tezepelumab in the clinic and at home. METHODS: This phase 3, multicenter, randomized, open-label, parallel-group study (PATH-HOME, ClinicalTrials.gov identifier: NCT03968978) was conducted in patients aged 12-80 years with asthma that was uncontrolled despite treatment with medium- to high-dose inhaled corticosteroids plus at least one additional controller medication. Patients received six subcutaneous doses of tezepelumab 210 mg via APFS or AI. The first dose was administered by a healthcare professional, and patients or caregivers administered subsequent doses. First, second, third and final doses were administered in the clinic; fourth and fifth doses were administered at home. The primary endpoint was the proportion of successful administrations of tezepelumab. Secondary endpoints included the functionality and performance of the devices, Asthma Control Questionnaire (ACQ)-6 score, pharmacokinetics and safety. RESULTS: Overall, 216 patients were randomized (APFS, n=111; AI, n=105). Tezepelumab was successfully administered via APFS by 91.7% of the participants (100/109) and via AI by 92.4% (97/105). Overall, 95.4-97.1% of at-home administrations were successful across device groups. Malfunction occurred in 6 of 655 dispensed APFSs and 5 of 624 dispensed AIs. Clinically meaningful improvements in ACQ-6 score were observed after 24 weeks in 81.1% and 76.2% of the patients in the APFS and AI groups, respectively. Tezepelumab pharmacokinetics were consistent between device groups and with previous studies. The most common adverse event was nasopharyngitis (9.3%). Injection-site reactions occurred in 5.7% and 0% of the patients in the AI and APFS groups, respectively. CONCLUSION: This study demonstrated that the APFS and AI were functional and reliable, and performed equally well at home and in the clinic.

17.
J Oncol Pharm Pract ; 27(5): 1214-1221, 2021 Jul.
Article in English | MEDLINE | ID: mdl-33719721

ABSTRACT

Pertuzumab plus trastuzumab, administered intravenously (IV) with chemotherapy, is standard treatment for HER2-positive metastatic or high-risk early breast cancer. Pertuzumab and trastuzumab are administered over 1-2.5 h traditionally; however, the need for IV infusions places a strain on medical centers with respect to scheduling, preparation, and administration. A novel fixed-dose combination of pertuzumab and trastuzumab for subcutaneous injection (PHESGO®, PH FDC SC) can be administered in approximately 5-8 min. PH FDC SC was non-inferior to IV pertuzumab plus trastuzumab in terms of pertuzumab and trastuzumab serum levels in the phase III FeDeriCa study, which enrolled 500 patients with HER2-positive early breast cancer. Total pathologic complete response rates were comparable after PH FDC SC (59.7%) or IV pertuzumab plus trastuzumab (59.5%), as was the incidence of grade ≥3 (48.8% vs 52.8%) and serious adverse events (16.1% vs 17.9%). The results of a phase II clinical trial (PHranceSCa) showed that a majority of patients (85%) preferred PH FDC SC treatment over IV pertuzumab plus trastuzumab. A US multicenter expanded access study (NCT04395508) is evaluating the safety of PH FDC SC administered at home by nurse providers in patients receiving maintenance HER2-targeted therapy every 3 weeks. This product takes much less time to administer than IV pertuzumab-trastuzumab and has the potential to alleviate time constraints for patients and busy clinics. In this review we provide an overview of PH FDC SC, and discuss our experience in preparing and administering this product to patients with HER2-positive breast cancer during clinical trials.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/administration & dosage , Breast Neoplasms/drug therapy , Antibodies, Monoclonal, Humanized/administration & dosage , Female , Humans , Injections, Subcutaneous , Receptor, ErbB-2/metabolism , Trastuzumab/administration & dosage
18.
Pediatr Rheumatol Online J ; 19(1): 8, 2021 Jan 22.
Article in English | MEDLINE | ID: mdl-33482852

ABSTRACT

BACKGROUND: Overall outcomes of pediatric rheumatic diseases (RD) have improved due to treatment with biologic agents and methotrexate. For many children, this treatment often entails regular needle injections. Pain and fear of needle injections are common in childhood, but how children and parents handle long-term needle injections at home has not been fully explored. This study aimed to explore how regular needle injections affect children with RD and their parents in their daily living. METHODS: This explorative qualitative study used individual interviews and focus groups to ensure a comprehensive investigation of the topic. Children aged 6 to 16 years (n = 7) and their parents (n = 8) were interviewed individually 4 to 6 months after the onset of needle injection treatment. The focus groups included children aged 11 to 17 years (n = 9) and parents (n = 8) with a minimum of 6 months of experience with injection treatment. Data were analyzed using thematic analysis. RESULTS: The main themes; "challenges," "motivational factors," and "routines" captured experiences and strategies that influenced the continuation of needle injections at home. Many children feared the moment immediately before the needle stick, although they had become accustomed to the pain. Most parents felt insecure about handling needle injections and lacked follow-up from healthcare providers. The children's experience of treatment effects and self-confidence were essential to maintain motivation for further injections. A number of coping strategies helped children focus away from injection related discomfort, often discovered by chance. Facilitating firm routines and shared responsibility within families helped children develop self-confidence during the procedure. Children and parents struggled to find suitable information on the Internet. CONCLUSIONS: Children and parents experienced long-term needle injections challenging. They used their own limited resources and cooperated within the families to create routines and to introduce coping strategies necessary to manage and keep up with the procedure. Although the injection itself was not experienced very painful, the discomfort, worries and impact on daily life represented far more than a little needle stick, and thus needs more attention from healthcare providers.


Subject(s)
Antirheumatic Agents/administration & dosage , Injections/psychology , Parents/psychology , Rheumatic Diseases/psychology , Adolescent , Antirheumatic Agents/therapeutic use , Child , Focus Groups , Humans , Interviews as Topic , Qualitative Research , Rheumatic Diseases/drug therapy
19.
Expert Opin Biol Ther ; 21(4): 499-507, 2021 04.
Article in English | MEDLINE | ID: mdl-33504237

ABSTRACT

Introduction: Omalizumab is used to treat severe uncontrolled allergic asthma and chronic spontaneous urticaria (CSU), and is approved for self-administration in prefilled syringes. It is thus important to understand the advantages, critical issues, and indications for home administration.Areas covered: The present review summarizes the available evidence on home administration of omalizumab in asthma and CSU to illustrate the advantages derived from self-administration of patients in this setting.Expert opinion: The available data suggest that patients can safely administer biologics at home with suitable training, and that home administration is time saving and cost-effective. The majority of patients with severe asthma or CSU treated with omalizumab are likely to be suitable candidates for self-administration, which can be proposed to anyone that the clinician deems suitable. In addition to clinicians, pharmacists can also play a key role in managing patients who are prescribed home administration. A practical flow chart is proposed on selection of patients and their management during home administration. Self-administration of biologics can be considered as a valid alternative to traditional injections in a clinical setting, and the evidence has shown that no major issues need to be overcome in terms of safety or efficacy.


Subject(s)
Anti-Allergic Agents , Urticaria , Anti-Allergic Agents/therapeutic use , Chronic Disease , Expert Testimony , Humans , Omalizumab/adverse effects , Treatment Outcome , Urticaria/drug therapy
20.
J Appl Gerontol ; 40(1): 14-17, 2021 01.
Article in English | MEDLINE | ID: mdl-32940123

ABSTRACT

This article describes an outbreak of COVID-19 in a long-term care facility (LTCF) in West Virginia that was the epicenter of the state's pandemic. Beginning with the index case, we describe the sequential order of procedures undertaken by the facility including testing, infection control, treatment, and communication with facility residents, staff, and family members. We also describe the lessons learned during the process and provide recommendations for handling an outbreak at other LTCFs.


Subject(s)
COVID-19/prevention & control , Communication , Disease Outbreaks , Infection Control/methods , Nursing Homes/organization & administration , Aged , COVID-19/diagnosis , COVID-19 Testing , Female , Humans , Patient Isolation , SARS-CoV-2
SELECTION OF CITATIONS
SEARCH DETAIL