Syringe Research Articles

Abstract PO3-11-01: Single centre experience of the adoption of self-administered HER2-directed therapy in patients with breast cancer

Abstract Single centre experience of the adoption of self-administered HER2-directed therapy in patients with breast cancer Background: Programs to promote the self-administration of systemic anti-cancer therapy (SACT) offer greater convenience and shared decision making for patients with the opportunity to alleviate pressures on cancer services. Aims and Objective: The aims of this study were to quantify the uptake/acceptability of self-administration (SA) of subcutaneous trastuzumab (sc T), to evaluate safety, patients’ perception of the programme and the chair capacity released as a consequence. Methods: Patients receiving T for the treatment of HER2 +ve breast cancer were offered training in SA. The competency-based training programme, under the supervision of a chemotherapy-trained nurse, consisted of a minimum of 3 training sessions. Patients were also provided with printed and electronic material (via an App) on how to self-administer sc T, with 24/7 contact details in the event of an adverse event or device failure. Once trained and deemed competent, sc T was shipped to the patients’ home in a temperature-controlled environment, in a pre-filled syringe. All patients were assessed by telephone one day before and one day after SA using the Common Terminology Criteria for Adverse Events (CTCAE). Analysis of the total number of administrations of sc T, between February 2022 and June 2023 was conducted. A telephone survey using a validated questionnaire Self-Management Assessment scale (SMASc) was also undertaken. Results Of 46 breast cancer patients receiving single agent sc T, 32 agreed to participate in the program and were trained. 2 patients were undergoing training at data analysis. 6 patients declined and 6 were ineligible for the programme on the basis of inclusion criteria. The median age of the 32 patients that participated was 62, (range 27-77). The average distance from their home address to the cancer centre was 11.7 miles (range 3.5-27.9). 25 (78%) patients were Caucasian, 4 (13%) were Asian and 3 (9%) were of African/Caribbean origin. Patients had received an average of 10 sc injections in the hospital environment (median 5, range 1-103) before starting the training sessions. They required an average of 3 training sessions before sign-off (median 3, range 1-4). In the 32 patients studied, a total of 302 SA injections were delivered median 9 (range 1- 24) No Grade 3 or 4 CTCAE toxicities or infusion-related reactions were reported. During the 17-month period, a total of 302 hours of chair time was saved. 25 of the 32 patients responded to SMASc questionnaires utilising the six-point Likert scale. Patients reported average scores of 5.32 (median 6) and 5.56 (median 6) respectively, for questions relating to having information about their condition and sufficient training to self-administer. They felt that they had sufficient support to participate in the programme (average 5.56 median 6). 80% of the patients would recommend this programme and 88% felt they had benefited. Comments from patients themed around the value of the support provided, ease of administration and time saved. Discussion Programs such as these empower patients and carers to take a more active role in managing their condition with consequent reduced hospital attendance. Safety and acceptability for those patients who agreed to the program has been confirmed. Success of this program with sc T has enabled expansion to incorporate self-administration of Phesgo (sc trastuzumab and pertuzumab) with 31% (14/45) of the current P patient cohort enrolled onto the programme within 2 weeks of roll out and the first patients self-administering their treatment from August 2023. With the continued expansion of SACT treatments, we encourage stakeholders to consider self-administration of SACT as an option. Formulation of treatments conducive to patient self-administration is a key component to this. Citation Format: Wendy Ng, Vikash Dodhia, Amy Guppy, Stephanie Sutherland, Marlgozata Wojtas, Karen Harrold, Adisa Aolat, Tome Tapiwa, David Miles. Single centre experience of the adoption of self-administered HER2-directed therapy in patients with breast cancer [abstract]. In: Proceedings of the 2023 San Antonio Breast Cancer Symposium; 2023 Dec 5-9; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2024;84(9 Suppl):Abstract nr PO3-11-01.

Efficacy and safety of ongericimab given by prefilled syringe or autoinjector in primary hypercholesterolemia and mixed hyperlipidemia

Background and aimsLimited evidence exist regarding the association between ongericimab, a novel recombinant humanized anti-PCSK9 monoclonal antibody, and primary hypercholesterolemia and mixed dyslipidemia. This study aimed to evaluate the efficacy and safety of ongericimab administered by prefilled syringe (PFS) or autoinjector (AI) in Chinese patients with primary hypercholesterolemia and mixed dyslipidemia on stable optimized lipid-lowering therapy. Methods and resultsA total of 255 patients on stable optimized lipid-lowering therapy were randomized in a 2:1:2:1 ratio to receive PFS for the subcutaneous injection of ongericimab 150 mg every 2 weeks (Q2W) or a matching placebo, or AI for the subcutaneous injection of ongericimab 150 mg Q2W or a matching placebo. The primary efficacy endpoint was the percent change in low-density lipoprotein cholesterol (LDL-C) levels from baseline to week 12. Safety was also evaluated. At week 12, the least squares mean percent changes were −72.7% (3.9%) for PFS and −71.1% (3.8%) for AI (all P < 0.001) compared to respective matching placebo groups. Beneficial effects were also seen for all secondary lipid parameters, notably with robust reduction in Lp (a). Treatment-emergent adverse events (TEAEs) and serious AEs with ongericimab were reported in 46.2% and 2.4% of patients, compared to 44.2% and 3.5% with placebo. ConclusionIn Chinese patients with primary hypercholesterolemia and mixed dyslipidemia, a 12-week treatment regimen with ongericimab administered by PFS or AI significantly reduced LDL-C and other lipid parameters, proving to be safe and well tolerated. Patients experienced consistent effects from PFS or AI devices. Clinical trial registrationCTR20220027; January 11, 2022; http://www.chinadrugtrials.org.cn/index.html.

IJCM_249A: Assessment of availability of drugs &amp; logistics on Village Health Sanitation and Nutrition Day (VHSND) sessions of Raipur district, CG- A cross-sectional observational study

Background: Maternal and Child health remains one highly pervasive and damaging condition in low-middle-income countries. To improve the situation Govt. of India in 2007 initiated VHSND, as an effective platform for delivering healthcare services at the doorsteps of the unserved and underserved village population, improving awareness and access of the community for health services thereby leading to improvement in the health indicators.,(VHSND) are community-based health initiatives designed to bring essential healthcare services to the doorsteps of rural populations. These sessions serve as a crucial platform for promoting health, hygiene, and nutrition awareness within villages. Organized regularly, VHSNDs aim to address a spectrum of health issues, ranging from maternal and child health to sanitation and nutrition. The success of VHSNDs relies heavily on community participation. These sessions not only offer immediate health services but also empower communities by fostering a sense of ownership over their well-being. By engaging with local residents, VHSNDs contribute to the overall improvement of health indicators and the quality of life in rural areas. In summary, VHSNDs play a vital role in bridging the healthcare gap in rural communities, emphasizing preventive healthcare, and promoting a holistic approach to well-being. They embody the collaborative efforts of health professionals, community leaders, and residents to create healthier and more resilient villages. Objective: 1. To assess the status of logistic availability on VHSND sessions of Raipur District Methodology: A cross-sectional study was conducted to assess the status of logistic availability on 30 VHSND sessions of Raipur district during March- July 2023 in Chhattisgarh by observation and pre-tested pre-designed semi- structured questionnaires. Results: It was observed that out of 30 VHSND sessions site, 77 % were held as per the micro plan and from those 90% ANM, 97% ASHA, 84% Anganwadi workers, 57% Anganwadi helpers, and only 10% PRI members were present at the site of the session. Only 56% of session sites were supervised by supervisors, 28 (93.33%) session sites had drinking water facilities, 21 (70%) sites had toilet facilities, and only 25(83.33%) sites had electricity connectivity. BP Instrument, Stethoscope, Weighing scale, Hemoglobinometer, Glucometer, Disposable syringe 5ml, Disposable syringe 0.5 ml, Disposable syringe 0.1, MCP card, Examination table, were above (90%) present in most of the VHSND sessions. Out of 30 Sessions Stadiometer (19) Fetal Doppler (15), Curtains (21), Stepping stool for climbing on the examination table (17), and Referral slip (5) are present in the VHSND sessions. Nischaya kit, VDRL, HIV, and RDK for malaria kit were present in 74%,43%,97%, and 93% respectively. Iodized salt testing is not available in any sessions. All vaccines were available 100% except BCG, DPT, and Td, which were present in 87%,93%, and 90% sessions. AEFI Kit was available in 80% of sessions. Condom, OCPs, and Centchroman were present most of the site of the sessions but Inj. MPA, IUCD, and emergency contraceptive pills were available only in 14%,37%, and 14% of sessions respectively, 7.23 (77%) of the session sites have Information displayed about the day, time, and site of the VHSND session, Conclusion: Most of the session sites were held as per the micro plan, there is some lacuna in the availability of logistics although a majority of essential items were found at session sites special focus needs to be given to fetal doppler, HIV kit cold-chain maintenance, Iodized salt kit, Cotrimoxazole, Anti-malaria drugs, Td, and BCG vaccine. Satisfactory maternal and child health services were provided in many sessions.

Evaluation of the Efficacy of a Customized Mucosal Vibrator in Alleviating Pain Perception Associated with Local Anesthesia Administration in Children Aged 6-10 Years.

Local anesthetics are used to alleviate pain, but the prick of the injection delivering anesthesia is known to cause anxiety and pain that affect dental treatment. The most difficult aspect of pediatric dentistry is minimizing discomfort while the intraoral local anesthetic is administered. This pain has been treated using physical, psychological, pharmacological, and combinations of these approaches. Recently, the idea of vibration, which is based on the gates control theory, has gained popularity as a way to reduce discomfort while local anesthesia (LA) is being administered. The aim of this trial was to evaluate the efficacy of mucosal vibrators in children aged 6-10 years to alleviate pain associated with LA administration. A total of 60 patients aged 6-10 years requiring inferior alveolar nerve block were enrolled for this randomized, single-blind clinical trial. In group I, before and during LA administration, the customized mucosal vibrator was placed at the injection site. In group II, the topical local anesthetic gel was applied to the injection site prior to the administration of LA. Then, the local anesthetic solution was deposited using a disposable syringe needle on both groups. The pain was evaluated using the physiological scale (pulse rate and oxygen saturation), the subjective scale (Wong-Baker scale), and the objective scale [Face, Legs, Activity, Cry, Consolability (FLACC) scale] by an experienced assistant who was unaware of the procedure. A customized mucosal vibrator along with local anesthetic injections resulted in significantly less pain (p = 0.001*) when compared with the injections with topical anesthetic gel. The results show that the customized mucosal vibrator is an effective and inexpensive means to reduce pain during LA administration. Tatiya N, Singh C, Surana P, et al. Evaluation of the Efficacy of a Customized Mucosal Vibrator in Alleviating Pain Perception Associated with Local Anesthesia Administration in Children Aged 6-10 Years. Int J Clin Pediatr Dent 2024;17(4):404-409.

Adsorption of chlorpyrifos in water using polyaniline/graphene oxide composites

Graphene oxide and polyaniline have some unique properties and are considered as new generation materials for various applications. One major application of these materials is the adsorption of pollutants. In this study, Graphene oxide was synthesized with different levels of oxidation by using the modified Hummers method. Polyaniline/graphene oxide composite was synthesized by in situ polymerization with GO loading at 10% and 50% and further the composite is casted inside a disposable syringe by using N-methyl-2-pyrrolidone (NMP) as a dispersing agent. An adsorption experiment was carried out for water containing pesticide chlorpyrifos. The produced materials were characterized by FTIR spectroscopy &amp; and XRD. Morphology was studied by SEM images. The FTIR spectra shows the formation of functional groups like -OH, -COOH on graphene, which may increase the hydrophilicity and adsorption properties. FTIR spectra of the composite portrayed the formation of bonds between polyaniline and graphene oxide. XRD peaks were obtained corresponding to crystals of polyaniline and graphite sheets. The adsorption efficiency was determined by analysis of water samples before and after filtration by using GC-MS. The composite produced with 50% amount of GO showed optimum results for the removal of chlorpyrifos. However, the composite with 10% GO loading is showing very low efficiency for the removal of chlorpyrifos. The PANI/GO composite is a possible candidate for the treatment of river water polluted by agricultural pollutants.

Transdermal Administration of Nanobody Molecules using Hydrogel‐Forming Microarray Patch Technology: A Unique Delivery Approach

AbstractNanobody molecules, derived from heavy‐chain only antibodies in camelids, represent the next generation of biotherapeutics. In addition to low immunogenicity, high stability, and potency, their single‐domain format facilitates the construction of multivalent molecules for therapeutic applications. Although predominantly administered using a hypodermic syringe and needle, alternative delivery methods are under investigation. That said, the transdermal route has yet to be explored. Therefore, microarray patch (MAP) technology, offering a potentially high dose, pain‐free transdermal system, is employed in this study. Trivalent Nanobody molecules, with and without half‐life extension (VHH and VHH[HLE]), are formulated into hydrogel‐forming MAPs, with pharmacokinetic parameters assessed in Sprague–Dawley rats. VHH MAPs exhibited a sustained release profile, with a serum concentration of 19 ± 9 ng mL−1 24 h post‐administration. In contrast, a subcutaneous (SC) injection showed faster clearance, with a serum concentration of 1.1 ± 0.4 ng mL−1 at 24 h. For VHH(HLE), both SC and MAP cohorts achieved a maximum serum concentration (Tmax) at 24 h. The MAP cohort displayed a notable increase in VHH(HLE) serum levels between 6–24 h, dropping after MAP removal. This study has exemplified MAPs potential for delivering advanced biologics, indicating the transdermal route's promise for pain‐free, patient‐friendly administration of Nanobody molecules.

Impact of Replacing Fentanyl With Hydromorphone as the First-Line Postoperative Opioid Among Patients Undergoing Outpatient Cancer Surgery

In response to a nationwide fentanyl shortage, our institution assessed whether changing our first-line postoperative intravenous opioid from fentanyl to hydromorphone impacted patient outcomes. The primary research aim was to evaluate the association between first-line opioid and rapidity of recovery. The study team retrospectively obtained data on all consecutive patients extracted from the electronic medical record. The rapidity of recovery was defined as the time from entry into the postanesthesia care unit to the transition to Phase 2 for ambulatory extended recovery patients and as the length of total postanesthesia care unit stay for outpatients. Following intent-to-treat-principles, we tested the association between study period and rapidity of recovery (a priori clinically meaningful difference: 20minutes) using multivariable linear regression, adjusting for anesthesia type (general vs monitored anesthesia care), American Society of Anesthesiologst physical status (ASA) score (1-2 vs 3-4), age, service, robotic procedure, and surgery start time. Ambulatory extended recovery patients treated in the hydromorphone period had, on average, a 0.25minute(95% confidence interval [CI] -6.5, 7.0), nonstatistically significant (P>.9) longer time to transition. For outpatient procedures, those who received hydromorphone had, on average, 8.5-minute longer stays (95% CI 3.7-13, P<.001). Although we saw statistical evidence of an increased risk of resurgery associated with receiving hydromorphone (0.5%; 95% CI -0.1%, 1.0%; P=.039 on univariate analysis), the size of the estimate is clinically and biologically implausible and is most likely a chance finding related either to multiple testing or confounding. The multidisciplinary team concluded that the increase in postoperative length of stay associated with hydromorphone was not clinically significant and the decrease waste of prefilled syringes outweighed the small potential increased risk of resurgery compared to the shorter-acting fentanyl. We will therefore use hydromorphone moving forward.

Were Needles Everywhere?: Differing Views on Syringe Waste and Disposal Associated With Needs-Based Syringe Services Programs Among Community Partners and Persons Who Inject Drugs

Background Community concerns surrounding syringe waste are a common barrier to syringe services program (SSP) implementation. In Kanawha County, West Virginia, community opposition to SSPs resulted in the closure of needs-based SSPs prior to and during an HIV outbreak among persons who inject drugs (PWID). This qualitative analysis examines views of PWID and community partners on syringe waste and disposal associated with needs-based SSPs. Methods Qualitative interviews with 26 PWID and 45 community partners (medical and social service providers, law enforcement personnel, policymakers, and religious leaders) were conducted. Interviews were recorded, transcribed, and coded. Code summaries described participants’ views on syringe waste and disposal and needs-based SSPs. Results Community partners and PWID who favored needs-based SSPs reported that needs-based SSPs had not affected or reduced syringe waste. Conversely, community partners who favored one-to-one exchange models and/or barcoded syringes described needs-based SSPs increasing syringe waste. Community partners often cited pervasive community beliefs that SSPs increased syringe waste, risk of needlesticks, drug use, and crime. Community partners were unsure how to address syringe waste concerns and emphasized that contradictory views on syringe waste posed barriers to discussing and implementing SSPs. Conclusions Participants’ views on whether syringe waste was associated with needs-based SSPs often aligned with their support or opposition for needs-based SSPs. These differing views resulted in challenges finding common ground to discuss SSP operations amid an HIV outbreak among PWID. SSPs might consider addressing syringe waste concerns by expanding syringe disposal efforts and implementing community engagement and stigma reduction activities.

Pharmacokinetics and safety of candidate tocilizumab biosimilar CT-P47 administered by auto-injector or pre-filled syringe: a randomized, open‑label, single-dose phase I study

ABSTRACT Background This study compared the pharmacokinetics (PK), immunogenicity, and safety of candidate tocilizumab biosimilar, CT-P47, administered via auto-injector (CT-P47 AI) or pre-filled syringe (CT-P47 PFS), in healthy Asian adults. Research design and methods In this phase I, multicenter, open-label study, participants were randomized 1:1 to receive a single 162 mg/0.9 mL dose of CT-P47 via AI or PFS. Primary endpoints were area under the concentration – time curve from time zero to infinity (AUC0–inf) and maximum serum concentration (Cmax). PK equivalence was determined if 90% confidence intervals (CIs) for the ratios of geometric least-squares means (gLSMs) were within the predefined 80–125% equivalence margin. Secondary PK parameters, immunogenicity, and safety outcomes were also assessed. Results Of 314 participants randomized (155 CT-P47 AI; 159 CT-P47 PFS), 310 received the study drug (153 CT-P47 AI; 157 CT-P47 PFS). Primary and secondary PK results, immunogenicity and safety were similar between groups. Ninety percent CIs for the ratio of gLSMs were within the predefined equivalence margin for AUC0–inf (85.87–102.94) and Cmax (82.98–98.16). Conclusions PK equivalence between CT-P47 AI and CT-P47 PFS was demonstrated in healthy Asian adults, with comparable immunogenicity and safety between the two devices. Trial registration ClinicalTrials.gov: NCT05617183.

Relevance of Adalimumab Product Attributes to Patient Experience in the Biosimilar Era: A Narrative Review.

Adalimumab (ADL, Humira®, reference product), an anti-TNF-α biologic, has transformed the treatment of chronic, immune-mediated inflammatory diseases. However, the high cost of ADL therapy has driven the development of more affordable ADL biosimilars, agents with no clinically meaningful differences from the reference product. This review summarizes the product attributes of reference ADL and the nine ADL biosimilars approved and available in the USA in relation to patient experience of injection-site pain (ISP). Product formulation, delivery volume and device features (e.g., type and needle gauge size) influence patient experience of ISP with potential clinical consequences. Citrate-free formulations generally cause less ISP; injection volumes of > 1.5ml may be associated with increased ISP. Reference ADL and all ADL biosimilars offer a citrate-free formulation, and reference ADL and four ADL biosimilars offer a high-concentration solution that allows a smaller injection volume. All available ADL products are injected subcutaneously using either a pre-filled pen (PFP) or pre-filled syringe (PFS). Patients prefer the PFP, but the PFS permits better control over the speed and duration of injection. Smaller (29-gauge) needle outer diameter is associated with less ISP; reference ADL and seven ADL biosimilars offer a device with a 29-gauge needle. In the USA, an approved biosimilar can be designated "interchangeable," allowing pharmacy-level substitution, where state law permits. In the USA, two ADL biosimilars have received interchangeability designation; others are seeking interchangeability designation from the Food and Drug Administration (n = 2), are being evaluated in clinical studies to support interchangeability (n = 2), or do not have/are not seeking interchangeability designation (n = 3). Product-related attributes influence patient experience of ISP caused by subcutaneous ADL injection. Reference ADL and ADL biosimilar products differ in their attributes, so discussion with patients about treatment options is essential to optimize adherence and outcomes.

International Survey to Evaluate Current Options for Subcutaneous Injection of Methotrexate (MTX) and a New Button-Free MTX Autoinjector.

Prefilled syringes (PFS) and various types of pens are available for subcutaneous injection of methotrexate (MTX) in patients with rheumatoid arthritis or moderate to severe psoriasis. A new MTX pen with modernized button-free autoinjection technology was developed as a successor to a button-activated pen (metoject®/metex®PEN). To assess the needs of users and the relevance of features of the new MTX autoinjector an international online survey was performed. A structured questionnaire was distributed to physicians, nurses and patients in Germany, France, and the United Kingdom. Participants received illustrations and information about features of the new MTX autoinjector. In total, 189 rheumatologists, 111 dermatologists, 90 nurses, and 180 patients answered the questions. Specific reasons for a preference for the use of MTX pens over PFS could predominantly be assigned to the categories "dosing/administration" and "ease of use". The first impression of the new MTX autoinjector was positive in 82% of physicians, 87% of nurses, and 76% of patients, respectively. The four most important features of the new MTX autoinjector were 2-step autoinjector mechanism (receiving a mean 14.1 to 18.1 chips of a total of 100 chips), small injection volume (9.7 to 11.7 chips), 10different doses for dose flexibility (8.0 to 13.2 chips), and short injection time below 5seconds (8.5 to 11.1 chips). Arguments for the use of MTX pens as opposed to PFS predominantly refer to dosing/administration and ease of use. The new button-free MTX autoinjector combines a number of advantageous features identified by the international survey.

Availability of basic infection control items and personal protection equipment in 7948 health facilities in eight low- and middle-income countries: Evidence from national health system surveys.

Hundreds of millions of people become infected globally every year while seeking care in health facilities that lack basic needs like infection control measures and personal protective equipment (PPE). We aimed to evaluate the availability of infection control items and PPE in eight low- and middle-income countries and identify disparities in the availability of those items. In this study, we combined publicly available nationally representative cross-sectional health system surveys (Service Provision Assessments by the Demographic and Health Survey Programme) conducted in eight countries between 2013 and 2018: Afghanistan, Bangladesh, the Democratic Republic of the Congo, Haiti, Malawi, Nepal, Senegal, and Tanzania. The availability of infection control items was evaluated using a list of six items (a waste receptacle, a sharps container, disinfectant, single-use disposable or auto-disposable syringes, soap and running water, or an alcohol-based hand rub, and guidelines for standard precautions). PPE includes four items: gloves, medical masks, gowns, and eye protection. We considered these items available in a facility if they were observed in general outpatient areas or any service-specific area (i.e. delivery room). We analysed data from 7948 health facilities (694 hospitals and 7254 health centres/clinics). Overall, among the infection control items and PPE, most surveyed facilities had high availability of single-use disposable or auto-disposable syringes (91.40%) and latex gloves (92.56%). Of infection control measures, guidelines for infection control were the least available during the survey, with the lowest (6.15%) in Nepal and the highest (68.18%) in Malawi. Of the PPE items, eye protection was the least available during the survey, with the lowest (5.4% in Senegal) and the highest (28.17%) in Haiti. Only 1567 (19.71%) facilities looked to have all the basic infection control materials, and 1023 (12.87%) of the analysed facilities possessed all of the PPE. Within the same country, the availability of items varied more between hospitals and health centres/clinics than between them. All eight of our study countries experience shortages of the most fundamental standard precaution items to avert infection. Steps must be taken in each of these countries to reduce inadequacies and disparities and enhance efficiency in the conversion of health-system inputs into the facility's availability of standard precaution items for infection control - to curb the risk of infectious disease transmission.

A study of Vitamin D and parathyroid hormone levels in patients with prostatic cancer

Background: Vitamin D, a key nutrient in the body, has been linked to a decrease in prostate cancer (PCa) morbidity and mortality rates. The study concluded that any compensation mechanism may no longer be adequate for patients with PCa, and further research is needed to understand the mechanisms underlying the relationship between serum Vitamin D and parathyroid hormone (PTH) homeostasis. The findings will help determine cancer prevalence and trends in India and support public health initiatives to control cancer. Aims and Objectives: The aim is to assess the mean values of Vitamin D and PTH in patients with PCa and also to compare these levels with that of healthy controls (non-PCa). Materials and Methods: One hundred participants in the outpatient department of the Department of Biochemistry were assigned as control subjects, and another 100 participants were participants with PCa. 5 mL of fasting venous blood were drawn into red top vials using a disposable syringe and needle in an aseptic manner. PTH and serum Vitamin D were estimated. Results: When comparing PCa patients to healthy controls, the observed Vitamin D level was significantly lower in the former group. Furthermore, a notable distinction in Vitamin D levels was noted between the two groups. Furthermore, we found that PCa patients had higher PTH values than healthy controls. When we compared the PTH values of the two groups, we found a substantial difference. Conclusion: The authors conclude from the study that with alterations in the study parameters in patients with PCa, any compensation mechanism may become insufficient.

Bioequivalence Between a New Omalizumab Prefilled Syringe With an Autoinjector or with a Needle Safety Device Compared with the Current Prefilled Syringe: A Randomized Controlled Trial in Healthy Volunteers.

Omalizumab is an anti-IgE monoclonal antibody currently approved for the treatment of asthma, nasal polyps/chronic rhinosinusitis with nasal polyps, and chronic spontaneous urticaria. Omalizumab is available as an injection in a prefilled syringe (PFS) with a needle safety device (NSD). New product configurations were developed to reduce the number of injections per dose administration, improve patient convenience and treatment compliance. The objective of this randomized open-label 12-week study was to demonstrate pharmacokinetic bioequivalence between (1) new PFS with autoinjector (PFS-AI), (2) new PFS-NSD configuration, and (3) current PFS-NSD configuration. Each new configuration was considered bioequivalent to the current configuration if the confidence intervals (CIs) for the geometric mean ratios (GMR) were contained in the 0.80-1.25 range for maximum concentration (Cmax), area under the concentration-time curve until the last quantifiable measurement (AUClast), and AUC extrapolated to infinity (AUCinf). Safety was assessed throughout the study. In total, 193 healthy volunteers were randomized at 1:1:1 ratio to omalizumab 1×300mg/2mL via new PFS-AI (n = 66), omalizumab 1×300mg/2mL via new PFS-NSD (n = 64), or omalizumab 2×150mg/1mL via current PFS-NSD (n = 63). Comparing new PFS-AI versus current PFS-NSD, the GMRs were: Cmax, 1.085; AUClast, 1.093; AUCinf, 1.100. Comparing new PFS-NSD versus current PFS-NSD, the GMRs were: Cmax, 1.006; AUClast, 1.016; AUCinf, 1.027. The 95% CIs for all GMR parameters were contained within the 0.80-1.25 range. Safety findings were consistent with the known safety profile of omalizumab. Single-dose omalizumab administered as the new PFS-AI or new PFS-NSD was bioequivalent to the current PFS-NSD.

Subcutaneous immunoglobulin replacement therapy in patients with immunodeficiencies – impact of drug packaging and administration method on patient reported outcomes

BackgroundHere, the perspective of patients with primary and secondary immunodeficiency receiving subcutaneous immunoglobulin (SCIg) via introductory smaller size pre-filled syringes (PFS) or vials were compared.MethodsAn online survey was conducted in Canada by the Association des Patients Immunodéficients du Québec (APIQ) (10/2020–03/2021). Survey questions included: reasons for choosing SCIg packaging and administration methods, training experiences, infusion characteristics, and switching methods. The survey captured structured patient-reported outcomes: treatment satisfaction and its sub-domains, symptom state, general health perception, and physical and mental function. Respondents using PFS were compared with vial users, overall and stratified by their administration method (pump or manual push).ResultsOf the 132 total respondents, 66 respondents used vials, with 38 using a pump and 28 using manual push. PFS (5 and 10 mL sizes) were being used by 120 respondents, with 38 using a pump and 82 using manual push. PFS users were associated with a 17% lower median (interquartile range) SCIg dose (10 [8, 12] vs. 12 [9, 16] g/week, respectively), a significantly shorter infusion preparation time (15 [10, 20] vs. 15 [10, 30] mins, respectively), and a trend for shorter length of infusion (60 [35, 90] vs. 70 [48, 90] mins, respectively) compared with those on vials. Patient-reported treatment satisfaction scores were overall similar between vial and PFS users (including on the domains of effectiveness and convenience), except for a higher score for vials over PFS on the domain of global satisfaction (p=0.02).ConclusionsConsistent with prescribing that reflects a recognition of less wastage, PFS users were associated with a significantly lower SCIg dose compared with vial users. PFS users were also associated with shorter pre-infusion times, reflecting simpler administration mechanics compared with vial users. Higher global satisfaction with treatment among vial users compared with PFS users was consistent with users being limited to smaller PFS size options in Canada during the study period. Patient experience on PFS is expected to improve with the introduction of larger PFS sizes. Overall, treatment satisfaction for SCIg remains consistently high with the introduction of PFS packaging compared with vials.

Abatacept in individuals at high risk of rheumatoid arthritis (APIPPRA): a randomised, double-blind, multicentre, parallel, placebo-controlled, phase 2b clinical trial

Individuals with serum antibodies to citrullinated protein antigens (ACPA), rheumatoid factor, and symptoms, such as inflammatory joint pain, are at high risk of developing rheumatoid arthritis. In the arthritis prevention in the pre-clinical phase of rheumatoid arthritis with abatacept (APIPPRA) trial, we aimed to evaluate the feasibility, efficacy, and acceptability of treating high risk individuals with the T-cell co-stimulation modulator abatacept. The APIPPRA study was a randomised, double-blind, multicentre, parallel, placebo-controlled, phase 2b clinical trial done in 28 hospital-based early arthritis clinics in the UK and three in the Netherlands. Participants (aged ≥18 years) at risk of rheumatoid arthritis positive for ACPA and rheumatoid factor with inflammatory joint pain were recruited. Exclusion criteria included previous episodes of clinical synovitis and previous use of corticosteroids or disease-modifying antirheumatic drugs. Participants were randomly assigned (1:1) using a computer-generated permuted block randomisation (block sizes of 2 and 4) stratified by sex, smoking, and country, to 125 mg abatacept subcutaneous injections weekly or placebo for 12 months, and then followed up for 12 months. Masking was achieved by providing four kits (identical in appearance and packaging) with pre-filled syringes with coded labels of abatacept or placebo every 3 months. The primary endpoint was the time to development of clinical synovitis in three or more joints or rheumatoid arthritis according to American College of Rheumatology and European Alliance of Associations for Rheumatology 2010 criteria, whichever was met first. Synovitis was confirmed by ultrasonography. Follow-up was completed on Jan 13, 2021. All participants meeting the intention-to-treat principle were included in the analysis. This trial was registered with EudraCT (2013-003413-18). Between Dec 22, 2014, and Jan 14, 2019, 280 individuals were evaluated for eligibility and, of 213 participants, 110 were randomly assigned to abatacept and 103 to placebo. During the treatment period, seven (6%) of 110 participants in the abatacept group and 30 (29%) of 103 participants in the placebo group met the primary endpoint. At 24 months, 27 (25%) of 110 participants in the abatacept group had progressed to rheumatoid arthritis, compared with 38 (37%) of 103 in the placebo group. The estimated proportion of participants remaining arthritis-free at 12 months was 92·8% (SE 2·6) in the abatacept group and 69·2% (4·7) in the placebo group. Kaplan-Meier arthritis-free survival plots over 24 months favoured abatacept (log-rank test p=0·044). The difference in restricted mean survival time between groups was 53 days (95% CI 28-78; p<0·0001) at 12 months and 99 days (95% CI 38-161; p=0·0016) at 24 months in favour of abatacept. During treatment, abatacept was associated with improvements in pain scores, functional wellbeing, and quality-of-life measurements, as well as low scores of subclinical synovitis by ultrasonography, compared with placebo. However, the effects were not sustained at 24 months. Seven serious adverse events occurred in the abatacept group and 11 in the placebo group, including one death in each group deemed unrelated to treatment. Therapeutic intervention during the at-risk phase of rheumatoid arthritis is feasible, with acceptable safety profiles. T-cell co-stimulation modulation with abatacept for 12 months reduces progression to rheumatoid arthritis, with evidence of sustained efficacy beyond the treatment period, and with no new safety signals. Bristol Myers Squibb.

Unraveling Pre-filled Syringe Needle Clogging: Exploring a Fresh Outlook Through Innovative Techniques.

This study aimed to investigate the movement of liquid in the needle region of staked-in-needle pre-filled syringes using neutron imaging and synchrotron X-ray tomography. The objective was to gain insights into the dynamics of liquid presence and understand the factors contributing to needle clogging. Staked-in-needle pre-filled syringes were examined using neutron radiography and synchrotron X-ray phase-contrast computed tomography. Neutron radiography provided a 2D visualization of liquid presence in the needle, while synchrotron X-ray tomography offered high-resolution 3D imaging to study detailed morphological features of the liquid. Neutron radiography revealed liquid presence in the needle region for as-received samples and after temperature and pressure cycling. Pressure cycling had a more pronounced effect on liquid formation. Synchrotron X-ray tomography confirmed the presence of liquid and revealed various morphologies, including droplets of different sizes, liquid segments blocking sections of the needle, and a thin layer covering the needle wall. Liquid presence was also observed between the steel needle and the glass barrel. The combination of neutron imaging and synchrotron X-ray tomography provided valuable insights into the dynamics of liquid movement in staked-in-needle pre-filled syringes. Temperature and pressure cycling were found to contribute to additional liquid formation, with pressure changes playing a significant role. The detailed morphological analysis enhanced the understanding of microstructural arrangements within the needle. This research contributes to addressing the issue of needle clogging and can guide the development of strategies to improve pre-filled syringe performance.

Implementing a 4% EDTA Central Catheter Locking Solution as a Quality Improvement Project in a Large Canadian Hospital.

Oncology and critical care patients often require central vascular access devices (CVADs), which can make them prone to central line-associated bloodstream infections (CLABSIs) and thrombotic occlusions. According to the literature, CLABSIs are rampant and increased by 63% during the COVID-19 pandemic, highlighting the need for innovative interventions. Four percent ethylenediaminetetraacetic acid (4% EDTA) is an antimicrobial locking solution that reduces CLABSIs, thrombotic occlusions, and biofilm. This retrospective pre-post quality improvement project determined if 4% EDTA could improve patient safety by decreasing CLABSIs and central catheter occlusions. This was implemented in all adult cancer and critical care units at a regional cancer hospital and center. Before implementing 4% EDTA, there were 36 CLABSI cases in 16months (27 annualized). After implementation, there were 6 cases in 6months (12 annualized), showing a statistically significant decrease of 59% in CLABSIs per 1000 catheter days. However, there was no significant difference in occlusions (alteplase use). Eighty-eight percent of patients had either a positive or neutral outlook, while most nurses reported needing 4% EDTA to be available in prefilled syringes. The pandemic and nursing shortages may have influenced the results; hence, randomized controlled trials are needed to establish a causal relationship between 4% EDTA and CLABSIs and occlusions.

Serological detection of Newcastle disease virus in backyard poultry production system in Woliso District South West Shewa, Central Ethiopia.

Newcastle disease (ND)is one of the most important respiratory viral diseases. The disease is endemic in many parts of Ethiopia. However, there is no clear record about the introduction of the virus to the country (Ethiopia). Hence, detail about the ND is very important in its (ND) control and prevention. Despite these facts, there is no available research work done on ND in the current research area that would help either as references for researchers or that could help in the control and prevention of the disease. Therefore, the objective of this study was to detect the ND virus (NDV), using serological methods in from December 2018 to November 2019. A cross-sectional type of study was conducted to detect the NDV. The convenience sampling method was used for sample data collection. Before data collection, chicken with previous history of vaccination against the NDV was excluded from the sampling animals. Then, a total of 348 blood samples of 2 mLwere collected from the brachial vein in 3 mLdisposable syringes. The serum was collected in labeled 2 mL cryovial tubes. Indirect enzyme-linked immunosorbent assay(ELISA) tests were performed to detect antibodies against NDV and to determine its antibody titer. The test was performed using (ID.vetinnovative version 2) procedure. In the indirect ELISA test, 37.64% (131/348) were positive and antibody titer mean value of (1761.9088) was scored. The standard deviation of 2592.42160 and a percentage coefficient of variation of147% was scored. From the finding, we conclude that indirect ELISA test detected the presence of the NDV in the study area and the heterogeneousity of antibody titer in the study area. Therefore, further molecular characterization and epidemiological investigation should be carried and vaccination of animals is critical in the study area.

An Analysis of Visible Particulates Introduced to Liquid Pharmaceuticals By Disposable Syringes

An Analysis of Visible Particulates Introduced to Liquid Pharmaceuticals By Disposable Syringes