Management of chronic rheumatic diseases in women 18-45 years of age in Asia Pacific: insights from patient and clinician surveys.

Objective: Perspectives of women aged 18-45 years with chronic rheumatic diseases (CRD), and clinicians, in the Asia-Pacific (APAC) region are reported.

Methods: Online surveys were completed by women, pregnant in the past 2-5 years, with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA), and rheumatologists, obstetricians, orthopaedic surgeons who medically manage CRDs.

Results: Among 210 (RA 122, PsA 48, axSpA 40) patients, 52% (n = 109/210) delayed their decision to have children, most commonly due to concerns of passing on disease to offspring.

Proposal for capturing patient experience through extended value frameworks of health technologies.

Inclusion of patient experience (PEx) in health technology assessment (HTA) has become increasingly important; however, no harmonized approach exists to help manufacturers or decision makers ensure PEx considerations are fair, consistent, and thorough within global HTA frameworks. To develop a proposal for including PEx in the HTA frameworks of health technologies. A systematic literature review (SLR) on existing value frameworks (VFs) was conducted to capture how PEx-related value judgment is currently considered.

Development and psychometric evaluation of the assessment of self-injection questionnaire: an adaptation of the self-injection assessment questionnaire.

Background: Patient-reported outcome (PRO) instruments provide robust and effective means of evaluating patients' treatment experience; however, none adequately cover experience using self-injection devices with enhanced features, such as an electromechanical autoinjector (e-Device). The aim of this study was to develop a PRO instrument that accurately assesses patient experience of using an e-Device and to evaluate its psychometric properties.

Methods: A mixed-methods approach was taken; two parallel, targeted literature reviews were conducted to identify relevant concepts and existing self-injection PRO instruments that could be adapted.

A Companion App to Support Rheumatology Patients Treated with Certolizumab Pegol: Results From a Usability Study.

Background: Certolizumab pegol (CZP) is an anti-tumor necrosis factor drug approved for the treatment of multiple moderate to severe chronic inflammatory diseases. In the European Union, CZP is approved for administration by subcutaneous self-injection using a prefilled syringe, prefilled pen, or reusable electromechanical auto-injector (electronic device). CimplyMe is a companion app for use alongside CZP self-injection devices, designed to support CZP-treated patients self-managing their treatment and disease.

A multicenter, open-label study to evaluate the safe and effective use of a new electromechanical auto-injection device for self-injection of certolizumab pegol.

Background: ava® is a new reusable electromechanical auto-injector (e-Device) with disposable, single-use certolizumab pegol (CZP) dispensing cartridges.

Methods: RA0098 (NCT03357471) was a US, multicenter, open-label, phase 3 study designed to assess whether the e-Device can be used safely and effectively by self-injecting patients. CZP pre-filled syringe (PFS) self-injecting patients (≥18 years) diagnosed with rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis, plaque psoriasis, and Crohn's disease received training and self-injected CZP using the e-Device at 2 visits.

A pilot study examining patient preference and satisfaction for ava®, a reusable electronic injection device to administer certolizumab pegol.

: Anti-tumor necrosis factor (anti-TNF) adherence is suboptimal. ava®, a reusable electromechanical self-injection device (e-Device) developed for certolizumab pegol (CZP) administration, aims to overcome some barriers to increase adherence. This study evaluates patient experience of the e-Device and its training materials and determines patient device preference.

Patient Satisfaction with CIMZIA (Certolizumab Pegol) AutoClicks in the UK.

Introduction: The CIMZIA AutoClicks pre-filled pen (CZP PFP) was developed to overcome barriers to self-injection, by improving self-injection confidence, reducing fear associated with needle use, and supporting patients with impaired dexterity. The purpose of this research was to gather feedback on injection experience and the usefulness of training materials.

Methods: Eligible patients with rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) or psoriatic arthritis (PsA) were at least 18 years of age and initiated onto the CZP PFP.

From drug-delivery device to disease management tool: a study of preferences for enhanced features in next-generation self-injection devices.

Purpose: To quantify rheumatology patient preferences and willingness to pay (WTP) for features differentiating enhanced from standard self-injection devices and to investigate differences among subgroups.

Patients And Methods: Patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA) were recruited in the UK. A discrete-choice experiment was used to elicit preferences; respondents were presented with 10 choices between 3 different devices: a free standard disposable device, and 2 hypothetical reusable devices characterized by presence/absence of skin sensor, injection speed control, on-screen instructions, injection reminders, electronic log, and large grip.

A portfolio of biologic self-injection devices in rheumatology: how patient involvement in device design can improve treatment experience.

Biologic drugs (e.g. anti-tumor necrosis factors) are effective treatments for multiple chronic inflammatory diseases including rheumatoid arthritis, axial spondyloarthritis, and psoriatic arthritis.

A Targeted Literature Review Examining Biologic Therapy Compliance and Persistence in Chronic Inflammatory Diseases to Identify the Associated Unmet Needs, Driving Factors, and Consequences.

Unlabelled: Chronic inflammatory diseases (CIDs) represent a substantial clinical and economic burden to patients, providers, payers and society overall. Biologics, such as tumor necrosis factor inhibitors (TNFi), have emerged as effective treatment options for patients with CIDs. However, the therapeutic potential of biologics is not always achieved in clinical practice, with results from studies examining the use of biologics in real-world settings suggesting lower levels of treatment effectiveness compared with clinical trial results.

The Parker Model: Applying a Qualitative Three-Step Approach to Optimally Utilize Input from Stakeholders When Introducing New Device Technologies in the Management of Chronic Rheumatic Diseases.

Background And Objective: Qualitative methods such as semi-structured interviews and focus-groups are used to evaluate the applicability and relevance of device technologies in clinical practice, but when used alone, often lack generalizability. This study aimed to assess the face validity and feasibility of using a composite, three-step qualitative method (the Parker Model), to inform the development and implementation of ava, an electromechanical device (e-Device) for subcutaneous self-administration of the biologic, certolizumab pegol (CZP), used to treat rheumatic diseases.

Methods: The Parker Model combines concept mapping (CM), participatory design (PD), and stakeholder evaluation (SE).

Using Patient Feedback to Optimize the Design of a Certolizumab Pegol Electromechanical Self-Injection Device: Insights from Human Factors Studies.

Introduction: We incorporated patient feedback from human factors studies (HFS) in the patient-centric design and validation of ava, an electromechanical device (e-Device) for self-injecting the anti-tumor necrosis factor certolizumab pegol (CZP).

Methods: Healthcare professionals, caregivers, healthy volunteers, and patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or Crohn's disease participated in 11 formative HFS to optimize the e-Device design through intended user feedback; nine studies involved simulated injections. Formative participant questionnaire feedback was collected following e-Device prototype handling.

Chronic Disease and Self-Injection: Ethnographic Investigations into the Patient Experience During Treatment.

Introduction: Drug administration by self-injection provides an option to treat chronic inflammatory diseases such as rheumatoid arthritis (RA) and Crohn's disease (CD). However, a negative self-injection experience for patients may reduce patient adherence to the recommended treatment regimen. In this study, a holistic approach was used to identify common themes along the treatment pathway and at self-injection that, if changed, could improve patient experience and treatment outcomes.

Long-Term Maintenance of Certolizumab Pegol Safety and Efficacy, in Combination with Methotrexate and as Monotherapy, in Rheumatoid Arthritis Patients.

Introduction: The safety and efficacy of certolizumab pegol (CZP) 400 mg every 4 weeks (Q4W) monotherapy (FAST4WARD/NCT00548834) and in combination with methotrexate (MTX) (014/NCT00544154) in active rheumatoid arthritis (RA) has been published previously. This report outlines final long-term outcomes from the open-label extension (OLE) study (015/NCT00160693), which enrolled patients from these randomized controlled trials (RCTs).

Methods: Patients who withdrew from or completed the 24-week 014/FAST4WARD RCTs were enrolled and received CZP 400 mg Q4W with/without MTX.

Comparative usability study for a certolizumab pegol autoinjection device in patients with rheumatoid arthritis.

Objectives: To compare the usability of a new certolizumab pegol (CZP) autoinjector with the adalimumab, etanercept, and golimumab devices in patients with rheumatoid arthritis.

Methods: Two identical studies were performed in 2013 and 2016; patients performed a simulated self-injection with the CZP autoinjector and the most up-to-date device versions at the time in a randomized, consecutive sequence. The primary end point was the ranking of the four autoinjectors in order of preference.

Certolizumab pegol plus methotrexate 5-year results from the rheumatoid arthritis prevention of structural damage (RAPID) 2 randomized controlled trial and long-term extension in rheumatoid arthritis patients.

Introduction: As patients with rheumatoid arthritis (RA) receive treatment with anti-tumour necrosis factors over several years, it is important to evaluate their long-term safety and efficacy. The objective of this study was to examine the safety and benefits of certolizumab pegol (CZP)+methotrexate (MTX) treatment for almost 5 years in patients with RA.

Methods: Patients who completed the 24-week Rheumatoid Arthritis Prevention of Structural Damage (RAPID) 2 randomized controlled trial (RCT; NCT00160602), or who were American College of Rheumatology (ACR) 20 non-responders at Week 16, entered the open-label extension (OLE; NCT00160641).

Stimulatory effects on Na+ transport in renal epithelia induced by extracts of Nigella arvensis are caused by adenosine.

Effects of the extract of Nigella arvensis (NA) seeds on transepithelial Na(+) transport were studied in cultured A6 toad kidney cells by recording short-circuit current (I(sc)), transepithelial conductance (G(T)), transepithelial capacitance (C(T)) and fluctuation in I(sc). Apical application of NA extract had merely a small stimulatory effect on Na(+) transport, whereas basolateral administration markedly increased I(sc), G(T) and C(T). A maximal effect was obtained at 500 microll(-1) of lyophilized NA extract.

Expression of Ca(2+) Transport Genes in Platelets and Endothelial Cells in Hypertension.

-Altered Ca(2+) handling is observed in different cells in essential hypertension. We investigated the expression of sarco(endo)plasmic reticulum Ca(2+)-ATPase (SERCA) and inositol 1,4,5-trisphosphate receptor (IP(3)R) isoforms in platelets and aortic endothelial cells (EC) isolated from spontaneously hypertensive (SHR) and Wistar-Kyoto (WKY) rats by ratio reverse-transcriptase-polymerase chain reaction (RT-PCR) analysis and Western blotting. SERCA2b and SERCA3 were assessed at mRNA (EC and platelets) and at protein level (platelets).