Dataset Information

Patient Perspectives on Switching from Infliximab to Infliximab-dyyb in Patients with Rheumatologic Diseases in the United States.

ABSTRACT: Objective:The introduction of biosimilars for rheumatologic diseases (RDs) has provided a potentially lower-cost therapy compared with their bio-originator products; however, adoption of biosimilars may be challenged by patient perceptions. The objective of this study was to describe patients' perspectives of switching from infliximab to infliximab-dyyb. Methods:This was a survey of adult patients with RDs who qualified for switching from infliximab to infliximab-dyyb therapy between September 1 2017 and January 31 2018. Verbal consent was obtained prior to administration of a telephone survey. Survey questions were focused on the safety, efficacy, and knowledge of biosimilar therapy. Results:A total of 108 patients were identified with 52 (48%) patients consenting to study participation. Forty (77%) and 12 (23%) patients reported switching and not switching, respectively, to infliximab-dyyb. Regarding disease control, most respondents (80%) were satisfied to very satisfied with the switch to infliximab-dyyb. Major concerns reported for switching included not knowing enough about the medication (38%), potential side effects (35%), and loss of disease activity control (35%). Conclusion:Overall, patients reported satisfaction with switching from infliximab to infliximab-dyyb, but concerns regarding safety and efficacy were expressed. Patient involvement in the switching decision-making process may allay concerns and enhance biosimilar uptake.

SUBMITTER: Chau J

PROVIDER: S-EPMC6858025 | biostudies-literature | 2019 Mar

REPOSITORIES: biostudies-literature

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Patient Perspectives on Switching from Infliximab to Infliximab-dyyb in Patients with Rheumatologic Diseases in the United States.

Chau Jason J Delate Thomas T Ota Taylor T Bhardwaja Bharati B

ACR open rheumatology 20190315 1

<h4>Objective</h4>The introduction of biosimilars for rheumatologic diseases (RDs) has provided a potentially lower-cost therapy compared with their bio-originator products; however, adoption of biosimilars may be challenged by patient perceptions. The objective of this study was to describe patients' perspectives of switching from infliximab to infliximab-dyyb.<h4>Methods</h4>This was a survey of adult patients with RDs who qualified for switching from infliximab to infliximab-dyyb therapy betw ...[more]

PMID: 31777780

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Project description:Abstract Background Real-world assessments of biosimilars are needed to understand their effectiveness and safety in practice settings that may differ from those seen in clinical trials or healthcare systems in different countries. To assess the effectiveness and safety of a biosimilar (infliximab-dyyb) and its reference product (infliximab) in patients with inflammatory bowel disease (IBD) in the United States. Methods We conducted a retrospective cohort study of biologic-naive patients with IBD who started treatment with infliximab-dyyb or infliximab. The study included 3206 patients identified through electronic health records in a US integrated healthcare delivery system. The effectiveness outcome was a composite of IBD-related surgery, IBD-related emergency room visit, and IBD-related hospitalization within 12 months of initiation. Safety outcomes included incidence of any or serious infection, cancer, acute liver dysfunction, and tuberculosis. We used a non-inferiority test with an upper-limit margin of 10% to analyze effectiveness. Doubly robust methods incorporating Cox proportional hazard regression with standardized inverse probability of treatment weighting were used to analyze both effectiveness and safety outcomes. Results The composite effectiveness outcome occurred in 107 of 870 patients (12.3%) in the infliximab-dyyb and 379 of 2336 patients (16.2%) in the infliximab groups. Infliximab-dyyb was non-inferior (P < .01) and was not different (hazard ratio [HR] 0.81; confidence interval [CI] 0.65–1.01; P = .06) to infliximab. Safety outcomes were not different between infliximab-dyyb and infliximab for any infections (HR 1.01; CI 0.86–1.17; P = .95), serious infections (HR 0.83; CI 0.54–1.26; P = .38), cancers (HR 0.83; CI 0.44–1.54; P = .55), and tuberculosis (HR 0.59; CI 0.10–3.55; P = .57). Conclusions Initiation of infliximab-dyyb was non-inferior to infliximab among biologic-naive patients with IBD in an US integrated healthcare delivery system. Graphical Abstract

Project description:BackgroundThere are limited real-world data on the diagnostic experiences of patients with psoriatic arthritis (PsA), including medical care sought and potential barriers to diagnosis. We aim to describe patient experiences related to receiving a PsA diagnosis.MethodsOurs was a mixed-method, 2-phase study. Phase 1 comprised concept elicitation and cognitive interviews with clinical experts and adults diagnosed with PsA to develop a cross sectional, web-based survey. US adults with a self-reported PsA diagnosis were recruited through a patient support community (CreakyJoints), an online patient research registry (ArthritisPower), and social media outreach. In Phase 2, the online survey collected data on sociodemographics, clinical symptoms, disease burden, and diagnosis history of survey respondents with PsA.ResultsOf the 203 respondents included, 172 (84.7%) were female, and the mean (SD) age was 51.6 (10.8) years. The time between seeking medical attention and receiving a diagnosis was < 6 months for 69 respondents, 6 months to 4 years for 68 respondents, and ≥ 5 years for 66 respondents. Most respondents sought care from general practitioners (79.8%) and rheumatologists (66.5%). Common initial symptoms that led respondents to seek medical attention were joint pain (70.0%) and stiffness (53.7%). Among the initial symptoms that led respondents to seek care, joint pain, swollen joints, and sausage-like fingers or toes (indicating dactylitis) were more common among respondents with shorter time to diagnosis, whereas stiffness, fatigue, enthesitis (indicated by foot problems, tendon and ligament pain), and back pain were more common among respondents with longer time to diagnosis. Common misdiagnoses were psychosomatic issues (26.6%) and osteoarthritis (21.7%). Respondents with shorter times to diagnosis had lower frequencies of misdiagnosis.ConclusionsRespondents with PsA reported delays in diagnosis and misdiagnoses on their journey to a PsA diagnosis. Symptom differences, such as enthesitis and stiffness, were noted among respondents with shorter vs longer time to diagnosis. Increased understanding of diagnostic barriers may lead to earlier diagnosis and appropriate management to improve outcomes.

Project description:BackgroundPatient-Powered Research Networks (PPRNs) are a unique type of patient-powered patient registry for patient-centered outcomes research requiring that stakeholder engagement play a key role in governance (eg, research guidance and decision making). The purpose of this report is to describe the governance structure of a newly formed PPRN and the activities undertaken prelaunch and postlaunch to evaluate and improve the engagement of patient stakeholders in governance.MethodsDuring the 18-month start-up period of ArthritisPower, a PPRN for adult rheumatologic conditions, 12 members of the patient body of the PPRN governance completed a 12-item preassessment and postassessment based on the Patient-Centered Outcomes Research Institute (PCORI) Engagement Rubric. The assessment was intended to measure Patient Governor (PG) perceptions of their engagement in governance within the first 3 months of their involvement at an in-person orientation. Six months later, the PG Chair initiated a mid-year evaluation with the same group to identify areas for improvement. Semistructured phone interviews were conducted with 11 PGs who were asked to rate and explain their perceptions about their participation in PPRN governance, the progress of the PPRN toward conducting research, the support they receive from staff, and the support they receive from other PGs. Results were compiled and interpreted by the Chair with help from the coprincipal investigator.ResultsPreassessment/postassessments indicated that PGs understood their governance role and decision-making authority after in-person orientation and felt that major PPRN decisions were being made with their input. Feedback and scores from the PG-led mid-year evaluation coalesced around 3 themes: a preference for receiving news and updates via email to allow more discussion and decision making during conference calls, a desire for guidance about how best to help advance the PPRN toward the conduct of research, and a need to communicate with each other as a group outside of monthly conference calls. Suggested activities to support patient engagement in PPRN governance include communicating clear expectations, providing well-prepared tools for engagement, and conducting regular assessments.ConclusionsMembers of an online patient community are willing to share their expertise to participate in and shape research governance and bring both their professional and lived health experience to the development and improvement of PPRN governance structure. A patient-initiated and patient-led evaluation of governance communication procedures within the PPRN provided more specific recommendations for improvement than did an investigator-led preevaluation/postevaluation based on the PCORI Engagement Rubric.

Dataset Information

Patient Perspectives on Switching from Infliximab to Infliximab-dyyb in Patients with Rheumatologic Diseases in the United States.

Publications

Patient Perspectives on Switching from Infliximab to Infliximab-dyyb in Patients with Rheumatologic Diseases in the United States.

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