ObjectivesTo determine if disease duration and number of prior disease-modifying antirheumatic drugs (DMARDs) affect response to therapy in patients with established rheumatoid arthritis (RA).MethodsAssociations between disease duration or number of prior DMARDs and response to therapy were assessed using data from two randomised controlled trials in patients with established RA (mean duration, 11 years) receiving adalimumab+methotrexate. Response to therapy was assessed at week 24 using disease activity outcomes, including 28-joint Disease Activity Score based on C-reactive protein (DAS28(CRP)), Simplified Disease Activity Index (SDAI) and Health Assessment Questionnaire Disability Index (HAQ-DI), and proportions of patients with 20%/50%/70% improvement in American College of Rheumatology (ACR) responses.ResultsIn the larger study (N=207), a greater number of prior DMARDs (>2 vs 0–1) was associated with smaller improvements in DAS28(CRP) (–1.8 vs –2.2), SDAI (–22.1 vs –26.9) and HAQ-DI (–0.43 vs –0.64) from baseline to week 24. RA duration of >10 years versus <1 year was associated with higher HAQ-DI scores (1.1 vs 0.7) at week 24, but results on DAS28(CRP) and SDAI were mixed. A greater number of prior DMARDs and longer RA duration were associated with lower ACR response rates at week 24. Data from the second trial (N=67) generally confirmed these findings.ConclusionsNumber of prior DMARDs and disease duration affect responses to therapy in patients with established RA. Furthermore, number of prior DMARDs, regardless of disease duration, has a limiting effect on the potential response to adalimumab therapy.

In the USA, an interchangeability designation provides biosimilar sponsors with a pathway for achieving what is standard for small-molecule generics: pharmacy-level auto-substitution for an innovator. No other major health authority links interchangeability to automatic substitution, as all require the involvement of the prescriber or patient in a medication change. This editorial considers the clinical impact and practicality of auto-substitution. First, interchangeability is linked to non-medical switching (NMS), the practice of switching treatment in patients with stable disease for non-clinical reasons. NMS may generate negative sentiment in those unwilling or reluctant to switch, which can adversely impact treatment outcomes (i.e., nocebo effect). Indeed, in real-world studies of tumor necrosis factor inhibitors, discontinuation rates have been shown to be higher in patients switched to biosimilars for non-medical reasons than in historical cohorts maintained on innovators. Second, interchangeability may impede pharmacovigilance and traceability, as not all jurisdictions require innovators and biosimilars to have distinct biologic names. Third, an interchangeability designation from the US Food and Drug Administration only permits a biosimilar to be automatically substituted for its innovator, not other biosimilars (if available). Pharmacist education would be needed to avoid off-label, automatic substitution among biosimilars of a single innovator. Last, once granted, an interchangeability designation exists in perpetuity under current US federal law. However, the supply chains of innovators and biosimilars are maintained independently, with no requirement for reconfirmation of biosimilarity or interchangeability. We feel that additional guidance is needed for the auto-substitution of biosimilars and innovators to become a reality.

A number of developments, including increasing regulatory and compliance scrutiny, increased transparency expectations, an increasingly vocal patient, patient centricity and greater requirements for real-world evidence, have driven the growth and importance of medical affairs as a trusted, science-driven partner over the past decade. The healthcare environment is shifting towards a digital, data-driven and payor-focused model. Likewise, medical affairs as a function within the pharmaceutical industry has become more “patient-centric” with strategic engagements embracing payers and patients apart from clinicians. The pandemic has impacted the healthcare industry as well as the function of medical affairs in numerous ways and has brought new challenges and demands to tackle. There is indeed a silver lining due to intense digital transformation within this crisis. The emerging digital innovation and new technologies in healthcare, medical education and virtual communications are likely to stay and advance further. In this review, we discuss how the digital transformation sparked by the pandemic has impacted the medical affairs function in pharmaceuticals and provide further insights and learnings from the COVID-19 era and beyond. Based on the learning and insights, digital innovation in three key strategic imperatives of medical affairs—HCP engagement, external partnerships and data generation will enable medical affairs to become future-fit as a strategic leadership function.

Background Real-world data (RWD) related to patient health status or health care delivery can be broadly defined as data collected outside of conventional clinical trials, including those from databases, treatment and disease registries, electronic medical records, insurance claims, and information directly contributed by health care professionals or patients. RWD are used to generate real-world evidence (RWE), which is increasingly relevant to policy makers in Asia, who use RWE to support decision-making in several areas, including public health policy, regulatory health technology assessment, and reimbursement; set priorities; or inform clinical practice. Objective To support the achievement of the benefits of RWE in Asian health care strategies and policies, we sought to identify the linked contemporary databases used in real-world studies from three representative countries—India, Thailand, and Taiwan—and explore variations in results based on these countries’ economies and health care reimbursement systems by performing a systematic scoping review. Herein, we describe the protocol and preliminary findings of our scoping review. Methods The PubMed search strategy covered 3 concepts. Concept 1 was designed to identify potential RWE and RWD studies by applying various Medical Subject Headings (MeSH) terms (“Treatment Outcome,” “Evidence-Based Medicine,” “Retrospective Studies,” and “Time Factors”) and related keywords (eg, “real-world,” “actual life,” and “actual practice”). Concept 2 introduced the three countries—India, Taiwan, and Thailand. Concept 3 focused on data types, using a combination of MeSH terms (“Electronic Health Records,” “Insurance, Health,” “Registries,” “Databases, Pharmaceutical,” and “Pharmaceutical Services”) and related keywords (eg, “electronic medical record,” “electronic healthcare record,” “EMR,” “EHR,” “administrative database,” and “registry”). These searches were conducted with filters for language (English) and publication date (publications in the last 5 years before the search). The retrieved articles will undergo 2 screening phases (phase 1: review of titles and abstracts; phase 2: review of full texts) to identify relevant and eligible articles for data extraction. The data to be extracted from eligible studies will include the characteristics of databases, the regions covered, and the patient populations. Results The literature search was conducted on September 27, 2022. We retrieved 3,172,434, 1,094,125, and 672,794 articles for concepts 1, 2, and 3, respectively. After applying all 3 concepts and the language and publication date filters, 2277 articles were identified. These will be further screened to identify eligible studies. Based on phase 1 screening and our progress to date, approximately 44% (1003/2277) of articles have undergone phase 2 screening to judge their eligibility. Around 800 studies will be used for data extraction. Conclusions Our research will be crucial for nurturing advancement in RWD generation within Asia by identifying linked clinical RWD databases and new avenues for public-private partnerships and multiple collaborations for expanding the scope and spectrum of high-quality, robust RWE generation in Asia. International Registered Report Identifier (IRRID) DERR1-10.2196/43741

BACKGROUND real-world data (RWD) relating to patient health status and/or the delivery of healthcare can be broadly defined as data collected outside of conventional clinical trials in the context of databases, treatment and disease registries, electronic medical records, insurance claims, and information directly contributed by healthcare professionals and/or the patients themselves. RWD is used to generate real-world evidence, which is increasingly relevant to policymakers in Asia to support decision-making from several perspectives, including public health policy, regulatory, health technology assessments, and reimbursement, and to set priorities or inform (clinical) practice. OBJECTIVE To support the purpose of achieving the benefits of RWE in Asian healthcare strategy and policy, we sought to identify linked contemporary databases used in real-world studies in three representative countries (India, Thailand, and Taiwan) to reflect the diversity in Asia by performing a systematic scoping review. In this article, we describe the protocol and preliminary literature search for the scoping review. METHODS The PubMed search strategy covered three concepts. Concept 1 was designed to identify potential RWE/RWD studies by applying a variety of MeSH terms (“Treatment Outcome”, “Evidence-Based Medicine”, “Retrospective Studies”, “Time Factors”) and related keywords (e.g. “real-world”, “actual life”, “actual practice”). Concept 2 introduced the three countries (India, Taiwan, and Thailand). Concept 3 focused on data types, by using a combination of MeSH terms (“Electronic Health Records”, “Insurance, Health”, “Registries”, “Databases, Pharmaceutical”, “Pharmaceutical Services”) and related keywords (e.g., electronic medical record, electronic healthcare record, EMR, EHR, administrative database, registry). These searches were combined with filters for the English language and publications in the last 5 years before the search. In the next step, the retrieved articles will undergo two screening phases (phase 1: review of the title and abstract; phase 2: review of full text) in order to identify relevant and eligible articles for data extraction. Data to be extracted from eligible studies will include characteristics of the database itself, region(s) covered, and the patient population. RESULTS The literature search was conducted on Sep 27, 2022 and retrieved 3,172,434 (concept 1), 1,094,125 (concept 2), and 672,794 (concept 3) articles. After applying all three concepts together with the language and publication date filters, 2,277 articles were identified. These articles will be further screened to identify eligible studies. Based on phase 1 screening to date, we estimate that approximately 20% (~450) of the articles will require full-text review to judge their eligibility, and that 100–200 studies will be used for data extraction. CONCLUSIONS We believe that this research will be crucial in nurturing advancement in RWD generation in Asia by identifying linked clinical RWD databases and identifying new avenues for public-private partnerships and multiple collaborations to expand the scope and spectrum of high-quality, robust RWE generation in Asia. CLINICALTRIAL NA