Predictors of extra-articular manifestations in axial spondyloarthritis and their influence on TNF-inhibitor prescribing patterns:Results from the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis

OBJECTIVES: Extra-articular manifestations (EAMs) are important systemic features of axial spondyloarthritis (axSpA), which may influence the choice of tumour necrosis factor-inhibitor (TNFi). We examined the cumulative incidence and predictors of EAMs and the influence of these on first TNFi choice in a 'real-world' cohort of patients with axSpA. METHODS: Clinical and patient-reported outcomes of 2420 patients with axSpA from 83 centres were collected by the British Society for Rheumatology Biologics Register in Ankylosing Spondylitis. Lifestyle factors for EAMs (acute anterior uveitis (AAU), inflammatory bowel diseases (IBD), psoriasis) were compared with those without EAMs. Also, the association between pretreatment EAMs and choice of first TNFi (adalimumab, etanercept, certolizumab) was analysed. RESULTS: AAU was directly associated with human leukocyte antigen (HLA)-B27 (incidence rate ratio (IRR) 1.95, 95% CI 1.40 to 2.73) and inversely associated with ever-smoking (IRR=0.71, 95% CI 0.55 to 0.92). For both psoriasis and IBD, there was an inverse relationship with HLA-B27 (IRR 0.54, 95% CI 0.36 to 0.79 and IRR 0.63, 95% CI 0.43 to 0.91, respectively). A diagnosis of either AAU (OR 3.79, 95% CI 2.11 to 6.80) or IBD (OR 5.50, 95% CI 2.09 to 14.46) was associated with preference for adalimumab versus others. In contrast, a diagnosis of either AAU (OR 0.14, 95% CI 0.06 to 0.33) or IBD (OR 0.17, 95% CI 0.05 to 0.57) was associated with less preference for etanercept over other TNFi. CONCLUSION: The higher occurrence of AAU and lower occurrence of psoriasis and IBD in HLA-B27-positive patients with axSpA are consistent with current pathophysiology. Patients with previous AAU and IBD are more likely to be prescribed adalimumab and less likely to receive etanercept, consistent with the superior efficacy of monoclonal TNFi for these indications. Future work will determine whether EAMs influence TNFi survival, or effectiveness, and whether this varies between agents

Diagnostic delay in axial spondylarthritis:A lost battle?

Diagnostic delay in axial spondylarthritis (axSpA) remains an unacceptable worldwide problem; with evidence suggesting significant detrimental impact both clinically on the individual, and economically on society. There is therefore, a need for global action across various healthcare professions that come into contact with patients living, and suffering, with undiagnosed axSpA. Recent estimates of the median diagnostic delay suggest that globally, individuals with axSpA wait between 2 and 6 years for a diagnosis – revealing a clear benchmark for improvement. This timespan presents a window of opportunity for earlier diagnosis and intervention, which will likely improve patient outcomes. This review describes the current diagnostic delay as estimated across countries and over time, before presenting evidence from published strategies that may be implemented to improve this delay across primary and secondary care, including for specialties treating extra-musculoskeletal manifestations of axSpA (ophthalmology, gastroenterology, dermatology). Ongoing campaigns tackling delayed diagnosis in axSpA are also highlighted

Current evidence on the use of the adalimumab biosimilar SB5 (ImraldiTM): a multidisciplinary perspective

This review provides an overview of data from trials and real-world studies available for SB5 (ImraldiTM) across three main therapeutic areas: rheumatology, gastroenterology, and dermatology. Areas covered A literature search for publications on data for SB5 efficacy/effectiveness, safety, and immunogenicity was undertaken. Expert opinion, Evidence derived from clinical studies suggest that the biosimilar SB5 is a safe and effective alternative to reference adalimumab. Considering that patients suffering from immune-mediated inflammatory diseases such as inflammatory arthritis, inflammatory bowel disease and psoriasis often require long-term biologic treatment, biosimilar medicines (such as SB5) can reduce healthcare costs while increasing access to effective treatment

What Contribution Did Economic Evidence Make to the Adoption of Universal Newborn Hearing Screening Policies in the United States?

Universal newborn hearing screening (UNHS), when accompanied by timely access to intervention services, can improve language outcomes for children born deaf or hard of hearing (D/HH) and result in economic benefits to society. Early Hearing Detection and Intervention (EHDI) programs promote UNHS and using information systems support access to follow-up diagnostic and early intervention services so that infants can be screened no later than 1 month of age, with those who do not pass their screen receiving diagnostic evaluation no later than 3 months of age, and those with diagnosed hearing loss receiving intervention services no later than 6 months of age. In this paper, we first document the rapid roll-out of UNHS/EHDI policies and programs at the national and state/territorial levels in the United States between 1997 and 2005. We then review cost analyses and economic arguments that were made in advancing those policies in the United States. Finally, we examine evidence on language and educational outcomes that pertain to the economic benefits of UNHS/EHDI. In conclusion, although formal cost-effectiveness analyses do not appear to have played a decisive role, informal economic assessments of costs and benefits appear to have contributed to the adoption of UNHS policies in the United States

Current evidence on the use of the adalimumab biosimilar SB5 (ImraldiTM):a multidisciplinary perspective

Introduction: This review provides an overview of data from trials and real-world studies available for SB5 (ImraldiTM) across three main therapeutic areas: rheumatology, gastroenterology, and dermatology. Areas covered: A literature search for publications on data for SB5 efficacy/effectiveness, safety, and immunogenicity was undertaken. Expert opinion: Evidence derived from clinical studies suggest that the biosimilar SB5 is a safe and effective alternative to reference adalimumab. Considering that patients suffering from immune-mediated inflammatory diseases such as inflammatory arthritis, inflammatory bowel disease and psoriasis often require long-term biologic treatment, biosimilar medicines (such as SB5) can reduce healthcare costs while increasing access to effective treatments

Likely Impact of the COVID-19 Pandemic on Newborn Hearing Screening and Follow-up Services in the United States in 2020

This perspective aims to highlight aspects of the Early Hearing Detection and Intervention (EHDI) newborn hearing screening and follow-up processes that were impacted by the COVID-19 pandemic and considers factors that likely impacted follow-up after newborn hearing screening among infants born in the United States during 2020. Efforts to minimize the potential impact of missed or delayed identification of hearing loss in infants and young children will also be discussed to help guide future program improvement activities

The prevalence of axial spondyloarthritis in the UK: a cross-sectional cohort study

Background: Accurate prevalence data are important when interpreting diagnostic tests and planning for the health needs of a population, yet no such data exist for axial spondyloarthritis (axSpA) in the UK. In this cross-sectional cohort study we aimed to estimate the prevalence of axSpA in a UK primary care population. Methods: A validated self-completed questionnaire was used to screen primary care patients with low back pain for inflammatory back pain (IBP). Patients with a verifiable pre-existing diagnosis of axSpA were included as positive cases. All other patients meeting the Assessment of SpondyloArthritis international Society (ASAS) IBP criteria were invited to undergo further assessment including MRI scanning, allowing classification according to the European Spondyloarthropathy Study Group (ESSG) and ASAS axSpA criteria, and the modified New York (mNY) criteria for ankylosing spondylitis (AS). Results: Of 978 questionnaires sent to potential participants 505 were returned (response rate 51.6 %). Six subjects had a prior diagnosis of axSpA, 4 of whom met mNY criteria. Thirty eight of 75 subjects meeting ASAS IBP criteria attended review (mean age 53.5 years, 37 % male). The number of subjects satisfying classification criteria was 23 for ESSG, 3 for ASAS (2 clinical, 1 radiological) and 1 for mNY criteria. This equates to a prevalence of 5.3 % (95 % CI 4.0, 6.8) using ESSG, 1.3 % (95 % CI 0.8, 2.3) using ASAS, 0.66 % (95 % CI 0.28, 1.3) using mNY criteria in chronic back pain patients, and 1.2 % (95 % CI 0.9, 1.4) using ESSG, 0.3 % (95 % CI 0.13, 0.48) using ASAS, 0.15 % (95 % CI 0.02, 0.27) using mNY criteria in the general adult primary care population. Conclusions: These are the first prevalence estimates for axSpA in the UK, and will be of importance in planning for the future healthcare needs of this population. Trial registration: Current Controlled Trials ISRCTN7687321