A Clinical Update and Global Economic Burden of Rheumatoid Arthritis

Fazal, Syed Ali; Khan, Mohammad; Nishi, Shamima Easmin; Alam, Fahmida; Zarin, Nowshin; Bari, Mohammad Tariful; Ashraf, Ghulam Md

doi:10.2174/1871530317666171114122417

Cited by 74 publications

(61 citation statements)

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“…In addition to the progressive loss of working ability associated with RA, the high cost of therapy poses an additional burden to affected patients, their families, and society. 30 In the present study, we attempted to provide guidance with respect to introduction of tofacitinib to the public hospital formulary by analysing the budgetary impact of this change. Drug listing and subsidy decisions rely on the principles of efficacy, safety, and cost-effectiveness; thus, they must consider a variety of factors, including clinical evidence and impact on healthcare costs.…”

Section: Discussionmentioning

confidence: 99%

Budget impact of introducing tofacitinib to the public hospital formulary in Hong Kong, 2017-2021

Pathadka

Man

et al. 2019

Hong Kong Med J

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As the first approved oral kinase inhibitor, tofacitinib is effective and well-tolerated, but more expensive than conventional treatments for uncontrolled rheumatoid arthritis. Public formulary listing typically exerts a positive impact on the uptake of new drugs. We aimed to assess the budgetary impact of introducing tofacitinib into the Hospital Authority Drug Formulary as a fully subsidised drug in Hong Kong. Methods: We applied a population-based budget impact model to trace the number of eligible patients receiving biologics or tofacitinib treatment, then estimated the 5-year healthcare expenditure on rheumatoid arthritis treatments, with or without tofacitinib (2017-2021). We used linear regression to estimate the number of target patients and compound annual growth rate to estimate market share. Competing treatments included abatacept, adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, and tofacitinib. Retail price was used for drug costs, valued in Hong Kong dollars

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Section: Discussionmentioning

confidence: 99%

Budget impact of introducing tofacitinib to the public hospital formulary in Hong Kong, 2017-2021

Pathadka

Man

et al. 2019

Hong Kong Med J

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“…Approximately 1.5 million people in the United States have RA. In European countries, between 20 and 50 cases per 100,000 inhabitants are newly diagnosed each year [1]. Worldwide, 0.24% of the adult population have RA.…”

Section: Introductionmentioning

confidence: 99%

An Open-Label, Randomized, Single-Dose, Crossover, Comparative Pharmacokinetics Study of YLB113 and the Etanercept Reference Product in Healthy Adult Male Subjects

Shennak¹,

Al-Jaouni²,

Kshirasagar

et al. 2020

Eur J Drug Metab Pharmacokinet

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Background and Objectives YLB113 is being developed as a biosimilar of the antitumor necrosis factor-alpha antagonist etanercept, which is approved for the treatment of moderate-to-severe rheumatoid arthritis (RA) and other chronic immunemediated inflammatory diseases. An open-label, crossover, pharmacokinetic study was conducted to compare the relative bioavailability and safety of YLB113 and the etanercept reference product (RP) Enbrel ®. Methods Healthy male subjects aged 18-50 years were randomized to receive a single subcutaneous dose of YLB113 in one period and the etanercept RP in another period. A washout period of 28 days separated the two treatment periods. Blood samples were collected for pharmacokinetic analysis predose and until 480 h postdose during both periods. Results Overall, 52 subjects were enrolled, including 51 subjects who completed the first period and 43 subjects who completed the second period. The 90% confidence intervals for the least squares means derived from an analysis of the logtransformed pharmacokinetic parameters maximum serum concentration (C max), area under the serum concentration-time curve (AUC) from 0 to the last measurable concentration (AUC (0-t)) and AUC from 0 to infinity (AUC (0-∞)) for etanercept were between the limits of 80 and 125%. Thus, YLB113 met the bioequivalence criterion. YLB113 and the etanercept RP were well tolerated, with 24 subjects reporting 53 adverse events, including 42 mild and 11 moderate events. Treatmentemergent adverse events were reported by 14 and 16 subjects following the administration of YLB113 and the etanercept RP, respectively. Conclusions A single dose of YLB113 exhibited pharmacokinetic and safety profiles comparable with those of the etanercept RP in healthy adult male subjects. Therefore, YLB113 and the etanercept RP can be considered bioequivalent. These findings support the continued development of YLB113 for use in patients with RA. Jordan Food & Drug Administration unique trial number 31/Clinical/2018.

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“…Up to 90% of patients with RA report wrist or hand problems, especially metacarpophalangeal (MCP), and proximal interphalangeal (PIP) joints (6), with symptoms such as pain, swelling, decreased mobility (7), loss of muscle mass (8), hand deformities, reduced strength (9), and stiffness (10), which causes impaired function and social participation (11). This leads to a huge socioeconomic burden, higher than that of other non-communicable diseases (12), with an estimated annual loss of productivity of 11.500$ per person (13), and an increased 50% risk of unemployment (14).…”

Section: Introduction Background and Rationale {6a}mentioning

confidence: 99%

A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis. A randomized controlled trial protocol.

Sánchez-Laulhé¹,

Romero

Blanquero

et al. 2020

Preprint

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• Background: Therapeutic exercise is a safe and cost-effective approach to alleviate hand rheumatoid arthritis (RA) related symptoms. This study aims to investigate the differences in self-management between a smartphone app (CareHand), using hand exercises and educational advices, compared with a standard approach, on hand overall function, pain intensity, stiffness, and grip and pinch strength in patients with hand RA.• Methods: The project is a prospective, longitudinal, superiority, randomized controlled trial. Fifty-eight participants with hand RA will be randomly assigned into an experimental group (CareHand app) or a control group (conventional treatment). Control intervention involves a paper sheet with exercises and recommendations, and the experimental group includes the use of a smartphone app, which provides individualized exercise programmes, self-management and educational strategies to promote adherence to treatment. Both intervention protocols will last for 3 months. The principal investigator will conduct an educational session at baseline for all participants. Primary outcome comprises the overall hand function, assessed with the Michigan Hand Outcome Questionnaire (MHQ). Secondary outcomes include self-reported functional ability with the Quick DASH questionnaire, self-reported pain intensity and morning stiffness using a Visual Analogue Scale (VAS), and hand grip and pinch strength (dynamometer). Outcome measures will be collected at baseline, and at 1 month and 3-month follow-up.• Discussion: This study will evaluate the effectiveness of a telerehabilitation tool, which uses exercise and self-management strategies, compared to a conventional approach, in patients with hand RA. The smartphone app will allow to monitor the patient´s status, and to enhance patient-therapist communication. Some limitations may be related to the short follow-up duration and the lack of evaluation of psychosocial factors. Overall, this new way of promoting long-term effects in patients with a chronic rheumatic disease could be feasible and easy to implement in daily life clinical practice and current musculoskeletal care.• Trial registration: ClinicalTrials.gov Identifier: NCT04263974. Registered 7 March 2020. Date of last update 15 April 2020. Ethics committee code: PI_RH_2018.

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A Clinical Update and Global Economic Burden of Rheumatoid Arthritis

Cited by 74 publications

References 0 publications

Budget impact of introducing tofacitinib to the public hospital formulary in Hong Kong, 2017-2021

Budget impact of introducing tofacitinib to the public hospital formulary in Hong Kong, 2017-2021

An Open-Label, Randomized, Single-Dose, Crossover, Comparative Pharmacokinetics Study of YLB113 and the Etanercept Reference Product in Healthy Adult Male Subjects

A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis. A randomized controlled trial protocol.

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