Attitudes of patients with a rheumatic disease on drug use in the COVID-19 pandemic.

BACKGROUND: Anti-rheumatic drugs can increase the predisposition to infection, and patients may be unaware of continuing their treatment during the COVID-19 pandemic. OBJECTIVE: This study aimed to assess whether patients maintain their treatment for rheumatic conditions during the pandemic period and determine the factors responsible for discontinuation. METHODS: Patients were randomly selected from the prospectively collected database of our tertiary referral center. The patients were interviewed by telephone through a standardized closed-ended questionnaire, which is targeting the continuity of the treatment plan and the considerations related to the individual choice. The patients were asked whether they hesitated to visit the hospital for follow-up or intravenous drug administration. RESULTS: A total of 278 patients completed the questionnaire. While 62 of the patients (22.3%) had reduced or interrupted the treatment, only 11 patients (3.9%) stopped the treatment completely. A significant difference was observed between the duration of illness and the discontinuation of treatment. (p = 0.023) There was a significant difference in disease activity between the group that stopped treatment and continued treatment. (p = 0.001) There was no statistically significant difference in other demographic characteristics. One hundred thirty-five patients (48.6%) made the treatment decision by themselves, and 80% continued the treatment. Reasons for stopping the treatment were anxiety (48.4%), not being able to go to the hospital for intravenous treatment (45.1%), and not being able to find the drug (6.5%). CONCLUSION: Since patients with long-term illnesses were found to be significantly more likely to stop their treatment, this group of patients should be monitored.

Hydroxychloroquine availability during COVID-19 crisis and its effect on patient anxiety.

OBJECTIVE: To report the results of a survey exploring the experience of patients with SLE facing hydroxychloroquine (HCQ) shortage that occurred during the early phases of the COVID-19 pandemic. METHODS: A survey was designed by Lupus Europe's patient advisory network and distributed through its social media, newsflash and members' network. People with lupus were asked about their last HCQ purchases and their level of anxiety (on a 0-10 scale) with regard to not being able to have access to HCQ, once in April 2020 (first wave) and after 11 August (second wave). The results were compared. RESULTS: 2075 patients responded during the first wave; 1001 (48.2%) could get HCQ from the first place they asked, 230 (11.1%) could get the drug by going to more than one pharmacy, 498 (24.0%) obtained HCQ later from their usual pharmacy and 126 (6.1%) from other sources. 188 (9.1%) could not get any; 32 (1.5%) did not respond to this question. All countries showed significant improvement in HCQ availability during the second wave. 562 (27.4%) patients reported an extremely high level of anxiety in wave 1 and 162 (10.3%) patients in wave 2; 589 (28.7%) and 268 (17.1%) patients reported a high level of anxiety in wave 1 and wave 2, respectively. CONCLUSIONS: The HCQ shortage had a significant impact on patients with SLE and has been responsible for psychological consequences including anxiety. Indeed, despite an objective improvement in drug availability, the event is leaving significant traces in patients' mind and behaviours.

The impact of COVID-19 pandemic on rheumatology practice: a cross-sectional multinational study.

OBJECTIVE: To evaluate the impact of the coronavirus disease 2019 (COVID-19) pandemic on rheumatology practice. METHOD: A cross-sectional web survey was designed by the members of the Arab League of Associations for Rheumatology (ArLAR), validated by its scientific committee and disseminated through e-mail and social media. It included close-ended questions about the impact of the pandemic on the rheumatology activities, including outpatient visits and hospitalizations (in percentage, 100% corresponds to complete suspension) and open-ended questions about unmet needs. Univariate and multivariable logistic regression analyses were used to evaluate the predictors of impact. Suggestions were developed to improve the practice. RESULTS: A total of 858 rheumatologists were included in the analysis (27.3% of registered in ArLAR), 37% were 35-44 years old, 60% were females, and 48% worked in the private sector. The impact of COVID-19 was a decrease of 69% in hospitalizations, 65% in outpatient clinic, 56% in infusion centers, and 43% in income. It was associated with the region (highest in the Gulf), use of telemedicine, impact on income and practice sector (lowest in private). There was a hydroxychloroquine shortage in 47%. Telemedicine was mostly based on traditional telephone contacts and e-mails and reimbursed in 12%. Fifteen rheumatologists (1.8%) were infected and 156 cases of COVID-19 were reported among patients. The top-cited unmet needs in rheumatology practice were access to drugs and a telemedicine platform. CONCLUSIONS: The negative impact of the COVID-19 pandemic on rheumatology practice may compromise rheumatic diseases control. Better access to drugs and providing telemedicine platforms are recommended to improve the practice. Key Points • The COVID-19 pandemic had a significant negative impact on the rheumatology practice, including access to outpatient clinic, hospitalization, and to anchor drugs. • The compromised access to rheumatology care may jeopardize the control of chronic rheumatic diseases and the long-term prognosis. • Better access to drugs and providing telemedicine platforms are strongly recommended.

Access to high-cost medications for psoriatic arthritis in the National Health System in Brazil: the long path up to dispensation.

BACKGROUND: Pharmaceutical Assistance (PA) is a dynamic and multidisciplinary process that aims to supply health systems, programs or services with quality medicines, enabling access and health care, in an efficient and timely manner. The objective of the study was to evaluate the profile of administrative processes for the treatment of PsA, identify the time elapsed in the flow of processes and its associated factors. METHODS: A cross-sectional study of medication requests for the treatment of PsA was carried out between November 2014 and December 2016. Linear regression was used to verify the factors associated with time to delivery. RESULTS: A total of 218 cases containing 250 drugs were analyzed. The median time between the medical appointment and the first dispensation was 66 days (interquartile range, 44-90). The State proceedings, which includes requesting the drug until the authorization of treatment, was the stage that most contributed to the total time spent. The factors associated with the longer time to delivery of medications were prescriptions coming from clinics and specialty centers, from dermatologists, non-authorized processes and non-persistent patients in the treatment in 12 months. CONCLUSION: The median time to receive medicines for the PsA treatment in Belo Horizonte health region after a medical prescription was higher than 2 months. The time between the solicitation of the medicines and the authorization of the treatment in the SUS (State administrative procedure) was the main component of the total time spent.

Of patents and patent disputes - The TNFα patent files. Part 2: Enbrel, Remicade, Cimzia and Simponi.

This article is the second part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics. TNFα is the world's most valuable target, with accumulated sales of TNFα biologics of 34 bn USD in 2014. While in the first part of this trilogy, Humira was discussed, this second parts discusses the patent strategies of Enbrel, Remicade, Cimzia and Simponi.

Treatment of moderate rheumatoid arthritis with different strategies in a health resource-limited setting: a cost-effectiveness analysis in the era of biosimilars.

OBJECTIVES: This paper aims to explore the cost-effectiveness of reduced doses or discontinuation of etanercept biosimilar (Yisaipu) in patients with moderately active rheumatoid arthritis (RA). METHODS: A discrete event simulation model was developed to project lifetime medical costs and quality-adjusted life-years (QALYs) in moderately active RA. Strategies starting with Yisaipu 50 mg/week for nine months following Yisaipu 50 mg/week, 25 mg/week or MTX maintenance were compared. Resource consumptions related to RA were estimated from the perspective of the Chinese health care system. An endpoint of the American College of Rheumatology (ACR) response was used to estimate the utility scores. Uncertainty in model parameters was analysed by sensitivity analyses. RESULTS: When using ACR as an endpoint for determining successful treatment, strategies starting with Yisaipu 50 mg/week for nine months following Yisaipu 50 mg/week or 25 mg/week maintenance showed the greatest number of QALYs gained (nearly 11.9 and 11.3 with or without rituximab after the failure of Yisaipu, respectively). If decision makers use a threshold of 3×the per capita GDP of China or Shanghai City in 2012, then the strategies most likely to be cost-effective are initial treatment with Yisaipu 50 mg/week for nine months following MTX maintenance and Yisaipu 25 mg/week maintenance, respectively. Results were sensitive to the cost of Yisaipu. CONCLUSIONS: The analysis indicates that, in China, replacing branded etanercept with Yisaipu is likely to be a cost-effective strategy in patients with moderately active RA.

Barriers to accessing biologic treatment for rheumatoid arthritis in Greece: the unseen impact of the fiscal crisis--the Health Outcomes Patient Environment (HOPE) study.

The latest regulatory change in the distribution system of biologic disease-modifying, antirheumatic drugs limited their sale only through the designated pharmacies of the National Organization for Healthcare Services Provision (EOPYY) or the National Health System (NHS) hospitals, adding to the complexity of access to effective treatment for rheumatoid arthritis (RA) in Greece. The aim of this paper was to assess the barriers to access RA treatment, by recording patients', rheumatologists' and EOPYY pharmacists' experiences. One twenty-three patients, 12 rheumatologists and 27 pharmacists from Athens and other urban areas in Greece participated in the study. Three types of standardized questionnaires were used to elicit information from each group of respondents using the method of personal interview for patients and the method of postal survey for doctors and pharmacists. During the last year, 26% of patients encountered problems in accessing their rheumatologist and 49% of patients experienced difficulties in accessing their medication. Ninety-two percent of rheumatologists and 96% of pharmacists confirmed that patients experience difficulties in accessing RA medication. The most commonly reported reasons for reduced access to medical treatment were travel difficulties and long distance from doctor's clinic, as well as delays in booking an appointment. The most frequently reported barriers to access pharmaceutical treatment were difficulties in the prescription process, distance from EOPYY pharmacies and medicine shortages in NHS hospitals. The study showed that RA patients are facing increased barriers to access timely and effective treatment. Redesign of the current system of distribution ensuring the operation of additional points of sale is deemed necessary.

Patient's access to healthcare and treatment in rheumatoid arthritis: the views of stakeholders in Portugal.

BACKGROUND: The access to healthcare and treatment by rheumatoid arthritis (RA) patients, particularly to biologics, differs significantly among European countries.We aimed to explore the views and experiences of Portuguese healthcare stakeholders on key barriers which limit the access to treatment, and ultimately to biologics, by RA patients and to find potential solutions (leverage points) to overcome the identified barriers. METHODS: This was a qualitative research consisting of semi-structured face-to-face interviews with key stakeholders in RA framework. Thirty four individuals from eight groups of stakeholders were interviewed: rural and urban general practitioners (GPs), rheumatologists, hospital managers, hospital pharmacists, budget holders, representatives from the Portuguese Rheumatology Society and the RA Patient Association. Interviews were conducted between May and June 2011. Conventional content analysis with research triangulation was used. RESULTS: The key barriers identified were related to the accessibility to primary healthcare services, difficulties in RA diagnosis among GPs, inefficient referral to secondary healthcare and controlled process of biologics prescription in public hospitals. The leverage points identified included the improvement of epidemiological and clinical knowledge about RA in Portugal, a better understanding of the disease among patients and GPs, the clarification of biologics benefits among budget holders and a raised awareness of the current treatment guidelines. In order to further address the leverage points, the following key initiatives were proposed: optimization of RA national registry; dissemination of information on rheumatic symptoms in primary care facilities and among the general public; increase interaction between rheumatologists and GPs through clinical discussions of successfully treated patients or workshops; broader utilization of disease diagnosis and monitoring tools, such as DAS28, and implementation of hospital-based research to collect real-world data. CONCLUSIONS: Most of the key barriers limiting the access to treatment, including biologics, in RA in Portugal are upstream of rheumatology practice. Our findings suggest that future actions should be focused on the primary care level to improve referral to rheumatologists. In addition, the collection of real-world data seems essential to characterise the RA population, to improve disease management and to increase compliance with current treatment guidelines.

Patients' access to biologics in rheumatoid arthritis: a comparison between Portugal and other European countries.

BACKGROUND: Despite the widespread availability of biologics across Europe, rheumatoid arthritis (RA) patients' access to these drugs differs significantly among countries. OBJECTIVES: To compare the proportion of RA patients treated with biologics across Europe and investigate the factors that most influence it, with focus on the Portuguese case, reportedly with low access rates to biologics. METHODS: The biologics' market was characterized for 15 selected European countries. Variables potentially influencing patients' access to biologics (PAB) in RA were also collected, including demographic, disease, economic, funding and biologics' market-related data. A multivariable regression model identified the factors that best explain PAB. Based on these determinants, a cluster analysis was performed to group the countries with most similar behaviour regarding PAB allowing the evaluation of Portugal's relative position among these countries. RESULTS: The regression model (R(2) = 0.953) indicated that PAB in selected countries is explained mostly by its gross domestic product (GDP) per capita, the usage of methotrexate (MTX) and the biologics' distribution channel. Current MTX usage in Portugal shows similarity with practice from UK, France, Germany or Spain 5 years before, explaining why PAB in Portugal stood at 7% in 2010, 12 percentage points below the average of selected countries. CONCLUSIONS: Variations in RA PAB were found across selected countries with Portugal showing the lowest proportion. GDP per capita, biologics distribution channel and consumption of MTX appear to be the best explanatory factors for these fluctuations in European countries.

UK consultant rheumatologists' access to biological agents and views on the BSR Biologics Register.

OBJECTIVES: The British Society for Rheumatology Biologics Register (BSRBR) is a prospective cohort study to determine the efficacy and toxicity of biological agents in rheumatoid arthritis (RA) patients compared with RA controls. Entry of patients to the register is a condition of use of anti-tumour necrosis factor (anti-TNF) therapy in the UK, but little is known of clinicians' views of its usefulness. Data from the register suggest uneven provision of anti-TNF-alpha therapy. METHODS: A questionnaire was sent on behalf of the BSRBR to all UK consultant rheumatologists concerning provision and use of anti-TNF-alpha therapy and their experience of working with the BSRBR. RESULTS: Response rate was 49.5% representing 252 consultants. Fourty-six per cent had some limitation of access to anti-TNF-alpha drugs, usually a financial cap (70%), even for RA patients meeting National Institute for Health and Clinical Excellence (NICE) criteria. Sixty-seven per cent could prescribe for ankylosing spondylitis (AS) or psoriatic arthritis (PsA) in some circumstances but only 25 and 35%, respectively, could prescribe according to BSR guidance. More than 50% found the workload involved in submitting data to the registry at least difficult, but most had favourable impressions of the BSRBR and thought similar registries desirable or essential for PsA, AS and rituximab. CONCLUSIONS: Access to anti-TNF therapy for patients with inflammatory arthritis is variable in the UK, even for RA where it is NICE-approved. Access is more limited for conditions where NICE has not yet issued guidance. The BSRBR generates a significant workload for rheumatology staff but is generally well-regarded.

Barriers to providing adequate rheumatology care: implications from a survey of rheumatologists in ontario, Canada.

OBJECTIVE: To determine what, if any, barriers exist that prevent rheumatologists from providing adequate rheumatology care. METHODS: All 158 identified rheumatologists in Ontario were sent a self-administered questionnaire and followed up by telephone. RESULTS: The response rate was 83%. All but 6 rheumatologists reported at least one barrier to the provision of service. The 3 most commonly reported barriers were the cost of drugs for patients (83%), billing policies and regulations for consultation and followup visits (72%), and long waiting times for patients (61%). Rheumatologists reporting the latter had significantly longer waiting times (12 vs 4 wks) for new non-urgent patients, although there was no difference for new patients with inflammatory arthritis. Nearly three-quarters of respondents had changed the patterns of their practice over the last 3 years, with significant increases in the amount of independent medical services (e.g., third party billing) and pharmaceutical company work. The majority (89%) of responding rheumatologists reported having at least some difficulty in making ends meet from rheumatology practice alone and 28% found it was not possible. CONCLUSION: These results indicate that the majority of rheumatologists face significant barriers to providing adequate care. Given the recruitment and service provision concerns in Canada, these barriers to service need to be addressed to ensure adequate provision of care.

[Anti-TNF alpha in rheumatoid arthritis]. / Les anti-TNF alpha dans la polyarthrite rhumatoïde.

Thanks to the better understanding of the physiopathological mechanisms in action in rheumatoid arthritis (RA), new therapeutic weapons have appeared, which have dramatically modified our approach of the disease. These so-called "biological" therapies antagonize the action of the cytokine at the top of the cascade which maintains the synovial inflammation, and leads to the joint destruction, i.e. the Tissue Necrosis Factor alpha (TNF alpha). Several controlled clinical studies have clearly demonstrated their short and middle term efficacy and safety profile, and they will soon become at the Belgian clinicians disposal. They have a rapid and dramatic effect on the signs and symptoms of RA and they slow down the radiologic progression. Some questions remain unresolved concerning their place in the general therapeutic strategy against RA, due to the uncertainties of their use in the long run, and to their cost.