ABSTRACT
BackgroundPrevious studies have shown that using a finger prick as the primary method for blood withdrawal is an efficient way to collect blood samples remotely, and data on blood levels from a finger prick are directly comparable to that obtained by a venepuncture. During the COVID-19 pandemic, we therefore complemented our large digital research platform with serum collection via a home finger prick testing in order to collect samples without the need of visits to a hospital. This repeatedly enabled us to rapidly answer new and relevant clinical research questions about COVID-19, thereby showing the potential of the finger prick for research purposes. However, the use of finger pricks in a research or clinical practice setting is still uncommon, and not yet tested on a large scale. In addition, there is limited data on peoples' willingness and ability to successfully use the finger prick at home, especially in patients with inflammatory rheumatic diseases (iRD) who may have impaired hand function.ObjectivesTo investigate the feasibility of finger prick testing in combination with a digital research platform by evaluating the success rate and patients' perspective towards the use of the finger prick.MethodsData were collected from an ongoing prospective cohort study including patients with iRD from the Amsterdam Rheumatology & immunology Center and healthy controls. Serum samples were collected up to eight times during follow-up via blood withdrawal by venepuncture at the local research institute or via a finger prick that could be performed at home. For the latter option, participants were instructed to collect three drops of blood, which would yield approximately 40-80 µL of serum after clotting. All study participants were questioned about their preference for a particular sampling method for individual healthcare and for scientific research. Participants who received a finger prick test before June 26, 2021, were asked to complete a digital evaluation questionnaire of the finger prick after their attempt. The finger prick was defined as failed when less than 10 µL of serum could be recovered from the collection device, or if no sample was returned to the laboratory and participants indicated in the questionnaires that they did not succeed in collecting the required amount of serum.ResultsA total of 3080 patients with iRD and 1102 healthy controls were included in the study. Of these, 2135 (69%) patients and 899 (82%) controls attempted to execute at least one finger prick, and 1439 (67%) patients and 712 (21%) controls executed multiple finger pricks. The first finger prick was successfully done by 92% (CI 90 – 93) of iRD patients, 94% (CI 92 – 95) of healthy controls, 93% (CI: 92 – 94) of all participants aged 70 years or younger, and 89% (CI 86 – 92) of all participants aged above 70 years (Table 1). Sex did not impact these success rates. Repeated failure occurred in 11 of 1439 (0.8%) patients and 4 of 712 (0.6%) controls. The two most common reasons for perceived failure of the finger prick were related to insufficient blood yield when applying the finger prick. Finally, both patients and controls were less willing to perform a finger prick for individual healthcare compared to scientific research;31% of patients and 61% of controls were willing to perform a finger prick for scientific research compared to 19% of patients and 39% of controls for healthcare. The most important reason for this was lower confidence in the execution and laboratory measurements when blood was drawn via a venepuncture compared to a finger prick.ConclusionIn this study, we demonstrated that the vast majority of participants, among which elderly and patients of whom hand function may be impaired by an underlying rheumatic disease, were able to successfully draw the required amount of blood for serological analyses. This shows that the finger prick testing is suitable for a high-throughput implementation to monitor patients remotely, which will likely contribute to improving the efficiency and cost-effectiveness of b th healthcare and scientific research.REFERENCES:NIL.Acknowledgements:NIL.Disclosure of InterestsNone Declared.
ABSTRACT
Background: Concerns have been raised regarding risks of COVID-19 breakthrough infections in vaccinated patients with immune-mediated infammatory diseases (IMIDs) treated with immunosuppressants, but data on COVID-19 breakthrough infections in these patients are still scarce. Objectives: The primary objective was to compare the incidence and severity of COVID-19 breakthrough infections with the SARS-CoV-2 delta variant between fully vaccinated IMID patients with immunosuppressants, and controls (IMID patients without immunosuppressants and healthy controls). The secondary objective was to explore determinants of breakthrough infections. Methods: In this study we pooled data collected from two large ongoing prospective multi-center cohort studies (Target to-B! [T2B!] study and ARC study). Clinical data were collected between February and December 2021, using digital questionnaires, standardized electronic case record forms and medical files. Post-vaccination serum samples were analyzed for anti-RBD antibodies (T2B! study only) and anti-nucleocapsid antibodies to identify asymptomatic breakthrough infections (ARC study only). Logistic regression analyses were used to assess associations with the incidence of breakthrough infections. Multivariable models were adjusted for age, sex, cardiovascular disease, chronic pulmonary disease, obesity and vaccine type. Results: We included 3207 IMID patients with immunosuppressants and 1810 controls (985 IMID patients without immunosuppressants and 825 healthy controls). The incidence of COVID-19 breakthrough infections was comparable between patients with immunosuppressants (5%) and controls (5%). The absence of SARS-CoV-2 IgG antibodies after COVID-19 vaccination was independently associated with an increased incidence of breakthrough infections (P 0.044). The proportion of asymptomatic COVID-19 breakthrough cases that were additionally identifed serologically in the ARC cohort was comparable between IMID patients with immunosuppressants and controls;66 (10%) of 695 patients vs. 64 (10%) of 647 controls. Hospitalization was required in 8 (5%) of 149 IMID patients with immunosuppressants and 5 (6%) of 86 controls with a COVID-19 breakthrough infection. Hospitalized cases were generally older, and had more comorbidities compared with non-hospitalized cases (Table 1). Hospitalization rates were signifcantly higher among IMID patients treated with anti-CD20 therapy compared to IMID patients using any other immunosuppres-sant (3 [23%] of 13 patients vs. 5 [4%] of 128 patients, P 0.041;Table 1). Conclusion: The incidence of COVID-19 breakthrough infections in IMID patients with immunosuppressants was comparable to controls, and infections were mostly mild. Anti-CD20 therapy might increase patients' susceptibility to severe COVID-19 breakthrough infections, but traditional risk factors also continue to have a critical contribution to the disease course of COVID-19. Therefore, we argue that most patients with IMIDs should not necessarily be seen as a risk group for severe COVID-19, and that integrating other risk factors should become standard practice when discussing treatment options, COVID-19 vaccination, and adherence to infection prevention measures with patients.
ABSTRACT
Background: Therapeutic Drug Monitoring (TDM) is a tool to determine the optimal dose of a drug for individual patients using measurement of blood concentrations and, optionally, anti-drug antibodies (ADA). In the feld of rheumatology interest in applying TDM is increasing. A recent study by Syversen et al., the NOR-DRUM B trail, supports TDM as a treatment strategy. This study showed that treatment with proactive TDM was more effective then treatment without TDM. Applying TDM creates a more personalized treatment for individual patients, therefore it is relevant to understand the patients perspective towards TDM. Objectives: To study the perspective of rheumatology patients treated with a bDMARD in a personalized fashion using TDM. Methods: Adult rheumatology patients from the Amsterdam Rheumatology and immunology Center who participate in the COVID-19 prospective cohort study (Nederlands Trial Register, trial ID NL8513) received a digital questionnaire which comprised, in addition to demographic items, of three TDM topics: familiarity, attitude and risk assessment. Results: Participants were selected based on the following criteria: treatment with a bDMARD and a fully completed questionnaire (n=888). Table 1 shows characteristics of study population. Sixty-six percent (n=582) of the participants had never heard of the concept 'personalized dosing, using TDM'. After explaining the concept 60% (n=535) of the participants answered they have a positive attitude towards the concept (Figure 1). Participants with a positive attitude received a follow-up question. They were asked which of the following related aspects: individual dosing, costs, safety and other, they thought was most relevant regarding the concept. Multiple answers were possible. Ninety-four percent (n=502) reported as the main reason for having a positive attitude, that the treatment can be personally adjusted. The second and third reasons, respectively, were safety 43% (n=230) and costs 27% (n=142) of the treatment. Five percent (n=43) of the participants had a negative attitude towards the concept. Main reasons were;previous experience with unsuccessful dose reduction and unwillingness to change current treatment due to the fact that several previous treatments were ineffective. Participants were also asked what amount of risk they are willing to take when presented with five different situations;worsening rheumatologically symptoms: e.g. pain and swelling, increased fatigability, necessary treatment with prednisone, switching to another bDMARD or more frequent visits to rheumatologist. Majority of the patients reported for each of the five situations, respectively: 37% (n=330), 40% (n=359), 51% (n=453), 48% (n= 426) and 29% (n=262) that they would only be willing to take a negligible risk, < 0.1%. Conclusion: Majority of participants was not familiar with the concept of personalized dosing using TDM. However, the majority had a positive attitude towards the concept. The main reason for a positive attitude is that the treatment can be personally adjusted. On the other hand, patients who are currently being treated with a bDMARD were only willing to take a negligible risk when it comes to their own treatment.