Self-evidence-based digital care programme improves health-related quality of life in adults with a variety of autoimmune diseases and long COVID: a retrospective study.

OBJECTIVE: To retrospectively investigate the feasibility and impact on health-related quality of life (HRQoL) of a digital care programme (DCP) designed to guide personalised diet and integrative interventions in a variety of autoimmune diseases and long COVID. METHODS: Adults who participated in the DCP between April 2020 and June 2022, and for whom baseline (BL) and end-of-programme (EOP) Patient-Reported Outcomes Measurement Information System (PROMIS) scores were available, were included in this retrospective study. Changes from BL to EOP were calculated using standardised T-scores. RESULTS: Two hundred two adults between 17 and 82 years old were included. Diagnoses included: rheumatoid arthritis (20.1%); long COVID (14.9%); psoriatic arthritis (10.9%); psoriasis (8.9%); systemic lupus erythematosus (6.4%); inflammatory bowel disease (5.9%); multiple sclerosis (5.9%); ankylosing spondylitis (5.4%) and other (23.3%). On average, individuals entered observations 7.6 times/day on 86% of programme days, attended 14 coach sessions and completed the programme in an average of 17.2 weeks. Statistically significant improvements were seen in all 10 PROMIS domains analysed. Individuals with higher severity of compromise at BL experienced greater average improvements than all-comers in all 10 PROMIS domains included. CONCLUSION: An evidence-based DCP that uses patient data to help identify hidden symptom triggers and guide personalised dietary and other non-pharmacological interventions was associated with a high level of engagement and adherence and statistically significant, clinically meaningful improvements in HRQoL. Those with the least favourable PROMIS scores at BL experienced the greatest improvements.

COVID-19 with rheumatic diseases: a report of 5 cases.

The coronavirus disease 2019 (COVID-19), the result of an infection with the new virus, SARS-CoV-2, is rapidly spreading worldwide. It is largely unknown whether the occurrence of COVID-19 in patients with rheumatic immune diseases has some specific manifestations, or makes them more prone to rapidly progress into severe COVID-19. In this case report, we describe the clinical features of 5 rheumatic immune disease patients with the concomitant presence of COVID-19. Amongst these patients, 4 had rheumatoid arthritis (RA) and 1 had systemic sclerosis (SSc). Two patients had a history of close contact with a COVID-19 patient. The age of the patients ranged between 51 and 79 years. Fever (80%), cough (80%), dyspnea (40%), and fatigue (20%) were the most common presenting symptoms. Laboratory investigations revealed leukopenia and lymphopenia in 2 patients. In all the patients, chest computerized tomography (CT) revealed patchy ground glass opacities in the lungs. During the hospital stay, the condition of two patients remained the same (i.e., mild COVID-19), two patients progressed to the severe COVID-19, and one patient worsened to the critically ill COVID-19. These patients were treated with antiviral agents for COVID-19, antibiotics for secondary bacterial infections, and immunomodulatory agents for rheumatic immune diseases. All the patients responded well, were cured of COVID-19, and subsequently discharged.

Feasibility of a physiotherapist-led behaviour change intervention to improve physical activity in people with rheumatoid arthritis.

INTRODUCTION: Physical activity (PA) interventions incorporating behaviour change (BC) theory are needed to improve PA levels in people with rheumatoid arthritis. A pilot feasibility study of a Physiotherapist-led Intervention to Promote PA in Rheumatoid Arthritis (PIPPRA) was undertaken to obtain estimates for recruitment rate, participant retention and protocol adherence. METHODS: Participants were recruited at University Hospital (UH) rheumatology clinics and randomly assigned to control group (physical activity information leaflet) or intervention group (four BC physiotherapy sessions in 8 weeks). Inclusion criteria were diagnosis of RA (ACR/EULAR 2010 classification criteria), aged 18+ years and classified as insufficiently physically active. Ethical approval was obtained from the UH research ethics committee. Participants were assessed at baseline (T0), 8 weeks (T1) and 24 weeks (T2). Descriptive statistics and t-tests were used to analyse the data with SPSS v22. RESULTS: 320 participants were approached about the study with n=183 (57%) eligible to participate and n=58 (55%) consented to participate (recruitment rate: 6.4 per month; refusal rate 59%). Due to the impact of COVID-19 on the study, n=25 (43%) participants completed the study (n=11 (44%) intervention and n=14 (56%) control). Of the 25, n=23 (92%) were female, mean age was 60 years (s.d. 11.5). Intervention group participants completed 100% of BC sessions 1 and 2, 88% completed session 3 and 81% completed session 4. DISCUSSION: The intervention to promote physical activity was feasible and safe and provides a framework for larger intervention studies. Based on these findings, a fully powered trial is recommended.

'I learnt so much about being active': experiences of people with rheumatoid arthritis on the impact of a physiotherapist-led intervention to encourage physical activity.

INTRODUCTION: Physical activity (PA) is an important component in improving the health of people with rheumatoid arthritis (RA). A Physiotherapist-led Intervention to Promote PA in people with RA (PIPPRA) was undertaken using the Behaviour Change (BC) Wheel. A qualitative study was conducted post intervention involving participants and healthcare professionals who participated in a pilot RCT. METHODS: Face-to-face semi-structured interviews were conducted with the schedule exploring: experience and views of the intervention; experience and suitability of outcome measures used; and perceptions of BC and PA. Thematic analysis was used as an analytical approach. The COREQ checklist provided guidance throughout. RESULTS: Fourteen participants and eight healthcare staff participated. Three main themes were generated from participants: (1) positive experience of intervention - 'I found it very knowledgeable to help me get stronger'; (2) improvement in self-management - '… motivate me maybe to go back to doing a little bit more exercise'; and (3) negative impact of COVID-19 - 'I don't think doing it online again would be really good at all'. Two main themes were generated from healthcare professionals: (1) positive learning experience of delivery - 'Really made me realise the importance of discussing physical activity with patients'; and (2) positive approach to recruitment - 'Very professional team showing the importance of having a study member on site'. DISCUSSION: Participants had a positive experience of being involved in a BC intervention in order to improve their PA and found it acceptable as an intervention. Healthcare professionals also had a positive experience, in particular the importance of recommending PA in empowering patients.

The potential role of ischaemia-reperfusion injury in chronic, relapsing diseases such as rheumatoid arthritis, Long COVID, and ME/CFS: evidence, mechanisms, and therapeutic implications.

Ischaemia-reperfusion (I-R) injury, initiated via bursts of reactive oxygen species produced during the reoxygenation phase following hypoxia, is well known in a variety of acute circumstances. We argue here that I-R injury also underpins elements of the pathology of a variety of chronic, inflammatory diseases, including rheumatoid arthritis, ME/CFS and, our chief focus and most proximally, Long COVID. Ischaemia may be initiated via fibrin amyloid microclot blockage of capillaries, for instance as exercise is started; reperfusion is a necessary corollary when it finishes. We rehearse the mechanistic evidence for these occurrences here, in terms of their manifestation as oxidative stress, hyperinflammation, mast cell activation, the production of marker metabolites and related activities. Such microclot-based phenomena can explain both the breathlessness/fatigue and the post-exertional malaise that may be observed in these conditions, as well as many other observables. The recognition of these processes implies, mechanistically, that therapeutic benefit is potentially to be had from antioxidants, from anti-inflammatories, from iron chelators, and via suitable, safe fibrinolytics, and/or anti-clotting agents. We review the considerable existing evidence that is consistent with this, and with the biochemical mechanisms involved.

Exploring the physical, psychological and social well-being of people with rheumatoid arthritis during the coronavirus pandemic: a single-centre, longitudinal, qualitative interview study in the UK.

OBJECTIVE: Rheumatoid arthritis (RA) is an autoimmune, inflammatory, systemic condition that requires specific drug treatment to suppress disease activity and prevent joint deformity. To manage the ongoing symptoms of joint pain and fatigue patients are encouraged to engage in self-management activities. People with RA have an increased incidence of serious illness and mortality, with the potential to impact on quality of life. This study explored patients' experiences of living with RA on physical, psychological and social well-being as well as their ability to employ self-management skills during the coronavirus pandemic. DESIGN: Qualitative, longitudinal (baseline, 16 September to 23 November 2020 and after 2-4 months, 11 January to the 17 January 2021), semistructured telephone interviews. SETTING: A rheumatology service based in a community hospital. PARTICIPANTS: 15 adults with RA. MAIN OUTCOMES: Data were analysed using interpretative phenomenological analysis. RESULTS: Five themes were identified that related to impact on (1) fear: the dominant emotion, (2) social connections and work practices, (3) physical health, (4) identity and (5) self-management as a coping mechanism. The overriding emotion was one of fear, which remained high throughout both interviews. The negative impact on social well-being increased as the pandemic progressed. Conversely, physical health was not affected at either time point, although participants reported difficulty in interpreting whether physical symptoms were attributable to their RA or COVID-19. Recognition of increased vulnerability led to a reassessment of self-identity; however, respondents reported using previously learnt self-management techniques to cope in the context of the pandemic. CONCLUSIONS: The main impact was on emotional and social well-being. Levels of fear and vulnerability which affected self-identity remained high throughout the pandemic and the impact on social well-being increased over time. Physical health remained largely unaffected. Self-management skills were used to maintain a sense of well-being.

An Exercise and Educational and Self-management Program Delivered With a Smartphone App (CareHand) in Adults With Rheumatoid Arthritis of the Hands: Randomized Controlled Trial.

BACKGROUND: Rheumatoid arthritis (RA) is a prevalent autoimmune disease that usually involves problems of the hand or wrist. Current evidence recommends a multimodal therapy including exercise, self-management, and educational strategies. To date, the efficacy of this approach, as delivered using a smartphone app, has been scarcely investigated. OBJECTIVE: This study aims to assess the short- and medium-term efficacy of a digital app (CareHand) that includes a tailored home exercise program, together with educational and self-management recommendations, compared with usual care, for people with RA of the hands. METHODS: A single-blinded randomized controlled trial was conducted between March 2020 and February 2021, including 36 participants with RA of the hands (women: 22/36, 61%) from 2 community health care centers. Participants were allocated to use the CareHand app, consisting of tailored exercise programs, and self-management and monitoring tools or to a control group that received a written home exercise routine and recommendations, as per the usual protocol provided at primary care settings. Both interventions lasted for 3 months (4 times a week). The primary outcome was hand function, assessed using the Michigan Hand Outcome Questionnaire (MHQ). Secondary measures included pain and stiffness intensity (visual analog scale), grip strength (dynamometer), pinch strength (pinch gauge), and upper limb function (shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire). All measures were collected at baseline and at a 3-month follow-up. Furthermore, the MHQ and self-reported stiffness were assessed 6 months after baseline, whereas pain intensity and scores on the shortened version of the Disabilities of the Arm, Shoulder, and Hand questionnaire were collected at the 1-, 3-, and 6-month follow-ups. RESULTS: In total, 30 individuals, corresponding to 58 hands (CareHand group: 26/58, 45%; control group: 32/58, 55%), were included in the analysis; 53% (19/36) of the participants received disease-modifying antirheumatic drug treatment. The ANOVA demonstrated a significant time×group effect for the total score of the MHQ (F1.62,85.67=9.163; P<.001; η2=0.15) and for several of its subscales: overall hand function, work performance, pain, and satisfaction (all P<.05), with mean differences between groups for the total score of 16.86 points (95% CI 8.70-25.03) at 3 months and 17.21 points (95% CI 4.78-29.63) at 6 months. No time×group interaction was observed for the secondary measures (all P>.05). CONCLUSIONS: Adults with RA of the hands who used the CareHand app reported better results in the short and medium term for overall hand function, work performance, pain, and satisfaction, compared with usual care. The findings of this study suggest that the CareHand app is a promising tool for delivering exercise therapy and self-management recommendations to this population. Results must be interpreted with caution because of the lack of efficacy of the secondary outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT04263974; https://clinicaltrials.gov/ct2/show/NCT04263974. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): RR2-10.1186/s13063-020-04713-4.

The development of inflammatory arthritis following SARS-CoV-2 infection: a systematic review of the literature.

BACKGROUND: Given the widespread impact of COVID-19, it is important to explore any atypical presentations and long-term sequelae associated with this viral infection, including the precipitation of inflammatory arthritis. OBJECTIVE: To identify and summarize clinical reports of acute inflammatory arthritis associated with COVID-19. METHODS: A systematic review of the PubMed (MEDLINE), Google Scholar, and Cochrane Central databases through January 31, 2022 was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis guidelines. The inclusion criteria were: human subjects and English language. Data extraction and qualitative synthesis of the demographics, clinical presentations, treatments, and outcomes were performed. Quality assessment was performed using the Joanna-Briggs Institute critical appraisal tools. RESULTS: A total of 37 articles collectively describing the cases of 54 patients were included. The mean age was 48.2 years (6-78 years). 53.7% of patients were male and 46.3% were female. The onset of articular symptoms varied considerably, and the majority of cases were described as polyarticular (29). The classification of inflammatory arthritis in the included studies was as follows: reactive (19), post-viral (13), new-onset rheumatoid arthritis (RA) (8), crystal-proven arthropathy flare (4), acute viral (2), new-onset psoriatic arthritis (2), flare of preexisting RA (2), and other (4). Arthritis treatment regimens varied but consisted largely of NSAIDs and corticosteroids with most patients experiencing improvement or resolution of their joint symptoms. CONCLUSION: There is limited low-level evidence suggesting that patients may develop acute arthritis during or after SARS-CoV-2 infection. This review highlights the need for further research to elucidate the relationship between COVID-19 and the development of inflammatory arthritis.

This review paper sought to explore the relationship between COVID-19 disease and acute joint pain/inflammation (arthritis) through a systematic search of the literature. This review found limited low-level evidence suggesting that patients may develop inflammatory arthritis during or after COVID-19 disease. However, there is a need for further research to improve our understanding of the relationship between COVID-19 and the development of inflammatory arthritis.

Patient Reported Outcome Measures for Rheumatoid Arthritis Disease Activity: a systematic review following COSMIN guidelines.

BACKGROUND: The current standard of care in rheumatoid arthritis (RA) requires regular assessment of disease activity (DA). All standard RA DA measurement instruments require joint counts to be undertaken by a healthcare professional with/without a blood test. Few healthcare providers have the capacity to assess patients as frequently as stipulated by guidelines. Patient Reported Outcome Measures (PROMs) could be an efficient and informative way to assess RA DA, which is highlighted by the SARS-COV-2 pandemic, as most consultations are remote rather than face-to-face. We aimed to assess all PROMs for RA DA against the internationally recognised COSMIN guidelines to provide evidence-based recommendations to select the most suitable PROMs. METHODS: Review registered on PROSPERO as CRD42020176176. The search strategy was based on a previous similar systematic review and expanded to include all articles up to January 2019. All identified articles were rated by two independent assessors following the COSMIN guidelines. RESULTS: 668 abstracts were identified, with 10 articles included. A further 21 were identified from a previous review. Ten PROMs were identified. There was insufficient evidence to place any of the identified PROMs into recommendation for use category A due to lack of evidence for content validity, as stipulated by the COSMIN guidelines. CONCLUSION: Lack of evidence of content validity limits suitable PROM selection, therefore none can be recommended for use. It is acknowledged that all included PROMs were developed before the COSMIN guidelines were published. Future research on PROMs for RA DA must provide evidence of content validity.

Telemedicine in the Management of Patients with Rheumatic Disease during COVID-19 Pandemic: Incidence of Psychiatric Disorders and Fibromyalgia in Patients with Rheumatoid Arthritis and Psoriatic Arthritis.

The management of patients with immuno-rheumatological diseases has profoundly changed during the COVID-19 pandemic and telemedicine has played an important role in the disease follow-up. In addition to monitoring disease activity and any adverse events, especially infectious events, assessing the psychological situation of the patient can be fundamental. Furthermore, COVID-19 has a serious impact on mental health and, since the beginning of the pandemic, a significantly higher incidence of anxiety disorders and depressive symptoms especially in younger people was observed. In this study, we evaluated the incidence of depressive disorders, anxiety, and fibromyalgia (FM) in our patients with rheumatoid arthritis and psoriatic arthritis during the lockdown period due to the COVID-19 pandemic and we validate the use of telemedicine in the clinical management of these patients. Mental and physical stress during the COVID-19 pandemic can greatly worsen FM symptoms and intensify patients' suffering without a clinical flare of the inflammatory disease for patients affected by rheumatoid arthritis. Telemedicine has allowed us to identify patients who needed a face-to-face approach for therapeutic reevaluation even if not related to a flare of the inflammatory disease. Even if our data does not allow us to draw definitive conclusions regarding the effectiveness of telemedicine as greater than or equal to the standard face-to-face approach, we continue to work by modifying our approach to try to ensure the necessary care in compliance with safety and, optimistically, this tool will become an important part of rheumatic disease management.

The Effect of Periodontal Treatment on Clinical and Biological Indicators, Quality of Life, and Oral Health in Rheumatoid Arthritis Patients: A Quasi-Experimental Study.

Non-surgical periodontal therapy (NSPT) has been shown to have systemic effects. It has been suggested that, similar to rheumatoid arthritis (RA), periodontitis (PD) has an impact on general health, in terms of psychological, physical, and social aspects. This study determines the effect of periodontal treatment in RA activity, health-related quality of life, and oral health self-perception before and after periodontal treatment in RA patients. A quasi-experimental, prospective, non-randomized study was conducted, and 52 patients were included in the study. Periodontal parameters and the instruments disease activity score-28 (DAS-28), SF-36, and OHIP-14 were measured at baseline and at 3 months after NSPT. All differences were statistically assessed. The study protocol was registered in Clinical Trials (NCT04658615). No statistically significant differences were found in the scores of DAS-28 before and after the intervention in the group with PD and reduced periodontium. When the effect of periodontal treatment was analyzed in the group of 29 patients who were followed up, it was found that there were statistically significant differences before and after in variables such as psychological distress, emotional role, and mental health, which indicates an improvement in the scores of these variables. NSPT influenced the health-related quality of life measured with SF-36 and OHIP-14 in patients with RA. In conclusion, NSPT has an effect on self-reported quality of life and health indicators more than the RA activity as measured with DAS-28. However, the clinical effect of periodontal treatment in RA patients provides important data to support periodontal care in patients.

IL-6 Revisited: From Rheumatoid Arthritis to CAR T Cell Therapy and COVID-19.

The diverse biological activity of interleukin-6 (IL-6) contributes to the maintenance of homeostasis. Emergent infection or tissue injury induces rapid production of IL-6 and activates host defense through augmentation of acute-phase proteins and immune responses. However, excessive IL-6 production and uncontrolled IL-6 receptor signaling are critical to pathogenesis. Over the years, therapeutic agents targeting IL-6 signaling, such as tocilizumab, a humanized anti-IL-6 receptor antibody, have shown remarkable efficacy for rheumatoid arthritis, Castleman disease, and juvenile idiopathic arthritis, and their efficacy in other diseases is continually being reported. Emerging evidence has demonstrated the benefit of tocilizumab for several types of acute inflammatory diseases, including cytokine storms induced by chimeric antigen receptor T cell therapy and coronavirus disease 2019 (COVID-19). Here, we refocus attention on the biology of IL-6 and summarize the distinct pathological roles of IL-6 signaling in several acute and chronic inflammatory diseases.

Risk of infection associated with Janus Kinase (JAK) inhibitors and biological therapies in inflammatory intestinal disease and rheumatoid arthritis. Prevention strategies. / Riesgo de infección asociado a los inhibidores de las quinasas Janus (JAK) y las terapias biológicas en enfermedad inflamatoria intestinal y artritis reumatoide. Estrategias de prevención.

Patients with certain immune-mediated inflammatory diseases, such as rheumatoid arthritis (RA) and inflammatory bowel disease (IBD), have an increased risk of severe infectious diseases than the general population, which are mainly associated with the immunosuppressive treatments that they receive. These treatments act on the immune system through different mechanisms, causing different degrees of immunosuppression and a variable risk depending on whether the pathogen is a virus, bacteria or fungus. This article reviews the most relevant literature on the subject, which was selected and discussed by a panel of experts. The aim of this article is to review the risk of infections in patients with IBD and RA, and the potential preventive measures.

COVID-19 and Rheumatoid Arthritis Crosstalk: Emerging Association, Therapeutic Options and Challenges.

Hyperactivation of immune responses resulting in excessive release of pro-inflammatory mediators in alveoli/lung structures is the principal pathological feature of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The cytokine hyperactivation in COVID-19 appears to be similar to those seen in rheumatoid arthritis (RA), an autoimmune disease. Emerging evidence conferred the severity and risk of COVID-19 to RA patients. Amid the evidence of musculoskeletal manifestations involving immune-inflammation-dependent mechanisms and cases of arthralgia and/or myalgia in COVID-19, crosstalk between COVID-19 and RA is often debated. The present article sheds light on the pathological crosstalk between COVID-19 and RA, the risk of RA patients in acquiring SARS-CoV-2 infection, and the aspects of SARS-CoV-2 infection in RA development. We also conferred whether RA can exacerbate COVID-19 outcomes based on available clinical readouts. The mechanistic overlapping in immune-inflammatory features in both COVID-19 and RA was discussed. We showed the emerging links of angiotensin-converting enzyme (ACE)-dependent and macrophage-mediated pathways in both diseases. Moreover, a detailed review of immediate challenges and key recommendations for anti-rheumatic drugs in the COVID-19 setting was presented for better clinical monitoring and management of RA patients. Taken together, the present article summarizes available knowledge on the emerging COVID-19 and RA crosstalk and their mechanistic overlaps, challenges, and therapeutic options.

Chronic pharmacological antagonism of the GM-CSF receptor in mice does not replicate the pulmonary alveolar proteinosis phenotype but does alter lung surfactant turnover.

Granulocyte macrophage colony stimulating factor (GM-CSF) is a key participant in, and a clinical target for, the treatment of inflammatory diseases including rheumatoid arthritis (RA). Therapeutic inhibition of GM-CSF signalling using monoclonal antibodies to the α-subunit of the GM-CSF receptor (GMCSFRα) has shown clear benefit in patients with RA, giant cell arteritis (GCAs) and some efficacy in severe SARS-CoV-2 infection. However, GM-CSF autoantibodies are associated with the development of pulmonary alveolar proteinosis (PAP), a rare lung disease characterised by alveolar macrophage (AM) dysfunction and the accumulation of surfactant lipids. We assessed how the anti-GMCSFRα approach might impact surfactant turnover in the airway. Female C57BL/6J mice received a mouse-GMCSFRα blocking antibody (CAM-3003) twice per week for up to 24 weeks. A parallel, comparator cohort of the mouse PAP model, GM-CSF receptor ß subunit (GMCSFRß) knock-out (KO), was maintained up to 16 weeks. We assessed lung tissue histopathology alongside lung phosphatidylcholine (PC) metabolism using stable isotope lipidomics. GMCSFRß KO mice reproduced the histopathological and biochemical features of PAP, accumulating surfactant PC in both broncho-alveolar lavage fluid (BALF) and lavaged lung tissue. The incorporation pattern of methyl-D9-choline showed impaired catabolism and not enhanced synthesis. In contrast, chronic supra-pharmacological CAM-3003 exposure (100 mg/kg) over 24 weeks did not elicit a histopathological PAP phenotype despite some changes in lung PC catabolism. Lack of significant impairment of AM catabolic function supports clinical observations that therapeutic antibodies to this pathway have not been associated with PAP in clinical trials.

ImmunosuppressiveTherapies Differently Modulate Humoral- and T-Cell-Specific Responses to COVID-19 mRNA Vaccine in Rheumatoid Arthritis Patients.

Objective: To assess in rheumatoid arthritis (RA) patients, treated with different immunosuppressive therapies, the induction of SARS-CoV-2-specific immune response after vaccination in terms of anti-region-binding-domain (RBD)-antibody- and T-cell-specific responses against spike, and the vaccine safety in terms of clinical impact on disease activity. Methods: Health care workers (HCWs) and RA patients, having completed the BNT162b2-mRNA vaccination in the last 2 weeks, were enrolled. Serological response was evaluated by quantifying anti-RBD antibodies, while the cell-mediated response was evaluated by a whole-blood test quantifying the interferon (IFN)-γ-response to spike peptides. FACS analysis was performed to identify the cells responding to spike stimulation. RA disease activity was evaluated by clinical examination through the DAS28crp, and local and/or systemic clinical adverse events were registered. In RA patients, the ongoing therapeutic regimen was modified during the vaccination period according to the American College of Rheumatology indications. Results: We prospectively enrolled 167 HCWs and 35 RA patients. Anti-RBD-antibodies were detected in almost all patients (34/35, 97%), although the titer was significantly reduced in patients under CTLA-4-inhibitors (median: 465 BAU/mL, IQR: 103-1189, p<0.001) or IL-6-inhibitors (median: 492 BAU/mL, IQR: 161-1007, p<0.001) compared to HCWs (median: 2351 BAU/mL, IQR: 1389-3748). T-cell-specific response scored positive in most of RA patients [24/35, (69%)] with significantly lower IFN-γ levels in patients under biological therapy such as IL-6-inhibitors (median: 33.2 pg/mL, IQR: 6.1-73.9, p<0.001), CTLA-4-inhibitors (median: 10.9 pg/mL, IQR: 3.7-36.7, p<0.001), and TNF-α-inhibitors (median: 89.6 pg/mL, IQR: 17.8-224, p=0.002) compared to HCWs (median: 343 pg/mL, IQR: 188-756). A significant correlation between the anti-RBD-antibody titer and spike-IFN-γ-specific T-cell response was found in RA patients (rho=0.432, p=0.009). IFN-γ T-cell response was mediated by CD4+ and CD8+ T cells. Finally, no significant increase in disease activity was found in RA patients following vaccination. Conclusion: This study showed for the first time that antibody-specific and whole-blood spike-specific T-cell responses induced by the COVID-19 mRNA-vaccine were present in the majority of RA patients, who underwent a strategy of temporary suspension of immunosuppressive treatment during vaccine administration. However, the magnitude of specific responses was dependent on the immunosuppressive therapy administered. In RA patients, BNT162b2 vaccine was safe and disease activity remained stable.

EULAR points to consider for conducting clinical trials and observational studies in individuals at risk of rheumatoid arthritis.

BACKGROUND: Despite growing interest, there is no guidance or consensus on how to conduct clinical trials and observational studies in populations at risk of rheumatoid arthritis (RA). METHODS: An European League Against Rheumatism (EULAR) task force formulated four research questions to be addressed by systematic literature review (SLR). The SLR results informed consensus statements. One overarching principle, 10 points to consider (PTC) and a research agenda were proposed. Task force members rated their level of agreement (1-10) for each PTC. RESULTS: Epidemiological and demographic characteristics should be measured in all clinical trials and studies in at-risk individuals. Different at-risk populations, identified according to clinical presentation, were defined: asymptomatic, musculoskeletal symptoms without arthritis and early clinical arthritis. Study end-points should include the development of subclinical inflammation on imaging, clinical arthritis, RA and subsequent achievement of arthritis remission. Risk factors should be assessed at baseline and re-evaluated where appropriate; they include genetic markers and autoantibody profiling and additionally clinical symptoms and subclinical inflammation on imaging in those with symptoms and/or clinical arthritis. Trials should address the effect of the intervention on risk factors, as well as progression to clinical arthritis or RA. In patients with early clinical arthritis, pharmacological intervention has the potential to prevent RA development. Participants' knowledge of their RA risk may inform their decision to participate; information should be provided using an individually tailored approach. CONCLUSION: These consensus statements provide data-driven guidance for rheumatologists, health professionals and investigators conducting clinical trials and observational studies in individuals at risk of RA.

Experiences of self-care during the COVID-19 pandemic among individuals with rheumatoid arthritis: A qualitative study.

OBJECTIVES: This study aimed to explore the impact of the coronavirus disease 2019 (COVID-19) pandemic on self-care of individuals living with rheumatoid arthritis (RA). METHODS: Guided by a constructivist, qualitative design, we conducted one-to-one in-depth telephone interviews between March and October 2020 with participants with RA purposively sampled for maximum variation in age, sex and education, who were participating in one of two ongoing randomized-controlled trials. An inductive, reflexive thematic analysis approach was used. RESULTS: Twenty-six participants (aged 27-73 years; 23 females) in British Columbia, Canada were interviewed. We identified three themes: (1) Adapting to maintain self-care describes how participants took measures to continue self-care activities while preventing virus transmissions. While spending more time at home, some participants reported improved self-care. (2) Managing emotions describes resilience-building strategies such as keeping perspective, positive reframing and avoiding negative thoughts. Participants described both letting go and maintaining a sense of control to accommodate difficulties and emotional responses. (3) Changing communication with health professionals outlined positive experiences of remote consultations with health professionals, particularly if good relationships had been established prepandemic. CONCLUSION: The insights gained may inform clinicians and researchers on ways to support the self-care strategies of individuals with RA and other chronic illnesses during and after the COVID-19 pandemic. The findings reveal opportunities to further examine remote consultations to optimize patient engagement and care. PATIENT OR PUBLIC CONTRIBUTION: This project is jointly designed and conducted with patient partners in British Columbia, Canada. Patient partners across the United Kingdom also played in a key role in providing interpretations of themes during data analysis.

Impact of the COVID-19 pandemic on treat-to-target strategies and physical consultations in >7000 patients with inflammatory arthritis.

OBJECTIVES: To explore the impact of the COVID-19 pandemic on treat-to-target strategies (disease activity, remission rates) and access to physical consultations in patients with inflammatory rheumatic disease, as well as to explore characteristics of patients with/without physical consultations in the clinic and the impact of early vs established disease. METHODS: Patients with RA, PsA or axial SpA (axSpA) prospectively followed in the nationwide DANBIO registry answered online questionnaires and reported patient-reported outcomes (PROs) in June and November 2020. Patient characteristics, disease activity and physical consultations in the clinic before and during the pandemic were identified in DANBIO [all patients and subgroups with early disease (disease duration ≤2 years)]. In individual patients, changes in PROs before and during the pandemic were calculated. Characteristics of patients with/without physical consultations were described (age, gender, education level, comorbidities, disease duration, treatment). RESULTS: We included 7836 patients (22% of eligible patients), 12% of which had early disease. PROs were stable before and during the pandemic, with median changes approximating zero, as well as in patients with early disease. Remission rates were stable. The relative decrease in the number of patients with physical consultations was 21-72%, which was highest in axSpA. Characteristics of patients with/without physical consultations were similar. Self-reported satisfaction with treatment options and access was >70%; the preferred contact form was physical consultation (66%). CONCLUSION: In this nationwide study performed during the first 8 months of the pandemic, patient satisfaction was high and the PROs and remission rates remained stable despite the remarkable reduction in physical consultations, as well as in patients with early disease. Characteristics of patients with/without physical consultations appeared similar.

A novel approach utilizing laser acupuncture teletherapy for management of elderly-onset rheumatoid arthritis: A randomized clinical trial.

INTRODUCTION: Rheumatoid arthritis (RA) disease is a systemic progressive inflammatory autoimmune disorder. Elderly-onset RA can be assumed as a benign form of RA. Until recently, face-to-face therapeutic sessions between health professionals and patients are usually the method of its treatment. However, during pandemics, including coronavirus disease 2019 (COVID-19), teletherapeutic sessions can extensively increase the patient safety especially in elderly patients who are more vulnerable to these infections. Thus, the aim of this randomized clinical trial was to evaluate a novel teletherapy approach for management of elderly patients suffering from RA by utilizing laser acupuncture. METHODS: A teletherapy system was used for management of elderly patients suffering from RA. Sixty participants were allocated randomly into two groups and the ratio was 1:1. Patients in the first group were treated with laser acupuncture and telerehabilitation sessions, which consisted of aerobic exercise and virtual reality training. Patients in the second group received telerehabilitation sessions, which consisted of aerobic exercise and virtual reality training. Evaluation of patients was done by using the Health Assessment questionnaire (HAQ), the Rheumatoid Arthritis Quality of Life (RAQoL) questionnaire, and the analysis of interleukin-6 (IL-6), serum C-reactive protein (CRP), plasma adenosine triphosphate (ATP) concentration and plasma malondialdehyde (MDA). RESULTS: A statistically significant difference was found in CRP, RAQoL, IL-6 and MDA between the pre- and post-treatments in the first group (p < 0.05) favouring the post-treatment group, while the HAQ showed a statistically significant difference between pre- and post-treatments (p < 0.05) in both groups. Statistically significant post-treatment differences were also observed between the two groups (p < 0.05) in RAQoL, CRP, ATP and MDA, favouring the first group. DISCUSSION: Laser acupuncture teletherapy could be suggested as a reliable treatment method for elderly patients suffering from RA, as it can provide a safe and effective therapeutic approach. Teletherapy provided safer access to health professionals and patients while giving a high patient satisfaction value with a relatively lower cost (ClinicalTrials.gov Identifier: NCT04684693).