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Saranya Panichaporn,1 Wanwisa Chanapai,2 Ananya Srisomnuek,2 Phakhamon Thaweeratthakul,1 Wanruchada Katchamart1 1Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand; 2Division of Clinical Trials, Research Department, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, ThailandCorrespondence: Wanruchada Katchamart, Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University, 2 Wanglang Road, Bangkok Noi, Bangkok, 10700, Thailand, Tel +66 2 419 7775, Fax +66 2 418 3222, Email wanruchada.kat@mahidol.ac.thPurpose: To evaluate the psychometric properties and feasibility of the Thai version of Compliance-Questionnaire-Rheumatology (CQR)-19.Patients and Methods: A cross-sectional study was conducted in the Rheumatology clinic of Siriraj hospital from October 2020 to March 2022. Literate patients diagnosed with rheumatoid arthritis and aged ≥ 18 years old were included. Participants completed the Thai CQR-19 at baseline and during a follow-up visit. A pill count at the follow-up visit indicating that ≤ 80% of prescribed pills were taken was defined as poor compliance. Feasibility was assessed by the time to completion and the number of missing questions.Results: 156 participants were enrolled and 88% were in good compliance. The sensitivity of the CQR-19 to detect good compliance was 78.2% and the specificity was 27.8%. The Thai CQR-19 showed moderate agreement (Gwet’s AC1= 0.61, p < 0.01) with 72.2% agreement against pill counts. The Thai CQR-19 had good internal consistency (Cronbach’s alpha = 0.83) with moderate test-retest reliability (intraclass coefficients = 0.64, 95% CI 0.54– 0.73; p < 0.05). There was a weak correlation between the Thai CQR-19 and disease activity (rs = 0.20, p < 0.05), and no correlation with functional disability (rs = 0.09, p = 0.25). The median (IQR) completion time was 4.42 (3.25– 6.16) minutes and 114 (73%) completed all 19 questions.Conclusion: The Thai version of CQR-19 is a valid and reliable tool to assess medication compliance in Thai patients with RA. To ensure completeness and accuracy, this questionnaire may be administered by interview.Keywords: medication compliance, rheumatoid arthritis, validity, reliability, feasibility, psychometric property

Objective: To survey the management of hyperuricemia and gout among Thai physicians. Materials and Methods: The present study was a cross-sectional questionnaire survey sent to 3,916 Thai physicians working in Thailand. Participants with no experience managing hyperuricemia and gout were excluded. Results: Of the 742 (18.9%) physician respondents, 607 (81.8%) reported having experience managing hyperuricemia and gout. Regarding acute gouty arthritis management, oral colchicine (98%) and non-steroidal anti-inflammatory drugs (91%) were the two most commonly prescribed medications to control acute gouty arthritis. High-dose regimen of colchicine (1.2 mg followed by 0.6 mg every two hours until symptom relief or marked toxicity) would be ordered by 28% of physicians. Regarding urate-lowering therapy (ULT), 33% of participants would start ULT in a patient with asymptomatic hyperuricemia, and 59% would start ULT if serum uric acid (sUA) was more than 11 mg/dl. Approximately 70% of physicians would start allopurinol at no more than 100 mg/day, 63% set the sUA target at less than 6 mg/dl, and, 80% would limit the maximal dosage of allopurinol according to renal function. Only 14% of respondents would continue ULT lifelong. Most physicians (95%) would prevent gout flare when starting ULT, and most (95%) used colchicine to prevent gout flare. Conclusion: The results of the present study revealed suboptimal management of hyperuricemia and gout, especially high-dose regimen of colchicine for acute gout, the sUA target and ULT duration, among Thai physicians. Improved condition-specific training and updated management guidelines are needed to improve the care and outcomes of hyperuricemia and gout patients in Thailand. [ABSTRACT FROM AUTHOR]

Objectives: This study aimed to systematically evaluate the efficacy of plasma exchange (PLEX) in patients with idiopathic inflammatory myositis (IIM) complicated by interstitial lung disease (ILD)., Method: We conducted a comprehensive literature search in Medline and EMBASE from their inception to August 2023, focusing on randomized controlled trials, cohort studies, and case-control studies involving IIM patients with ILD treated with PLEX compared to those treated with standard therapies. The primary outcome was the one-year survival rate. All the statistical analyses were performed using RevMan version 4.12.0., Results: Out of 438 retrieved studies, 16 were selected for full-text review. Six cohort studies involving 148 patients with anti-melanoma differentiation-associated gene 5 (MDA5)-positive dermatomyositis or antisynthetase syndrome-related dermatomyositis with rapidly progressive ILD refractory to standard treatments (including glucocorticoids, immunosuppressive agents, or intravenous immunoglobulin) met the inclusion criteria. Patients receiving PLEX in addition to other therapies demonstrated a greater one-year survival rate (relative risk [RR] 1.59, 95 % CI 0.96-2.65, I 2 52 %) than did patients in the non-PLEX group. Significance was reached in a sensitivity analysis after excluding one outlier (RR 1.71, 95 % confidence intervals [CI] 1.30-2.25; I 2 0 %). Additionally, there was a trend suggesting that PLEX improved lung function, radiographic outcomes, and key serum biomarkers, such as Krebs von den Lungen-6 and ferritin. Funnel plot asymmetry suggested publication bias due to the lack of reporting of negative trials. All studies had a low risk of bias., Conclusions: As an adjunctive therapy, PLEX improved one-year survival in IIM patients with rapidly progressive ILD who were unresponsive to standard treatments., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier Inc.)

Objective: To determine the occurrence of breakthrough COVID-19 infections (BIs) in patients with systemic lupus erythematosus (SLE) compared with patients with other rheumatic autoimmune diseases (rAIDs), patients with non-rheumatic autoimmune diseases (nrAIDs), and healthy controls (HCs)., Methods: The study was based on data from 7035 fully vaccinated respondents to the online COVAD questionnaire with SLE (N = 852), rAIDs (N = 3098), or nrAIDs (N = 414), and HCs (N = 2671). BI was defined as COVID-19 infection occurring in individuals vaccinated with ≥ 2 doses (or 1 dose of J&J) ≥ 14 days after vaccination and not after 6 months since the last vaccine dose. Data were analysed using linear and logistic regression models., Results: A total of 91/852 (10.7%) SLE patients reported at least one BI. The frequency of BIs in SLE patients was comparable to that among HCs (277/2671; p = 0.847) and patients with nrAID (39/414; p = 0.552) but higher than that among patients with other rAIDs (235/3098; p = 0.005). No demographic factors or treatments were associated with BIs in SLE patients (p ≥ 0.05 for all). Joint pain was more frequent in SLE patients than in HCs (odds ratio [OR]: 3.38; 95% confidence interval [CI]: 1.89-6.04; p < 0.001) or nrAID patients (OR: 2.44; 95% CI: 1.04-5.75; p = 0.041). Patient with SLE did not report a higher frequency of hospitalisation or need for advanced treatment for COVID-19 infection compared with disease controls and HCs, respectively., Conclusion: COVID-19 vaccination conferred similar protection against COVID-19 infection in terms of frequency and severity in patients with SLE to that reported by healthy individuals., (© 2024. The Author(s).)

Objective: The presence of comorbidities can substantially affect patients' quality of life, but data regarding their impact on idiopathic inflammatory myopathies (IIMs) are limited., Methods: We examined the prevalence of comorbidities in IIM patients, other autoimmune rheumatic diseases (oAIRDs), and healthy controls (HCs), using data from the self-reported COVAD-2 survey. We defined Basic Multimorbidity (BM) as the presence of ≥ 2 non-rheumatic chronic conditions and Complex Multimorbidity (CM) as the presence of ≥ 3 non-rheumatic chronic conditions affecting ≥3 organ systems. Hierarchical Clustering on Principal Components was performed for grouping., Results: Among the COVAD respondents, 1558 IIMs, 4591 oAIRDs, and 3652 HCs were analysed. IIMs exhibited a high burden of comorbidities (OR: 1.62 vs oAIRDs and 2.95 vs HCs, p< 0.01), BM (OR 1.66 vs oAIRDs and 3.52 vs HCs, p< 0.01), CM (OR: 1.69 vs AIRDs and 6.23 vs HCs, p< 0.01), and mental health disorders (MHDs) (OR 1.33 vs oAIRDs and 2.63 vs HCs, p< 0.01). Among the IIM patients, those with comorbidities or MHDs had lower PROMIS Global Physical (PGP), PROMIS Global Mental (PGM), and PROMIS Physical Function (SF10) scores, and higher fatigue (F4a) scores (all p< 0.001). PGP, PGM, SF10a and F4a were influenced by age, active disease, BM, and MHDs. Four distinct clusters were identified among the IIMs according to comorbidities and PROMIS scores., Conclusion: Patients with IIMs have a higher burden of comorbidities that influence physical and mental health, identifiable as clinical clusters for optimized and holistic management approaches., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology.)

Objectives: We investigated coronavirus disease 2019 (COVID-19) vaccine safety in pregnant and breastfeeding women with autoimmune diseases (AID) in the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study., Methods: Delayed-onset (>7 days) vaccine-related adverse events (AE), disease flares and AID-related treatment modifications were analysed upon diagnosis of AID vs healthy controls (HC) and the pregnancy/breastfeeding status at the time of at least one dose of vaccine., Results: Among the 9201 participants to the self-administered online survey, 6787 (73.8%) were women. Forty pregnant and 52 breastfeeding patients with AID were identified, of whom the majority had received at least one dose of COVID-19 vaccine (100% and 96.2%, respectively). AE were reported significantly more frequently in pregnant than in non-pregnant patients (overall AE 45% vs 26%, P = 0.01; minor AE 40% vs 25.9%, P = 0.03; major AE 17.5% vs 4.6%, P < 0.01), but no difference was found in comparison with pregnant HC. No difference was observed between breastfeeding patients and HC with respect to AE. Post-vaccination disease flares were reported by 17.5% of pregnant and 20% of breastfeeding patients, and by 18.3% of age- and disease-matched non-pregnant and non-breastfeeding patients (n = 262). All pregnant/breastfeeding patients who experienced a disease flare were managed with glucocorticoids; 28.6% and 20% of them required initiation or change in immunosuppressants, respectively., Conclusion: This study provides reassuring insights into the safety of COVID-19 vaccines administered to women with AID during the gestational and post-partum periods, helping overcome hesitant attitudes, as the benefits for the mother and for the fetus by passive immunization appear to outweigh potential risks., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective: To determine the construct validity, reliability, and treatment goal threshold of a Thai-language version of the 12-item Psoriatic Arthritis Impact of Disease (Thai-PsAID) questionnaire in patients with psoriatic arthritis (PsA)., Methods: This cross-sectional study involved administering the proposed Thai-PsAID to 117 Thai patients with PsA. Reliability was assessed by Cronbach's α test and intraclass correlation coefficient (ICC). Construct validity was assessed using Spearman correlation with clinical disease activity index for psoriatic arthritis (cDAPSA), the Health Assessment Questionnaire (HAQ), EQ-5D index, and the patient-acceptable symptom state (PASS). The optimal cutoff score of the Thai-PsAID for minimal disease activity (MDA) was determined by receiver operating characteristic curves., Results: Participants had a mean age of 49.5 years, 61 (52.1%) were female, and the median disease duration was 5 years. The median Thai-PsAID score was 2.1, with a Cronbach's α coefficient of .95 and an ICC of 0.77. The mean time to complete the Thai-PsAID was 2.1 min, with no missing data. The Thai-PsAID score demonstrated a moderate correlation with the cDAPSA, HAQ, and EQ-5D with indices (Spearman's rho of .64, .54, and -.55, respectively). The cutoff of 2.7 has 81%-84% sensitivity and 69%-85% specificity for classifying patients with MDA, satisfied PASS, and indicating no need to escalate medication., Conclusions: The Thai-PsAID is a valid, reliable, and feasible tool for measuring PsA prognosis. A cutoff of 2.7 accurately discriminates MDA and PASS and indicates no need for medication escalation. The Thai-PsAID may be used as a standalone measure., (© 2024 Asia Pacific League of Associations for Rheumatology and John Wiley & Sons Australia, Ltd.)

Objectives: To explore prevalence, characteristics and risk factors of COVID-19 breakthrough infections (BIs) in idiopathic inflammatory myopathies (IIM) using data from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study., Methods: A validated patient self-reporting e-survey was circulated by the COVAD study group to collect data on COVID-19 infection and vaccination in 2022. BIs were defined as COVID-19 occurring ≥14 days after 2 vaccine doses. We compared BIs characteristics and severity among IIMs, other autoimmune rheumatic and non-rheumatic diseases (AIRD, nrAID), and healthy controls (HC). Multivariable Cox regression models assessed the risk factors for BI, severe BI and hospitalisations among IIMs., Results: Among 9449 included response, BIs occurred in 1447 (15.3%) respondents, median age 44 years (IQR 21), 77.4% female, and 182 BIs (12.9%) occurred among 1406 IIMs. Multivariable Cox regression among IIMs showed age as a protective factor for BIs [Hazard Ratio (HR)=0.98, 95%CI = 0.97-0.99], hydroxychloroquine and sulfasalazine use were risk factors (HR = 1.81, 95%CI = 1.24-2.64, and HR = 3.79, 95%CI = 1.69-8.42, respectively). Glucocorticoid use was a risk factor for severe BI (HR = 3.61, 95%CI = 1.09-11.8). Non-White ethnicity (HR = 2.61, 95%CI = 1.03-6.59) was a risk factor for hospitalisation. Compared with other groups, patients with IIMs required more supplemental oxygen therapy (IIM = 6.0% vs AIRD = 1.8%, nrAID = 2.2%, and HC = 0.9%), intensive care unit admission (IIM = 2.2% vs AIRD = 0.6%, nrAID, and HC = 0%), advanced treatment with antiviral or monoclonal antibodies (IIM = 34.1% vs AIRD = 25.8%, nrAID = 14.6%, and HC = 12.8%), and had more hospitalisation (IIM = 7.7% vs AIRD = 4.6%, nrAID = 1.1%, and HC = 1.5%)., Conclusion: Patients with IIMs are susceptible to severe COVID-19 BI. Age and immunosuppressive treatments were related to the risk of BIs., (© The Author(s) 2024. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objectives: Disease flares in the post-coronavirus disease 2019 (COVID-19) vaccination period represent a prominent concern, though risk factors are poorly understood. We studied these flares among patients with idiopathic inflammatory myopathies (IIMs) and other autoimmune rheumatic diseases (AIRDs)., Methods: The COVAD-1 and -2 global surveys were circulated in early 2021 and 2022, respectively, and we captured demographics, comorbidities, AIRDs details, COVID-19 infection history and vaccination details. Flares of IIMs were defined as (a) patient self-reported, (b) immunosuppression (IS) denoted, (c) clinical sign directed and (d) with >7.9-point minimal clinically significant improvement difference worsening of Patient-Reported Outcomes Measurement Information System (PROMIS) PROMISPF10a score. Risk factors of flares were analysed using regression models., Results: Of 15 165 total respondents, 1278 IIMs (age 63 years, 70.3% female, 80.8% Caucasians) and 3453 AIRDs were included. Flares of IIM were seen in 9.6%, 12.7%, 8.7% and 19.6% patients by definitions (a) to (d), respectively, with a median time to flare of 71.5 (10.7-235) days, similar to AIRDs. Patients with active IIMs pre-vaccination (OR 1.2; 95% CI 1.03, 1.6, P = 0.025) were prone to flares, while those receiving rituximab (OR 0.3; 95% CI 0.1, 0.7, P = 0.010) and AZA (OR 0.3, 95% CI 0.1, 0.8, P = 0.016) were at lower risk. Female gender and comorbidities predisposed to flares requiring changes in IS. Asthma (OR 1.62; 95% CI 1.05, 2.50, P = 0.028) and higher pain visual analogue score (OR 1.19; 95% CI 1.11, 1.27, P < 0.001) were associated with disparity between self-reported and IS-denoted flares., Conclusion: A diagnosis of IIMs confers an equal risk of flares in the post-COVID-19 vaccination period to AIRDs, with active disease, female gender and comorbidities conferring a higher risk. Disparity between patient- and physician-reported outcomes represents a future avenue for exploration., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Background: The safety profile of COVID-19 vaccination is well documented, but hesitancy among people with immune-mediated inflammatory diseases, often immunocompromised, remains high, partially due to a scarcity of data on safety over a longer term. We herein aimed to assess delayed adverse events (DAEs) occurring >7 days after COVID-19 vaccination in systemic lupus erythematosus (SLE) versus other rheumatic autoimmune diseases (rAIDs), non-rheumatic AIDs (nrAIDs), and healthy controls (HCs)., Methods: Self-reported data were captured within the COVID-19 Vaccination in Autoimmune Diseases (COVAD)-2 online survey, which comprised >150 centres and responses from 106 countries, between February and June 2022. Logistic regression analysis adjusting for important confounders (age, sex, ethnicity) was used to compare groups., Results: Of 7203 eligible individuals, 882 (12.2%) patients had SLE, 3161 (43.9%) patients had rAIDs, 426 (5.9%) patients had nrAIDs, and 2734 (38.0%) were HCs. SLE patients had a median age of 39 years (IQR: 31-50); 93.7% were women. SLE patients reported, more frequently, major DAEs (OR: 1.6; 95% CI: 1.2-2.0; p = 0.001) and hospitalisation (OR: 2.2; 95% CI: 1.4-3.4; p < 0.001) compared to HCs, severe rashes (OR: 2.4; 95% CI: 1.3-4.2; p = 0.004) compared to people with rAIDS, and hospitalisation (OR: 2.3; 95% CI: 1.1-4.9; p = 0.029) as well as several minor DAEs compared to people with nrAIDs. Differences were observed between vaccines in terms of frequency of major DAEs and hospitalisations, with the latter seen more frequently in patients receiving the Moderna vaccine. People with SLE with no autoimmune multimorbidity less frequently reported overall minor DAEs compared to SLE patients with comorbid nrAIDs (OR: 0.5; 95% CI: 0.3-1.0; p = 0.036)., Conclusion: Hospitalisations post-vaccination were more frequent in SLE patients than in HCs. Monitoring of SLE patients following COVID-19 vaccination can help in identifying DAEs early, informing patients about expected DAEs, and supporting patients, especially those with autoimmune multimorbidity.

Data on short-term safety of COVID-19 vaccination in patients with systemic sclerosis (SSc) were explored previously in the first COVID-19 vaccination in autoimmune diseases (COVAD) survey conducted in 2021. However, delayed adverse events (ADEs) (occurring > 7 days post-vaccination) are poorly characterized in these patients with SSc. In this study, we analysed delayed COVID-19 vaccine-related ADEs among patients with SSc, other systemic autoimmune and inflammatory disorders (SAIDs) and healthy controls (HCs) using data from the second COVAD study conducted in 2022. The COVAD-2 study was a cross-sectional, patient self-reported global e-survey conducted from February to June 2022. Data on demographics, SSc/SAID disease characteristics, COVID-19 infection history, and vaccination details including delayed ADEs as defined by the Centre for Disease Control were captured and analysed. Among 17,612 respondents, 10,041 participants fully vaccinated against COVID-19 were included for analysis. Of these, 2.6% (n = 258) had SSc, 63.7% other SAIDs, and 33.7% were HCs. BNT162b2 Pfizer (69.4%) was the most administered vaccine, followed by MRNA-1273 Moderna (32.25%) and ChadOx1 nCOV-19 Oxford/AstraZeneca (12.4%) vaccines. Among patients with SSc, 18.9% reported minor, while 8.5% experienced major delayed ADEs, and 4.6% reported hospitalization. These frequencies were comparable to those of the ADEs reported by other patients with SAIDs and HCs. However, patients with SSc reported a higher frequency of difficulty in breathing than HCs [OR 2.3 (1.0-5.1), p = 0.042]. Patients with diffuse cutaneous SSc experienced minor ADEs [OR 2.1 (1.1-4.4), p = 0.036] and specifically fatigue more frequently [OR 3.9 (1.3-11.7), p = 0.015] than those with limited cutaneous SSc. Systemic sclerosis patients with concomitant myositis reported myalgia more frequently [OR 3.4 (1.1-10.7), p = 0.035], while those with thyroid disorders were more prone to report a higher frequency of joint pain [OR 5.5 (1.5-20.2), p = 0.009] and dizziness [OR 5.9 (1.3-27.6), p = 0.024] than patients with SSc alone. A diagnosis of SSc did not confer a higher risk of delayed post-COVID-19 vaccine-related ADEs overall compared with other SAIDs and HCs. However, the diffuse cutaneous phenotype and coexisting autoimmune conditions including myositis and thyroid disease may increase the risk of minor ADEs. These patients may benefit from pre-vaccination counselling, close monitoring, and early initiation of appropriate care in the post-COVID-19 vaccination period., (© 2023. The Author(s), under exclusive licence to Springer-Verlag GmbH Germany, part of Springer Nature.)

Objective: Flares of autoimmune rheumatic diseases (AIRDs) following COVID-19 vaccination are a particular concern in vaccine-hesitant individuals. Therefore, we investigated the incidence, predictors and patterns of flares following vaccination in individuals living with AIRDs, using global COVID-19 Vaccination in Autoimmune Diseases (COVAD) surveys., Methods: The COVAD surveys were used to extract data on flare demographics, comorbidities, COVID-19 history, and vaccination details for patients with AIRDs. Flares following vaccination were identified as patient-reported (a), increased immunosuppression (b), clinical exacerbations (c) and worsening of PROMIS scores (d). We studied flare characteristics and used regression models to differentiate flares among various AIRDs., Results: Of 15 165 total responses, the incidence of flares in 3453 patients with AIRDs was 11.3%, 14.8%, 9.5% and 26.7% by definitions a-d, respectively. There was moderate agreement between patient-reported and immunosuppression-defined flares (K = 0.403, P = 0.022). Arthritis (61.6%) and fatigue (58.8%) were the most commonly reported symptoms. Self-reported flares were associated with higher comorbidities (P = 0.013), mental health disorders (MHDs) (P < 0.001) and autoimmune disease multimorbidity (AIDm) (P < 0.001).In regression analysis, the presence of AIDm [odds ratio (OR) = 1.4; 95% CI: 1.1, 1.7; P = 0.003), or a MHD (OR = 1.7; 95% CI: 1.1, 2.6; P = 0.007), or being a Moderna vaccine recipient (OR = 1.5; 95% CI: 1.09, 2.2; P = 0.014) were predictors of flares. Use of MMF (OR = 0.5; 95% CI: 0.3, 0.8; P = 0.009) and glucocorticoids (OR = 0.6; 95% CI: 0.5, 0.8; P = 0.003) were protective.A higher frequency of patients with AIRDs reported overall active disease post-vaccination compared with before vaccination (OR = 1.3; 95% CI: 1.1, 1.5; P < 0.001)., Conclusion: Flares occur in nearly 1 in 10 individuals with AIRDs after COVID vaccination; people with comorbidities (especially AIDm), MHDs and those receiving the Moderna vaccine are particularly vulnerable. Future avenues include exploring flare profiles and optimizing vaccine strategies for this group., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Objective: COVID-19 vaccines have a favorable safety profile in patients with autoimmune rheumatic diseases (AIRDs) such as idiopathic inflammatory myopathies (IIMs); however, hesitancy continues to persist among these patients. Therefore, we studied the prevalence, predictors and reasons for hesitancy in patients with IIMs, other AIRDs, non-rheumatic autoimmune diseases (nrAIDs) and healthy controls (HCs), using data from the two international COVID-19 Vaccination in Autoimmune Diseases (COVAD) e-surveys., Methods: The first and second COVAD patient self-reported e-surveys were circulated from March to December 2021, and February to June 2022 (ongoing). We collected data on demographics, comorbidities, COVID-19 infection and vaccination history, reasons for hesitancy, and patient reported outcomes. Predictors of hesitancy were analysed using regression models in different groups., Results: We analysed data from 18 882 (COVAD-1) and 7666 (COVAD-2) respondents. Reassuringly, hesitancy decreased from 2021 (16.5%) to 2022 (5.1%) (OR: 0.26; 95% CI: 0.24, 0.30, P < 0.001). However, concerns/fear over long-term safety had increased (OR: 3.6; 95% CI: 2.9, 4.6, P < 0.01). We noted with concern greater skepticism over vaccine science among patients with IIMs than AIRDs (OR: 1.8; 95% CI: 1.08, 3.2, P = 0.023) and HCs (OR: 4; 95% CI: 1.9, 8.1, P < 0.001), as well as more long-term safety concerns/fear (IIMs vs AIRDs - OR: 1.9; 95% CI: 1.2, 2.9, P = 0.001; IIMs vs HCs - OR: 5.4 95% CI: 3, 9.6, P < 0.001). Caucasians [OR 4.2 (1.7-10.3)] were likely to be more hesitant, while those with better PROMIS physical health score were less hesitant [OR 0.9 (0.8-0.97)]., Conclusion: Vaccine hesitancy has decreased from 2021 to 2022, long-term safety concerns remain among patients with IIMs, particularly in Caucasians and those with poor physical function., (© The Author(s) 2023. Published by Oxford University Press on behalf of the British Society for Rheumatology. All rights reserved. For permissions, please email: journals.permissions@oup.com.)

Limited evidence on long-term COVID-19 vaccine safety in patients with idiopathic inflammatory myopathies (IIMs) continues to contribute to vaccine hesitancy. We studied delayed-onset vaccine adverse events (AEs) in patients with IIMs, other systemic autoimmune and inflammatory disorders (SAIDs), and healthy controls (HCs), using data from the second COVID-19 Vaccination in Autoimmune Diseases (COVAD) study. A validated self-reporting e-survey was circulated by the COVAD study group (157 collaborators, 106 countries) from Feb-June 2022. We collected data on demographics, comorbidities, IIM/SAID details, COVID-19 history, and vaccination details. Delayed-onset (> 7 day) AEs were analyzed using regression models. A total of 15165 respondents undertook the survey, of whom 8759 responses from vaccinated individuals [median age 46 (35-58) years, 74.4% females, 45.4% Caucasians] were analyzed. Of these, 1390 (15.9%) had IIMs, 50.6% other SAIDs, and 33.5% HCs. Among IIMs, 16.3% and 10.2% patients reported minor and major AEs, respectively, and 0.72% (n = 10) required hospitalization. Notably patients with IIMs experienced fewer minor AEs than other SAIDs, though rashes were expectedly more than HCs [OR 4.0; 95% CI 2.2-7.0, p < 0.001]. IIM patients with active disease, overlap myositis, autoimmune comorbidities, and ChadOx1 nCOV-19 (Oxford/AstraZeneca) recipients reported AEs more often, while those with inclusion body myositis, and BNT162b2 (Pfizer) recipients reported fewer AEs. Vaccination is reassuringly safe in individuals with IIMs, with AEs, hospitalizations comparable to SAIDs, and largely limited to those with autoimmune multimorbidity and active disease. These observations may inform guidelines to identify high-risk patients warranting close monitoring in the post-vaccination period., (© 2023. The Author(s).)

Background: Sarcopenia is a common condition that can occur in people with chronic inflammatory diseases, including rheumatoid arthritis (RA). The aim of this study was to determine the prevalence and factors associated with this condition in patients with RA., Methods: This prospective cross-sectional study was conducted on 182 adult patients with RA. They were diagnosed with sarcopenia using the Asian Working Group's 2019 update on sarcopenia diagnosis. The body composition was estimated using a body impedance analyzer. Physical performance and muscle strength were evaluated with six-meter walk test and hand grip dynamometer, respectively. The Disease Activity Score (DAS) 28 and the Health Assessment Questionnaire (HAQ) were used to assess disease activity and functional status, respectively., Results: The majority (87.4%) were female with a mean age (SD) of 59.2 (10.2) years. They had been suffering from RA for a long time (median disease duration [Interquartile range (IQR)] 11 [6-16] years) and had mildly active disease [mean DAS28 (SD) 2.61 (0.83)] with slightly functional disability [median HAQ (IQR) 0.34 (0-0.65)]. Of these, 26.4% had sarcopenia. Advanced age [relative risk (RR) 1.07 (95% confidence interval (CI) 1.02-1.11), p = 0.002], low body mass index (BMI) [RR (95% CI) 0.81 (0.72-0.90), p < 0.001], high disease activity [RR (95% CI) 1.64 (1.22-2.12), p = 0.045], and depression [RR (95% CI) 1.18 (1.01-1.37), p = 0.04] were independently associated with sarcopenia., Conclusions: Sarcopenia was found to be common in Thai RA, and its independent risk factors are age, disease activity, BMI, and depression. Well-controlled disease activity may be beneficial for preventing or minimizing sarcopenia and improving patient outcomes., Competing Interests: The authors declare no conflict of interest., (© 2023 The Author(s). Published by Discovery Medicine.)

Background: New biologic disease-modifying antirheumatic drugs (bDMARDs), targeted synthetic DMARDs (tsDMARDs) and biosimilar DMARDs (bsDMARDs) all showed greater clinical benefits in the treatment of patients with rheumatoid arthritis (RA) with high disease activity, but imposed higher costs than standard treatment. This study evaluated the cost-effectiveness of 11 alternative treatment strategies for RA patients with high disease activity whose treatment with three conventional synthetic DMARDs (csDMARDs) failed., Methods: A Markov model was constructed using a societal perspective to estimate relevant costs and health outcomes in terms of quality-adjusted life years (QALYs) for a lifetime horizon (100 years), given a 3% annual discount. Alternative treatment strategies including five bDMARDs, two tsDMARDs, and four bsDMARDs in combination with methotrexate (MTX) were compared with the standard of care (SoC), i.e., cyclosporine and azathioprine. Direct and non-medical care costs were estimated by identifying the resources used, then multiplied by the standard costing menu in the year 2022. Utility and transitional probabilities were collected in three advanced tertiary hospitals. A network meta-analysis was used to estimate the efficacy of each treatment. Lifetime cost, QALYs and an incremental cost-effectiveness ratio were calculated and compared to the cost-effectiveness threshold of 160,000 THB per QALY gained (US $4,634, where 1 USD = 34.53 THB in 2022). Probabilistic and one-way sensitivity analyses were performed to estimate parameter uncertainties., Results: The bDMARDs, tsDMARDs or bsDMARDs combined with MTX provided 0.09 to 0.33 QALYs gained with additional costs of 550,986 to 2,096,744 THB (US $15,957 to $60,722) compared to the SoC. The ICER ranged from 2.3 to 8.1 million THB per QALY (US $65,935 to $234,996) compared to the SoC. None of these combinations was cost-effective in the Thai context. The results were sensitive to the mortality hazard ratio of patients with high disease activity., Conclusions: Combinations of MTX with either bDMARDs, tsDMARDs or bsDMARDs were not economically attractive compared to the standard practice. However, they reduced disease activity and improved patient quality of life. The price negotiation process for these treatments must be conducted to ensure their financial value and affordability before they are included in the pharmaceutical reimbursement list., (© 2023. The Author(s).)

Background: Rituximab (RTX), anti-CD 20 monoclonal antibodies, has been approved for many rheumatic and autoimmune diseases, the use of RTX is still limited due to financial constrain. Biosimilar RTX may increase access by offering patients a more affordable option, lead to improved patient outcomes. However, real-world data related to its immediate and short-term safety is scarce. This study aimed to evaluate the real-world immediate and short-term safety profiles of CT-P10, a biosimilar of Rituximab, in patients with rheumatic and autoimmune diseases., Methods: This prospective study included patients diagnosed with rheumatic or autoimmune diseases, aged ≥ 18 years, who were treated with biosimilar RTX at Siriraj or Ramathibodi Hospital during February 2019 to May 2019. Patients were followed up through 6 months after the infusions., Results: Of the 74 patients, with 124 infusions, 84% were females with mean age (SD) of 49.4 (15.7) years. The most common rheumatic and autoimmune disease included in this study was systemic lupus erythematosus (26%). All immediate adverse events (AEs) (15 out of 124 infusions) were mild requiring only symptomatic and supportive treatment. Short-term AEs included infection (N = 35), hematologic abnormalities (N = 33), chylous ascites (N = 1), and others (N = 10). Two deaths were related to serious bacterial and viral infection. Hematologic AEs comprised anemia (N = 5), neutropenia (N = 10), lymphopenia (N = 15), and thrombocytopenia (N = 3)., Conclusion: In this real-world study, biosimilar RTX (CT-P10) has favorable immediate and short-term safety profiles. However, further studies with large sample size and long-term follow-up in real-world practice are still required to confirm the result., (© 2022. The Author(s).)

To investigate the risk factors, clinical characteristics, management, and outcomes of musculoskeletal fungal infection in Thai patients, patients aged ≥18 years definitively diagnosed with musculoskeletal fungal infection by culture and/or histopathology at Siriraj Hospital (Bangkok, Thailand) during 2002-2020 were retrospectively enrolled. Twenty-eight patients (median age: 58.5 years [range: 22-81], 57.1% male) with fungal osteomyelitis (n = 22), septic arthritis (n = 1), or fungal osteomyelitis with septic arthritis (n = 5) were included. Immunocompromised status was common (82%). Most patients had de novo infection from hematogenous spreading that usually presented at a single, non-contiguous site. The median symptom duration prior to diagnosis was 2 months. The tibia and knee were the most common site of osteomyelitis (30%) and septic arthritis (72%), respectively. The most common pathogens were Talaromyces marneffei and Cryptococcus neoformans. Organism identification from tissues at the affected sites was required in all cases. Most patients (82%) required combination surgery and systemic antifungal therapy. Among those with complete follow-up (23/28), 61% and 39% had complete and partial responses, respectively. Musculoskeletal fungal infection is an uncommon disease with insidious onset and non-specific manifestations that requires pathogen identification via tissue cultures and histopathologic studies. Combination surgery and systemic antifungal therapy yielded generally favorable outcomes.

Background: Clinical remission is an attainable goal for Rheumatoid Arthritis (RA). However, data on RA remission rates from multinational studies in the Asia-Pacific region are limited. We conducted a cross-sectional multicentric study to evaluate the clinical remission status and the related factors in RA patients in the Asia-Pacific region., Methods: RA patients receiving standard care were enrolled consecutively from 17 sites in 11 countries from APLAR RA SIG group. Data were collected on-site by rheumatologists with a standardized case-report form. Remission was analyzed by different definitions including disease activity score using 28 joints (DAS28) based on ESR and CRP, clinical disease activity index (CDAI), simplified disease activity index (SDAI), Boolean remission definition, and clinical deep remission (CliDR). Logistic regression was used to determine related factors of remission., Findings: A total of 2010 RA patients was included in the study, the overall remission rates were 62•3% (DAS28-CRP), 35•5% (DAS28-ESR), 30•8% (CDAI), 26•5% (SDAI), 24•7% (Boolean), and 17•1% (CliDR), respectively, and varied from countries to countries in the Asia-Pacific region. Biological and targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs) prescription rate was low (17•9%). Compared to patients in non-remission, patients in remission had higher rates of b/tsDMARDs usage and lower rates of GC usage. The favorable related factors were male sex, younger age, fewer comorbidities, fewer extra-articular manifestations (EAM), and use of b/tsDMARDs, while treatment with GC was negatively related to remission., Interpretation: Remission rates were low and varied in the Asia-Pacific region. Treatment with b/tsDMARDs and less GC usage were related to higher remission rate. There is an unmet need for RA remission in the Asia-Pacific region., Competing Interests: ML reports speaker fees from Abbvie and Johnson & Johnson, conference sponsorship from Johnson & Johnson, Pfizer, and Sanofi, and has provided advisory services for Gilead, Eli Lilly. KF has received grants or contracts from Chugai, Bristol Myers, Abbvie, Otsuka Pharmaceutical, Eli Lilly, Pfizer, Tsumura, Asahi Kasei, Mitsubishi Tanabe, Esai, Japan Blood Products Organization, Novartis, Sanofi, and Astellas, reports payments or honoraria from Astellas, Abbvie, Amgen, Ayumi, MSD, Esai, Ono, Gilead, Kowa, Sanofi, Japan Blood Products Organization, Novartis, Pfizer, Bristol Myers, Mylan EPD, Janssen, Asahi Kasei, Daiichi Sankyo, Chugai, Mitsubishi Tanabe, Eli Lilly, and Boehringer Ingelheim and has participated in the Data Safety Monitoring Board or Advisory Board for Asahi Kasei, Astellas, Abbvie, Amgen, Ono, Gilead, Chugai, Eli Lilly, Bristol Myers, and Mylan EPD. PC reports honoraria from Novartis and Johnson and Johnson, is a member of the advisory board for Johnson & Johnson, and reports samples of Amgevita, Baricitinib, and Ixekizumab. All other authors declare no competing interests., (© 2021 The Authors. Published by Elsevier Ltd.)