Cost-utility analysis of biologic disease-modifying antirheumatic drugs (bDMARDs), targeted synthetic DMARDs (tsDMARDs) and biosimilar DMARDs (bsDMARDs) combined with methotrexate for Thai rheumatoid arthritis patients with high disease activity.

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.

Efficacy and Safety of Hepatitis B Vaccination in Rheumatoid Arthritis Patients Receiving Disease-Modifying Antirheumatic Drugs and/or Biologics Therapy.

OBJECTIVES: The aims of this study were to assess efficacy and safety of the hepatitis B vaccination in rheumatoid arthritis (RA) patients receiving conventional and/or biological disease-modifying antirheumatic drugs (DMARDs). METHODS: A longitudinal open-label study was conducted. Of 46 RA patients, 33 received only conventional synthetic DMARDs, and 13 received both conventional synthetic DMARDs and biological DMARDs, and 9 healthy age- and sex-matched control subjects were vaccinated with 20 µg recombinant hepatitis B vaccine (EuVax B) at weeks 0, 4, and 24. Hepatitis B surface antibody levels were measured 8 weeks after the last dose of vaccination. Seroprotection was defined as hepatitis B surface antibody level of 10 mIU/mL or greater. Disease Activity Score in 28 Joints scores were recorded at weeks 0, 4, and 32 in 46 RA patients who received hepatitis B vaccination and 47 treatment-matched RA patients who did not receive it. Adverse events were recorded at each visit.Statistical analyses were performed using SPSS version 16.0. RESULTS: Seroprotection was lower in the RA patients than in the control subjects (64% vs. 100%, p = 0.045). Patients receiving biological DMARDs and conventional DMARDs had a lower proportion of seroprotection compared with the control group (50% vs. 100% [p = 0.02] and 69.7% vs. 100% [p = 0.09], respectively). Among RA patients, responders were younger than nonresponders with a mean age of 57.5 (SD, 9.0) years and 64.9 (SD, 10.9) years (p = 0.04) and less likely to be treated with rituximab (6.9% vs. 37.5%, p = 0.01). Overall, hepatitis B vaccination was well tolerated. The rate of RA flare was not increased after hepatitis B vaccination. CONCLUSIONS: Patients with RA receiving DMARDs had less humoral response to hepatitis B vaccination as compared with control subjects. Aging and rituximab use were associated with impaired response to hepatitis B vaccination. Hepatitis B vaccination is safe and well tolerated in RA patients.

Effectiveness and Drug Survival of Anti-Tumor Necrosis Factor α Therapies in Patients With Spondyloarthritis: Analysis From the Thai Rheumatic Disease Prior Authorization Registry.

OBJECTIVE: This study aimed to evaluate the long-term effectiveness and safety of the first anti-tumor necrosis factor α therapy (TNFi) and to identify the associated factors of drug discontinuation in patients with spondyloarthritis. METHODS: This was a medical records review study. Patients with spondyloarthritis who were prescribed the first TNFi between December 2009 and October 2014 in the Rheumatic Disease Prior Authorization registry were enrolled. Baseline clinical data were retrieved. The Cox proportional hazards model was used to identify factors associated with discontinuation of drugs. RESULTS: Among 138 patients, 97 had ankylosing spondylitis (AS), and 41 had psoriatic arthritis (PsA). The effectiveness of TNFi in AS and PsA was 55% to 59% at 4 months and 75% to 96% at 3 years, as measured by a 50% decrease in the Bath Ankylosing Spondylitis Disease Activity Index from baseline. For PsA with peripheral arthritis, improvement of the joint count by 50% was observed in 61.8% of patients at 4 months and 100% at 3 years. Survival from TNFi was 63% for AS and 56% for PsA at 3 years. For AS, the factors associated with good response leading to discontinuation of TNFi were baseline patient global assessment 3 to 6/10 (hazard ratio [HR], 6.3) and the use of leflunomide (HR, 6.0) and infliximab (HR, 4.8). A good response (38.5%) was the most common cause of discontinuation of the first TNFi, followed by toxicity (28.2%), nonadherence (20.5%), and lack of effectiveness (12.8%). CONCLUSIONS: Ankylosing spondylitis and PsA responded well to TNFi during the 3-year follow-up. The retention rate was approximately 60% for AS and PsA. A good response to the first TNFi was the most common reason for discontinuation.

Lupus Damage and Waist Circumference as the Independent Risk Factors for Cardiovascular Disease in SLE Patients from Phramongkutklao Hospital.

BACKGROUND: Cardiovascular disease (CVD) has been reported to be a major cause of both morbidity and premature mortality in systemic lupus erythematosus (SLE) patients. OBJECTIVE: To determine the prevalence of cardiovascular disease and associated risk factors in Thai SLE patients from Phramongkutklao Hospital, Thailand. MATERIAL AND METHOD: A retrospective cross-sectional study was performed to investigate the frequency of CVD in SLE patients in Phramongkutklao Hospital on the basis of medical record documentation. CVD was defined as coronary heart disease, congestive heart failure, cerebrovascular disease (stroke), transient ischemic attack, and peripheral arterial disease (PAD). The associated risk factors of CVD were examined by univariate and multivariate logistic regression analyses. RESULTS: One hundred fifty nine SLE patients were enrolled in the present study. Nine female and one male SLE patients had CVD (prevalence 6.3%). SLE patients with CVD had higher Systemic Lupus International Collaborating Clinics Damage Index (SDI) score (p-value = 0.025) and received higher average dose of corticosteroid (p-value = 0.034) than SLE patients without CVD. Patients with CVD were more likely to present with malar rash (p-value = 0.054), discoid rash (p-value = 0.047), and more likely to used cyclophosphamide (p-value = 0.045) than patients without CVD. SLE patients with CVD were more likely to have diabetes mellitus (p-value = 0.037), antiphospholipid syndrome (p-value = 0.055), and had higher proportion of patients whose waist circumference more than 90 centimeters in male or more than 80 centimeters in female (p-value = 0.06) than SLE patients without CVD. The presence of antiphospholipid antibodies was higher in SLE patients with CVD than SLE patients without CVD (p-value = 0.076). The multivariate regression analysis identified that SDI score (odds ratio (OR) = 1.74 with 95% confidence interval (CI) 1.12-2.69, p-value = 0.013), and waist circumference more than 90 centimeters in male or more than 80 centimeters in female (OR = 6.9 with 95% CI 1.20-38.46, p-value = 0.031) were independently associated risk factors for the occurrence of CVD in SLE patients. The presence of antiphospholipid antibodies also had a trend toward increased risk of CVD in SLE patients (OR = 4.1 with 95% CI 0.96-17.8, p-value = 0.057). CONCLUSION: Lupus damage, waist circumference more than 90 centimeters in male or more than 80 centimeters in female were the independent risk factors for CVD in SLE patients.

Reliability and validity of the Thai version of bath ankylosing spondylitis indices.

OBJECTIVE: Translate the Thai version of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and Bath Ankylosing Spondylitis Global Score (BASG), and assess their validity in Thai patients with ankylosing spondylitis (AS). MATERIAL AND METHOD: The original BASDAI, BASFI, and BASG were translated to Thai language and re-translated back by professional translators. The translated questionnaires were subsequently modified by a panel of rheumatologists and small group of AS patients to suit the Thai culture. To assess the validity, scores from these instruments were validated against clinical signs and symptoms and inflammatory indices including arthritis and fatigue symptoms, occiput to wall distance, chest expansion, Schober's test, finger to ground distance, erythrocyte sedimentation rate, and C-reactive protein. Reliability was tested by internal consistency. RESULTS: Thirty-eight patients were included in the present study. The BASDAI, BASFI, and BASG showed a significant correlation with arthritis and fatigue symptoms, finger to ground distance, erythrocyte sedimentation rate, and C-reactive protein. Internal consistency (Cronbach's alpha) of BASDAI, BASFI, and BASG were 0.867, 0.915, and 0.315 respectively. CONCLUSION: Thai version BASDAI, BASFI, and BAS-G showed good validity in patients with AS. There was a good internal consistency for BASDAI and BASFI. These questionnaires are feasible for application in clinical practice on Thai AS patients.

Current daily glucocorticoid use and serum creatinine levels are associated with lower 25(OH) vitamin D levels in Thai patients with systemic lupus erythematosus.

BACKGROUND AND OBJECTIVE: Because vitamin D deficiency has been previously reported in patients with systemic lupus erythematosus (SLE), we decided to examine the prevalence of vitamin D deficiency in Thai SLE patients, to identify possible independent factors affecting serum 25-hydroxyvitamin D(2) and D(3) [25(OH)] vitamin D levels, and to examine the associations of serum 25(OH) vitamin D and disease activity and damage in Thai SLE patients. METHODS: A cross-sectional study was performed in 101 SLE patients. Blood samples were prospectively collected. The levels of 25(OH) vitamin D were measured by radioimmunoassay. The cutoffs for vitamin D deficiency and insufficiency were 30 and 20 ng/mL, respectively. Demographic, clinical, and laboratory data were collected, and their associations with 25(OH) vitamin D level were examined by univariate and multivariate linear regression analyses. RESULTS: The level of 25(OH) vitamin D (mean [SD]) was 27.9 (7.6). Seventeen patients (17%) had vitamin D deficiency, 41 patients (41%) had vitamin D insufficiency, and 43 patients (42%) had normal vitamin D levels. Two thirds of the patients were taking relatively low-dose vitamin D supplementations. Current daily glucocorticoid dose and serum creatinine levels were negatively correlated with vitamin D levels (ß = -0.207, P = 0.023; and ß = -3.770, P = 0.003, respectively). There were no associations between disease activity or damage and 25(OH) vitamin D levels. CONCLUSIONS: Vitamin D deficiency and insufficiency are common in SLE patients despite more than half of them taking vitamin D supplementations. Higher serum creatinine level and higher current daily glucocorticoid dose are associated with lower serum 25(OH) vitamin D levels. These patients may require higher doses of vitamin D supplementations.

Performance of systemic lupus erythematosus responder index for detecting clinician-rated responders in patients with active systemic lupus erythematosus.

OBJECTIVE: Disease activity measures in systemic lupus erythematosus (SLE) are critical tools for trial endpoints. We aimed to evaluate the performance of current treatment outcome measures in SLE. METHODS: Individuals with active SLE with a clinical SLE Disease Activity Index-2000 (SLEDAI-2K) score of at least 4 were followed up for two or more visits and classified as responders and non-responders based on a physician's judgment of improvement. The treatment outcome measures including SLEDAI-2K responder index-50 (SRI-50), SLE responder index-4 (SRI-4), substituting SLEDAI-2K with SRI-50 in SRI-4 (SRI-4(50)), SLE Disease Activity Score (SLE-DAS) responder index (Δ ≥ 1.72) and the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) were tested. The performance of those measures was shown by sensitivity, specificity, predictive value, positive likelihood ratio, accuracy, and agreement against a physician-rated improvement. RESULTS: Twenty-seven patients with active SLE were followed. The total cumulative pair of visits (baseline and follow up) was 48. The overall accuracies (95% confidence interval [CI]) of SRI-50, SRI-4, SRI-4(50), SLE-DAS, and BICLA for detecting responders in all patients were 72.9 (58.2-84.7), 75.0 (60.4-86.4), 72.9 (58.2-84.7), 75.0 (60.4-86.4), and 64.6 (49.5-77.8), respectively. Subgroup analyses of lupus nephritis (23 patients had a pair of visits) found the accuracies (95% CI) of SRI-50, SRI-4, SRI-4(50), SLE-DAS, and BICLA were 82.6 (61.2-95.0), 73.9 (51.6-89.8), 82.6 (61.2-95.0), 82.6 (61.2-95.0), and 78.3 (56.3-92.5), respectively. However, there were no significant differences between the groups (P > 0.05). CONCLUSION: SRI-4, SRI-50, SRI-4(50), SLE-DAS responder index, and BICLA demonstrated comparable abilities to identify clinician-rated responders in patients with active SLE and lupus nephritis.

Risk Factors for Sarcopenia in Thai Patients with Rheumatoid Arthritis.

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.

The effect of systemic lupus erythematosus (SLE) Disease Activity Score and SLE Disease Activity Index 2000-based remission states in patients with SLE on damage accrual.

BACKGROUND/OBJECTIVE: This study aimed to compare the effect of the Systemic Lupus Erythematosus Disease Activity Score (SLE-DAS) with the SLE Disease Activity Index 2000 (SLEDAI-2K) remission state on damage accrual. METHODS: This study classified SLE patients from the Lupus Clinic of the Royal Thai Army (LUCRA) cohort based on the SLE-DAS index, or Boolean-based, and SLEDAI-2K (Doria) remission state. Regression analysis models were constructed to identify predictors of the Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI) during follow-up. RESULTS: There were 197 patients identified; 97 patients met at least one definition of remission state, and 100 patients were in the non-remission group at enrollment. Of 97 patients, 97 achieved the SLE-DAS index-based definition, 74 achieved the SLE-DAS Boolean-based definition, and 55 achieved the Doria definition. The mean ± SD of follow-up was 4.77 ± 0.6 years. The changes in SDI over time were non-significantly lower in patients who met any definition of remission compared with those who did not. Multivariate analysis revealed that predictive factors for increased SDI were age and baseline SDI ≥ 1. SLE-DAS index, Boolean, and Doria-based definitions of remission at enrollment had no significant risk reduction on SDI compared with the non-remission group (HR 0.7, 95% CI 0.37-1.32, p = .27; HR 0.73, 95% CI 0.37-1.44, p = .37; HR 0.8, 95% CI 0.39-1.65, p = .55, respectively). CONCLUSIONS: Patients with SLE who achieved remission status according to the SLE-DAS index or SLEDAI-2K definitions did not show any significant difference in damage accrual compared to those who were not in remission.

Glucocorticoid Withdrawal Symptoms and Quality of Life in Patients with Systemic Lupus Erythematosus.

Methods: SLE patients whose prednisolone had been previously withdrawn or taken <5 mg/day were enrolled. Serum morning cortisol levels were collected after 72-hour GCS discontinuation, and low-dose ACTH stimulation test (LDST) was performed. Patient report outcomes (PROs) included SLE-specific quality of life questionnaire (SLEQoL), functional assessment of chronic illness therapy (FACIT), patient health questionnaire (PHQ-9), and Pittsburgh's sleep quality index (PSQI). Results: Serum morning cortisol of 100 SLE patients was tested. Most patients were female (88%). Seventy-four patients showed remission. The mean ± SD of prednisolone was 0.73 ± 1.08 mg/day. Total SLEQoL and FACIT (mean ± SD) of all patients were 67.05 ± 26.15 and 13.7 ± 8.87, respectively. Eighteen percent of patients had moderate-severe depressive symptoms, and 49% were poor sleepers. Adrenal function was determined by LDST in only 39 patients; 5 patients (12.8%) were adrenal insufficiency (AI), and 34 patients were normal adrenal function. Compared to normal adrenal function patients, SLE patients with AI had higher proportion of moderate-severe depressive symptom (PHQ - 9 > 9), but not statistically significant (40% vs. 20.6%, p = 0.34). PROs were comparable between groups. Independent factors associated with SLEQoL were FACIT (adjusted ß 1.31, 95% CI 0.76, 1.86, p < 0.001), PHQ-9 (adjusted ß 5.21, 95% CI 4.32, 6.09, p < 0.001), and PSQI (adjusted ß 4.23, 95% CI 3.01, 5.45, p < 0.001), but not with AI (adjusted ß -5.2, 95% CI -33.26, 22.93, 0.71, p = 0.71). Conclusion: SLE patients with previous GCS exposure could experience AI and withdrawal symptoms such as sleep disturbance and depression during discontinuation of low-dose GCS. Fatigue, depression, and poor sleeper were significantly associated with poor SLEQoL.

Prevalence of low trabecular bone score and its association with disease severity and activity in patients with axial spondyloarthritis.

Axial spondyloarthritis (axSpA) increases the risk of osteoporosis and vertebral fractures. Bone mineral density (BMD) measured by dual X-ray absorptiometry (DXA) has limitations in axSpA patients. Trabecular bone score (TBS) indirectly assesses bone microarchitecture and can be used to predict fracture risk. However, few studies have investigated the role of TBS in axSpA patients. The objective of this study were to compare TBS between axSpA patients and 1:1 sex- and age-matched healthy volunteers and determine factors associated with low TBS in axSpA patients. A cross-sectional study was conducted in two tertiary-care hospitals. A total of 137 axSpA patients and healthy volunteers were enrolled. Demographics, disease characteristics, and risk factors for osteoporosis were recorded. TBS, BMD at the lumbar spine, hip, and vertebral fractures were assessed by DXA. Low TBS was defined as a TBS value < 1.230. Factors associated with low TBS were examined by logistic regression. Most patients were male (75.9%) and tested positive for HLA-B27 (88.3%). The mean (SD) age was 42.8 (12.0) years. The mean (SD) of TBS in the axSpA patients was lower than those in the healthy volunteers [1.402 (0.107) vs 1.440 (0.086), respectively; p = 0.002]. The mean (SD) of lumbar BMD in the axSpA patients was higher than in healthy volunteers [1.186 (0.212) vs 1.087 (0.124), p < 0.001], whereas the mean (SD) of femoral neck BMD in the axSpA group was lower than that in the healthy volunteers [0.867 (0.136) vs 0.904 (0.155), p = 0.038]. Disease severity as indicated by sacroiliac joint fusion and a high ASDAS score were associated with low TBS with the odds ratios (95% confidence interval) of 11.8 (1.2-115.4) and 5.2 (1.6-16.9), respectively. In conclusion, axSpA patients had a higher prevalence of low TBS than healthy volunteers. Sacroiliac joint fusion and a high ASDAS score were associated with low TBS.

Validation of diagnostic codes for subtrochanteric, diaphyseal, and atypical femoral fractures using administrative claims data.

Administrative claims databases have large samples and high generalizability. They have been used to evaluate associations of atypical femoral fractures with bisphosphonates. We developed and assessed accuracy of claims-based algorithms with hospital and physician diagnosis codes for these fractures. Medical records and radiology reports of all adults admitted at University of Alabama at Birmingham Health System from 2004 to 2008 with International Classification of Diseases, Ninth Revision hospital discharges and surgeons' fracture repair codes for subtrochanteric femoral fractures and random sample of other femoral fractures were reviewed. We identified 137 persons with suspected subtrochanteric femoral fractures and randomly selected 50 persons with either suspected diaphyseal femoral fractures or hip fractures other than subtrochanteric and diaphyseal femoral fractures (typical hip fractures). Eleven patients had radiographic features indicative of atypical femoral fractures. The positive predictive value (PPV) of claims-based algorithms varied with primary or secondary positions on discharge diagnoses and the sources of diagnosis codes. The PPV for fractures ranged 69-89% for subtrochanteric femoral, 89-98% for diaphyseal femoral, and 85-98% for typical hip fractures. The PPV of administrative codes for defining a femoral fracture as atypical was low and imprecise. Claims-based algorithms combining hospital discharges with surgeon's diagnosis codes had high PPV to identify the site of subtrochanteric or diaphyseal femoral fractures vs typical hip fractures. However, claims-based data were not accurate in identifying atypical femoral fractures. These claims algorithms will be useful in future population-based observational studies to evaluate associations between osteoporosis medications and subtrochanteric and diaphyseal femoral fractures.

Predictors of flare in rheumatoid arthritis patients with persistent clinical remission/low disease activity: Data from the TARAC cohort.

To identify predictors of rheumatoid arthritis (RA) disease activity flare in RA patients who achieved low disease activity (LDA) or persistent remission from the observational Thai Army Rheumatoid Arthritis Cohort study. RA patients with persistent clinical remission, defined by disease activity score 28 (DAS28) < 2.6 and LDA defined by DAS28 ≤ 3.2 for 3 consecutive months, were recruited and followed-up for at least 2 years. The flare was defined by an escalation of DAS28 ≥ 1.2 plus their physicians' decision to enhance RA treatment. Differences between sustained remission/LDA and flare groups were analyzed, by Chi-square test and unpaired Student t test. Multivariate Cox proportional hazard regression analysis was conducted to determine flare predictors. From 199 RA patients, female were 82.9%. Anticitrullinated peptide antibodies (ACPA) or Rheumatoid factor (RF) were found in 69.8% of patients. Flares occurred in 69 patients (34.9%). Multivariate analysis found that the timescale from symptoms emergence to DMARD commencement, the timescale from DMARD commencement to when RA patients showed remission/LDA, the occurrence of RF or ACPA, LDA (in contrast to remission) and the increased DAS28 score when remission/LDA was achieved and tapering DMARDs promptly when persistent remission/LDA was achieved were predictors of RA flares with hazard ratios of (95% confidence interval [CI]) of 1.017 (1.003-1.030), 1.037 (1.015-1.059), 1.949 (1.035-3.676), 1.926 (0.811-4.566), 2.589 (1.355-4.947), and 2.497 (1.458-4.276), respectively. These data demonstrated that early and aggressive DMARDs treatment approach could maintain remission espcially in seropositive patients. Tapering should be applied minimally 6 months after reaching remission.

Effect of Curcumin on Serum Urate in Asymptomatic Hyperuricemia: A Randomized Placebo-Controlled Trial.

BACKGROUND/OBJECTIVE: Hyperuricemia leads to gout and renal complications and may increase cardiovascular risk. Curcumin inhibits xanthine oxidase and increases uricosuric activity and, as a result, decreases serum urate (SU). This randomized controlled trial aimed to determine the effects of curcumin versus placebo on SU in subjects with asymptomatic hyperuricemia (SU level ≥ 6 mg/dL in women or ≥ 7 mg/dL in men). METHODS: Thirty-nine subjects with persistent hyperuricemia were randomized to receive curcumin (500-mg capsules twice daily, 20 subjects) or placebo (19 subjects). Primary outcome was the difference between SU before and 8 weeks after randomization. Secondary outcomes were differences between urine uric acid (UUA) clearance, fasting plasma glucose (FPG), and lipid profiles before and 8 weeks after randomization and adverse events. RESULTS: Out of 39 subjects, there were no differences at baseline SU, UUA clearance, FPG, lipid profiles, and demographics between curcumin and placebo groups. After 8 weeks, SU was significantly decreased in both groups (6.9% in curcumin group, p = 0.002, and 5.0% in placebo group, p = 0.009). However, there was no difference in SU reduction between the two groups (p = 0.532). There were no differences in UUA, FPG, lipid profiles, or adverse events in either group at 8 weeks after randomization. The most common adverse event was diarrhea with no treatment required. CONCLUSION: Curcumin was not superior to placebo in reducing serum urate and in increasing UUA clearance.

Rate and causes of noncompliance with disease-modifying antirheumatic drug regimens in patients with rheumatoid arthritis.

INTRODUCTION/OBJECTIVES: To determine the prevalence and factors associated with medication noncompliance by Thai patients with rheumatoid arthritis (RA). METHODS: This prospective cohort study enrolled 443 adult RA patients (≥ 18 years) who were followed up at the outpatient rheumatology clinics of Siriraj Hospital and Phramongkutklao Hospital between May 2018 and December 2019. Medication noncompliance was assessed using the Compliance Questionnaire for Rheumatology-19 (CQR-19). A score of 0 indicated complete noncompliance, whereas a score of 100 indicated a perfect compliance. An unsatisfactory compliance was arbitrarily defined as a taking compliance of ≤ 80%. RESULTS: The prevalence of medication noncompliance was 22.1%. The most common cause was forgetting to take medications due to a busy work schedule. In a univariate analysis, the factors that were significantly related to medication noncompliance were age, income, number of comorbidities, functional status as measured by the Health Assessment Questionnaire (HAQ), number of prescribed pills per day, and number of types of prescribed medications per day. In a subsequent backward stepwise multiple logistic regression analysis, only 2 factors were found to be negatively associated with medication noncompliance: age (risk ratio, 0.98; 95% CI, 0.96-0.99; p, 0.048) and HAQ (risk ratio, 0.62; 95% CI, 0.39-0.98; p, 0.041). CONCLUSIONS: Medication noncompliance is common in patients with RA. As this may lead to unfavorable outcomes, patient education related to drug compliance should be addressed and emphasized in daily practice. Key Points • Medication noncompliance is common in patients with RA. • Forgetting to take pills was the most frequent explanation offered for noncompliance. • All patients should be strongly encouraged to comply with the recommended drug regimens.

Clinical remission of rheumatoid arthritis in a multicenter real-world study in Asia-Pacific region.

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.

Health-related quality of life and disease severity of SLE patients in Phramongkutklao Hospital.

BACKGROUND: The studies of association of disease activity and damage with health-related quality of life (HRQOL) in lupus have shown equivocal results and has not been studied in Thailand. OBJECTIVE: To examine the HRQOL and to examine the association between HRQOL and SLE disease severity (disease activity and damage) in Thai SLE patients. MATERIAL AND METHOD: The Short Form-36 (SF-36) was applied in 95 consecutive SLE patients. At the time of HRQOL assessment, all patients were evaluated for disease severity [disease activity as measured by Mexican Systemic Lupus Erythematosus Disease Activity Index (Mex-SLEDAI) and damage as measured by the Systemic Lupus International Collaborating Clinic/American College of Rheumatology (SLICC/ACR) damage index (SDI)]. The association between physical (PCS) and mental component summary (MCS) of the SF-36 and disease severity were examined by Pearson's correlation. RESULTS: Ninety-five SLE patients (93 females and 2 males) were included (mean age 39.84 +/- 10.91). The mean disease duration was 115 +/- 83 months. The mean scores of MCS and PCS were 45.5 +/- 9.5 and 41.1 +/- 9.3, respectively. The higher SDI scores were correlated with lower PCS but not the MCS (PCS, r = -0.411, p < 0.001). There was no correlation between HRQOL (both MCS and PCS) and disease activity. CONCLUSION: PCS of the SF-36 was inversely correlated with damage index in Thai SLE patients.

Clinical manifestations, clinical course, and outcomes of immunoglobulin G4-related disease.

BACKGROUND: Immunoglobulin G4-related disease (IgG4-RD) is an uncommon chronic systemic autoimmune disease, pathologically characterized by lymphoplasma cell and IgG4 plasma cell infiltration with storiform fibrosis. IgG4-RD is a new disease and is not yet widely recognized. The aim of this study was to describe the clinical manifestations and outcomes in Thai patients with IgG4-RD. METHODS: This multicenter retrospective cohort study included patients aged ≥ 18 years who were diagnosed with IgG4-RD, according to the 2011 comprehensive or consensus diagnostic criteria, between 2000 and 2019 in four academic centers in Thailand. Baseline characteristics, laboratory and pathologic findings, treatments, and outcomes were systematically reviewed. RESULTS: The study included 110 patients (71% male) with a mean age (SD) of 59.6 (13.3) years and median disease duration (interquartile range [IQR]) of 28.8 (14.6-53.5) months. Single organ involvement was observed in 60 patients (54.5%). Most patients (96%) had an IgG4 level of more than 135 mg/dL at presentation. Also, most (92%) were treated with corticosteroid (CS) alone or in combination with immunosuppressive agents. The most commonly used immunosuppressive agents were azathioprine (47%) and methotrexate (11%). Additionally, 20% required surgery, and 6.4% underwent stent insertion. One-quarter (26%), 37%, and 29% were in remission with successfully tapering CS, complete and partial response. Nevertheless, 22% relapsed, with a median time to relapse (IQR) of 22.2 (12.8-41.1) months. CONCLUSION: IgG4-RD is a chronic systemic autoimmune disease with diverse manifestations, response to treatment, and outcomes. Most patients responded well to treatments but with a notable relapse rate.

Prevalence of and factors associated with depression and anxiety in patients with rheumatoid arthritis: A multicenter prospective cross-sectional study.

AIM: To investigate the prevalence of and factors associated with depression and anxiety in patients with rheumatoid arthritis (RA). METHODS: This prospective cross-sectional study included patients who were consecutively enrolled in the Siriraj Rheumatoid Arthritis Registry or the Thai Army Rheumatoid Arthritis Cohort during the September 2016 to March 2018 study period. Demographic data and clinical variables, including disease activity, functional status, health-related quality of life, and cognitive function, were collected. Depression and anxiety were assessed using the Thai version of the Hospital Anxiety and Depression Scale (Thai HADS). RESULTS: Four hundred and sixty-four patients were included. Mean age was 59 years, median disease duration was 9.9 years, and 85% of patients were female. Based on the Thai HADS cutoff value of 8 or higher, 12.5% and 14.5% of patients had some degree of depression and anxiety, respectively. Multivariate analysis revealed global health score (risk ratio [RR]: 0.98, P = .001) to be the only factor independently negatively associated with depression. Regarding anxiety, functional disability (RR: 2.46, P = .004) and married status (RR: 2.43, P = .009) were significantly associated with increased risk, whereas disease duration of 10 years or more (RR: 0.45, P = .007) and global health score (RR: 0.97, P < .001) were significantly associated with decreased risk of developing anxiety. CONCLUSION: Depression and anxiety are common in patients with RA. Patients' perceptions of their current health are significantly related to mood disorders. Therefore, mental health status, especially mood disturbances, should be addressed in routine practice to improve quality of life in RA.

Factors associated with and cutoff points for Patient Acceptable Symptom State (PASS) in rheumatoid arthritis.

INTRODUCTION/OBJECTIVES: To identify factors associated with and cutoff points for patients' acceptance of symptom state in Thai patients with rheumatoid arthritis (RA). METHOD: Patients aged ≥ 18 years diagnosed with RA who were followed-up at the outpatient rheumatology clinics of Siriraj Hospital and Phramongkutklao Hospital during May 2017 to May 2019 responded to the Patient Acceptable Symptom State (PASS) questionnaire. The PASS questionnaire comprises three questions, including current PASS, future PASS (3 months), and lifelong PASS. Univariate (p < 0.2) and multivariate (p < 0.05) analyses were performed to identify factors significantly associated with PASS. Cutoff points of indices related to disease activity, functional status, and health-related quality of life (HRQoL) in patients with PASS were identified using the 75th percentile and receiver operating characteristic curve analysis based on optimal sensitivity and specificity. RESULTS: From the 443 enrolled patients, 85%, 80%, and 84% considered themselves to be in current, future, and lifelong PASS, respectively. Step-wise backward multivariate analysis revealed disease duration, disease activity, functional status, cardiovascular comorbidities, and HRQoL to be independently associated with PASS. PASS cutoff points were identified, as follows: Disease Activity Score 28, 3.40-3.52; Health Assessment Questionnaire, 0.69-1; Patient Global Assessment of Disease Activity, 2.5-3; Physician Global Assessment of Disease Activity, 1-1.5; and EuroQoL-5 Dimensions, 0.83-0.86. CONCLUSIONS: PASS was high in Thai patients with RA. Patients accepted their disease state at moderate disease activity and mild functional impairment. More shared decision-making and patient education should be incorporated into daily practice to improve patient outcomes.Key Points•Patients with RA accepted their disease state at moderate disease activity and mild functional impairment, while a "treat-to-target" strategy aiming at remission or low disease activity is recommended as a standard goal.•More shared decision-making and patient education should be incorporated into daily practice to improve outcomes.