The efficacy of intra-articular triamcinolone acetonide 10 mg vs. 40 mg in patients with knee osteoarthritis: a non-inferiority, randomized, controlled, double-blind, multicenter study.

BACKGROUND: Intra-articular (IA) corticosteroid injection is recommended in refractory knee osteoarthritis patients. However, 40-mg of triamcinolone IA every 3 months for 2 years reduces cartilage volume as compared to saline IA. OBJECTIVE: To determine the non-inferiority of 10-mg versus 40-mg of triamcinolone acetonide (TA) for treatment of pain in symptomatic knee osteoarthritis at week 12. METHODS: This was a double-blind, randomized, controlled trial conducted in 84 symptomatic knee osteoarthritis patients. The 10-mg or 40-mg of TA were 1:1 randomized and injected to the affected knees. The primary outcome was the 12-week difference from baseline in pain VAS, with a pre-specified lower margin for non-inferiority of 10 mm. The measuring instruments used were: Visual analog scale (VAS: 0-10), modified Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), EuroQol Group 5 Dimensions (EQ5D), Knee Injuries and Osteoarthritis Outcome Score (KOOS) questionnaire, chair standing test and 20-m walking time at baseline, at week 4, and week 12 after randomization. Adverse events were recorded. RESULTS: Baseline characteristics were similar between two groups. The mean differences of pain VAS (95% confidence interval: CI) between the two groups at baseline and week 12 were 0.8 (-0.8, 2.4) with p of 0.002 for non-inferiority. There were no differences in pain reduction and quality of life improvement between 10-mg and 40-mg groups. The mean differences (95%CI) of WOMAC, KOOS pain, EQ5D and KOOS quality of life between baseline and week 12 were 0.4 (-1.1, 1.9). -8.7 (-21.3, 3.9), 1.3(-7.1, 9.6) and 1.8 (-11.5, 15.0), respectively. There were significant improvements in pain and quality of life between baseline and week 12 in both groups. CONCLUSION: The 10 mg of TA is non-inferior to 40 mg TA in improving pain in patients with symptomatic knee OA. Both 10 mg and 40 mg of TA significantly improved pain and quality of life in patients with symptomatic knee OA. TRIAL REGISTRATION: TCTR, I TCTR20210224002. Retrospectively registered 24 February 2021, http://www.thaiclinicaltrials.org/show/TCTR20210224002.

A randomized double-blinded placebo controlled trial of ergocalciferol 40,000 versus 100,000 IU per week for vitamin D inadequacy in institutionalized postmenopausal women.

BACKGROUND: Vitamin D inadequacy is common in institutionalized post-menopausal women who are at the highest risk for osteoporotic fracture. AIM: To evaluate efficacy and safety of ergocalciferol 40,000 versus 100,000 IU per week for 12 weeks for vitamin D inadequacy in institutionalized postmenopausal women. METHOD: A randomized double-blinded placebo-controlled trial was conducted in 94 institutionalized subjects with baseline 25(OH)D levels < 30 ng/mL. Subjects were randomized to receive ergocalciferol 40,000 (standard dose) or ergocalciferol 100,000 IU (high dose) per week. Serum 25(OH)D levels, calcium, phosphate, handgrip strength, time up and go (TUG) test and quality of life by EQ-5D-5L were measured at baseline and 12 weeks after randomization. RESULTS: Of the 94 subjects enrolled, 85 subjects completed the study. Subjects in the high dose group had higher mean 25(OH)D levels than subjects in the standard group (51.73 ± 19.35 and 34.5 ± 9.12, p < 0.001). More subjects in the high dose group (90.9%) achieved optimal 25(OH)D levels (> 30 ng/mL) than those in the standard group (65.9%), p = 0.007. In a subgroup analysis of subjects with vitamin D deficiency (< 20 ng/mL, n = 44) and severe vitamin D deficiency (< 10 ng/mL, n = 9), more subjects in the high dose group achieved optimal 25(OH)D levels than those in the standard group (88% and 100% versus 47.4% and 16.7% with p of 0.007 and 0.018, respectively). There were no differences in handgrip strength, TUG, EQ-5D-5L and adverse events between groups. DISCUSSION/CONCLUSIONS: Subjects who received high dose ergocalciferol achieved more optimal 25(OH)D levels than those who received standard dose. High dose ergocalciferol is preferred to optimize 25(OH)D levels in subjects with severe vitamin D deficiency.

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.

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.

Comparative evaluation of screening tools for sarcopenia in patients with axial spondyloarthritis.

Sarcopenia is linked to chronic inflammation and muscle wasting. This research aims to compare the screening accuracy of tools for sarcopenia in axial spondyloarthritis (axSpA). A cross-sectional study involving 104 axSpA patients was conducted at Phramongkutklao Hospital between January 2020 and February 2021. Sarcopenia was diagnosed according to the AWGS 2019 criteria. Appendicular skeletal muscle mass was measured using DXA. SARC-F, SARC-CalF, and SARC-F+EBM, muscle strength, and physical performance were assessed. The screening tests were evaluated using ROC curves. The optimal cutoffs were identified with the Youden index. Most patients were male (74%), with a mean (SD) age and disease duration of 42.6 (12.22) and 8.3 (8.5), respectively. The prevalence of sarcopenia was 22.1%. The AUCs (95% CI) for calf circumference, SARC-F, SARC-CalF, SARC-F+EBM, handgrip strength, chair stand time, gait speed, and time and go test were 0.830 (0.734, 0.925), 0.509 (0.373-0.645), 0.782 (0.670-0.894), 0.856 (0.758-0.954), 0.710 (0.594-0.825), 0.640 (0.508-0.772), 0.689 (0.539-0.839), and 0.711 (0.576-0.846), respectively. The optimal cutoffs for SARC-F, SARC-CalF, and SARC-F+EBM were 1, 10, and 10, with sensitivity/specificity of 81.0%/29.7%, 90.5%/68.9%, and 77.3%/87.2%, respectively. Calf circumference, SARC-CalF, and SARC-F+EBM had the best performance to screen for sarcopenia in axSpA patients. Lowering the thresholds would potentially enhance the performances of SARC-CalF and SARC-F+EBM.

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.

Age, body mass index, and function as the independent predictors of sarcopenia in axial spondyloarthritis: a cross-sectional analysis.

BACKGROUND/OBJECTIVE: Sarcopenia is characterized by a decline in muscle strength, muscle mass, and physical performance. Persistent inflammation may lead to muscle wasting. This research aims to determine the prevalence and associated factors of sarcopenia in axial spondyloarthritis (ax-SpA). METHOD: A cross-sectional study of 104 ax-SpA patients who met the 2009 ASAS criteria was conducted at Phramongkutklao Hospital between January 2020 and February 2021. Sarcopenia-related factors and disease characteristics were recorded. Sarcopenia was diagnosed according to the Asian Working Group for Sarcopenia 2019. Appendicular skeletal muscle mass was measured by dual-energy X-ray absorptiometry. Strength, ambulation, rising from a chair, stair climbing and history of falling (SARC-F) was evaluated. Muscle strength was measured by hand grip strength and chair stand time. Physical performance was assessed by 6-m walk and time up and go tests. Logistic regression was performed to identify factors associated with sarcopenia. RESULTS: Most patients were male (74%), with a mean (standard deviation, SD) age and disease duration of 42.6 (12.2) and 8.3 (8.5) years, respectively. The mean BMI (SD) was 23.8 (4.4). The prevalence of sarcopenia was 22.1%. There were no differences in disease activity (BASDAI and ASDAS) between ax-SpA patients with and without sarcopenia. Age, low BMI, and BASFI score were independently associated with sarcopenia, with adjusted odds ratios and 95% confidence intervals of 1.08 (1.01-1.16), 0.39 (0.25-0.63), and 1.41 (1.07-1.86), respectively. CONCLUSION: Sarcopenia is common in ax-SpA patients and is independently associated with older age, low BMI, and high BASFI score but not disease activity. Key Points • Despite the fact that ax-SpA patients are typically young, sarcopenia is frequently observed within this population. • Sarcopenia in ax-SpA patients has an independent association with older age, low BMI, and functional limitations (high BASFI scores). • Sarcopenia in ax-SpA patients is not associated with disease activity; however, early treatment to prevent functional limitations may prevent sarcopenia in ax-SpA patients.

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.

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.

Safety and effectiveness of intravenous CT-P13 in inflammatory arthritis: post-marketing surveillance study in Thailand.

Background: The infliximab biosimilar CT-P13 was approved in Thailand in 2015. Methods: This open-label, multicenter, post-marketing surveillance study evaluated the safety (events of special interest [ESIs]; primary end point) and effectiveness of 46 weeks of CT-P13 treatment according to routine practice in patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), or psoriatic arthritis (PsA), with 1 year follow-up post-treatment. Results: 30 patients were enrolled (16 RA, 8 AS and 6 PsA). Infections were the most frequently reported study drug-related ESIs (2 RA and 2 AS). One patient with RA and one with PsA experienced infusion-related reactions. No cases of tuberculosis, malignancy (as expected, given 1 year follow-up), or drug-induced liver disease were reported. Disease activity improved across indications. Conclusion: CT-P13 was well tolerated and effective across indications.

Infliximab is one biological medicine used to treat inflammatory diseases, including rheumatoid arthritis (RA), ankylosing spondylitis (AS) and psoriatic arthritis (PsA). CT-P13 is a near-identical copy, called a biosimilar, of the original ('reference') version of infliximab. CT-P13 is the first biosimilar to receive regulatory approval for treatment of the same three diseases from the European Medicines Agency (EMA) and US Food and Drug Administration. Biosimilarity means that CT-P13 does not differ from the original version of infliximab in clinically important ways, such as how safe it is and how well it works. CT-P13 and reference infliximab provided similar symptom relief during previous clinical trials, and both drugs caused similar side effects. It is important to monitor the safety and performance of CT-P13 when given during routine clinical practice, and in different ethnic populations, such as through the study reported here. Following regulatory approval in Thailand, 30 patients prescribed CT-P13 during routine clinical practice participated in this study. The study included 16 patients with RA, eight with AS and six with PsA. The patients took CT-P13 for 46 weeks and were monitored for a further year. Side effects of CT-P13 were as expected based on previous experience and did not raise any safety concerns. Based on the known safety profile of CT-P13, the study looked at some side effects in particular: infections were the most common of these side effects, experienced by 16 patients overall (seven patients with RA, five patients with AS and four patients with PsA). CT-P13 improved symptoms for all of the diseases. The study suggests that CT-P13 can be given safely and reduces symptoms in Thai patients with AS, RA or PsA. Thai Clinical Trials Registry: TCTR20170817005 (www.thaiclinicaltrials.org/show/TCTR20170817005).

Summary of the Thai Osteoporosis Foundation (TOPF) Clinical Practice Guideline on the diagnosis and management of osteoporosis 2021.

Objectives: The Thai Osteoporosis Foundation (TOPF) is an academic organization that consists of a multidisciplinary group of healthcare professionals managing osteoporosis. The first clinical practice guideline for diagnosing and managing osteoporosis in Thailand was published by the TOPF in 2010, then updated in 2016 and 2021. This paper presents important updates of the guideline for the diagnosis and management of osteoporosis in Thailand. Methods: A panel of experts in the field of osteoporosis was recruited by the TOPF to review and update the TOPF position statement from 2016. Evidence was searched using the MEDLINE database through PubMed. Primary writers submitted their first drafts, which were reviewed, discussed, and integrated into the final document. Recommendations are based on reviews of the clinical evidence and experts' opinions. The recommendations are classified using the Grading of Recommendations, Assessment, Development, and Evaluation classification system. Results: The updated guideline comprises 90 recommendations divided into 12 main topics. This paper summarizes the recommendations focused on 4 main topics: the diagnosis and evaluation of osteoporosis, fracture risk assessment and indications for bone mineral density measurement, fracture risk categorization, management according to fracture risk, and pharmacological management of osteoporosis. Conclusions: This updated clinical practice guideline is a practical tool to assist healthcare professionals in diagnosing, evaluating, and managing osteoporosis in Thailand.

Intravenous Zoledronate 4 mg for the treatment of post-menopausal osteoporosis: A prospective open-labeled study.

BACKGROUND: Zoledronate 5 mg intravenous (IV) annually is approved for treatment of post-menopausal osteoporosis. Zoledronate 4 mg which is approved for the treatment of cancer related hypercalcemia can be an alternative for Asian women who have smaller stature. OBJECTIVES: To examine the efficacy and safety of Zoledronate 4 mg IV annually for the treatment of post-menopausal osteoporosis. METHOD: A prospective open-labeled study was performed on 33 post-menopausal osteoporosis patients. All patients received a dose of IV Zoledronate 4 mg. Bone mineral density (DXA) was examined at baseline and 12 months after treatment. Beta-C-terminal telopeptide (ß-CTX) and procollagen type-1-amino-terminal propeptide (P1NP) were obtained at baseline, 6, and 12 months after treatment. Adverse events were recorded. RESULTS: The mean age (SD) was 69 (11.1) years old. The lumbar spine BMD increased significantly from the mean (SD) lumbar spine BMD at baseline of 0.833 (0.132) g/cm2 to 0.862 (0.132) after treatment (p = 0.001). There was no significant differences in total hip and femoral neck BMDs between baseline and 12 months after treatment. The ß-CTX and P1NP decreased significantly from the mean (SD) of 0.44 (0.24) and 55.57 (38.6) ng/ml at baseline to 0.21 (0.11) and 27.26 (10.95) ng/ml after treatment (p < 0.001), respectively. Infusion reaction was observed in five patients. There were two fractures observed. CONCLUSION: Zoledronate 4 mg improved lumbar BMD and decreased ß-CTX and P1NP significantly after 12 months of treatment. Zoledronate 4 mg could be an alternative to Zoledronate 5 mg for the treatment of post-menopausal osteoporosis.

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.

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.

Practice Advisory on the Appropriate Use of NSAIDs in Primary Care.

Cyclo-oxygenase (COX)-2 selective and nonselective nonsteroidal anti-inflammatory drugs (NSAIDs) are important in managing acute and chronic pain secondary to inflammation. As a greater understanding of the risks of gastrointestinal (GI), cardiovascular (CV) and renal events with NSAIDs use has emerged, guidelines have evolved to reflect differences in risks among NSAIDs. Updated guidelines have yet to reflect new evidence from recent trials which showed similar CV event rates with celecoxib compared to naproxen and ibuprofen, and significantly better GI tolerability for celecoxib. This practice advisory paper aims to present consensus statements and associated guidance regarding appropriate NSAID use based on a review of current evidence by a multidisciplinary group of expert clinicians. This paper is especially intended to guide primary care practitioners within Asia in the appropriate use of NSAIDs in primary care. Following a literature review, group members used a modified Delphi consensus process to determine agreement with selected recommendations. Agreement with a statement by 75% of total voting members was defined a priori as consensus. For low GI risk patients, any nonselective NSAID plus proton pump inhibitor (PPI) or celecoxib alone is acceptable treatment when CV risk is low; for high CV risk patients, low-dose celecoxib or naproxen plus PPI is appropriate. For high GI risk patients, celecoxib plus PPI is acceptable for low CV risk patients; low-dose celecoxib plus PPI is appropriate for high CV risk patients, with the alternative to avoid NSAIDs and consider opioids instead. Appropriate NSAID prescription assumes that the patient has normal renal function at commencement, with ongoing monitoring recommended. In conclusion, appropriate NSAID use requires consideration of all risks.

Factors associated with osteonecrosis in Thai lupus patients: a case control study.

OBJECTIVE: To identify associated factors for the development of osteonecrosis of a femoral head (ON) in patients with systemic lupus erythematosus (SLE). METHODS: We conducted a retrospective nested case-control study from SLE patients who attended the Rheumatology Clinic at Phramongkutklao Hospital from 1992-2008. Cases were defined as SLE patients, who had clinically apparent ON (confirmed by plain radiographs or magnetic resonance imaging). For each case, a control was selected and matched to the case by age and disease duration. The main outcome measure was the odds ratio (OR) of ON among SLE patients. The clinical and laboratory variables thought to be risk factors of ON variables were compared between patients who did and did not develop ON. Significant and clinically relevant variables were then examined by a stepwise logistic regression model. RESULTS: Of 186 SLE patients, we identified 41 patients who developed ON during the course of follow-up. Twenty patients were available for data analysis. From the univariate analysis, incidence of renal involvement and the use of steroids (recorded as evidenced by maximum and mean daily prednisolone dose) were significantly higher in the ON group than in controls. The use of antimalarials was significantly lower in patients with ON than in controls. No difference in disease activity, lipid profiles or anticardiolipin antibody was found between groups. In the logistic regression, the presence of renal involvement remained as a positive associated factor for ON (OR = 7.80, CI = 1.249-48.748, P = 0.028) and the use of antimalarial drugs was a negative associated factor for ON (OR = 0.09, CI = 0.009-0.961, P = 0.046). CONCLUSION: The presence of renal involvement was associated with ON and the antimalarial use may have a protective effect for ON in Thai patients with SLE. The findings from this study further support the use of antimalarial drugs in SLE patients.