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Methods: SLE patients whose prednisolone had been previously withdrawn or taken 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.

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.

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.

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.

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.

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 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.

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.

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.

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.

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.

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.

Group B streptococcus is the most common pathogen for septic arthritis with unique clinical characteristics: data from 12 years retrospective cohort study.

BACKGROUND: Group B Streptococcus (GBS) emerged as the frequent pathogen for septic arthritis. There was no study comparing risks, clinical presentations and outcomes between GBS septic arthritis and other bacterial septic arthritis.The aim of this study is to evaluate the differences in risks, clinical presentations, and outcomes of GBS septic arthritis and other bacterial septic arthritis, and identify independent risks and clinical presentations suggesting GBS septic arthritis. METHOD: Medical records of patients diagnosed with non-gonococcal bacterial arthritis admitted in Phramongkutklao Hospital during 2006-2018 were reviewed. Associated risks, clinical presentations and outcomes were compared between GBS septic arthritis (GBS group) and other bacterial septic arthritis (other bacterial group). RESULT: Two hundred and thirty one cases of non-gonococcal bacterial arthritis confirmed by positive joint fluid cultures and/or hemocultures were included. The three most common pathogens were GBS (37.7%), Staphylococcus aureus (23.4%) and Streptococcus viridans (7.4%). GBS group was more commonly found in rainy season than other bacterial group. Patients in GBS group were less likely to have underlying diseases and had more number of involved joints than those in other bacterial group. The clinical presentations more commonly found in GBS group than other bacterial group were oligo-polyarthritis, upper extremities joint involvement, axial joint involvement, tenosynovitis and central nervous system involvement.Multivariate analysis found the independent associated factors of GBS arthritis are tenosynovitis, oligo-polyarthritis and rainy season. CONCLUSIONS: GBS is now the most common pathogen for bacterial septic arthritis. The independent associated factors of GBS arthritis were oligo-polyarthritis, tenosynovitis and rainy season.

Effect of patient education on medication adherence of patients with rheumatoid arthritis: a randomized controlled trial.

PURPOSE: There is a general understanding that patient educational interventions for enhancing medication adherence are important. However, their success at improving adherence is debatable. This study aimed to assess the influence of different modes of patient education on medication adherence in patients with rheumatoid arthritis (RA). MATERIALS AND METHODS: One hundred and twenty RA patients with non-adherence, defined as pill count ≥80% or medication-taking behavior questionnaire for Thai patient ≥23, were randomized by block randomization and assigned in a 1:1 allocation ratio to two study arms: multi-component intervention group or single intervention group. The multi-component intervention group received 30-minute directed counseling and a disease information pamphlet. The single intervention group received only a disease information pamphlet. The primary outcomes were an improvement in an adherence rate measured by pill count after 12 weeks. The Thai Clinical Trial Registry number is TCTR20171207003. RESULTS: After 12 weeks, the pill count adherence rate increased significantly from baseline in both study groups. In the multi-component intervention group, adherence rate increased from 92.21±14.05 to 97.59±10.07 (P=0.002) and in the single intervention group, it increased from 88.60±19.66 to 92.42±14.27 (P=0.044). However, the mean difference between the multi-component intervention group and the single intervention group was not significant (5.38±12.90 vs 3.18±14.23, P=0.531). Clinical outcomes, including disease activity score 28, EuroQoL-5D, EuroQol visual analog scale, pain score, and physician global assessment were unchanged from baseline in both groups. CONCLUSION: Patient education significantly improved adherence. However, there were no differences between single education intervention and multi-component education intervention in improving medication adherence. Provision of a disease information pamphlet with or without directed counseling can equally enhance medication adherence of patients with RA.

Necrobiotic xanthogranuloma scleritis in a case of granulomatosis with polyangiitis (Wegener's granulomatosis).

The purpose of this study was to describe a case of necrobiotic xanthogranuloma scleritis in a 53-year-old male with unilateral progressive visual loss, scleritis, prolonged fever, and multiple mononeuropathy. Scleral biopsy showed necrosis with small abscess, and the pathological tissues revealed submucosal infiltration of mononucleated foamy histiocytes (xanthoma cells), hemosiderin-laden macrophages, neutrophils, lymphocytes, plasma cells, and erythrocytes without Touton giant cells or cholesterol clefts. Serum protein electrophoresis showed polyclonal gammopathy. All infectious investigations were negative. Afterward, this patient was diagnosed with granulomatosis with polyangiitis based on granuloma found in scleral tissue, vasculitis seen in sural nerve biopsy and positive serologies (C-ANCA and anti-PR3 antibody). He was treated with high-dose corticosteroid and later with intravenous cyclophosphamide monthly. He responded well to treatment, both eye and systemic conditions. Necrobiotic xanthogranuloma scleritis could be an early presentation of granulomatosis with polyangiitis.

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.

The association between serum vitamin D Level and disease activity in Thai rheumatoid arthritis patients.

BACKGROUND: Serum vitamin D level was inversely associated with the risk of developing new onset rheumatoid arthritis (RA) and disease activity, but some conflicting results have been reported. OBJECTIVE: To examine the serum vitamin D status in Thai RA patients and possible independent factors affecting serum 25 hydroxyvitamin vitamin D (25(OH)D) and the associations of serum 25(OH)D level and the disease activity and functional status in Thai RA patients. METHODS: A cross-sectional study was performed in 239 Thai RA patients. The blood levels of 25(OH)D2 and D3 were measured by chemiluminescent immunoassay. Disease activity was assessed according to tender and swollen joint counts, erythrocyte sedimentation rate (ESR), visual analog scale for global patient assessment, Disease Activity Score-28 (DAS-28) and Thai Health Assessment Questionnaire (Thai HAQ). RESULT: The mean vitamin D level was 28.79 ng/mL. There were no associations between 25(OH)D levels and number of tender and swollen joint counts, DAS-28 score, HAQ score or rheumatoid factor (RF) and/or anti-cyclic citrulinated peptide (CCP) positivity. After multivariated analysis, Bangkok residents, non-farmer, obesity and non-vitamin D supplementation were the predictors for vitamin D insufficiency in Thai patients with RA. CONCLUSION: There are no associations of serum 25(OH)D levels with disease activity or functional status in Thai RA patients. The factors associated with vitamin D insufficiency are Bangkok resident, non-farmer, obesity and not taking vitamin D supplementation.

The good EULAR response at the first year is strongly predictive of clinical remission in rheumatoid arthritis: results from the TARAC cohort.

The purpose of this study was to identify the prevalence and prognostic factors of clinical remission in patients with rheumatoid arthritis (RA). The Thai Army Rheumatoid Arthritis Cohort (TARAC) patients were included if baseline data were available. Clinical remission was defined as 28-joint count disease activity scores (DAS28) <2.6 in the last two consecutive visits, at least 3 months apart. Three hundred and thirty-five patients were enrolled, and 89.9 % were female. Mean (SD) age was 61 years (11.4), and mean disease duration was 145.9 months (93.7). Rheumatoid factor (RF) and anti-citrullinated protein antibody (ACPA) were positive in 69.9 and 67.8 %, respectively. Eighty-nine percent of patients were treated with synthetic DMARDs, of which 29 % received monotherapy. The combination of biologic and synthetic DMARDs was used in 10.4 % of the patients. Clinical remission was observed in 49 patients (14.6 %). Early diagnosis and treatment within 12 months of onset (odds ratio (OR) 1.95, 95 % confidence interval (CI) 1.02-3.74, p = 0.04), rheumatoid factor negativity (OR 2.10, 95 % CI 1.04-4.21, p = 0.04) and good EULAR response at the end of the first year of treatment (OR 2.75, 95 % CI 1.08-6.99, p = 0.03) were associated with clinical remission in univariate analysis. In multivariate regression analysis, only a good EULAR response at the first year was significantly correlated with clinical remission in this study (OR 3.1, 95 % CI 1.15-8.36, p = 0.03). Although remission is currently a treatment goal in patients with RA, only one-seventh of patients have achieved sustained clinical remission in clinical practice. The good EULAR response at the end of the first year was an independent predictive factor of clinical remission.