The efficacy of induction treatment in Thai patients with lupus nephritis: Observational cohort analysis.

BACKGROUND: For active proliferative lupus nephritis (LN), intravenous cyclophosphamide (IVCYC) is a standard therapy whereby mycophenolate mofetil (MMF) is less effective than IVCYC, according to the clinical trials in non-Asians. In this observational study, the clinical outcomes will be compared among Thai patients. METHODS: We had analyzed 93 adult patients who underwent a renal biopsy for active proliferative LN confirmation between January 2013 and June 2021. The assessment of the response outcomes compared the induction treatment of IVCYC versus MMF. The primary endpoint had achieved complete remission (CR) at 24 weeks, while the secondary endpoint is overall remission (OR) and urine protein creatinine ratio (UPCR) changed over time. RESULTS: 93 LN patients were separated into two groups; 40 in IVCYC and 53 in MMF. In the 24th week, based on unadjusted analysis, patient had achieved CR 20.0% of IVCYC, whereas 28.3% of MMF had achieved CR. Unadjusted CR Risk difference was -0.08 (95% CI -0.26, -0.09, p-value = 0.351) and the adjusted CR risk difference was -0.19 (95% CI -0.42, 0.04, p-value = 0.098). The unadjusted OR risk difference was -0.06 (95% CI -0.26, 0.14, p-value = 0.553) while adjusted OR risk difference was -0.24 (95% CI -0.50, 0.02, p-value = 0.067). Unadjusted UPCR mean was -0.29 (95% CI -0.77, 0.17, p-value = 0.210) and adjusted UPCR mean was -0.27 (95% CI -0.88, 0.32, p-value = 0.366). CONCLUSIONS: The induction treatment with either IVCYC or MMF had similar efficacy in Thai LN patients. The decision of treatment should be taken by applying an individualized therapeutic strategy and balancing risks, costs, and benefits.

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.

2016 updated Thai Rheumatism Association Recommendations for the use of biologic and targeted synthetic disease-modifying anti-rheumatic drugs in patients with rheumatoid arthritis.

AIM: In June 2015, the Thai Rheumatism Association (TRA) approved an update of its recommendation for the use of biologic disease-modifying anti-rheumatic drugs (bDMARDs) and targeted synthetic (tsDMARD) in the treatment of rheumatoid arthritis (RA) to cover those currently available in Thailand (etanercept, infliximab, golimumab, rituximab, tocilizumab, abatacept and tofacitinib). METHOD: A search of the literature was performed between January 2000 and June 2015. Existing RA recommendations, in relation to the use of bDMARDs and tsDMARD, were identified and evaluated by the AGREE II instrument prior to their use as a 'guide' for developing this TRA recommendation. An additional literature search was performed in order to answer specific clinical questions that could not be found in existing guidelines. RESULT: Thirteen recommendations were developed. They covered the use of RA classification criteria, the aim of RA treatment, when to initiate bDMARDs/tsDMARD or taper or switch them to other medications, as well as monitoring these drugs during their use. In addition, specific issues including their use and vaccination, malignancies, pregnancy and lactation, and perioperative period also were addressed. Public hearings were performed at the annual meeting of the TRA and of the Royal College of Physicians of Thailand. The recommendations were distributed to other professional associations related to RA management, as well as government sectors associated with the reimbursement policy, prior to development of the final version. CONCLUSION: These recommendations will help Thai rheumatologists prescribe bDMARDs and tsDMARD more appropriately when treating RA patients.

Decreased pain and synovial inflammation after etanercept therapy in patients with reactive and undifferentiated arthritis: an open-label trial.

OBJECTIVE: Elevated levels of tumor necrosis factor alpha (TNFalpha) have been identified in the synovium of patients with reactive and undifferentiated arthritis, implicating TNFalpha in the pathogenesis of these disorders. This finding has provided a rationale for the use of TNFalpha antagonists in the treatment of reactive arthritis; however, the possibility that the triggering microorganism might persist in affected joints and become activated with use of these agents has been of concern. METHODS: The efficacy and safety of etanercept (25 mg subcutaneous twice weekly) in 16 patients with undifferentiated or reactive arthritis was assessed in a 6-month open-label trial. Synovial biopsies were performed before and after treatment with etanercept. Polymerase chain reaction (PCR) analysis was performed on the synovial biopsy samples to evaluate for the presence of nucleic acid material of bacterial organisms. Outcome measures including tender and swollen joint counts, pain assessment on a 10-point visual analog scale, and functional ability as measured by the Health Assessment Questionnaire were determined before and after etanercept therapy. RESULTS: Ten of 16 patients completed the trial. Six patients withdrew, but none had a worsening of arthritis or infection. Of the 10 completers, 9 could be classified as treatment responders, despite the evidence of bacterial organisms on PCR analysis prior to initiating etanercept in 3 patients; 2 patients became PCR negative on etanercept. Five of 6 patients with adequate synovial biopsy specimens showed improvement, but not normalization of histology. CONCLUSION: Etanercept was well-tolerated without clinical exacerbation of any suspected underlying infections and appeared to provide therapeutic benefit in our cohort of patients with reactive and undifferentiated arthritis.

Ultrasonography for assessment of subcutaneous nodules.

OBJECTIVE: To characterize a variety of subcutaneous lesions by their ultrasonographic (US) appearance, and establish these images as a starting point to measure changes with treatments. METHODS: Twenty-six patients with 48 subcutaneous nodular swellings of various types were imaged using a portable US machine equipped with a 10 MHz linear transducer. All patients had a known diagnosis of a rheumatic disease. We used US to examine subcutaneous lesions and the underlying cortical surface of the bone or joint. Two measurements of some tophi and rheumatoid nodules were done on different dates to examine reproducibility of the measurements. RESULTS: Nodular lesions included 20 tophi and 20 rheumatoid nodules, 2 sarcoid nodules, 2 lipomas, and 4 synovial cysts. Tophi most often appeared as heterogeneous masses; hypoechoic areas in 2 tophi were decreased after aspiration of chalky liquid tophaceous material. Occasionally tophi had calcifications appearing hyperechoic with acoustic shadowing. Cortical bone erosions could be seen adjacent to some tophi. The nodules in patients with rheumatoid arthritis were often attached closely to the bone surface and less erosive to bone, allowing the cortical bone to be seen easily. The nodules were more homogeneous. Some showed a central sharply demarcated hypoechoic area, possibly corresponding to necrosis inside the rheumatoid nodules. Nodules were easily measured. The repeated measurements of both tophi and rheumatoid nodules showed excellent reproducibility. Lipomas had different echogenic patterns depending on composition of the associated connective tissue and position of the mass. They could be hypoechogenic, hyperechogenic, or mixed, but were easily distinguished by oval shapes with well demarcated capsules. Synovial cysts seen in this study had a characteristic hypoechoic pattern. CONCLUSION: Subcutaneous nodules examined by sonography show characteristics and patterns that, although not diagnostic, can be used to help distinguish their etiology. Tophi and rheumatoid nodules can be easily measured and these measurements used to help follow disease progression or response to therapy.