DMARDs Group Research Articles

A Comparative Study to assess the Treatment Cost of Ayurvedic Medicine (Ginger and Castor Oil) and Modern Medicine (DMARDs) in Amavata (Rheumatoid Arthritis)

Ama and Vata are the initial elements in the pathophysiology of Tridosha, whereas Amavata is a result of their vitiation. The expense of treatment is a major factor in the economic burden of RA for both the patient and the health and social care systems. Objective: a. To assess the socio-demographic conditions of the patients of Amavata. b. To compare the cost of a one-month treatment of ginger and castor oil with DMARD in the management of Amavata. Methodology: Total 72 patients of RA Fulfilling the inclusion criteria and having symptoms of RA were enrolled for this Interventional study. Patients were treated in two different groups- Group A- 36 clinically diagnosed and registered patients of Amavata were treated by DMARD Group B- 36 clinically diagnosed and registered patients of Amavata were treated with ginger and castor oil. After the completion of the study, total 62 patients came after one month of treatment, so we included 62 patients in this study. 32 patients in group A and 30 patients in group B Results: The average direct cost of treatment of RA patients in 2024 was estimated as Rs. 2669.17 ($31.96)/month in group A (DMARD Group) and Rs. 1386.69 ($16.62) in group B (Ginger and Castor oil). Major part of total direct costs was covered by medicines (Rs. 1583) in group A and Laboratory cost (Rs. 600) in group B. The ratio of one-month cost of DMARD and Ayurvedic medicine (ginger and castor oil) was 12:1. Discussion: The cost of Ayurvedic medicine was very low in comparison to DMARD. Ayurvedic Medicine ginger and castor oil were easily available, safe, effective and cheap.

Efficacy of JAK Inhibitors versus DMARDs in the Treatment of Polymyalgia Rheumatica in China.

This retrospective analysis was to assess the role of Janus kinases (JAK) inhibitors compared with conventional disease modifying anti-rheumatic drugs (DMRADs) in the treatment of polymyalgia rheumatica (PMR) with glucocorticoids (GCs) reduction. Clinical information was collected from PMR patients in the JAK inhibitor group and the DMARDs group from January 2020 to August 2021 at Jiaxing first Hospital. Serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), hemoglobin (Hb), albumin and dose of GCs before and after treatment were compared between two groups. Thirty female patients with PMR were included into this study. The dose of GCs in the JAK inhibitor group was significantly lower than in the DMARDs group at baseline and at 3 and 6 months after treatment. There were no significant differences in various laboratory parameters (including CRP, ESR, Hb and albumin) between two groups (P > 0.05) except that Hb in the DMARDs group was significantly higher than in the JAK inhibitor group at 3 and 6 months after treatment (P<0.05). One patient in the JAK inhibitor group developed herpes zoster, and received tofacitinib treatment after herpes zoster was relieved. Our study indicates that JAK inhibitors in the treatment of PMR are as effective as DMRADs and are also helpful for the reduction of GCs dose.

Antibody response to the COVID-19 ChAdOx1nCov-19 and BNT162b vaccines after temporary suspension of DMARD therapy in immune-mediated inflammatory disease: an extension study (RESCUE 2)

The persistence of immunogenicity in patients with immune-mediated inflammatory diseases (IMID) on disease-modifying antirheumatic therapy (DMARD) has been less well studied. This extension study evaluates the SARS-CoV2 antibody decay kinetics...

The Anxiety and Depression in Rheumatoid Arthritis Patients Treating with Disease-Modifying Anti-Rheumatic Drugs during the COVID-19 Pandemic.

Anxiety and depression are associated with the risk of illness, presence of physical symptoms, and poor health in the COVID-19 epidemic. Our aim is to assess the severity of anxiety and depression in rheumatoid arthritis (RA) patients treated with disease-modifying anti-rheumatic drugs during the COVID-19 pandemic. The study is a longitudinal, hospital-based survey study including 102 RA patients receiving disease-modifying anti-rheumatic drugs with a mean of 55,2±11,9 years. Demographic data, educational status, marital status, employment status, economic status, patients with psychiatric disorders (with the use of prescribed medication for treatment), and medications were recorded. The severity of depression and anxiety were evaluated with the Beck Anxiety and Depression Inventory at the first and second visit of the follow-up during the pandemic period. The mean Beck depression inventory score was found to be higher in the conventional synthetic DMARDs group than in biological DMARDs (12,1±8,2 vs 11,6±9,2, p=0,554). 46 (65,7%) had mild to severe anxiety symptoms in RA patients treated with conventional synthetic DMARDs, on the first visit. There was no significant difference in anxiety and depression status between the first and second visits. The difference in anxiety and depression symptoms between RA patients receiving conventional synthetic and biological DMARDs does not attain statistical significance. Also, no significant differences were found in anxiety and depression scores in the comparisons for gender, education, marital, working, and economic status. The severity of depression and anxiety were higher in RA patients receiving conventional synthetic DMARDs and biological DMARDs during the COVID-19 pandemic. Also, RA patients are likely to experience anxiety and depression during the period of the pandemic.

Efficacy of Atorvastatin Plus Conventional Disease-Modifying Antirheumatic Drugs on Disease Activity in Rheumatoid Arthritis: A Systematic Review and Meta-analysis of Randomized Controlled Trials.

We queried the PubMed, Embase, Web of Science, and the CENTRAL (Cochrane Central Register of Controlled Trials) databases for this study. The pooled efficacy was evaluated using standardized mean differences. The inverse of the variance model was used for data pooling. Based on the search, we identified 9 randomized controlled trials. The trials included 258 patients in the atorvastatin plus DMARD groups and 246 patients in the DMARD alone groups. The primary outcome was the change from baseline in the 2018 (209:228 Disease Activity Score in 28 Joints). Based on the Disease Activity Score in 28 Joints, disease activity in RA patients decreased significantly in patients given atorvastatin plus DMARD compared with patients given DMARD alone (standardized mean difference, -2.46; 95% confidence interval, -3.98 to -0.95; p = 0.0015; I2 = 97%; p < 0.01). Subgroup analysis did not identify any confounding factors, and no publication bias was detected in the meta-analysis. The result supports that atorvastatin could be added to DMARDs to treat patients with RA.

The association of preoperative TNF-alpha inhibitor use and reoperation rates in spinal fusion surgery

BACKGROUND CONTEXTPreoperative TNF-AI use has been associated with increased rate of postoperative infections and complications in a variety of orthopedic procedures. However, the association between TNF-AI use and complications following spine surgery has not yet been studied. PURPOSEThe purpose of the present study was to assess the risk of reoperation in patients prescribed TNF-AI undergoing spinal fusion surgery. STUDY DESIGNThis is a retrospective review. PATIENT SAMPLEA total of 427 patients who underwent spinal fusion surgery at a large healthcare system from 1/1/2009 to 12/31/2018. OUTCOME MEASUREReoperation within 1 year. METHODSWe retrospectively reviewed the records of patients who underwent spinal fusion surgery at a large healthcare system from 1/1/2009 to 12/31/2018. There were three distinct cohorts of spine surgery patients under study: patients with TNF-AI use in 90 days before surgery, patients with non-TNF-AI DMARD medications use in the 90 days before surgery, and patients taking neither TNF-AI nor other DMARD medications in 90 days before surgery. The primary outcome of interest was reoperation for any reason within 1 year following surgery. RESULTSOur study included 90 TNF-AI, 90 DMARD, and 123 control patients. Reoperation up to 1-year postsurgery occurred in 19% (n=17) of the TNF-AI group, 11% (n=10) of the DMARD group, and 6% (n=7) of the control group. The reasons for reoperation for TNF-AI group were 47% (n=8) infection and 53% (n=9) other causes which included failure to fuse and adjacent segment disease. Reasons for reoperation at 1 year were 40% (n=4) infection and 60% (n=6) other causes for DMARD patients and 14% (n=1) infection with 86% (n=6) other causes for control patients. The cox-proportional hazard model of reoperation within 1 year indicated that the odds of reoperation were 3.1 (95% CI:1.4–7.0) and 2.2 (95% CI 0.96–5.3) times higher in the TNF-AI and DMARD groups, respectively, compared to the control group. CONCLUSIONSPatients taking TNF-AIs before surgery were found to have a significantly higher rate of reoperation in the 1 year following surgery compared to controls. The higher rate of reoperation associated with TNF-AI use before spinal fusion surgery represents the potential for higher morbidity and costs for patient which is important to consider for both surgeon and patient in preoperative decision making.

SAT0426 CAN BIOLOGICS “PREVENT” THE DEVELOPMENT OF PSORIATIC ARTHRITIS IN PSORIASIS PATIENTS? DATA FROM A LARGE UNIVERSITY HOSPITAL COHORT IN ARGENTINA

Background:As psoriasis (Pso) commonly precedes psoriatic arthritis (PsA), an important unanswered question is whether treatment of Pso might influence the development of PsA in patients with psoriasisObjectives:The objective of this study was to analyze the incidence of PsA in a large cohort of patients with PsO according to different treatments, with the hypothesis that treatment with biologics might prevent the development of PsA.Methods:Patients with PsO without PsA followed at a University Hospital were included in this retrospective cohort study. Data was obtained from the Hospital Electronic Medical Record (EMR). Patients were classified according to their treatment in topics group (topic and phototherapy), conventional DMARDs (cDMARDs) group (Methotrexate (MTX) and cyclosporine (Cyc)), and biologic DMARDs group (bDMARDs) (TNFi, IL17i, and IL12-23i). Patients contributed time since beginning of the corresponding treatment until diagnosis of PsA, lost of follow up, end of treatment or end of study. Incident cases of PsA were attributed to one treatment if developed during the administration of that treatment and up to 6 months after its discontinuation if no other treatment was started. Incident cases that developed more than one year after discontinuation of treatment were disregarded (3 cases). Incidence rate was calculated for the whole population and for each one of the treatment groups and compared with chi2test, and rate ratios were calculated as well. A multivariable logistic model for the development of PsA was analyzed by treatment groups, adjusting by other variables.Topics, n= 599cDMARDs, n=106bDMARDs, n=92Total group, n=797Mean age at PsO diagnosis (SD)43.6 (20.6)46.2 (20.7)35.1 (18.9)42.9 (20.6)Female, n (%)314 (52)53 (50)36 (39)403 (50.5)Plaque PsO, n/N (%)514/578 (89)93/103 (90)85/90 (94)692/771 (90)BMI, n; Mean (SD)498; 27.6 (5.4)80; 28.5 (5.6)91; 30 (7)659; 28 (5.7)N Developed PsA (%)68 (8.5)3 (0.38)1 (0.13)72 (9)Follow up (patient/years)915331654810017Incidence rate/1000 Patient/ years (95% CI)7.4 (5.8-9.4)9.5 (1.9-27.5)1.81 (0.04-10)7.2 (5.6-9)Median years between PsO and PsA (IQR)10 (2-21)Patient 1: 23Patient 2: 11.7Patient 3: 24.7Patient (1): 9.610.5 (2-20.8)Results:797 patients, contributed a total of 10017 patient/years. Patient’s characteristics are shown in table 1. 599 (75%) patients were treated only with topics or phototherapy, 106 (13%) with cDMARDs (81% MTX and 19% Cyc) and 92 (11.5%) with biologics (TNFi: 64: etanercept: 44, adalimumab:23, infliximab:6; IL17i: 43: 14 Ixekizumab, 29 Secukinumab; IL12-23i: (Ustekinumab) 16; some patients received more than one biologic). During follow-up 72 patients developed PsA (68 under topics; 3 under cDMARDs (2 MTX and 1 Cyc) and 1 under biologics (1 Secukinumab): Global incidence rate: 7.2 per 1000 patient/years (table 1). Although numerically the incidence of PsA in PsO patients treated with biologics was lower, the difference was not statistically significant. In Cox regression analysis, after adjusting by sex, age, and BMI, treatment with biologics was significantly associated with a reduced risk of developing PsA: Hazard ratio (95% CI): 0.1 (0.013 – 0.7); p= 0.021.Conclusion:Treatment with biologics in patients with PsO seemed to reduce the risk of PsA and preventing its development in this retrospective single center cohort.Acknowledgments:This study was awarded with the PANLAR stimulus award 2019Disclosure of Interests:Luciano Lo Giudice: None declared, Maria Laura Acosta Felquer: None declared, Maria Laura Galimberti: None declared, Luis Mazzuoccolo: None declared, Enrique Soriano Grant/research support from: AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer Inc, Sandoz, Consultant of: AbbVie, Eli Lilly, GlaxoSmithKline, Novartis, Pfizer Inc, Sandoz, Speakers bureau: AbbVie, Amber, Bristol-Myers Squibb, Eli Lilly, Novartis, Pfizer Inc, Roche

OP0039 HOSPITALIZATION AND MORTALITY OUTCOMES IN RHEUMATOID ARTHRITIS PATIENTS WITH LUNG DISEASE

Background:Pulmonary manifestations such as interstitial lung disease (ILD) and chronic obstructive pulmonary disease (COPD) are frequent extra-articular features that carry a poor prognosis in rheumatoid arthritis (RA). Prior studies have demonstrated that respiratory-related mortality is the most overrepresented cause of death in RA.Objectives:To assess the risk of all-cause and respiratory-related hospitalization and mortality in RA patients with comorbid lung disease (LD) in comparison to those without and the differential risks associated with DMARD treatments.Methods:Eligible RA patients included those enrolled in the Forward Databank with ≥1 year observation after 2000 and had initiated a DMARD. Forward is a large longitudinal rheumatic disease registry in the US. RA patients’ diagnoses were rheumatologist-confirmed, and every 6 months participants completed comprehensive questionnaires regarding symptoms, disease outcomes, medications, and clinical events. LD was defined as one of the following: emphysema, asthma, bronchitis, COPD, pleural effusion, fibrosis of the lung, “RA lung“, or ILD (England 2019). DMARDs were categorized hierarchically into four groups: csDMARDs, TNFi and NTNFi (bDMARDs), and tsDMARDs. Patients were followed from DMARD initiation until event (death and/or hospitalization) or end of follow-up, whatever came first. Events were validated using medical records and the US National Death Index. Respiratory hospitalizations and deaths were identified with ICD9 (460-519). Events were analyzed using incidence rates (IR) and Cox regression models. Models were adjusted for LD, DMARDs, age, sex, education, HAQ disability, Rheumatic Disease comorbidity index, smoking, pain, glucocorticoids, year of entry, prior bDMARDs and csDMARDs counts and MRC breath scale.Results:Of the 21,525 eligible RA patients, 13.8% had LD at the time of DMARD initiation. Patients had 59 years old in both groups and 15% were male for LD+ vs 21% for LD-. Patients with LD+ showed worse disease outcomes (HAQ: 1.3 (0.7) vs 1.0 (0.7)) and comorbidities (2.9 (1.9) vs 1.5 (1.4)) overall and for all treatment groups, especially for NTNFi and tsDMARDi. The overall IR of any all-cause or respiratory-related events were higher in LD+ than LD- RA patients and across any DMARD treatments, with NTNFi having higher IR (Figure). In survival analyses, LD+ was associated with an increased risk for all-cause hospitalizations/deaths (HR 1.3; 95% CI 1.1-1.4) and a 3.95-fold increased risk of respiratory-related events (HR 4.0; 3.2-4.9) (Table). These risks did not differ significantly across DMARD treatment groups. Increased age, HAQ disability, comorbidities, glucocorticoids, prior bDMARDs and worse MRC breath scales were associated with an increased risk in both outcomes and smoking in respiratory-specific events.Conclusion:An increased risk of hospitalizations and/or deaths was demonstrated for RA patients with lung disease, most notably a 4-fold increased risk for respiratory-related events. No differences were found between incident DMARD groups. Additional studies accounting for channeling of treatments by baseline health status are needed.

Subclinical synovitis measured by ultrasound in rheumatoid arthritis patients with clinical remission induced by synthetic and biological modifying disease drugs

BackgroundRheumatoid arthritis (RA) patients with disease in clinical remission might show subclinical synovitis, which can be related to the progress of structural joint damage. ObjectiveTo determine and compare the degree of synovial inflammation by ultrasound (US) in patients with RA in clinical remission, treated with DMARD or combination therapy with DMARD and anti-TNF. MethodsHospital-based cross-sectional study of 58 patients with RA in sustained remission for at least 6 months by DAS28 <2.6, who attended the Rheumatology Service at the Hospital Universitario de Caracas. Patients underwent clinical, functional, and laboratory assessments. Ultrasound was performed in hands measuring synovial effusion, synovial hypertrophy and power Doppler signal; using a semiquantitative 4-point scale of 0=none to 3=severe. Chi-square and t-test were used to compare the clinical, functional, laboratory and US assessments between the DMARD (N=37) and combination therapy with DMARD and anti-TNF (N=21) groups. A p-value <0.05 was considered statistically significant. ResultsOut of 58 patients, 25.9% had remission by US and 74.1% had synovial effusion or hypertrophy or positive power Doppler signal. Non-significant differences in US synovitis between the two groups were found. ConclusionsPersistent US activity was evident in a high percentage of rheumatoid arthritis patients in clinical remission by DAS28. No differences in subclinical synovitis measured by US were found between patients with DMARD and anti-TNF-induced clinical remission.

Sex-associated Treatment Differences and Their Outcomes in Rheumatoid Arthritis: Results from the METEOR Register.

To assess differences in initial treatment and treatment response in male and female patients with rheumatoid arthritis (RA) in daily clinical practice. The proportion of patients with RA starting different antirheumatic treatments (disease-modifying antirheumatic drugs; DMARD) and the response to treatment were compared in the international, observational METEOR register. All visits from start of the first DMARD until the first DMARD switch or the end of followup were selected. The effect of sex on time to switch from first to second treatment was calculated using Cox regression. Linear mixed model analyses were performed to assess whether men and women responded differently to treatments, as measured by Disease Activity Score (DAS) or Health Assessment Questionnaire. Women (n = 4393) more often started treatment with hydroxychloroquine, as monotherapy or in combination with methotrexate (MTX) or a glucocorticoid, and men (n = 1142) more often started treatment with MTX and/or sulfasalazine. Time to switch DMARD was shorter for women than for men. Women had a statistically significantly higher DAS over time than men (DAS improvement per year β -0.69, 95% CI -0.75 to -0.62 for men and -0.58, 95% CI -0.62 to -0.55 for women). Subanalyses per DMARD group showed for the conventional synthetic DMARD combination therapy a slightly greater decrease in DAS over time in men (-0.89, 95% CI -1.07 to -0.71) compared to women (-0.59, 95% CI -0.67 to -0.51), but these difference between the sexes were clinically negligible. This worldwide observational study suggests that in daily practice, men and women with RA are prescribed different initial treatments, but there were no differences in response to treatment between the sexes.

The Effectiveness and Safety of Tripterygium wilfordii Hook. F Extracts in Rheumatoid Arthritis: A Systematic Review and Meta-Analysis.

Objective: To conduct a meta-analysis of the effectiveness and safety of Tripterygium wilfordii Hook. F (TwHF) extracts for the treatment of rheumatoid arthritis (RA).Methods: A systematic literature search was conducted in PubMed, EMBASE, Cochrane, Medline, CNKI, SinoMed and WanFang Library till 12 July 2017. All included studies were analyzed with the use of the Review Manager 5.2 software according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) Statement protocol.Results: Fourteen randomized controlled trials (RCTs) were identified. TwHF extracts provided a statistically significant improvement in grip strength (GS), swelling joint count (SJC) and morning stiffness (MS) compared with placebo (P < 0.001). The meta-analysis showed significant differences between TwHF extract-treated group and the DMARDs group in GS, MS, C-reactive protein (CRP), and tender joint count (TJC) (P < 0.05), aside from ESR and SJC (P > 0.05). The pooled results also displayed significant differences between the combination of TwHF extracts with DMARDs and the DMARDs alone group in ESR, CRP, SJC, and TJC (P ≤ 0.05). For the safety analysis, two trials favored TwHF extract-treatment and one trial favored non-TWHF extract-treatment in AEs (P < 0.05). Eleven trials showed no statistically significant differences between TwHF extract-treated group and the DMARDs group (P > 0.05).Conclusions: The findings of this systematic review with meta-analysis indicate that TwHF extracts provides statistically significant and clinically important improvement in RA symptoms and has an acceptable safety profile.

Rituximab as first choice for patients with refractory rheumatoid arthritis: cost-effectiveness analysis in Iran based on a systematic review and meta-analysis.

The aim of this study was to evaluate the effectiveness and cost-effectiveness of using rituximab as first line for patients with refractory rheumatoid arthritis in comparison with continuing conventional DMARDs, from a perspective of health service governors. A systematic review was implemented through searching PubMed, Scopus and Cochrane Library. Quality assessment was performed by Jadad scale. After meta-analysis of ACR index results, QALY gain was calculated through mapping ACR index to HAQ and utility index. To measure the direct and indirect medical costs, a set of interviews with patients were applied. Thirty-two patients were selected from three referral rheumatology clinics in Tehran with definite diagnosis of refractory rheumatoid arthritis in the year before and treatment regimen of either rituximab or DMARDs within last year. Incremental cost-effectiveness ratio was calculated for base case and scenario of generic rituximab. Threefold of GDP per capita was considered as threshold of cost-effectiveness. Four studies were eligible to be considered in this systematic review. Total risk differences of 0.3 for achieving ACR20 criteria, 0.21 for ACR50 and 0.1 for ACR70 were calculated. Also mean of total medical costs of patients for 24weeks were $3985 in rituximab group and $932 for DMARDs group. Thus, the incremental cost per QALY ratio will be $45,900-$70,223 in base case and $32,386-$49,550 for generic scenario. Rituximab for treatment of patients with refractory rheumatoid arthritis is not considered as cost-effective in Iran in none of the scenarios.

Biologics Treatment Limits Disease Activity and Bone Metabolism in Patients with Rheumatoid Arthritis

Introduction: Generalized bone loss in rheumatoid arthritis (RA) is multi-factorial, and can be divided into erosions of the joint and osteoporosis. Biomarkers of bone remodeling provide a dynamic view of the remodeling process and they contribute to a better understanding of bone physiology and the pathogenesis of metabolic bone diseases. To examine whether treatment with biologics agents reduces of disease activity and changes the markers of bone metabolism, including osteocalcin (OC), N-terminal propeptide of type I procollagen (PINP), cross-linked Cterminal telopeptide of type I collagen (CTX), receptor activator of the NF-κB ligand (RANKL) and osteoprotegerin (OPG). Materials and methods: 125 patients with active RA, who were treated with DMARDs (44 patients) and biologics agents including 49 patients on Etanercept, 16 patients on Adalibumab/Golibumab/Infliksimab and 16 patients on Rytuksymab/Tocilizumab were included in this study. Clinical and laboratory parameters of disease activity were measured at baseline and after 90 days of treatment and an index of disease activity (DAS-28) calculated. Changes in bone markers levels were measured by ELISA before start the treatment and after. Results: As a result of treatment of the active RA with biologics agents, after 90 days, parameters such as DAS-28, VAS, number of swollen/tender joints, CRP and ERS decreased in the biologics group compared to the DMARDs group. The sRANKL/OPG ratio, and carboxylated (GLA)–OC and CTX levels were higher in RA patients compared to healthy subjects (p<0.001, p=0.02 and p=0.002, respectively). DMARDs therapy decreased the CTX level and sRANKL/OPG ratio in RA patients (p=0.006 and p=0.06, respectively). OPG was increased, whereas the sRANKL/OPG ratio was decreased in RA patients after 90 days biologics treatment. Conclusion: The biologics therapy has protective effect against clinical disease activity as well as joint damage compared to conventional DMARDs in patients with RA.

Clinical and radiographic outcome of a treat-to-target strategy using methotrexate and intra-articular glucocorticoids with or without adalimumab induction: a 2-year investigator-initiated, double-blinded, randomised, controlled trial (OPERA)

ObjectivesTo study clinical and radiographic outcomes after withdrawing 1 year's adalimumab induction therapy for early rheumatoid arthritis (eRA) added to a methotrexate and intra-articular triamcinolone hexacetonide treat-to-target strategy (NCT00660647).MethodsDisease-modifying antirheumatic...

A Prospective Double Blind Placebo Controlled Trial of Combination Disease Modifying Antirheumatic Drugs vs. Monotherapy (Sulfasalazine) in Patients with Inflammatory Low Backache in Ankylosing Spondylitis and Undifferentiated Spondyloarthropathy

Objective: Inflammatory back pain (IBP) in Ankylosing Spondylitis (AS) and Undifferentiated Spondyloarthritis (UspA) adversely affects the quality of life. Herein combination DMARD vs. sulfasalazine (SSZ) monotherapy was evaluated in treatment of axial symptoms of AS and UspA. Methods: Patients with AS/UspA with disease duration ≤ 8 years, IBP of atleast 6 months duration, and BASDAI ≥ 4 or early morning stiffness ≥ 1 hour despite NSAID therapy for 6 weeks were included. Patients were initiated on SSZ with either combination DMARD [MTX (10 mg escalated by 2.5 mg every week up to 20 mg/week) and HCQS 200 mg/day] or SSZ Monotherapy group [placebo MTX and placebo HCQS]. ASAS20 response was assessed at baseline and at the end of 6 months. Results: Of thirty three patients (31 males) with mean disease duration 39 months and mean BASDAI of 6 at baseline, 27 completed the study (16 in Combination DMARD and 11 in SSZ monotherapy group). ASAS 20 response, was achieved in 68.4% (13/19) and 50% (7/14) in the Combination DMARD and SSZ monotherapy groups (p=0.47), respectively. BASDAI scores decreased significantly in both the groups after therapy. A significant improvement in BASFI, patient pain VAS, patient global disease VAS, HAQ, and MCS of SF-36 was observed in both the groups. In the combination DMARD group, significant improvement in BASMI, FACIT and PCS of SF-36 and decrease in the serum MMP-3 levels was observed following therapy. Conclusion: SSZ monotherapy is equally efficacious as combination DMARD group in a significant proportion of patients with NSAID refractory IBP associated with AS/ USpA.

PMS53 - Rituximab as First Choice for Patients With Refractory Rheumatoid Arthritis: Cost-Effectiveness Analysis in Iran Based on A Systematic Review and Meta-Analysis

The aim of this study was to evaluate the effectiveness and cost-effectiveness of using rituximab as first line for patients with refractory rheumatoid arthritis in comparison with continuing conventional DMARDs, from a perspective of health service governors. A systematic review was implemented through searching PubMed, Scopus and Cochrane Library. Quality assessment was performed by Jadad scale. After meta-analysis of ACR index results, QALY gain was calculated through mapping ACR index to HAQ and utility index. To measure the direct and indirect medical costs, a set of interviews with patients were applied. Thirty-two patients were selected from three referral rheumatology clinics in Tehran with definite diagnosis of refractory rheumatoid arthritis in the year before and treatment regimen of either rituximab or DMARDs within last year. Incremental cost-effectiveness ratio was calculated for base case and scenario of generic rituximab. Threefold of GDP per capita was considered as threshold of cost-effectiveness. Four studies were eligible to be considered in this systematic review. Total risk differences of 0.3 for achieving ACR20 criteria, 0.21 for ACR50 and 0.1 for ACR70 were calculated. Also mean of total medical costs of patients for 24 weeks were $3985 in rituximab group and $932 for DMARDs group. Thus, the incremental cost per QALY ratio will be $45,900–$70,223 in base case and $32,386–$49,550 for generic scenario. Rituximab for treatment of patients with refractory rheumatoid arthritis is not considered as cost-effective in Iran in none of the scenarios.

Psoriatic arthritis treatment and the risk of herpes zoster

ObjectivesTo study the association between traditional disease-modifying antirheumatic drugs (c-DMARD) or anti-TNF-α agents and herpes zoster (HZ) in patients with psoriatic arthritis (PsA).MethodsA retrospective cohort study was conducted in patients...

CXCL13 predicts disease activity in early rheumatoid arthritis and could be an indicator of the therapeutic 'window of opportunity'.

IntroductionA key phenomenon in rheumatoid arthritis is the formation of lymphoid follicles in the inflamed synovial membrane. C-X-C motif chemokine 13 (CXCL13) is central in this process as it attracts C-X-C chemokine receptor type 5 (CXCR5)-expressing B cells and T follicular helper cells to the follicle. We here examine the role of CXCL13 and its association with disease in patients with treatment-naïve early rheumatoid arthritis.MethodsPlasma samples from patients in the OPERA trial were examined for CXCL13 at treatment initiation and after 6 months of treatment with either methotrexate plus placebo (DMARD) (n = 37) or methotrexate plus adalimumab (DMARD + ADA) (n = 39). Treatment outcome was evaluated after 1 and 2 years. CXCL13 plasma levels in healthy volunteers (n = 38) were also examined.ResultsBaseline CXCL13 plasma levels were increased in early rheumatoid arthritis patients in comparison with healthy volunteers. Also, plasma CXCL13 correlated positively with disease activity parameters; swollen joint count 28 (rho = 0.34) and 40 (rho = 0.39), visual analog score (rho = 0.38) and simplified disease activity index (rho = 0.25) (all P <0.05). CXCL13 levels decreased a significantly twofold more in the DMARD + ADA group than in the DMARD group. Baseline CXCL13 plasma levels in the DMARD group correlated inversely with disease activity parameters; disease activity score in 28 joints, four variables, C-reactive protein based (DAS28CRP) (rho = 0.58, P <0.05) at 12 months. High baseline CXCL13 was associated with remission (DAS28CRP less than 2.6) after 2 years.ConclusionsIn treatment-naïve early rheumatoid arthritis patients, plasma CXCL13 levels were associated with joint inflammation. Furthermore, patients with high baseline plasma CXCL13 levels had an improved chance of remission after 2 years. We propose that high CXCL13 concentrations indicate recent onset of inflammation that may respond better to early aggressive treatment. Thus, high levels of CXCL13 could reflect the ‘the window of opportunity’ for optimal treatment effect.Trial registrationClinicaltrial.gov NCT00660647. Registered 10 April 2008

SAT0575 Ra Patients' Expectations of Treatment - Comparison with the Result of Surveys in Multi-Cohort-

BackgroundTo execute “Treat to Target's (T2T)” primary principal, it is very important to understand the extent of patient education and patients' understanding thereof, but these factors are not well understood.ObjectivesTo...

THU0178 Rates of Serious Infections and Malignancies among Rheumatoid Arthritis Patients Receiving Either Tnf-Blocker or Rituximab Therapy in Finland

BackgroundWhile randomized clinical trials have not showed an increased risk for serious infections among TNF-blocker users in comparison to methotrexate, we sought to confirm the results in Finnish routine care...