Patient Global Visual Analogue Scale Research Articles

Body mass index does not affect response of rituximab in patients with rheumatoid arthritis: results from the TURKBİO registry.

Adipose tissue produces several inflammatory mediators. Thus, obesity affects the disease course and the responses to the antirheumatic agents in inflammatory diseases. The aim of the study was to determine whether the body mass index (BMI) is involved in the response to rituximab in rheumatoid arthritis (RA). This multicenter retrospective study included 206 RA patients who received rituximab from the Turkish Biologic (TURKBIO) registry between 2011 and the end of May 2017. Demographic and clinical data including age, sex, disease type, disease duration, and previous or current treatment with disease-modifying antirheumatic drugs (DMARDs) and biological drug durations are stored in the database. Patients with a BMI ≥30 kg/m2 were classified as obese, and patients with a BMI <30 kg/m2 were classified as nonobese. Kaplan-Meier survival analysis was performed to estimate the drug survival. The subgroups were compared using the log-rank test. The mean BMI of 206 patients included in the study was 27.05 (17.2-43.4) kg/m2. There were 59 (28.6%) patients in the obese group and 147 (71.4%) patients in the nonobese group. The mean age, female percentage, and baseline disease activity score 28 (DAS28) were higher in the obese group than in the nonobese group. However, the ΔDAS28 at both 6 and 12 months were not significantly different between the groups (p = 0.785 and p = 0.512, respectively). Patient pain Visual Analogue Scale (VAS), patient fatigue VAS, and patient global VAS scores were also significantly higher at baseline in the obese group (p = 0.003, p = 0.006, and p = 0.006, respectively). However, no significant difference was found in terms of changes in patient pain VAS, patient fatigue VAS, patient global VAS and physician global VAS scores at 6 and 12 months compared to those at baseline. Rituximab treatment was ongoing for 71.2% of the obese and 63.3% of the nonobese patients (p = 0.279). The median drug survival duration was 77 months in the obese group and 62 months in the nonobese group (p = 0.053). The estimated drug survival rates for rituximab were not statistically significantly different in the obese and nonobese groups. Rituximab-related side effects were also similar between the groups. In obese and nonobese patients with RA, rituximab treatment exhibits similar side effects and similar long-term efficacy. These results suggest that obesity does not alter drug survival for rituximab and response rates, in RA and rituximab may be a favorable treatment agent in patients with RA and obesity.

18F-FDG and 18F-NaF PET/CT Global Assessment of Large Joint Inflammation and Bone Turnover in Rheumatoid Arthritis.

Rheumatoid arthritis (RA) involves chronic inflammation of synovial joints, causing pain, stiffness, and limited mobility. 18F-sodium fluoride (NaF) is a PET tracer whose uptake reflects bone turnover, while 18F-fludeoxyglucose (FDG) shows glucose metabolism and can serve as a marker for inflammation. The aim of this study is to determine the feasibility of calculating the FDG and NaF mean standardized uptake value (SUVmean) in the knee joint, hip joint, and sacroiliac (SI) joint of RA patients and to determine their association with patient characteristics. Prospective FDG-PET/CT as well as NaF-PET/CT imaging was performed on 18 RA patients. The global SUVmean was calculated on FDG-PET/CT and NaF-PET/CT images using a semiautomated CT-based method of segmentation. FDG and NaF uptake were found to be significantly correlated in the knee (r = 0.77, p < 0.001), but not in the hip and SI joints. In the knee, both NaF SUVmean and FDG SUVmean were significantly correlated with body weight, BMI, leptin, and sclerostin levels (p < 0.05). NaF SUVmean was significantly positively correlated with BMI and leptin for both the hip and SI joints (p < 0.05). No significant correlation was observed between either PET parameter and age, height, erythrocyte sedimentation rate (ESR), and interleukins 1 and 6 (IL-1 and IL-6); however, FDG was correlated with inflammatory markers such as C-reactive protein (CRP) and patient global visual analogue scale (VAS-PtGlobal) in some joints. In this study, both FDG and NaF uptake were quantified in large joints of patients with RA using CT segmentation. NaF and FDG SUVmean were correlated with clinical variables related to body weight and adiposity, suggesting that degenerative joint disease may play a larger role in influencing the uptake of these tracers in large joints than RA disease activity. FDG and its correlation with markers of inflammation such as CRP and VAS-PtGlobal suggests that this tracer may serve as a more specific marker for RA disease activity than NaF. Larger prospective and longitudinal data are necessary to gain a better understanding of the roles of FDG and NaF in evaluating RA joint activity in these joints.

POS1381 BIOLOGIC TREATMENT OF ADULT-ONSET STILL’S DISEASE: A SINGLE CENTER EXPERIENCE

Background:Even though corticosteroids and cDMARDs are effective for inducing remission in patients with Adult-Onset Still Disease (AOSD), relapse is common. Hence, maintaining the clinical stability is challenging. Almost all of the patients face side effects because of high dose steroid treatment. Biological DMARDs have been reported to be effective in refractory patients.Objectives:We aimed to evaluate the patients’ outcomes who were diagnosed with AOSD and treated with at least one bDMARDs in our tertiary center.Methods:Patients with AOSD who were followed in our clinic between 2007 and 2020 were screened retrospectively. For the diagnosis of AOSD, all of the patients fulfilled Yamaguchi criteria. The demographic characteristics, baseline and post-treatment clinical findings and outcomes were reported.Results:Twenty-eight patients (21 F, 7 M) were screened (Figure 1). The mean disease duration of the first bDMARD was 21,76 ± 28,05 months (mean ± SD). The mean duration of bDMARD treatment was 37,04 ± 30,75 months. The reasons for starting a bDMARD were systemic symptoms (%80) and chronic arthritis (%20). All of the patients used methotrexate (MTX) except one. This patient had macrophage activation syndrome during diagnosis and was treated with cyclosporine. All of the patients were treated with corticosteroids (34,28 ± 26,70 mg/d) and a cDMARD at initiation (22 of them MTX, 1 of them azathioprine, 2 of them cyclosporine and 1 of them IVIg). Anakinra was the most preferred biologic as a first-line treatment modality (TNF inhibitors=5, tocilizumab=4). The main reason for switching was loss of efficacy (8/22). Tocilizumab was the most used agent in 2nd line and canakinumab was in 3rd line. Twenty-two patients were in remission at last visit. Also, 15 patients were steroid-free, 14 patients were MTX-free. Patient global visual analogue scale, acute phase reactants and daily steroid dose were reduced significantly at last visit compared to the initial visit (Table 1).Table 1.Comparison of important laboratory findings and the mean steroid doseClinical findingAt initiation of bDMARDmean ± SDAt the last visitmean ± SDPG-VAS9.8 ± 0.82.3 ± 2.3ESR (mm/h)34,28 ± 33,9518.82 ± 11.60CRP (mg/l)70,76 ± 67,8013.44 ± 27.33Ferritin (ng/mL)1662 ± 1239275.7 ± 381.4Daily steroid dose (prednisolone, mg/d)34.28 ± 26.705.60 ± 8.60Figure 1.Presenting signs and the symptoms of the patientsbDMARD treatment was terminated in 5 patients due to complete remission (n=2) and side effects (1 of them pneumonia, 1 of them EBER (+) Hodgkin Lymphoma and 1 of them tuberculosis). Six patients experienced local injection site reaction, none of them stopped treatment. Also, one patient died while she was in remission under anakinra treatment with an unknown cause.Conclusion:The most common presenting symptoms in our cohort were fever and salmon-colored rash. Tocilizumab is an alternative treatment modality in cases with chronic arthritis and IL-1 inhibitors are an alternative for systemic course of disease. bDMARDs, especially IL-1 inhibitors are highly effective for refractory patients with AOSD.Disclosure of Interests:None declared

OP0224 CONTINUOUS COMPOSITE MEASURES FOR ROUTINE CARE IN PSORIATIC ARTHRITIS: THRESHOLDS OF MEANING AND CLINICALLY IMPORTANT DIFFERENCE ESTIMATES FOR THE 3 AND 4 VAS SCALES FROM A UK MULTICENTRE STUDY

Background:There is a recognised need for a continuous composite measure of disease activity for the assessment of Psoriatic Arthritis (PsA) in routine clinical settings to allow objective assessment of response and implementation of treat to target.1 Longer multidimensional measures are considered less feasible in routine care and a number of shorter measures have been proposed including, the Disease Activity Score for Psoriatic Arthritis (DAPSA), Disease Activity Score 28 (DAS28), the 3 Visual Analogue Scale (VAS) (comprising physician global VAS, patient global VAS and patient skin VAS) or 4 VAS (comprising physician global VAS, patient pain VAS, joint VAS and patient skin VAS). Testing of these measures in clinical trial datasets has been suggested but thresholds of meaning have not been established.2Objectives:To estimate clinically relevant thresholds of disease activity and improvement for composite measures for routine clinical practice in PsA.Methods:Clinical and patient reported outcome measures were assessed in patients fulfilling CASPAR criteria for PsA at three consecutive follow up visits in a UK multicentre observational study. Participants underwent clinical assessment and completed patient reported measures including health anchor questions. Estimates for Minimal Detectible Change (MDC) were derived using 1.96*2*Standard Error of the Mean (SEM). Minimal Clinically Important Difference (MCID) for improvement were derived using the health anchor method and two distribution methods (Table 1). Thresholds for low, moderate and high disease activity were triangulated from established cut-off values for the patient global VAS, PASDAS and DAPSA.Table 1.Minimal Clinically Important Difference (MCID) and Minimal detectable change (MDC)ANCHOR (MEDIAN)DISTRIBUTION#1DISTRIBUTION #2MDCCPDAI0.51.491.54.16GRACE0.260.60.772.18PASDAS1.220.640.761.58DAS280.20.850.621.463VAS1.131.160.913.124VAS1.110.960.942.45DAPSA7.259.0910.4035.63Disease Activity Score for Psoriatic Arthritis (DAPSA); Psoriatic Arthritis Disease Activity Score (PASDAS); Composite Psoriatic Arthritis Disease Activity Index (CPDAI); Disease Activity Score 28 (DAS28).Distribution #1: Baseline standard deviation (sd) * √ 1 – Cronbach’s alphaDistribution #2: 0.5 * baseline sdMinimal detectable change (MDC): 1.96*2*SEM where SEM = baseline sd √1 - ICCResults:139 subjects were recruited (59 male, 80 female, mean (range) age (years) 52.7 (19 – 83), mean (range) duration of psoriasis (years) 21.9 (2 – 71), mean (range) duration of psoriatic arthritis (years) 6.1 (0 – 41). Cut-off values for low, moderate and high disease activity were 1.3, 2.4, and 4.8 for the 3 Vas and 1.6, 2.8 and 5.0 for the 4 VAS (Figure 1). Estimates for the MCID and MDC for the continuous composite measures and are reported in Table 1.Conclusion:We report estimates of clinically relevant improvements for continuous composite measures in PsA and estimates of low, moderate and high disease activity for the 3 and 4 VAS scales. The thresholds of meaning can now be tested in independent observational and clinical trial datasets.

P150 Hand-held dynamometry may provide a valid and objective method of muscle strength quantification in adult inflammatory myopathy: results from clinical practice in a tertiary centre

Abstract Background/Aims Accurate methods of muscle strength assessment are vital in the care of patients with idiopathic inflammatory myopathy (IIM). Manual muscle testing (MMT) is limited in quantification of strength and has a demonstrated 'ceiling effect'. Recent research has indicated that hand-held dynamometry (HHD) may provide a user-friendly and patient-acceptable method to quantify muscle strength without a ceiling effect. This study aims to demonstrate routine clinical application of HHD and explore the ability to predict physical function and patient-rated impact in a tertiary IIM cohort. Methods Data was collected from adult IIM patients attending a UK tertiary centre between 2016 and 2019. Bilateral HHD of knee extension, shoulder abduction and grip strength were measured by a single specialist physiotherapist. Data was also collected on function (Health Assessment Questionnaire [HAQ]), muscle strength (MMT-8) and global activity (patient global visual analogue scale [VAS]). Generalised linear modelling, adjusted for age and sex was used to quantify associations between HHD values of each movement and HAQ score, MMT-8 score and patient global activity VAS. Results Data was collected on 57 patients (60% female) with a mean age of 56 years (SD 13), mean HAQ of 1 (SD 0.85), and mean MMT-8 of 75 (SD 6) out of a maximum score of 80. Summary values of each collected measurement and modelling results are displayed in Table 1. All HHD measurements significantly correlated with HAQ, MMT-8 and patient global VAS scores. The greatest magnitude of association was seen with shoulder abduction. The collection of strength measures by the HHD method was tolerable and time-efficient for patient and clinician. Patient feedback on being able to see their objective strength measures on the HHD was also encouragingly positive, boosting their intrinsic motivation to take part in rehabilitation. P150 Table 1:Summary HHD strength values and modelling resultsMeasurement using HHDMean (SD) (kg)Association with HAQ - Coef (p-value)Association with MMT-8 - Coef (p-value)Association with patient global VAS - Coef (p-value)Grip strength22.98 (12.41)-0.04 (&amp;lt;0.01)0.26 (&amp;lt;0.01)-1.53 (&amp;lt;0.01)Shoulder abduction10.39 (5.51)-0.11 (&amp;lt;0.01)0.60 (&amp;lt;0.01)-2.74 (&amp;lt;0.01)Knee extension13.03 (7.17)-0.06 (&amp;lt;0.01)0.51 (&amp;lt;0.01)-1.53 (&amp;lt;0.01)SD = standard deviation, HAQ = Health Assessment Questionnaire, MMT-8 = manual muscle testing, VAS = visual analogue scale, Coef = coefficient, HHD = hand held dynamometry. Conclusion This study indicates that HHD may provide an inexpensive, user-friendly method of strength assessment in IIM patients, providing accurate insights into function, strength and global activity. Undertaking HHD in clinic and by a specialist physiotherapist allows for stratified, personalised rehabilitation intervention. Following future validation, HHD could form a method of objective muscle strength assessment, thus focusing IIM clinical care and research. Disclosure W.J. Gregory: Honoraria; W.G. has received honoraria from Abbvie, Pfizer and UCB. A. Oldroyd: None. H. Chinoy: None.

Assessment of loneliness in patients with inflammatory arthritis.

This study aimed to explore loneliness and associated factors in Turkish patients with inflammatory arthritis. Adult patients with rheumatoid arthritis (RA) (n=58), ankylosing spondylitis (AS) (n=53), and psoriatic arthritis (PsA) (n=30), respectively, were included in the study. A single-item visual analog scale (VAS) for loneliness, UCLA Loneliness Scale-8 (ULS-8), Beck depression inventory (BDI), Beck anxiety inventory (BAI), revised multidimensional scale of perceived social support, Health Assessment Questionnaire-Disability Index (HAQ-DI) were used for the psychometric and functional assessments. Multiple regression models were generated for predicting the ULS-8 and HAQ-DI scores. There was no difference between disease groups in terms of the ULS-8 and HAQ-DI scores. Among demographic and clinical parameters, only the education status and number of drugs used had associations with the ULS-8 score. Single-item VAS score for loneliness did not predict the ULS-8 score well. There were significant correlations between the ULS-8 and HAQ-DI, depression, anxiety, social support, and physician global VAS scores. Only the education status significantly predicted (β=-0.208) the ULS-8 score in multiple regression analysis (adjusted R2 =0.15, P<.001). Beck depression, anxiety, and patient global VAS scores remained significant for predicting the HAQ-DI after multiple regression with the covariates ULS-8, depression, anxiety, social support, patient and physician global VAS scores, and the number of drugs used (adjusted R2 =0.53, P<.001). Disease activity and the ULS-8 scores were not found to be associated in any disease group. Loneliness is associated with depression, anxiety, lack of social support, disability, higher number of drugs used, and lower education but not with disease activity in Turkish patients with RA, AS, and PsA. Perception and expression of loneliness vary according to the cultural background. Single-item scales for loneliness may lack reliability compared to the more comprehensive ULS-8.

Clinico-demographic Profile of Undifferentiated Inflammatory Arthritis Patients.

Undifferentiated inflammatory arthritis is a group of inflammatory joint diseases that do not fulfil the classification criteria for any other rheumatic or connective tissue disorders. This study aims to describe the clinical, demographic and serological features of undifferentiated inflammatory arthritis cases presenting at a tertiary level rheumatology centre from Nepal. A descriptive cross-sectional study conducted at National Centre for Rheumatic Diseases, Kathmandu, Nepal which represents a midterm analysis of the undifferentiated inflammatory arthritis registry maintained at the centre. Patients more than 18 years of age, who consented for the study having least one swollen or tender joint were enrolled. Ethical approval was obtained from Nepal Health Research Council. A total of 1120 patients were enrolled in the study out of which 941 (84%) were females. The mean age at diagnosis was 46.0±12.8 years and most of them were in overweight range (mean BMI: 27.0±5.8) with 818 (73%) patients having BMI more than 24.0. Patients mostly had low disease activity at presentation (DAS 28 score of 2.5±0.8). Other markers of inflammation and patient reported outcome measures (health assessment questionnaire, patient global assessment and visual analogue scale) were also in the moderate range. Seropositivity for anti-citrullinated peptides and anti-nuclear antibodies was seen in 5 (0.45%) and 43 (3.8%) patients respectively. Majority of patients were non-smokers (77%). Inflammatory arthritis on musculoskeletal ultrasonography was seen in 638 (57%). Undifferentiated inflammatory arthritis was more common in overweight females. Serological markers and smoking status are not common features in these patients.

AB0773 THE INCIDENCE OF RESIDUAL DISEASE ACTIVITY FOLLOWING DIVERSE DISEASE ACTIVITY MEASUREMENTS FOR PSORIATIC ARTHRITIS

Background:Due to the complex nature of psoriatic arthritis (PsA), diverse disease activity measures have been developed, the most common of which include Disease Activity Score for Psoriatic Arthritis (DAPSA), Minimal Disease Activity (MDA) and Very Low Disease Activity (VLDA). Recently, new composite measures have been developed such as Psoriatic Arthritis Disease Activity Score (PASDAS) and GRACE index. Due to different domains and assessments, even though these measures may indicate remission or low disease activity, residual disease activity (RDA) may persist.Objectives:The aim of this study was to evaluate RDA in patients with PsA.Methods:A total of 148 patients (105 female, 43 male; mean age 47.5 (SD:12.6) years) who met the CASPAR criteria for PsA were recruited. Demographic and clinical characteristics of patients were recorded, including pain visual analog scale (VAS), joint VAS, patient global VAS, and tender and swollen joint counts. Evaluations included the Leeds Enthesitis Index (LEI), Psoriasis Area and Severity Index (PASI), Psoriatic Arthritis Quality of Life (PsAQoL), Short-Form 36 Health Survey (SF-36) and Health Assesment Questionnaire (HAQ). Disease activity and remission were assessed using the DAPSA, MDA, VLDA, PASDAS and GRACE Index. MDA was calculated with 5 and 6 positivity criteria separately. Low disease activity (LDA) was defined as follows: DAPSA≤14, PASDAS≤3.2 and GRACE Index≤2.3. RDA was defined as the presence of at least one of the following criteria despite remission or LDA: tender and/or swollen joints &gt;1, dactilitis &gt;1, LEI&gt;1, HAQ&gt;0.5, PASI&gt;1, PtGA&gt;20, physician VAS&gt;20, or pain VAS&gt;15.Results:The mean duration of disease was 68.2 (SD:80.2) months. DAPSA-LDA, PASDAS-LDA, GRACE-LDA, MDA and VLDA were observed in 48.6%, 14.6%, 14.9%, 23.6% and 2% of PsA patients, respectively. RDA as determined by at least one domain was identified in 91%, 95%, 86% and 86% of patients who were classified as having MDA, DAPSA-LDA, PASDAS-LDA and GRACE-LDA, respectively. Undetected RDA was most common with DAPSA, whereas VLDA completely ruled out RDA. PASDAS and GRACE resulted in similar rates of RDA (Table-1). With DAPSA-LDA, the incidence of RDA in the pain domain was significantly lower with older age. Female patients had higher rates of RDA with the LEI and HAQ (p&lt;0.05).Conclusion:VLDA was the most and DAPSA was the least sensitive method to detect remission/LDA. RDA should be kept in mind in patients with PsA when using current measures to assess remission or LDA.

SAT0429 SECUKINUMAB IMPROVES CLINICAL AND PATIENT-REPORTED OUTCOMES AT 6 MONTHS AMONG PATIENTS WITH PSORIATIC ARTHRITIS IN THE US-BASED CORRONA PSORIATIC ARTHRITIS/SPONDYLOARTHRITIS (PsA/SpA) REGISTRY

Background:Secukinumab, an interleukin-17 antagonist approved for the treatment of PsA, improves all PsA manifestations in the GRAPPA-OMERACT core domain set.1Few US-based studies have evaluated the real-world effectiveness of secukinumab in patients with PsA.Objectives:To examine clinical and patient-reported outcomes (PROs) in patients with PsA enrolled in the Corrona PsA/SpA registry initiating secukinumab with ≥ 1 follow-up visit.Methods:Included were adult patients with PsA in the Corrona registry who initiated secukinumab after April 1, 2017 and remained on secukinumab at their 6-month (window, 5-8 months) follow-up visit. The primary outcome was achievement of minimal disease activity (MDA) at 6 months among patients not in MDA at secukinumab initiation. MDA was defined as meeting 5 of the 7 following criteria: tender joint count (TJC) ≤ 1, swollen joint count (SJC) ≤ 1, psoriasis affected body surface area (BSA) &lt; 3%, patient assessment of pain on visual analog scale (VAS) ≤ 15, patient global assessment VAS ≤ 20, HAQ-DI ≤ 0.5, and tender entheseal points ≤ 1 using the Leeds Enthesitis Index (LEI). Secondary outcomes included the proportion of patients who achieved resolution (0 sites) of TJC, SJC, enthesitis (using the LEI), and dactylitis among those with ≥ 1 site at initiation and improvement from baseline in clinical outcomes (BSA, nail psoriasis, physician global assessment, TJC, SJC, and DAPSA) and PROs (patient-reported pain, patient global assessment, HAQ-DI, and Work Productivity and Activity Impairment questionnaire) at 6 months. Outcomes were evaluated in the overall population and in potentially recalcitrant patients with failure of or intolerance to ≥ 3 previous biologics to examine if the later line biologic could be adequately effective.Results:A total of 100 patients with PsA who initiated and maintained secukinumab after 6 months were included. The mean (SD) age was 51.6 (11.6) years, 54.3% were male, and 96.8% were white. The mean (SD) symptom and disease duration were 10.8 (9.7) and 7.0 (7.0) years, respectively. Thirty patients (30.0%) initiated secukinumab 150 mg and 70 (70.0%) initiated secukinumab 300 mg. Most (83.0%) were biologic experienced; 17 patients initiated secukinumab as a 1st biologic, 34 as 2nd, 26 as 3rd, and 23 as ≥ 4th. At initiation, 75/90 patients (83.3%) were not in MDA; 26/71 (36.6%) of those with follow-up data available achieved MDA at 6 months (Figure 1). In the overall population, 28 patients (41.2%) with TJC ≥ 1, 24 (44.4%) with SJC ≥ 1, 17 (60.7%) with enthesitis, and 9 (75.0%) with dactylitis at initiation achieved resolution at 6 months (Table 1). Improvement was observed at 6 months in clinical outcomes and PROs in the overall population (Figures 1 and 2) and in patients who initiated secukinumab as a ≥ 4th-line biologic.Table 1.Resolution of Peripheral Arthritis, Enthesitis, and Dactylitis at 6 Months Among Patients With ≥ 1 Site at InitiationSecondary OutcomesInitiation,Mean (SD) [n]6-Month Follow-Up,Resolution (Count = 0), n (%)TJC (1-68)9.0 (9.7) [68]28 (41.2)SJC (1-66)4.7 (4.2) [54]24 (44.4)Enthesitis (1-6)1.9 (1.1) [28]17 (60.7)Dactylitis (1-20)2.1 (1.3) [12]9 (75.0)Conclusion:In the Corrona registry, most secukinumab initiators with PsA were biologic experienced and were not in MDA at time of initiation. Consistent with clinical trials, real-world patients treated with secukinumab achieved MDA as well as improvement in clinical manifestations, PROs, and work productivity.

Remission in psoriatic arthritis: Definition and predictors

ObjectiveTo determine the frequency of remission defined by the absence of the various disease manifestations of psoriatic arthritis (PsA) and identify predictors for remission. MethodsPatients followed at the PsA clinic between 2000 and 2015 were included. Patients are assessed at 6- to 12-month intervals according to a standard protocol. Remission was defined as a visit that patients had no tender or swollen joints, no inflammatory back pain, no tender entheseal sites, minimal skin involvement with BSA<1%, patient pain on visual analog scale (VAS) score of <15, patient global disease activity VAS score of <20, Health Assessment Questionnaire (HAQ) score <0.5. We used imputation approach to determine remission status for visits with incomplete criteria for each patient. ResultsData from 985 patients (57% males, average age of 47.4 years) were included in this study. From 2000 to 2015, 175 (18%) patients achieved remission at least once and 92 (9%) experienced sustained remission over at least 2 consecutive visits. In a multivariate Weibull regression analysis for the time to remission, higher BMI was associated with lower chance of remission (HR = 0.96, p = 0.012), while the use of biologics increased the chance of achieving remission (HR = 1.48, p = 0.034). The effect of biologics was also significant on the chance of achieving sustained remission for 2 or more consecutive visits (HR = 1.76, p = 0.020). However, biologics were not significantly associated with sustained remission when it was defined based on 3 or more consecutive visits. ConclusionRemission occurred at least once in 18% of the patients with PsA while sustained remission occurred in 9% of the study sample. Having higher BMI would reduce the achievement of remission. The use of biologic agents increased not only the chance of remission, but also the chance of sustained remission for at least 12 months.

Anti-interleukin-6 (tocilizumab) therapy in Takayasu's arteritis: a real life experience.

Background/aimTumour necrosis factor inhibitors and anti-interleukin-6 (anti-IL-6) therapies are increasingly being used in Takayasu’s arteritis (TA) patients who are unresponsive to corticosteroids ± conventional immunosuppressive agents. The aim of this study is to assess the efficacy and safety of anti-IL-6 (tocilizumab) therapy in refractory TA patients in real life.Materials and methodsFifteen TA patients (86.7% were female) who received at least 3 cycles of tocilizumab therapy were retrospectively assessed by clinical, laboratory, and radiological evaluations before and after tocilizumab therapy. ResultsThe median (min–max) age of the patients at evaluation was 35 (20–58) years and the median disease duration from diagnosis was 24 (12–168) months. The median (min.–max.) duration of follow-up after tocilizumab was 15 (3–42) months. There was a significant decrease in erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), and patient global visual analogue scale (VAS) scores of patients after tocilizumab therapy. The median (min.–max.) ESR was 26 (5–119) vs. 3 (2–49) mm/h, P = 0.02; CRP was 39.8 (2.4–149.0) vs. 7.9 (0–92.9) mg/L, P = 0.017; and patient global VAS was 50 (0–90) vs. 30 (0–60), P = 0.027, respectively. In 8 patients, ESR and CRP levels were in the normal range in the last control. Imaging modality results after tocilizumab were available for 9 patients; 8 patients were radiologically stable and regression was seen in 1 patient. Comparable imaging modality results before and after tocilizumab were available for 5 patients; 4 patients were radiologically stable and regression was seen in 1 patient. Radiological findings were consistent with laboratory responses. Glucocorticoid dosages decreased from a mean dosage of 16.2 (9.1) mg/day at baseline to 7.1 (3.8) mg/day (P = 0.001) at the last follow-up visit. There was no increase in the steroid dosage in any of the patients. All patients tolerated tocilizumab well. Conclusion Based on retrospective real life data, anti-IL-6 (tocilizumab) appears to be an effective and tolerable treatment option in refractory TA patients.

The American English version of the validated French Flare Assessment in RA Questionnaire (FLARE-RA).

To evaluate use of a British English version of the validated French FLARE-RA questionnaire among American English speaking patients. In addition, to create a culturally adapted American English (AmE) FLARE-RA questionnaire and to examine its attributes of patient-reported RA flare status. Using standardized cultural adaptation guidelines, we cognitively debriefed 25 American English speaking rheumatoid arthritis (RA) outpatients and created AmE-FLARE-RA with their input. One hundred three additional RA patients were recruited. Patients completed the Routine Assessment of Patient Index Data 3 (RAPID3), patient global visual analogue scale (VAS), AmE-FLARE-RA, and self-reports of flare. Physician global VAS, physician-assessed flare, swollen and tender joint count (TJC), and clinical disease activity index (CDAI) were documented. AmE-FLARE-RA and disease activity measures were compared between patient-reported and physician-reported flare categories. Patients were female (89%), with mean (SD) age 51.1 (± 15.3) years and mean disease duration (SD) 11.9 (± 10.1) years, with 26% in remission/low disease activity. Total AmE-FLARE-RA scores, RAPID3, CDAI, and patient global VAS were significantly higher for both patient-reported flares and physician-reported flares compared with non-flaring patients by self- or physician report (p< 0.05). Total AmE-FLARE-RA scores correlated significantly with RAPID3 (corr = 0.50, p< 0.0001) and with CDAI (corr = 0.45, p< 0.0001). Across "no flares," "one flare," and "several flare" groups, there was a non-significant increase in AmE-FLARE-RA scores (p= 0.07). The British English FLARE-RA was successfully adapted for AmE-speaking RA patients. AmE-FLARE-RA significantly correlated with RAPID3 and CDAI and distinguished between patient-reported and physician-reported flares, making it useful to detect flares in American RA patients.Key Points• The American English FLARE-RA (AmE-FLARE-RA) questionnaire is the result of cognitive debriefing with American RA patients using the British English version of the validated French FLARE-RA and incorporates patient-recommended language modifications..• Patients self-reporting flares had significantly higher AmE-FLARE-RA scores, compared with those without flares at the time of visit. AmE-FLARE-RA scores correlate with RAPID3 and CDAI.• There was a non-statistically significant trend using the AmE-FLARE-RA scores when examining patients with no flare, one flare, or several flares.• AmE-FLARE-RA total scores are uniformly elevated (~ 6.0 on a 0-10 scale), regardless of discordance between patient and MD assessment of flare at time of visit (~ 30%).

Discordance between doctor and patient assessments and non-adherence to subcutaneous biological drugs.

To estimate the agreement level between patient and physician assessment of disease activity and to explore whether agreement is associated with adherence to subcutaneous (SC) biological drugs in rheumatoid arthritis (RA). Cross-sectional study of RA patients who had been prescribed a SC biological drug in the past 12-18monthswas performed. Patients and physicians global disease activity on visual analogue scale (VAS) were collected. Disagreement was defined as an absolute difference ≥ 3 points between VAS scores. Adherence was assessed by the Medication Possession Ratio (MPR), considering adherence an MPR > 80%. We analysed 360 patients of whom 15.5% presented disagreement with their physicians. The mean patient global VAS was 5.75 ± 1.8 (median 5.5 [5-7]) in the disagreement group versus 2.7 ± 2.2 (median 2 [1-4]) in the agreement group (p < 0.001). There were also differences in physicians global VAS between groups (p = 0.01). The non-adherence to SC biological drugs rate was 10.7% and 14.5% in the disagreement and agreement groups (p = 0.45). No association between adherence and discordance was found. Disagreement in the global disease activity between patients and physicians was detected in 15.5% of patients. In general, patients perceived higher disease activity. No associations between patient-physician disagreement in VAS and adherence were observed.

Disability and health-related quality of life in Chinese patients with rheumatoid arthritis: A cross-sectional study.

The objective of this study was to evaluate the impact of rheumatoid arthritis (RA) on physical function and health-related quality of life (HRQoL) in China. A cross-section survey was conducted in 21 general hospitals in China. Eight hundred and seven patients were recruited. Data on demographics, clinical data, physical function (Stanford Health Assessment Questionnaire Disability Index, HAQ-DI) and HRQoL (Study Short Form 36 Health Survey, SF-36) were collected on site. In our cohort, physical function was impaired in 77.6% of patients (HAQ-DI >0). The median (interquartile range, IQR) of HAQ-DI was 0.750 (0.125, 1.500). Rated by HAQ-DI 0-1, >1-2, and >2-3, percentage of patients with mild, moderate and severe disability was 61.0%, 25.4%, and 13.6%, respectively. Older age, long disease duration, presence of extra-articular manifestations, tender joint count (TJC), overall status (assessed by patient Global Visual Analogue Scale [G-VAS] and physician G-VAS) and lacking disease-modifying anti-rheumatic drugs were identified as predictive factors for worse physical function (P<.05). The composite scores of SF-36 in the observed patients were: physical component summary 40.4 (IQR 27.4, 60.3), and mental component summary 49.0 (IQR 33.6, 70.9). Impaired physical health may be predicted by low income, presence of extra-articular manifestations, TJC, patient G-VAS and high HAQ-DI. Predictors for suboptimal mental health were low income, physical labor, married status, increased swollen joint count (SJC), physician G-VAS and high HAQ-DI. Rheumatoid arthritis has profound effects on physical function and HRQoL in Chinese patients. Patients with identified predictive factors for poor outcome should be closely monitored.

Cost-effectiveness of Different Intra-articular Drug Injections on Wrist and/or Elbow Compromise in Patients With Established Rheumatoid Arthritis: Short-term Results of an Open Observational Evaluation.

Intra-articular (IA) injections are an integral part of the management of rheumatoid arthritis (RA). However, there are few reports regarding the association between drug effectiveness and cost. The aim of this study was to assess the cost-effectiveness of various combinations of IA injections of betamethasone, hyaluronic acid (HA) or etanercept for oligoarthritis in RA. Seventy RA patients were assigned to 4 groups according to the IA injection drug(s): betamethasone alone, betamethasone + etanercept, betamethasone + HA, or etanercept alone. Data for the following were collected before and after IA injection: erythrocyte sedimentation rate, C-reactive protein (CRP), disease activity score in 28 joints calculated with CRP, and patient global visual analog scale. In addition, power Doppler ultrasonography and gray-scale ultrasonography scores were obtained for synovitis, and passive range of motion of joints was measured. Sixty-eight RA patients completed the trial. Compared with patients given etanercept alone, the visual analog scale, power Doppler ultrasonography, and gray-scale ultrasonography scores of each of the other groups were significantly better at each time point. At 1 month, the passive range of motion of joints in patients given betamethasone + HA was significantly better than that of each of the other groups. Synovial hyperplasia improved significantly in all groups, but less so in those given etanercept alone. All other clinical parameters of the 4 groups were similar. The costs per joint for the betamethasone-alone, betamethasone + etanercept, betamethasone + HA, and etanercept-alone groups were, respectively, $7.55, $181.77, $42.68, and $174.22. Intra-articular injection of betamethasone alone was the most cost-effective treatment for oligoarthritis of RA. Betamethasone combined with HA injection resulted in the best improvement in joint function.

An assessment of marital adjustment in patients with rheumatoid arthritis.

Aim To investigate marital adjustment in patients with rheumatoid arthritis and factors affecting this. Methods A total of 32 patients diagnosed with Steinbrocker class 1-2 rheumatoid arthritis and 32 healthy individuals from a similar age group were included. Sociodemographic characteristics, the Beck Depression Inventory (BDI), short-form 36(SF-36) and the dyadic adjustment scale (DAS) were evaluated in both groups. A visual analogue scale (VAS), the disease activity score 28(DAS28) and a health assessment questionnaire (HAQ) were also investigated in the patient group. Results Mean ages were 46.5±9.2 years in the patient group and 47.7±8.1 in the control group (p=0.5). No significant difference was determined between the two groups in terms of sociodemographic characteristics. No statistically significant correlation was observed between erythrocyte sedimentation rate (ESR), patient and physician global VAS, DAS28, HAQ and morning stiffness and DAS total score. Comparison of DAS subunits revealed a significant difference in dyadic satisfaction and affectional expression in the patient and control groups (p=0.046 and p=0.037). A statistically significant negative correlation was observed between duration of the disease and marital adjustment (p=0.01;r= -0.58). Conclusion Due to its progressive and prolonged course rheumatoid arthritis can also affect individuals' social relationships besides restricted daily living activities. Activation of rheumatoid arthritis did not affect marital adjustment in this study, but adjustment decreased with duration of the disease.

Disease Activity As a Major Determinant of Quality of Life and Physical Function in Patients With Early Axial Spondyloarthritis.

To describe health-related quality of life (HRQOL) and physical function in patients with early axial spondyloarthritis (SpA) and to assess their associations with disease activity and radiographic damage. This was a cross-sectional study drawing upon baseline data of axial SpA patients (Assessment of SpondyloArthritis international Society criteria) from the ESPERANZA cohort. Linear regression analyses were used to evaluate the associations between disease activity and radiographic damage (spine and sacroiliac joints) with HRQOL, physical function, and spinal mobility. In total, 259 patients were included. The mean ± SD age was 32.2 ± 6.9 years, disease duration was 13.3 ± 6.8 months, Ankylosing Spondylitis Quality of Life score was 5.9 ± 4.8, Bath Ankylosing Spondylitis Functional Index score was 2.4 ± 2.3, Bath Ankylosing Spondylitis Metrology Index score was 1.4 ± 1.3, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score was 3.8 ± 2.3, C-reactive protein (CRP) level was 9.7 ± 13.2 mg/liter, and Bath Ankylosing Spondylitis Radiology Index for the spine (BASRI-s) score was 1.7 ± 1.6. HRQOL was mainly associated with disease activity on univariate analysis (β values for BASDAI 0.646, patient global visual analog scale [VAS] 0.641, night back pain VAS 0.598, physician VAS 0.560, and CRP level 0.275; P < 0.01 for all), whereas the association with radiographic damage was weaker (standardized β for BASRI-s 0.142; P < 0.05). On multivariate models, HRQOL only remained significantly associated with disease activity (standardized β for BASDAI 0.330; P < 0.01, and physician VAS 0.205 and night back pain VAS 0.210; P = 0.01). Similarly, physical function was associated with disease activity and radiographic damage on univariate analysis, but only with disease activity (BASDAI β 0.466; P < 0.01) on multivariate analysis. However, spinal mobility was associated with radiographic damage in both univariate and multivariate analyses. Patients with axial SpA already have impaired quality of life and physical function, albeit mildly, at the beginning of their disease course. Both outcomes are mainly associated with disease activity in these patients.

Attainment of Minimal Disease Activity Using Methotrexate in Psoriatic Arthritis.

An international task force has recommended that disease remission or minimal disease activity (MDA) be the target of treatment for psoriatic arthritis (PsA) and that remission or MDA should be attained within 6 months of initiating medication. The aim of this study was to establish the proportion of patients with PsA who achieve MDA after 6 months of methotrexate (MTX) treatment. Patients who initiated MTX and were naive to biologics between 2004 and 2014 were included. The primary outcome was the achievement of MDA after 6 months of MTX, defined as the presence of at least 5 out of the following 7: tender joint count ≤ 1, swollen joint count (SJC) ≤ 1, Psoriasis Area Severity Index (PASI) ≤ 1 or body surface area ≤ 3%, tender entheseal points ≤ 1, Health Assessment Questionnaire score ≤ 0.5, patient global disease activity visual analog scale (VAS) score ≤ 20, and patient pain VAS ≤ 15. Of 204 patients identified, 167 were treated with MTX for at least 3 months and had sufficient data for analysis at 6 months. At 6 months, 29 patients (17.4%) achieved MDA; 97 patients (58.1%) achieved an SJC ≤ 1 and 138 (82.6%) a PASI ≤ 1. Only 22 (13.2%) achieved the patient global disease activity criterion. Lower back pain and dactylitis were associated with a lower probability of achieving MDA. MTX use achieves MDA by 6 months in < 20% of patients. This compares unfavorably with data for tumor necrosis factor inhibitor use.

Simultaneous Treatment with Subcutaneous Injection of Golimumab and Intra-articular Injection of Triamcinolone Acetonide (K-Method) in Patients with Rheumatoid Arthritis Undergoing Switching of Biologics: Retrospective Case-Control Study.

BACKGROUNDTight control of severe rheumatoid arthritis (RA) in patients with high disease activity, even when using biologics, is sometimes difficult using a treat-to-target strategy. Switching from one biologic to another is associated with lower efficacy than that in treatment-naive cases. We developed the K-method that involves simultaneous treatment with golimumab and intra-articular joint injection of triamcinolone acetonide (TA) in patients undergoing switching of biologics. We performed this retrospective case–control study to investigate the efficacy of achieving an immediate treatment response using the K-method.METHODSThis study involved 20 patients with RA (control group, 10 patients; K-method group, 10 patients). Patients in the control group were switched to golimumab from other biologics without intra-articular injection of TA. The K-method involved injection of 1 mL of TA (40 mg/mL) and 2 mL of 1% lidocaine hydrochloride into swollen or painful joints on the same day as golimumab treatment. A quick response one day after treatment was compared between the two groups according to the disease activity score 28 based on C-reactive protein (DAS28 CRP), clinical disease activity index (CDAI), simplified disease activity index (SDAI), European League Against Rheumatism (EULAR) response, and remission rate. These parameters were investigated for 24 weeks.RESULTSThe K-method group showed significant improvements in DAS28 CRP, CDAI, and SDAI at one day, 12 weeks, and 24 weeks compared with the control group. The number of swollen and tender joints and the patient and doctor global visual analog scale scores were also significantly different between the two groups. The remission rates based on DAS28 CRP were 30% at one day, 50% at 12 weeks, and 60% at 24 weeks in the K-method group. The EULAR good/moderate response rates were 80% at one day, 90% at 12 weeks, and 90% at 24 weeks in the K-method group; however, these rates were only 10%, 40%, and 40%, respectively, in the control group. No adverse events occurred in either group.CONCLUSIONSimultaneous treatment with biologics and intra-articular injection of TA is useful for cases involving switching of biologics for RA. This strategy is safe and practical for RA treatment.

Characteristics of regulatory B10 cells in patients with rheumatoid arthritis with different disease status.

In the present study, the frequency and function of B10 cells in patients with rheumatoid arthritis (RA) was examined. A total of 24 healthy controls and 97 patients with RA were enrolled in the present study. Among the 75 patients with an active disease status, 51 patients received either no treatment or were treated with non‑steroidal anti‑inflammatory drugs (NSAIDs) only, while 24 patients underwent a disease relapse. Flow cytometry was used to assess the frequency of CD19(+)CD24(hi)CD38(hi) interleukin (IL)‑10(+) cells stimulated by lipopolysaccharide plus CD40L for 48 h, followed by re‑stimulation with phorbol myristate acetate and ionomycin for 5 h. The correlation of CD19(+)CD24(hi)CD38(hi)IL‑10(+)‑cell frequency with clinical/laboratory characteristics and with levels of inflammatory cytokines were assessed along with the effects of CD19(+)CD24(hi)CD38(hi) cells on the proliferation and tumor necrosis factor α expression of CD3+ T cells. The median frequency of IL‑10‑competent cells among the CD19+ B cells was significantly increased among patients with RA with active disease. However, a sub‑group of patients with a high disease status that received no treatment/NSAIDs exhibited a significantly lower frequency (≤1% IL‑10+ B cells). These patients exhibited longer symptom duration, a greater number of tender and swollen joints and a higher patient global visual analogue scale and disease activity score in 28 joints‑C reactive protein. Functional assays further demonstrated that B10 cells from the sub‑group with ≤1% IL‑10+ B cells secreted significantly lower levels of IL‑10 and exerted a significantly decreased suppressive effect on CD3+ T-cell proliferation and tumor necrosis factor‑α production. The frequency and functional heterogeneity of B10 cells in patients with RA at different disease stage suggested that further investigation on the underlying mechanism of the generation and function of B10 cells in patients with RA is required prior to use in clinical practice.