Simplified Disease Activity Index Research Articles

The effect of concomitant hand osteoarthritis on pain and disease activity in patients with rheumatoid arthritis

IntroductionPain is a core complaint among rheumatoid arthritis (RA) patients, and persistent pain requires treatment adjustments according to current strategies. We aimed to quantify the impact of hand osteoarthritis (OA) on health status and residual pain in patients with RA.MethodsThis cross-sectional survey compared RA patients with and without osteoarthritis of the hand. The main outcome was pain intensity. Other measurements included disease activity scores (the Disease Activity Score 28-joints; the Simplified Disease Activity Index, SDAI; the Clinical Disease Activity Index, CDAI), functional disability and self-reported quality of life, and the proportion of patients with residual pain (Patient Acceptable Symptom State, PASS).ResultsEighty-one patients were analyzed, including 39 with RA and OA and 42 with RA only. The patients were mainly women (94%), with a median disease duration of 13 years. This group also reported a higher intensity of pain (visual analogue scale, VAS 70 mm vs. 30 mm; p = 0.003), higher disease activity (3.89 vs. 2.88; p = 0.001), and greater functional disability irrespective of treatment and comorbidities. A strong correlation (r2 = 0.69; p < 0.001) between pain and disease activity was observed, although no differences in pain were observed between groups according to disease activity categories. Patients with RA and OA had a higher proportion of residual pain (59% vs. 29%; p = 0.006) even in the absence of clinical inflammation.ConclusionThe coexistence of RA and hand OA is associated with distorted disease activity measurements in RA. Osteoarthritis contributes to persistent pain and greater disability in patients with RA.

Clinical deep remission and related factors in a large cohort of patients with rheumatoid arthritis.

Background:Clinical remission is the treatment target in rheumatoid arthritis (RA). This study aimed to investigate clinical remission and related factors in a large cohort of patients with RA.Methods:This study composed of 342 patients with RA. Data were collected by face-to-face interview of 1049 patients with RA who visited the Department of Rheumatology of three teaching hospitals from September 2015 to May 2016. The patients with RA were clinically assessed by rheumatologists and a four-page questionnaire was completed on site. Subsequently, patients fulfilled remission criteria were further analyzed. The practicability of different definitions of remission of RA was rated by a panel of rheumatologists. Sustained intensive disease modifying anti-rheumatic drug (DMARD) treatment was defined as a combination treatment with two or more DMARDs for at least 6 months.Results:In this cohort of 342 patients with RA, the proportions of patients achieving remission were 38.0%, 29.5%, 24.9%, 21.1%, 19.0%, 18.1%, and 17.0%, based on criteria of disease activity score in 28 joints (DAS28) using CRP (DAS28-CRP), DAS28 using ESR (DAS28-ESR), routine assessment of patient index data 3 (RAPID-3), Boolean, simplified disease activity index (SDAI), clinical disease activity index, and the newly described clinical deep remission (CliDR), respectively. Boolean and CliDR are the best in practicability scored by rheumatologists (7.5 and 8.0, respectively). Compared with the non-sustained intensive group, sustained intensive treatment with DMARDs yielded higher remission rates of 25.6%, 23.8%, and 21.3% in patients with RA based on Boolean (χ2 = 3.937, P = 0.047), SDAI (χ2 = 4.666, P = 0.031), and CliDR criteria (χ2 = 4.297, P = 0.038). The most commonly prescribed conventional synthesized DMARDs (csDMARDs) in patients with RA was leflunomide, followed by methotrexate, and hydroxychloroquine. Compared with the non-remission group, patients achieving remission had a longer median duration of DMARDs (45.0 [22.8–72.3] months, Z = −2.295, P = 0.022).Conclusions:The findings in this study indicated that clinical deep remission is achievable in patients with RA. Sustained intensive DMARD treatment is needed to achieve a better outcome in RA.

Measurement of Disease Activity in Ecuadorian Patients with Rheumatoid Arthritis: Does RAPID3 Correlate with Traditional Indexes?

Objective The aim of this study is to demonstrate if routine assessment of patient index data 3 has a correlation with disease's activity as much as disease activity score 28, clinical disease activity index, and simplified disease activity index in Ecuadorian patients with rheumatoid arthritis seen in Unidad de Enfermedades Reumáticas y Autoinmunes [UNERA] from December 2016 to December 2017. Methods This is a retrospective study in 200 patients that fulfill the American College of Rheumatology 2010 criteria for diagnosis of rheumatoid arthritis. The patients were evaluated from December 2016 to December 2017. Descriptive analyses were carried out, also Pearson correlation was used, and, to give a better clinical significance, a chi-square test was conducted. Whenever assumptions of chi-square test were violated, a Fisher's exact test was reported. Results RAPID3 correlated best with DAS28 (r.83, p < 0.001), followed by CDAI (r.80, p < 0.001) and then SDAI (r.77, p < 0.001). Conclusion RAPID3 is a questionnaire that only takes 10 seconds to calculate and correlates in a significant way with traditional clinical measures that require more time to perform, saving time in busy health facilities.

Mediastinal and axillar lymphadenopathy in patients with rheumatoid arthritis: prevalence and clinical significance

BackgroundWith recent advances of biological disease-modifying antirheumatic drugs, chest CT has been increasingly performed in rheumatoid arthritis (RA) patients, and mediastinal/axillar lymphadenopathy is being detected. PurposeTo determine the prevalence of mediastinal and axillar lymph node enlargements on chest CT in RA patients at the initial diagnosis, and to assess its clinical significance. Material and methodsWe retrospectively reviewed the medical records and chest CT findings of 78 consecutive RA patients. The short axis of the most enlarged lymph nodes (SLN) on CT was measured for the mediastinal and axillar regions separately. The SLN was classified into two groups: Group 1, 10 mm or less; and Group 2, larger than 10 mm. ResultsGroup 2 was observed in 13 of 78 patients (17%) for the mediastinum, and in 29 (37%) for the axilla; 11 patients (14%) showed Group 2 for both regions. The Group 2 patients (n = 31), either mediastinum or axilla, showed significantly higher simple disease activity index (SDAI) (mean, 36.0) than the patients of Group 1 (n = 47; mean SDAI, 23.0) (p < 0.001). For the mediastinal SLN, the RA-related lung disease was more frequently observed in the Group 2 patients than in the Group 1 (p = 0.036). ConclusionThe mediastinal and/or axillar lymphadenopathy on chest CT may reflect the activity of RA. The mediastinal lymphadenopathy also seems to relate to the RA-related lung disease.

Usefulness of composite indices in the assessment of joint involvement in systemic lupus erythematosus patients: correlation with ultrasonographic score.

Specific indices are not available to evaluate systemic lupus erythematosus (SLE) joint involvement; indeed, the application of indices validated for rheumatoid arthritis has been suggested. We evaluated the usefulness of organ specific composite indices, i.e. the Disease Activity Score on 28 joints (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), and the ratio of swollen to tender joints (STR), to assess SLE joint activity by analyzing the correlation between these indices and ultrasonography (US) inflammatory status. We evaluated SLE patients with arthralgia and/or arthritis: the above-mentioned indices were calculated and the SLE Disease Activity Index 2000 (SLEDAI-2k) was applied to assess global disease activity. US of I-V metacarpophalangeal, I-V proximal interphalangeal, wrist, and knee bilateral was performed. Synovial effusion/hypertrophy and power Doppler findings were scored according to a semi-quantitative scale (0-3) to obtain an inflammatory total score (0-216). One hundred and six patients (M/F 7/99, median age 49.5 years (IQR 17.0), median disease duration 8.5 years (IQR 17.0)) were enrolled. We identified a positive correlation between US score and DAS28-CRP ( r = 0.3, p = 0.007), STR ( r = 0.42, p = 0.0005), SDAI ( r = 0.33, p = 0.02), CDAI ( r = 0.29, p = 0.03); US score reflected different levels of clinimetric joint activity. In conclusion, we suggest the ability of composite indices in detecting SLE joint inflammation and their possible real-life use.

Effect of periodontal therapy on disease activity in patients of rheumatoid arthritis with chronic periodontitis

BackgroundEvidence have been proposed a positive association between severity of Periodontitis and Rheumatoid arthritis (RA) activity, individuals with advanced RA are more likely to develop periodontal problems compared to their non-RA counterparts, and vice versa. Studies have been suggested that RA manifest as a result of an inflammatory imbalance and autoimmunity. In this perspective, treatment modalities that lead to inhibition of proinflammatory mediators, may prove beneficial for reducing the severity of RA. This study examined the effects of non surgical periodontal therapy (NSPT) on disease activity of RA. MethodsDiagnosed patients of active rheumatoid arthritis with chronic periodontitis were recruited in this study and divided in to treatment and controls groups, both groups were similar in all demographics assessed. Treatment group (n = 20) and controls group (n = 20) underwent assessment for periodontal clinical parameters (plaque index, gingival index, probing pocket depth, clinical attachment level), Rheumatologic clinical (simplified disease activity index) and biochemical parameters(C-reactive protein, Rheumatoid factor, Anti-cyclic citrullinated protein) at baseline and 8 weeks. Serum levels of biochemical parameters were measured by enzyme-linked immunosorbent assay (ELISA). ResultsThe statistically significant (p < 0.001) reduction observed in mean values of PI, GI, PPD, CAL, SDAI in treatment group at 8weeks after NSPT as compare to control group. However serum level of ACCPA, CRP and RF did not show statistically significant (p > 0.05) changes from baseline to reassessment (8 weeks) in both groups. ConclusionsThe improvement in RA disease activity may occurs after non surgical periodontal therapy.

Simplified disease activity changes in real-world practice: a nationwide observational study of seropositive rheumatoid arthritis patients with moderate-to-high disease activity.

Background/AimsThe objective of this study was to compare changes in the simplified disease activity index (SDAI) between biologic (b) and conventional (c) disease-modifying antirheumatic drugs (DMARD) users with seropositive rheumatoid arthritis (RA) in daily clinical practice.MethodsThis was a nationwide multicenter observational study. Patients who had three or more active joint counts and abnormal inf lammatory marker in blood test were enrolled. The selection of DMARDs was determined by the attending rheumatologist. Clinical parameters, laboratory findings, and Health Assessment Questionnaire (HAQ) scores were obtained at baseline and at 6 and 12 months. Serial SDAI changes and clinical remission rate at 6 and 12 months were assessed.ResultsA total of 850 patients participated in this study. The mean baseline SDAI score in bDMARD group was higher than that in cDMARD group (32.08 ± 12.98 vs 25.69 ± 10.97, p < 0.0001). Mean change of SDAI at 12 months was –19.0 in the bDMARD group and –12.6 in the cDMARD group (p < 0.0001). Clinical remission rates at 12 months in bDMARD and cDMARD groups were 15.4% and 14.6%, respectively. Patient global assessment and HAQ at 12 months were also significantly improved in both groups. Multivariate logistic regression showed that baseline HAQ score was the most notable factor associated with remission.ConclusionsThere was a significant reduction in SDAI within 12 months after receiving DMARDs in Korean seropositive RA patients irrespective of bDMARD or cDMARD use in real-world practice. Clinical remission was achieved in those with lower baseline HAQ scores.

Clinical efficacy of the rituximab biosimilar Acellbia® 600 mg in patients with active rheumatoid arthritis in clinical practice

Objective: to evaluate the clinical efficacy of the rituximab biosimilar Acellbia® at a dose of 600 mg intravenously at a 2-week interval in patients with active rheumatoid arthritis (RA) 12 and 24 weeks after initiation of treatment.Subjects and methods. Examinations were made in 20 active seropositive RA patients who had not been previously treated with biological agents (BAs), but received two infusions of the rituximab biosimilar Acellbia® at a dose of 600 mg intravenously at a 2-week interval during stable therapy with methotrexate (MT) and glucocorticoids (GCs). The European League Against Rheumatism (EULAR) response criteria (Disease Activity Score 28 (DAS28), Clinical Disease Activity Index (CDAI), and Simplified Disease Activity Index) and the American College of Rheumatology (ACR) criteria were used to evaluate the efficiency of Acellbia® therapy. Disease remission was identified by DAS28 and 2011 ACR/EULAR criteria. The safety profile (the frequency of all reported adverse events) corresponds to the data on the safety of rituximab (MabThera®).Results and discussion. At the time of inclusion, median DAS28 was 5.6 [4.9; 6.8], SDAI – 27.1 [23.0; 39.9], and CDAI – 26.6 [22.2; 37.0]. At week 12 after initiation of Acellbia® therapy, they decreased to 4.2 [3.24; 4.75], 14.4 [8.5; 20.7], and 13.2 [7.9; 19.0] respectively, which remained at 24-week follow-up (p&lt;0.01). At week 12, the frequencies of ACR 20%, 50%, 70% improvements were 70, 55, and 5%; at week 24, these were 75, 45, and 15%, respectively. A good or moderate EULAR response at week 24 was observed in 25 and 60% of patients, respectively. At week 24, DAS28, SDAI, and CDAI remissions were achieved by 4 (20%), 2 (10%), and 1 (5%); low disease activity – by 4 (20%), 5 (25%), and 6 (30%) patients, respectively; high disease activity as measured by SDAI and CDAI remained in 3 (15%) patients. Two patients (10%) met the 2011 ACR/EULAR remission criteria at 24 weeks.Conclusion. The rituximab biosimilar Acellbia® 600 mg used in patients with active seropositive RA is clinically effective and comparable in the safety profile as shown in investigations of the brand-name MabThera® (F. Hoffman-La Roche Ltd., Switzerland) at a low dose (500 mg), as well as the first BA.

Influence of seasonal changes on disease activity and distribution of affected joints in rheumatoid arthritis

BackgroundPrevious studies suggest that RA activity is sensitive to seasonal changes. This study explored the influence of season on RA activity, particularly the distribution of affected joints, using a nationwide database in Japan.MethodsWe investigated 12,839 patients whose RA activity was recorded in spring (n = 3250), summer (n = 916), fall (n = 1021), and winter (n = 7652). Disease activity score (DAS) 28-CRP, simplified disease activity index (SDAI), and clinical disease activity index (CDAI) were used as indices of disease activity. Disease activity was also assessed according to DAS28-CRP scores (remission, low, moderate, or high). The affected joint distribution was investigated using novel joint indices (x, y, z), where x and y are indices for the upper and lower joints, respectively, and z is the index for large joint predominance.ResultsMean DAS28-CRP and median SDAI and CDAI scores were highest in spring and lowest in fall. There was a significant difference in the DAS28-CRP for fall versus spring and winter. Fall was associated with a higher remission rate, and spring and winter with high and moderate RA activity, respectively. Significant differences in x, y, SDAI, and CDAI scores were found for spring versus summer, fall, and winter, in addition to fall versus winter (except in y). There was no seasonal difference in the z index.ConclusionsRA activity in the upper and lower extremities may be highest in spring, followed by winter. Seasonal changes should be considered in patients with RA to better understand their symptoms.

A Study of Correlation of Disease Severity with Antibody Titers in Rheumatoid Arthritis

Introduction: Rheumatoid Arthritis (RA) is one of the most frequent autoimmune diseases in the world which affects about 1% of people. Anti-Cyclic Citrullinated Peptides (Anti-CCP) is shown to be more specific than rheumatoid factor in the diagnosis of RA. This test becomes positive in early stage of disease and it has a high predictive value. Aim: To correlate the relationship between anti-CCP antibody and rheumatoid factor titers and disease activity scores. Materials and Methods: A cross-sectional study was performed in 50 patients with RA for evaluating the relation between anti-CCP antibody titer and Disease Activity Score 28 (DAS28), Simplified Disease Activity Index (SDAI) and Clinical Disease Activity Index (CDAI). A detailed examination of each patient including their demographic characteristics, duration of disease, number of tender and swollen joints, ESR and C-reactive protein, patient’s and physician’s global assessment by VAS (0-10) and titers of rheumatoid factor and nti-CCP antibody. Patients who fulfilled the ACR-EULAR 2010 criteria were included. The statistical analysis was done using Pearson’s correlation coefficient. A p-value of less than 0.05 was considered significant. Results: Of the 50 patients which were included (mean age, 44.82 range, 18-70), 38 were females and 12 were males. Mean ESR was 54±27 mm/hr and Mean CRP was 17.277±23.41 mg/dL. Mean DAS 28 was 5.955±0.962; mean SDAI was 46.9±27.1 and CDAI 28.9±10.8. There was positive correlation (p<0.001) between DAS28 and SDAI (r=0.550) and CDAI (r=0.808). Anti-CCP level was associated with SDAI (r=0.317) and CDAI (r=0.282) (p<0.05). Conclusion: There was significant correlation in the titers of anti-CCP and disease activity indices-SDAI and CDAI. Patients with higher levels of anti-CCP antibody had greater activity.

Validity and interpretability of the QuickDASH in the assessment of hand disability in rheumatoid arthritis.

Objective of this study is to evaluate the construct validity and the interpretability of the shortened Disability of Arm, Shoulder and Hand Questionnaire (QuickDASH) in the assessment of rheumatoid arthritis (RA) hand disability. Consecutive RA patients were assessed through the QuickDASH and other function and disease activity indices, respectively, the Health Assessment Questionnaire-Disability Index (HAQ-DI) and the Recent-Onset Arthritis Disability questionnaire (ROAD). For each patient were evaluated the tender and swollen 28-joints counts. Interpretability was defined determining cut-off points of impairment in accordance to the Simplified Disease Activity Index (SDAI) definition of disease activity states. A total of 440 patients (89 men and 351 women, mean age of 57.0 ± 12.7years) were enrolled. Following the SDAI definition, 98 patients (22.3%) resulted in REM, 115 subjects (26.1%) in LDA, 74 patients (16.8%) in MDA, and 153 subjects (34.8%) in HDA. Mean QuickDASH differed significantly between patients classified as remission (REM), low disease activity (LDA), moderate disease activity (MDA), or high disease activity (HDA) (p < 0.001). High correlations were found comparing QuickDASH to composite indices of disease activity and of physical health function: of special interest are the correlations between the comparable dimension of the QuickDASH and the ROAD Upper Extremity Function (rho = 0.876; p < 0.001). The cut-off points for functional categories (SDAI categories as external criterion) resulted: no impairment ≤ 13, 13 < low impairment ≤ 18.5, 18.5 < moderate impairment ≤ 31.5, and high impairment > 31.5. QuickDASH is useful in clinical practice, for its ease of administration, and positively correlates with the disease activity. It may be a surrogate for evaluating upper extremity impairment, disability index and disease control in RA patients.

Abatacept in combination with methotrexate in Japanese biologic-naive patients with active rheumatoid arthritis: a randomised placebo-controlled phase IV study

ObjectivesTo evaluate efficacy and safety of abatacept+methotrexate (MTX) in biologic-naive, anticitrullinated protein antibody (ACPA)-positive Japanese patients with active rheumatoid arthritis (RA) and early erosion versus placebo+MTX.MethodsIn this phase IV, multicentre,...

Real World Experience of Disease Activity in Patients With Rheumatoid Arthritis and Response to Treatment With Varios Biologic DMARDs.

The current study investigate the disease activity and effectiveness of treatment in patients with RA on biological disease modifying antirheumatic drugs (bDMARDs) in combination with a conventional synthetic DMARD (csDMARD) and determine whether or not the benefits of different therapies were sustained over a follow up period of 1 year. 124 patients were selected with a mean age 55.26 ± 13, 18SD years, meeting the 1987 ACR and /or ACR/ EULAR (2010) classification criteria for Rheumatoid arthritis (RA). Patients were arranged according to treatment regimens: Tocilizumab (TCL) – 30 patients, Certolizumab (CZP) – 16, Golimumab (GOL) – 22, Etanercept (ETN) 20, Adalimumab (ADA) 20, Rituximab (RTX) – 16. Disease activities was the primary concern. Independent joint assessor evaluated 28 joints on baseline, 6th and 12th month’s thereafter. C-reactive protein (CRP) was used to measure the inflammatory process. DAS28-CRP, clinical disease activity index (CDAI) and simplified disease activity index (SDAI) were calculated. On baseline all of the patients’ groups had severe disease activity (mean DAS28-CRP > 5.2, mean CDAI > 22, mean SDAI > 26. It was noted that, during the 6th month follow-up period all of the treatment groups significantly decreased DAS28-CRP, CDAI, SDAI and reach moderate disease activity. After 6th and 12th months of treatment all of the groups on bDMARDs had significantly lower disease activity. The GOL group reach remission only according to DAS28-CRP: 2.49 ± 0.76, and low disease activity as measured by CDAI: 6.78 ± 4.51 and SDAI 7.80 ± 5.67. The other 5 groups after 12 months reach the level of low disease activity according to the three activity parameters: DAS28-CRP (TCL 3.07 ± 0.73, CZP 3.06 ± 0.65, ETN 2.85 ± 0.55, ADA 3.15 ± 0.82, RTX 2.90 ± 0.70), CDAI (TCL 9.80 ± 4.91, CZP – 9.33 ± 4.22, ETN 7.97 ± 3.80, ADA 10.00 ± 5.25, RTX 7.48 ± 2.99) and SDAI (TCL 10.45 ± 5.14, CZP 9.94 ± 4.43, ETN 9.03 ± 4.25, ADA 10.50 ± 5.61, RTX 8.08 ± 3.24). The therapy with different bDMARDs added to a csDMARD led to very similar results – a minimal disease activity and a state of remission in the GOL treatment group only as per DAS28-CRP.

2-D speckle-tracking assessment of left and right ventricular function in rheumatoid arthritis patients with and without disease activity

ObjectivesDisease activity has been considered as independent cardiovascular risk factor in rheumatoid arthritis (RA) patients. We aimed to evaluate the effect of RA disease activity on left ventricular (LV) and right ventricular (RV) functions by speckle tracking echocardiography (STE). Methods120 patients with RA without evidence of cardiovascular disease and 40 healthy control subjects were included. Disease activity was evaluated according to Simplified Disease Activity Index (SDAI) score and Disease Activity Score 28 (DAS28). LV and RV functions were assessed using conventional echocardiography and global longitudinal strain (GLS) technique measured by STE. Results81 patients had active disease while 39 patients were in remission. The LV and RV GLS value for active RA patients was reduced compared to RA patients in remission and control group (p = <0.001). There was a significant correlation between RA disease activity scores level and LV GLS value, increasing levels of disease activity was associated with worse LV GLS (r = −0.802, p value = <0.001) and r = −0.824, p value = <0.001) for SDAI and DAS28 scores respectively. Also, there were significant correlations between RA disease activity scores level and RV GLS value as the disease activity level increases the RV GLS value become worse (r = −0.682, p value = <0.001) and r = −0.731, p value = <0.001) for SDAI and DAS28 scores respectively Receiver operating characteristic (ROC) curve analysis showed that SDAI score and DAS28 were predictive for reduced LV GLS with a cut off value of >7 and >2.8 respectively with sensitivity of 77.6%, specificity of 85.0% and area under ROC curve = 90.4 for SDAI score and with sensitivity of 89.7%, specificity of 71.7% and area under ROC curve = 89.4 for DAS28 score. Also, SDAI score and DAS28 were predictive for reduced RV GLS with a cut off value of >11 and >3 respectively with sensitivity of 73.1%, specificity of 93.5% and area under ROC curve = 91.6 for SDAI score and with sensitivity of 84.6%, specificity of 80.4% and area under ROC curve = 90.8 for DAS28 score. ConclusionDisease activity in patients with rheumatoid arthritis is associated with lower left and right ventricular function. Disease activity scores can predict subclinical left and right ventricular dysfunction.

Effect of medication adherence on disease activity among Japanese patients with rheumatoid arthritis.

For the optimum efficacy of disease-modifying anti-rheumatic drugs (DMARDs), patients need to be adherent to their medication regimen. To clarify the effects of medication adherence on disease activity in Japanese patients with rheumatoid arthritis (RA), we conducted a cohort study in patients with various stages of RA. Patients were enrolled from the Kyoto University RA Management Alliance cohort, and followed up prospectively for 12 months. In this study, a total of 475 patients were analyzed and divided into 9 groups according to their medication adherence and the RA disease duration. The primary outcomes were based on the rate of a disease flare. The secondary outcomes were the changes in disease activity score using 28 joints (DAS28-ESR), simplified disease activity index (SDAI) and physical disability by health assessment questionnaire-disability index (HAQ). The changes in DAS28-ESR, HAQ, and the risk of disease flare in the highly adherent patients were significantly lower than those of the less adherent patients among the groups with RA ≤ 4.6 years but not those among the other groups. Taken together, this study identified a significant association between medication adherence and the disease flare during early-stage RA or short disease duration. These results emphasize the need to pay more attention to medication adherence in preventing the disease progression of RA.

Long-term prognosis and quality of life in patients with early rheumatoid arthritis treated according to the 2015 ACR guideline (LELAND): protocol for a multicentre prospective observational study in Southern China

IntroductionRheumatoid arthritis (RA) is a chronic systemic disease and one of the most disabling diseases for patients. The American College of Rheumatology (ACR) issued a new guideline in 2015 for...

Real-World Tocilizumab Use in Patients with Rheumatoid Arthritis in Canada: 12-Month Results From an Observational, Noninterventional Study.

IntroductionThis study was conducted to observe patterns of use of the interleukin-6 receptor-alpha inhibitor tocilizumab in routine clinical practice in patients with rheumatoid arthritis (RA).MethodsThis was a 12-month noninterventional, observational study in adult patients with RA who initiated tocilizumab in routine practice in Canada according to the local product monograph. The primary end point was the proportion of patients receiving tocilizumab at 6 months. Secondary end points were treatment patterns, effectiveness, and safety of tocilizumab over 12 months.ResultsOf 200 patients who initiated tocilizumab (91.0% at 8 mg/kg), 67 (33.5%) received tocilizumab monotherapy and 133 (66.5%) received tocilizumab combined with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs). Kaplan–Meier analysis estimated that 85% (95% CI 74–92%) of monotherapy and 89% (95% CI 82–93%) of combination therapy patients continued to receive tocilizumab at 6 months (log-rank p = 0.0888). During the observation period, 12 (17.9%) monotherapy and 27 (20.3%) combination therapy patients withdrew from the study. At month 12, 58.5% in the monotherapy group and 59.3% in the combination therapy group achieved Disease Activity Score at 28 joints remission (≤ 2.6), 25.6% and 24.7% achieved Simplified Disease Activity Index remission (≤ 3.3), and 18.2% and 22.3% achieved Clinical Disease Activity Index remission (≤ 2.8), respectively. Rates of serious adverse events and serious infections were found in 29.6/100 patient-years (PY) and 3.1/100 PY, respectively, for monotherapy and 19.2/100 PY and 4.8/100 PY, respectively, for combination therapy.ConclusionsPatients initiating tocilizumab in routine practice had comparable effectiveness and safety outcomes regardless of whether they received tocilizumab as monotherapy or as combination therapy with csDMARDs.Trial RegistrationClinicalTrials.gov identifier, NCT01613378FundingF. Hoffmann-La Roche (Roche) Canada.Electronic supplementary materialThe online version of this article (10.1007/s40744-018-0130-6) contains supplementary material, which is available to authorized users.

Joint index vector: a novel assessment measure for stratified medicine in patients with rheumatoid arthritis

ObjectiveTo predict the next-year status in patients with rheumatoid arthritis using big data.MethodsJoint index (JI) of upper/large (UL), upper/small (US), lower/large (LL), and lower/small (LS) was calculated as the sum of tender and swollen joint counts divided by the number of evaluable joints in each region of interest. Joint index vector V (x, y, z) was defined as x = JIUL + JIUS, y = JILL + JILS, and z = JIUL + JILL − JIUS − JILS. Low disease activity was defined as |Vxy| (= √x2 + y2) ≤ 0.1. Patients with |Vxy| > 0.1 were further classified into three groups: evenly affected (EVN): |z| ≤ 0.2, small joint dominant (SML): z < − 0.2, and large joint dominant (LAR): z > 0.2. To predict the next-year V (x, y, z) of each patient, a transformation matrix was computed from the mean vectors of the EVN, SML, and LAR groups and their translation vectors.Results|Vxy| was correlated with Simplified Disease Activity Index (SDAI) (r = 0.82). Z of mean vector increased as the disability index of the Health Assessment Questionnaire (HAQ-DI) and the Steinbrocker class worsened. The LAR group had the worst HAQ-DI and the second highest SDAI after those in the SML group. Positive predictive value and likelihood ratio in predicting the LAR group were 58.7% and 5.9, respectively. Likelihood ratio was greater with treatment, at 7.2, 7.4, and 8.6 when targeted patients were treated with methotrexate, biologics, and both drugs, respectively.ConclusionsPatients with high disease activity and poor functional state were predicted with high probability using joint index vectors.

Predicting achievement of the treatment targets at 6 months from 3-month response levels in rheumatoid arthritis: data from real-life follow-up in the NOR-DMARD study

ObjectiveWhen initiating a new therapy in patients with rheumatoid arthritis (RA), current treatment recommendations suggest escalating therapy in case of poor clinical improvement by 3 months or if the treatment...

Can disease activity in patients with psoriatic arthritis be adequately assessed by a modified Disease Activity index for PSoriatic Arthritis (DAPSA) based on 28 joints?

ObjectiveTo test the psychometric performance of a modified Disease Activity index for PSoriatic Arthritis (DAPSA) using 28 instead of 66 swollen/68 tender joint counts (SJC/TJC).MethodsWe included patients with psoriatic arthritis...