scholarly journals SAT0395 RESPONSIVENESS AND CLINICAL TRIAL DISCRIMINATION OF SWOLLEN AND TENDER JOINT COUNTS FOR THE MEASUREMENT OF MSK DISEASE ACTIVITY IN PSORIATIC ARTHRITIS

Author(s):  
Ali Duarte-Garcia ◽  
Lihi Eder ◽  
Niti Goel ◽  
Maarten de Wit ◽  
Dafna D. Gladman ◽  
...  
2009 ◽  
Vol 36 (12) ◽  
pp. 2635-2641 ◽  
Author(s):  
JENNIFER L. BARTON ◽  
LINDSEY A. CRISWELL ◽  
RACHEL KAISER ◽  
YEA-HUNG CHEN ◽  
DEAN SCHILLINGER

Objective.Patient self-report outcomes and physician-performed joint counts are important measures of disease activity and treatment response. This metaanalysis examines the degree of concordance in joint counts between trained assessors and patients with rheumatoid arthritis (RA).Methods.Studies eligible for inclusion met the following criteria: English language; compared patient with trained assessor joint counts; peer-reviewed; and RA diagnosis determined by board-certified or board-eligible specialist or met 1987 American College of Rheumatology criteria. We searched PubMed and Embase to identify articles between 1966 and January 1, 2008. We compared measures of correlation between patients and assessors for either tender/painful or swollen joint counts. We used metaanalysis methods to calculate summary correlation estimates.Results.We retrieved 462 articles and 18 were included. Self-report joint counts were obtained by a text and/or mannequin (picture) format. The summary estimates for the Pearson correlation coefficients for tender joint counts were 0.61 (0.47 lower, 0.75 upper) and for swollen joint counts 0.44 (0.15, 0.73). Summary results for the Spearman correlation coefficients were 0.60 (0.30, 0.90) for tender joint counts and 0.54 (0.35, 0.73) for swollen joint counts.Conclusion.A self-report tender joint count has moderate to marked correlation with those performed by a trained assessor. In contrast, swollen joint counts demonstrate lower levels of correlation. Future research should explore whether integrating self-report tender joint counts into routine care can improve efficiency and quality of care, while directly involving patients in assessment of RA disease activity.


2018 ◽  
Vol 77 (5) ◽  
pp. 690-698 ◽  
Author(s):  
Peter Nash ◽  
Kamal Ohson ◽  
Jessica Walsh ◽  
Nikolay Delev ◽  
Dianne Nguyen ◽  
...  

ObjectiveEvaluate apremilast efficacy across various psoriatic arthritis (PsA) manifestations beginning at week 2 in biological-naïve patients with PsA.MethodsPatients were randomised (1:1) to apremilast 30 mg twice daily or placebo. At week 16, patients whose swollen and tender joint counts had not improved by ≥10% were eligible for early escape. At week 24, all patients received apremilast through week 52.ResultsAmong 219 randomised patients (apremilast: n=110; placebo: n=109), a significantly greater American College of Rheumatology 20 response at week 16 (primary outcome) was observed with apremilast versus placebo (38.2% (42/110) vs 20.2% (22/109); P=0.004); response rates at week 2 (first assessment) were 16.4% (18/110) versus 6.4% (7/109) (P=0.025). Improvements in other efficacy outcomes, including 28-joint count Disease Activity Score (DAS-28) using C reactive protein (CRP), swollen joint count, Health Assessment Questionnaire-Disability Index (HAQ-DI), enthesitis and morning stiffness severity, were observed with apremilast at week 2. At week 16, apremilast significantly reduced PsA disease activity versus placebo, with changes in DAS-28 (CRP) (P<0.0001), HAQ-DI (P=0.023) and Gladman Enthesitis Index (P=0.001). Improvements were maintained with continued treatment through week 52. Over 52 weeks, apremilast’s safety profile was consistent with prior phase 3 studies in psoriasis and PsA. During weeks 0–24, the incidence of protocol-defined diarrhoea was 11.0% (apremilast) and 8.3% (placebo); serious adverse event rates were 2.8% (apremilast) and 4.6% (placebo).ConclusionsIn biological-naïve patients with PsA, onset of effect with apremilast was observed at week 2 and continued through week 52. The safety profile was consistent with previous reports.Trial registration numberNCT01925768; Results.


2020 ◽  
Vol 83 (6) ◽  
pp. AB166
Author(s):  
Luis R. Espinoza ◽  
Rocco Ballerini ◽  
Richard Chou ◽  
Stephen J. Rozzo ◽  
Alan M. Mendelsohn

2019 ◽  
Vol 47 (6) ◽  
pp. 854-864 ◽  
Author(s):  
Ana-Maria Orbai ◽  
Iain B. McInnes ◽  
Laura C. Coates ◽  
M. Elaine Husni ◽  
Dafna D. Gladman ◽  
...  

Objective.To compare the efficacy of secukinumab with that of placebo across the updated Group for Research and Assessment of Psoriasis and Psoriatic Arthritis and Outcome Measures in Rheumatology (GRAPPA-OMERACT) individual psoriatic arthritis (PsA) core domains using pooled data from 4 phase III PsA studies and 1 phase III ankylosing spondylitis (AS) study.Methods.Data were pooled from 2049 patients with PsA participating in 4 on-label phase III PsA studies (FUTURE 2–5), and the efficacy of each GRAPPA-OMERACT PsA core domain (musculoskeletal disease activity, skin disease activity, pain, patient’s global assessment, physical function, health-related quality of life, fatigue, and systemic inflammation) was assessed using multiple measures and definitions specific to each domain. The MEASURE 2 study, a phase III clinical trial in patients with AS, was used to assess improvement in spine symptoms at Week 16.Results.Treatment with secukinumab demonstrated robust and consistent efficacy across all GRAPPA-OMERACT PsA core domains, with secukinumab 300 mg showing the greatest response rates across most PsA core domains compared with placebo at Week 16. Notably, among patients treated with secukinumab 300 mg, 34.3% and 19.5% achieved complete resolution of swollen and tender joint counts, respectively; 53.2% and 61.5% achieved complete resolution of enthesitis and dactylitis, respectively; and 33.2% achieved 100% improvement in Psoriasis Area and Severity Index (all p < 0.05 vs placebo); similar improvements were shown for all other core domains.Conclusion.This analysis suggests that secukinumab can benefit people with PsA across the clinical phenotypic spectrum commonly encountered in this disease.


2009 ◽  
Vol 36 (12) ◽  
pp. 2751-2757 ◽  
Author(s):  
MILLICENT A. STONE ◽  
LAWRENCE M. WHITE ◽  
DAFNA D. GLADMAN ◽  
ROBERT D. INMAN ◽  
SAM CHAYA ◽  
...  

Objective.Rheumatologists base many clinical decisions regarding the management of inflammatory joint diseases on joint counts performed at clinic. We investigated the reliability and accuracy of physically examining the metacarpophalangeal (MCP) joints to detect inflammatory synovitis using magnetic resonance imaging (MRI) as the gold standard.Methods.MCP joints 2 to 5 in both hands of 5 patients with rheumatoid arthritis (RA) and 5 with psoriatic arthritis (PsA) were assessed by 5 independent examiners for joint-line swelling (visually and by palpation); joint-line tenderness by palpation (tender joint count, TJC) and stress pain; and by MRI (1.5 Tesla superconducting magnet). Interrater reliability was assessed using kappa statistics, and agreement between examination and corresponding MRI assessment was assessed by Fisher’s exact tests (p < 0.05 considered statistically significant).Results.Interrater agreement was highest for visual assessment of swelling (κ = 0.55–0.63), slight-fair for assessment of swelling by palpation (κ = 0.19–0.41), and moderate (κ = 0.41–0.58) for assessment of joint tenderness. In patients with RA, TJC, stress pain, and visual swelling assessment were strongly associated with MRI evaluation of synovitis. Visual swelling assessment demonstrated high specificity (> 0.8) and positive predictive value (= 0.8). For PsA, significant associations exist between TJC and MRI synovitis scores (p < 0.01) and stress pain and MRI edema scores (p < 0.04). Assessment of swelling by palpation was not significantly associated with synovitis or edema as determined by MRI in RA or PsA (p = 0.54–1.0).Conclusion.In inflammatory arthritis, disease activity in MCP joints can be reliably assessed at the bedside by examining for joint-line tenderness (TJC) and visual inspection for swelling. Clinical assessment may have to be complemented by other methods for evaluating disease activity in the joint, such as MRI, particularly in patients with PsA.


2017 ◽  
Vol 44 (3) ◽  
pp. 286-291 ◽  
Author(s):  
Lihi Eder ◽  
Vinod Chandran ◽  
Richard Cook ◽  
Dafna D. Gladman

Objective.To estimate the prevalence of diabetes mellitus (DM) in patients with psoriatic arthritis (PsA) in comparison with the general population and to assess whether the level of disease activity over time predicts the development of DM in these patients.Methods.A cohort analysis was conducted in patients followed in a large PsA clinic from 1978 to 2014. The prevalence of DM in the patients was compared with the general population of Ontario, Canada, and the age-standardized prevalence ratio (SPR) was calculated. For the assessment of risk factors for DM, time-weighted arithmetic mean (AM) levels of PsA-related disease activity measures were assessed as predictors for the development of DM. Multivariable Cox proportional hazards models were used to compute HR for incident DM after controlling for potential confounders.Results.A total of 1305 patients were included in the analysis. The SPR of DM in PsA compared with the general population in Ontario was 1.43 (p = 0.002). Of the 1065 patients who were included in the time-to-event analysis, 73 patients were observed to develop DM. Based on multivariable analyses, AM tender joint count (HR 1.53, 95% CI 1.08–2.18, p = 0.02) and AM erythrocyte sedimentation rate (HR 1.21, 95% CI 1.03–1.41, p = 0.02) predicted the development of DM.Conclusion.The prevalence of DM is higher in patients with PsA compared with the general population. Patients with elevated levels of disease activity are at higher risk of developing DM.


2021 ◽  
Author(s):  
Evangelia Passia ◽  
Marijn Vis ◽  
Laura Coates ◽  
Anuska Soni ◽  
Ilja Tchetverikov ◽  
...  

Abstract Objectives:The prevalence of Psoriatic Arthritis (PsA) is the same in men and women, however, the latter experience a higher burden of disease and are affected more frequently by polyarthritis. Here, we performed an early PsA cohort analysis to assess sex-related differences in demographics, disease characteristics and evolution over 1 year including applied treatment strategies. Methods:Our study is embedded in the Dutch south-west Early Psoriatic Arthritis cohoRt. We described patient characteristics and treatment decisions. For the comparison across sexes and baseline and 1 year follow up, appropriate tests depending on the distribution were used. Results:273 men and 294 women with no significant differences in age and ethnicity were included. Women reported significantly longer duration of symptoms before diagnosis and significantly higher tender joint count, a higher disease activity, higher levels of pain and lower functional capacity. Although minimal disease activity (MDA) rates increased over time for both sexes, MDA remained significantly more prevalent among men at one year (58.1% vs 35.7%, p<0.00). Initially, treatment strategies were similar in both sexes with Methotrexate being the most frequently used drug during the first year. Women received Methotrexate for a shorter period [196(93-364) vs 306(157-365), p<0.00] and therefore received a lower cumulative dose compared to men. Retention time was shorter for all DMARDs and women had a delayed start on b-DMARDs. Conclusion:After 1 year of standard-of-care treatment women didn’t surpass their baseline disadvantages. Despite the overall improvement, they still presented higher disease activity, higher levels of pain and lower functional capacity score than men. The nature of these findings may advocate a need for sex specific adjustment of treatment strategies and evaluation in early PsA patients.


2020 ◽  
Vol 58 (4) ◽  
pp. 401-406
Author(s):  
E. E. Gubar ◽  
E. Yu. Loginova ◽  
Yu. L. Kоrsakova ◽  
T. V. Korotayeva ◽  
S. I. Glukhova ◽  
...  

Objective. To compare clinical features in psoriatic arthritis (PsA) patients with and without axial involvement. Subjects and methods. 385 PsA patients (172 males and 213 females) from National PsA Register were examined, their diagnosis verified according to CASPAR criteria. Patients’ median age was 45 [35; 54] years, median disease duration – 5,1 [0; 8] years. Pelvis X-ray and HLA-B27 levels in addition to physical examinations were obtained in all patients. Sacroiliitis (SI) was established based on radiographic findings (rSI) including bilateral changes corresponding to at least stage II, or unilateral – corresponding to at least stage III of Kellgren-Lawrence radiographic grading scale. Patients’ radiographs were evaluated by an independent radiologist. Disease activity was assessed using the DAS28 (Disease activity score 28), DAS (Disease activity in psoriatic arthritis) and BASDAI (Bath ankylosing spondylitis disease activity index) scales. 100 mm visual analog scale (VAS) was used for assessment of pain intensity (PI) and the Patient’s Global Assessment of Disease Activity (PtGA). Patients were distributed into two groups: Group 1 included rSI(+) patients, Group 2 – patients without radiologically confirmed SI – rSI (-). Results. Group 1 included 214 (55,6%) patients with axial involvement, 106 males and 108 females, Group 2 rSI (-) – 171 (44,4%) patients, 66 males and 105 females Proportion of men was significantly higher in RSi(+) group – 49,5% vs 38,6% in rSi(-) group (Odds Ratio, OR – 1,56, 95% CI 1,6-2,4; р = 0,0324). Patient’s median age was 45 [35; 54] and 46 [34; 56] years, respectively (p=0,911). Higher rates of HLA-В27 positivity were found in group rSI(+) patients, than in rSI(-), respectively in 62 out of 126 and in 26 out of 78 patients (OR 1,9, 95% CI 1,1-3,5). Patients from RSI(+) group had more severe erosive peripheral arthritis. Median tender joint counts (TJC) were 9 [14; 18] and 6 [3; 12] (р=0,02), while radiographic feet bone erosions were found in 58 (27,1%) and 29 (17%) patients, respectively (OR 1,8, 95% CI 1,1-3,0). Disease activity was higher in rSI(+) group. Median DAS28 score was 4,3 [3,3; 5,6] and 4,05 [3,03; 4,88] (р=0,02), DAPSA – 28,40 [15,65; 43,65] and 20,0 [12,45; 30,0], (р < 0,01), BASDAI – 1,6 [0; 5,1] and 0 [0; 4,5] (р < 0,01), C-reactive protein (CRP) – 0,9 [0,4; 2,2] mg/dl and 0,8 [0,3; 1,3] mg/dl, respectively (р=0,029). PtGA VAS values were 56,5 [42,3; 70,0] mm and 50,0 [30,0; 60,0] mm (р < 0,01); physicians global assessment (PGA) – 54,0 [40,0; 69,5] mm and 40,0 [25,5; 50,0] mm (р < 0,01); PI VAS values were 50,0 [40,0; 70,0] mm and 50,0 [20,5; 58,8] mm, respectively (р < 0,01). Higher rates of entheses involvement based on the Leeds Enthesitis Index (LEI) and dactylitis were documented in rSI(+) group. Median LEI score was 0 [0; 2] and 0 [0; 1] (p=0,02), while dactylitis was established in 71 (31,2%) and 32 (18,7%) patients, respectively (OR 2,2, 95% CI 1,3-3,5). More severe cutaneous involvement was also found in rSI(+) patients as compared to rSI (-). BSA (Body Surface Area) > 3% involvement was established in 94 (43,9%) and 57 (33,3%) patients, respectively (OR 1,7, 95% CI 1,03-2,4). Axial involvement was associated with more pronounced functional impairment. Median HAQ was 1,0 [0,6; 1,5] and 0 [0-2,2] (р=0,02). Conclusion. Axial involvement in PsA patients is associated with more severe articular damage, higher enthesitis and dactylitis rates, more severe psoriasis, which should be considered when planning treatment.


2020 ◽  
Author(s):  
Carlos Montilla ◽  
Gómez-Lechón Luis ◽  
Esther Toledano ◽  
Elisa Acosta ◽  
Olga Compán ◽  
...  

Abstract Objectives To relate the levels of IL-6 and TNF-α in patients with psoriatic arthritis (PsA) with the clinical variants, the disease activity and the presence of comorbidities. Methods Cross-sectional observational study that included 184 patients with PsA according to CASPAR criteria. IL-6 and TNF-α levels were determined. As clinical variables, the clinical form (peripheral, axial or mixed), the presence of dactylitis, the severity of psoriasis measured by PASI and HLA-B27 were determined. Disease activity was measured by the tender joint count, swollen joint count, entheses affected, the severity of psoriasis measured by PASI, ESR, and CRP. The minimum disease activity (MDA) was also measured. Cardiovascular risk markers such as waist /hip ratio (w/ h) and analytical variables: apolipoprotein A, apolipoprotein B, lipoprotein a, insulin, insulin resistance (HOMA-R) and microalbuminuria in urine 24 hours (MA) were included in comorbidity. The presence of fatty liver was measured by ultrasound and fatigue by the FACIT-F questionnaire. Results The mean age of the patients was 55.12 years (SD: 11.29). One hundred and one were men (54.89%). 14.67% of the patients were on treatment with biologic DMARD (bDMARD). One hundred and two patients had peripheral involvement (55.43%), 69 mixed (37.5%) and 13 (7.07%) exclusively axial. 17.93% of the patients had a positive HLA-B27. 53.26% of the patients achieved a MDA. In the analysis of IL-6, we found a correlation with CRP (R: 0.32; P = 0.001), in addition, in patients with positive HLA-B27 we found lower concentrations of IL-6 (3.25 + 2, 26 Vs 5.81 + 7.23) -p < 0.001). We found no association with other variables related to inflammatory activity and / or comorbidity. TNF-α concentrations were higher in patients receiving TNF-α inhibitors ((178.89 SD: 181.31 vs 10.42 SD: 11.15; P < 0.001). Excluding these patients, we only found a correlation with the MA (R: 0.39; p < 0.001). Conclusions In our patients, the presence of HLA-B27 influenced IL-6 concentrations. TNF-α could be considered as a marker of subclinical renal damage.


2013 ◽  
Vol 40 (5) ◽  
pp. 647-652 ◽  
Author(s):  
Philip J. Mease ◽  
Michele Heckaman ◽  
Sonja Kary ◽  
Hartmut Kupper

Objective.This posthoc analysis evaluated the percentage of patients with psoriatic arthritis (PsA) who achieved minimal disease activity (MDA) and compared the results with a modified MDA substituting the physician global assessment (PGA) for the Psoriasis Activity and Severity Index (PASI) using data from the ADalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT; NCT00646386).Methods.Patients with active PsA were randomized to receive adalimumab 40 mg or placebo every other week for 24 weeks. MDA was defined as achieving ≥ 5 of the following criteria: tender joint count ≤ 1; swollen joint count ≤ 1; PASI ≤ 1 or body surface area ≤ 3%; patient pain score ≤ 15 [1–100 mm visual analog scale (VAS)]; patient global assessment (PGA) of disease activity ≤ 20 (1–100 mm VAS); Health Assessment Questionnaire ≤ 0.5; and tender entheseal points ≤ 1 (only heels assessed). For modification of the MDA, PASI ≤ 1 was substituted with PGA “Clear” as MDAPGA1 and PGA “Clear” or “Almost clear” as MDAPGA2.Results.Sixty-seven patients were treated with adalimumab and 69 with placebo. At Week 24, MDA, MDAPGA1, and MDAPGA2 were achieved by 39%, 37%, and 39%, respectively, of patients treated with adalimumab versus 7%, 5%, and 8% of patients on placebo (p < 0.001). Kappa coefficients indicated good agreement between PASI and PGA at Week 24.Conclusion.ADEPT results indicated that significantly more patients treated with adalimumab achieved MDA by Week 24 compared with placebo. Modification of the MDA by replacing PASI ≤ 1 with PGA assessments did not alter the results, which may improve feasibility of practical use of the index.


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