AB0839 RELIABILITY OF COMPOSITE MEASURES FOR THE ASSESSMENT OF PSORIATIC ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1725-1725
Author(s):  
W. Tillett ◽  
P. Helliwell ◽  
O. Fitzgerald ◽  
R. Waxman ◽  
A. Antony ◽  
...  

Background:Composite measures of disease activity have been developed for use in Psoriatic Arthritis (PsA) to capture the wide spectrum of disease but there is a lack of consensus regarding which to adopt for routine practice. It is recognised that more data is required to understand the measurement properties of existing instruments and consider the impact of modifications that may improve face validity, responsiveness or feasibility. It is important to have an estimate of a measurement instrument’s reliability in the setting of stable disease in order to understand measurement error and responsiveness. To our knowledge no data exists on the stability of composite measures in PsA.Objectives:To measure test re-test reliability of composite measures of disease activity in PsA.Methods:Clinical and patient reported outcomes to enable the calculation of composite measures were administered to 141 patients with PsA at five time points in a UK multicentre observational study. All patients fulfilled the CASPAR criteria. Twenty-nine patients with clinically stable disease and receiving no treatment intervention underwent repeat assessment by the same examiner within 2 weeks. Patients in high and low disease were included. Reliability was evaluated by intra-class correlation coefficient (ICC) and Bland Altman plots.Results:Of the 29 patients included 15 were male, the mean age was 52.4 years (SD 13.39), mean disease duration at T0was 9.2yrs (SD 8.11). The mean swollen joint count was 3.4 (SD 5.1), tender joint count 11.3 (SD 15.03) and PASI 1.0 (SD1.04). The ICC (95% CI) for tender and swollen joint counts were 0.94 (0.87-0.97) and 0.91 (0.80-0.96) respectively. The ICC for PASI was 0.95 (0.90-0.98). All composite measures demonstrated high levels of test-retest reliability with ICC >0.85, table. The most reliable measure was the PADAS ICC 0.98 (95% CI 0.954-0.991). The individual ICC for each composite measures are reported in the table and Bland Altman plots, figure.Conclusion:All composite measures show high levels of test-retest reliability in this cohort. The PASDAS was the most stable measure. Modifications to these instruments can now be tested and the impact compared to the original versions.Table.Test Re-Test reliability of each composite measureIntraclass Correlation Coefficient (95% Confidence Interval)GRACE0.929 (0.842-0.968)*CPDAI0.852 (0.635-0.940)*PASDAS0.978 (0.954-0.991)*DAPSA0.922 (0.831-0.964)*3VAS0.915 (0.815-0.960)*RAPID30.899 (0.782-0.953)*Disease Activity Index for PsA (DAPSA), PsA Disease Activity Score (PASDAS), Composite Psoriatic Disease Activity Index (CPDAI), GRAppa Composite Exercise (GRACE), 3 Visual Analogue Scale (3VAS), Routine Assessment of Patient Index (RAPID3),*P<0.001Figure.Bland Altman plots for each composite measureFunding:This report is independent research funded by the National Institute for Health Research, Programme Grants for Applied Research [Early detection to improve outcome in patients with undiagnosed PsA (‘PROMPT’), RP-PG-1212-20007]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care.Disclosure of Interests:William Tillett Grant/research support from: AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, UCB, Consultant of: AbbVie, Amgen, Celgene, Lilly, Janssen, Novartis, MSD, Pfizer Inc, UCB, Speakers bureau: AbbVie, Amgen, Celgene, Lilly, Janssen, Novartis, Pfizer Inc, UCB, Philip Helliwell: None declared, Oliver FitzGerald: None declared, Robin Waxman: None declared, Anna Antony: None declared, Laura C Coates: None declared, Deepak Jadon: None declared, Paul Creamer: None declared, Suzanne Lane: None declared, Marco Massarotti: None declared, Charlotte Cavill: None declared, Mel Brooke: None declared, Jonathan Packham: None declared, Eleanor Korendowych: None declared, Anya Lissina: None declared, Neil McHugh: None declared

Rheumatology ◽  
2020 ◽  
Author(s):  
Laura C Coates ◽  
Joseph F Merola ◽  
Philip J Mease ◽  
Alexis Ogdie ◽  
Dafna D Gladman ◽  
...  

Abstract Objectives To examine which composite measures are most sensitive to change when measuring psoriatic arthritis (PsA) disease activity, analyses compared the responsiveness of composite measures used in a 48-week randomized, controlled trial of MTX and etanercept in patients with PsA. Methods The trial randomised 851 patients to receive weekly: MTX (20 mg/week), etanercept (50 mg/week) or MTX plus etanercept. Dichotomous composite measures examined included ACR 20/50/70 responses, minimal disease activity (MDA) and very low disease activity (VLDA). Continuous composite measures examined included Disease Activity Score (28 joints) using CRP (DAS28-CRP), Clinical Disease Activity Index (CDAI), Simplified Disease Activity Index (SDAI), Disease Activity for Psoriatic Arthritis (DAPSA) and Psoriatic Arthritis Disease Activity Score (PASDAS). Results At week 24, etanercept-treated groups were significantly more effective than MTX monotherapy to achieve ACR 20 (primary end point) and MDA (key secondary end point). When examining score changes from baseline at week 24 across the five continuous composite measures, PASDAS demonstrated relatively greater changes in the etanercept-treated groups compared with MTX monotherapy and had the largest effect size and standardized response. Joint count changes drove overall score changes at week 24 from baseline in all the continuous composite measures except for PASDAS, which was driven by the Physician and Patient Global Assessments. Conclusion PASDAS was the most sensitive continuous composite measure examined with results that mirrored the protocol-defined primary and key secondary outcomes. Composite measures with multiple domains, such as PASDAS, may better quantify change in PsA disease burden. Trail registration https://ClinicalTrials.gov, number NCT02376790.


Nutrients ◽  
2019 ◽  
Vol 11 (3) ◽  
pp. 601 ◽  
Author(s):  
Mohammad Adawi ◽  
Giovanni Damiani ◽  
Nicola Bragazzi ◽  
Charlie Bridgewood ◽  
Alessia Pacifico ◽  
...  

Intermittent circadian fasting, namely Ramadan, is a common worldwide practice. Such fasting has a positive impact on psoriasis, but no data exist on its role in psoriatic arthritis (PsA)—a disease that is clearly linked to body mass index. We enrolled 37 patients (23 females and 14 males) with a mean age 43.32 ± 7.81 and they fasted for 17 h for one month in 2016. The baseline PsA characteristics were collected and 12 (32.4%) patients had peripheral arthritis, 13 (35.1%) had axial involvement, 24 (64.9%) had enthesitis, and 13 (35.1%) had dactylitis. Three patients (8.1%) were treated with methotrexate, 28 (75.7%) with TNF-α blockers, and 6 (16.2%) with IL-17 blockers. After a month of intermittent fasting, C-reactive protein (CRP) levels decreased from 14.08 ± 4.65 to 12.16 ± 4.46 (p < 0.0001), Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) decreased from 2.83 ± 1.03 to 2.08 ± 0.67 (p = 0.0078), Psoriasis Area Severity Index (PASI) decreased from 7.46 ± 2.43 to 5.86 ± 2.37 (p < 0.0001), and Disease Activity index for PSoriatic Arthritis (DAPSA) decreased from 28.11 ± 4.51 to 25.76 ± 4.48 (p < 0.0001). Similarly, enthesitis improved after fasting, with Leeds Enthesitis Index (LEI) decreasing from 2.25 ± 1.11 to 1.71 ± 0.86 (p < 0.0001) and dactylitis severity score (DSS) decreasing from 9.92 ± 2.93 to 8.54 ± 2.79 (p = 0.0001). Fasting was found to be a predictor of a decrease in PsA disease activity scores (DAPSA, BASDAI, LEI, DSS) even after adjustment for weight loss. IL-17 therapy was found to be an independent predictor of decreases in LEI after fasting. These preliminary data may support the use of chronomedicine in the context of rheumatic diseases, namely PsA. Further studies are needed to support our findings.


2017 ◽  
Vol 33 (S1) ◽  
pp. 232-232
Author(s):  
Michael da Silva ◽  
Jéssica dos Santos ◽  
Alessandra Almeida ◽  
Juliana Alvares ◽  
Augusto Guerra ◽  
...  

INTRODUCTION:Anti-tumor necrosis factor drugs (anti-TNF) are the last line of treatment for psoriatic arthritis (PsA) in the guideline of Brazilian Public Health System (SUS). Data of effectiveness of these drugs are scarce in the Latin American population. This study evaluated the effectiveness of the anti-TNF on a cohort of patients with PA in the SUS.METHODS:PsA patients treated with anti-TNF, were included in an open prospective cohort study. The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and Clinical Disease Activity Index (CDAI) were used to assess the effectiveness at six months of follow-up. The anti-TNF was considered effective when the patient achieves scores of four or less measured for BASDAI or scores of ten or less for CDAI. Frequency distributions were compiled for the sociodemographic variables and mean and standard deviation (SD) was used for clinical variables. The paired Student t-test was established to evaluate the differences between baseline and 6 months evaluated for BASDAI and CDAI.RESULTS:Fifty-four patients with PsA completed six months of follow-up. The mean age of patients was 54.03 years (10.44) and the mean disease duration was 8.00 years (7.49). Furthermore, 50 percent of the patients were female, 61.1 percent white and 59.6 percent married. The most used anti-TNF was adalimumab (63.0 percent), followed by etanercept (20.4 percent) and infliximab (16.7 percent). The anti-TNF reduced disease activity measured by BASDAI and CDAI at six months of follow-up (p<.001). The percentage of patients achieving the effectiveness with anti-TNF was 61.1 percent measured by BASDAI and 53.7 percent by CDAI.CONCLUSIONS:Anti-TNF drugs demonstrated to be effective in more than half of patients at six months. This result highlighted the importance of the treatment with the anti-TNF drugs in the Brazilian population. Long-term data are needed to confirm these results.


2021 ◽  
pp. jrheum.201674
Author(s):  
William Tillett ◽  
Oliver FitzGerald ◽  
Laura C. Coates ◽  
Jon Packham ◽  
Deepak R. Jadon ◽  
...  

Objective To test the addition of pain and fatigue to the Composite Psoriatic Arthritis Disease Activity (CPDAI) and the Group for Research and Assessment of Psoriasis and PsA (GRAPPA) Composite Exercise (GRACE) composite measures of psoriatic arthritis (PsA). Methods Clinical and patient-reported outcome measures were assessed in patients with PsA at 3 consecutive follow-up visits over 6 months in a UK multicenter observational study. A pain visual analog scale and Functional Assessment of Chronic Illness Therapy Fatigue scale were added as modifications to the CPDAI and GRACE composite measures. Original and modified versions were tested against the PsA Disease Activity Score (PASDAS) and the Disease Activity Index for PsA (DAPSA). Discrimination between disease states and responsiveness were tested with t-scores, standardized response means (SRMs), and effect sizes. Data were presented to members at the 2020 annual meeting who then voted on the GRAPPArecommended composite and treatment targets for clinical trials. Results One hundred forty-one patients were recruited with a mean PsA disease duration of 6.1 years (range 0–41 yrs). The SRMs for the GRACE and modified GRACE (mGRACE) were 0.67 and 0.64, respectively, and 0.54 and 0.46, respectively, for the CPDAI and modified CPDAI (mCPDAI). The t-scores for the GRACE and mGRACE were unchanged at 7.8 for both, and 6.8 and 7.0 for the CPDAI and mCPDAI, respectively. The PASDAS demonstrated the best responsiveness (SRM 0.84) and discrimination (t-scores 8.3). Most members (82%) agreed the composites should not be modified and 77% voted for the PASDAS as the GRAPPA-recommended composite for clinical trials, with 90% minimal disease activity (MDA) as the target. Conclusion Modifying the CPDAI and GRACE with the addition of pain and fatigue does not enhance responsiveness nor the measures’ ability to detect disease status in terms of requiring treatment escalation. GRAPPA members voted for the PASDAS as the composite measure in clinical trials and MDA as the target.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1629.2-1629
Author(s):  
K. Ben Abdelghani ◽  
Y. Gzam ◽  
A. Fazaa ◽  
S. Miladi ◽  
K. Ouenniche ◽  
...  

Background:Axial spondyloarthritis (ax-SpA) is a chronic rheumatic disease that mainly affects men. However, the female form of ax-SpA remains insufficiently studied.Objectives:The aim of this study was to determine the clinical characteristics, the disease activity and the functional impact of female ax-SpA in comparison with male ax-SpA.Methods:This is a retrospective study including patients diagnosed with ax-SpA fulfilling the criteria of the Assessment of SpondyloArthritis international Society (ASAS) 2009.Clinical parameters, erythrocyte sedimentation rate (ESR), C-reactive protein (CRP), Bath ankylosing spondylitis disease activity index (BASDAI) and Bath ankylosing spondylitis functional index (BASFI) were compared between groups of female and male ax-SpA.Results:Two hundred ax-SpA patients were included with 31% of female (n=62) and a mean age of 43,3 ± 11,2 years.The mean age at onset of symptoms was 31,8 ± 8,9 years for women and 25,3 ± 9,1 years for men (p <0,0001). The mean age at diagnosis was 36,4 ± 9,6 years for women and 31,7 ± 10,4 years for men (p = 0,003). Ax-SpA with juvenile onset was noted in 1,7% of women and 12,1% of men (p = 0,02). Male ax-SpA were significantly more smokers (46.8% vs 5.4%; p <0.001). The mean duration of morning stiffness was 11,3 ± 9,2 minutes for women versus 21,6 ± 19,3 minutes for men (p = 0,005).The mean ESR was 42,4 ± 29,8 mm for women and 28,3 ± 23,4 mm for men (p = 0,001). Radiographic sacroiliitis was present in 69,3% of women versus 84,7% of men (p = 0,01). The use of anti-TNF alpha was less frequent in women (29% vs 48,5%; p = 0,01).Our study didn’t found a statistically significant difference in peripheral manifestations, extraarticular manifestations, CRP, BASDAI and BASFI between the two groups.Conclusion:Female ax-SpA seems to have a better prognosis than male with older age in disease onset, less inflammation, less radiographic sacroiliitis and less use of biological treatments.References:[1]Rusman T, et al. Curr Rheumatol Rep. 2018; 20(6).[2]Siar N, et al. Curr Rheumatol Rev. 2019;Disclosure of Interests:None declared


2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Maria Chiara Ditto ◽  
Simone Parisi ◽  
Marta Priora ◽  
Silvia Sanna ◽  
Clara Lisa Peroni ◽  
...  

Abstract AntiTNF-α biosimilars are broadly available for the treatment of inflammatory arthritis. There are a lot of data concerning the maintenance of clinical efficacy after switching from originators to biosimilars; therefore, such a transition is increasingly encouraged both in the US and Europe. However, there are reports about flares and adverse events (AE) as a non-medical switch remains controversial due to ethical and clinical implications (efficacy, safety, tolerability). The aim of our work was to evaluate the disease activity trend after switching from etanercept originator (oETA-Enbrel) to its biosimilar (bETA-SP4/Benepali) in a cohort of patients in Turin, Piedmont, Italy. In this area, the switch to biosimilars is stalwartly encouraged. We switched 87 patients who were in a clinical state of stability from oETA to bETA: 48 patients were affected by Rheumatoid Arthritis (RA),26 by Psoriatic Arthritis (PsA) and 13 by Ankylosing Spondylitis (AS).We evaluated VAS-pain, Global-Health, CRP, number of swollen and tender joints, Disease Activity Score on 28 joints (DAS28) for RA, Disease Activity in Psoriatic Arthritis (DAPSA) for PsA, Health Assessment Questionnaire (HAQ) and Health Assessment Questionnaire for the spondyloarthropathies (HAQ-S),Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for AS patients. 11/85 patients (12.6%) stopped treatment after switching to biosimilar etanercept. No difference was found between oETA and bETA in terms of efficacy. However, some arthritis flare and AE were reported. Our data regarding maintenance of efficacy and percentage of discontinuation were in line with the existing literature.


2010 ◽  
Vol 38 (1) ◽  
pp. 60-63 ◽  
Author(s):  
DOMINIQUE IBAÑEZ ◽  
DAFNA D. GLADMAN ◽  
ZAHI TOUMA ◽  
MANDANA NIKPOUR ◽  
MURRAY B. UROWITZ

Objective.Adjusted mean Systemic Lupus Erythematosus Disease Activity Index (SLEDAI; AMS) measures lupus disease activity over time. Our aim was to determine optimal visit frequency for calculating AMS.Methods.Patients followed monthly for 12 consecutive visits were included. AMS was calculated using all of the SLEDAI 2000 (AMSGOLD using all 12 visits), only quarterly visits (AMS3, using visits 3 months apart), semiannual visits (AMS6, using first, middle, and last visits only), and annual visits (AMS12, using only the first and last visits). Comparisons of AMS3, AMS6, and AMS12 with AMSGOLD are made using descriptive statistics.Results.Seventy-eight patients were included (92% women, mean age at SLE diagnosis 30.1 yrs and at study start 46.2 yrs). The mean (SD) AMSGOLD for the entire year was 2.05 (1.66), for AMS3 1.99 (1.65), for AMS6 2.12 (1.87), and for AMS12 2.08 (1.83). Mean (SD) of the absolute differences with AMSGOLD: for AMS3 0.29 (0.33), for AMS6 0.45 (0.59), and for AMS12 0.61 (0.58). Differences that were < 0.5 were considered minimal while those ≥ 1 were deemed important. Comparing AMSGOLD to AMS3, 82% of the differences were minimal and 3% were important. When comparing to AMS6, 68% were minimal and 10% were important, while comparing to AMS12, 50% were minimal and 21% were important.Conclusion.Usual clinic visits occurring quarterly offer a good estimation of disease activity over a 1-year period and are preferred over semiannual and annual visits.


2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1699.1-1700
Author(s):  
F. Masini ◽  
K. Gjeloshi ◽  
E. Pinotti ◽  
F. Danzo ◽  
F. Guarino ◽  
...  

Background:The association between hyperuricemia and psoriatic arthritis (PsA) is actually generally accepted. Previous studies have demonstrated that uric acid suppress 25(OH)D metabolism [1]. More evidence is required to demonstrate the immune modulatory effects in psoriasis, psoriatic arthritis and other autoimmune diseases. In particular, the potential association between 25-hydroxyvitamin D serum levels and PsA still remains unknown.Objectives:To assess a clinical association between uric acid/25(OH)D serum levels ratio related to PASI, BASDAI and DAPSA, if any, in patients with psoriatic arthritis.Methods:We retrospectively observed 61 patients with psoriatic arthritis referred to our outpatients clinic, independently from already being on therapy or naïve. All selected patients underwent only conventional non-biological therapy at baseline and none received vitamin D supplementation and either allopurinol or febuxostat previously. Blood samples were drawn from all participants for assessment of 25-hydroxyvitamin D and uric acid serum levels. Disease activity of psoriasis and psoriatic arthritis were assessed by the Psoriasis Area and Severity Index (PASI), the Disease Activity Index for Psoriatic Arthritis (DAPSA) and the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). We assessed the covariates of interest by the Wilcoxon non parametric test, through the SPSS 24 Software.Results:We observed 61 patients, mainly females (83.6%). At the univariate analysis, the uric acid/25(OH)D serum levels ratio revealed significantly associated with DAPSA and BASDAI indexes (p<0.001 and p<0.001, respectively), whilst no significant association emerged with the PASI index (p=0.462).Conclusion:Data in the literature about these associations in the context of psoriatic arthritis are really poor. As a consequence, our findings, though preliminary, suggest us to hypothesize a potential role of uric acid/25(OH)D serum levels ratio as potential inflammation marker in order to better assess the disease activity. However, future larger studies are needed to investigate more in depth this association.[1]Charoenngam N, Ponvilawan B, Ungprasert P. Vitamin D insufficiency and deficiency are associated with a higher level of serum uric acid: A systematic review and meta-analysis. Mod Rheumatol. 2019 Mar 4:1-6.Disclosure of Interests:None declared


1990 ◽  
Vol 4 (7) ◽  
pp. 468-471 ◽  
Author(s):  
MG Robinson ◽  
DL Decktor

The efficacy of 4 g 5-aminosalicylic acid (5-ASA, mesalamine) enemas was assessed in 666 patients with distal ulcerative colitis. Patients were enrolled in an open-label compassionate use program. One 4 g 5-ASA enema was administered each night for a period of four weeks and the disease activity index was assessed at baseline and on days 14 and 28. On days 14 and 28, 78.0% and 88.1% of patients, respectively, demonstrated an improvement in disease activity index. The mean decline in disease activity index on day 14 was 40.7% (P=0.0001) and on day 28 it was 55.4% (P=0.0001). Efficacy was similar whether the disease was confined to or extended beyond 30 cm from the anus. There was no difference in efficacy in patients suffering their first episode of disease compared to patients suffering subsequent attacks. In conclusion, high dose 5-ASA enemas are a highly effective treatment for distal ulcerative colitis.


RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000765 ◽  
Author(s):  
Silva Pukšić ◽  
Pernille Bolton-King ◽  
Joseph Sexton ◽  
Brigitte Michelsen ◽  
Tore K Kvien ◽  
...  

ObjectivesDisease Activity index for PSoriatic Arthritis (DAPSA) (sum score 68/66 tender/swollen joint counts (68TJC/66SJC), patient’s global assessment, pain and C-reactive protein (CRP)) is recommended for clinical assessment of disease activity in patients with psoriatic arthritis (PsA). Ultrasound (US) (grey scale (GS) and power Doppler (PD)) detects inflammation in joints and extra-articular structures. The present objectives were to explore the longitudinal relationships between DAPSA, clinical assessment as well as patient-reported outcome measures (PROMs) with US in patients with PsA initiating biological DMARDs and the associations between DAPSA and US remission.Methods47 patients with PsA were examined at baseline and after 3, 6, 9 and 12 months. Assessments included 68TJC/66SJC, examiner’s global assessment (EGA), PROMs, CRP, erythrocyte sedimentation rate (ESR) and US GS and PD (48 joints, 10 flexor tendons, 14 entheses, 4 bursae). Clinical composite scores and PD sum scores (0=remission) were calculated. Longitudinal associations were explored by generalised estimating equations with linear and logistic regression.ResultsDAPSA was not longitudinally associated to PD. 66SJC, ESR, 28-joint Disease Activity Score, EGA and CRP were longitudinally associated with PD (p<0.001–0.03), whereas the pain-related components of DAPSA (68TJC and pain) as well as PROMs were not associated. At 6–12 months, remission was achieved in 29%–33 % of the patients for DAPSA and 59%–70 % for PD. The association between DAPSA and PD remission was not significant (p=0.33).ConclusionsDAPSA was not associated with US inflammatory findings which indicates that DAPSA and US may assess different aspects of PsA activity.


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