Determinants of the physician global assessment of disease activity and influence of contextual factors in early axial spondyloarthritis.

2020 ◽  
Author(s):  
Fumio Hirano ◽  
Robert B.M. Landewé ◽  
Floris A. van Gaalen ◽  
Désirée van der Heijde ◽  
Cécile Gaujoux‐Viala ◽  
...  
Keyword(s):  
Disease Activity ◽  
Global Assessment ◽  
Axial Spondyloarthritis ◽  
Contextual Factors ◽  
Physician Global Assessment ◽  
Assessment Of Disease Activity

The Uses of Disease Activity Scoring and the Physician Global Assessment of Disease Activity for Managing Rheumatoid Arthritis in Rheumatology Practice

2009 ◽  
Vol 36 (5) ◽  
pp. 925-929 ◽  
Author(s):  
J. TIMOTHY HARRINGTON
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Global Assessment ◽  
Office Visit ◽  
Inactive Disease ◽  
Tender Joint Count ◽  
Physician Global Assessment ◽  
Soft Tissue Rheumatism ◽  
Assessment Of Disease Activity ◽  
Rheumatology Practice

Objective.To evaluate the uses of quantitative disease activity scoring and a physician global assessment of disease activity for managing rheumatoid arthritis (RA) in rheumatology practice.Methods.The Global Arthritis Score (GAS) and a physician global assessment (Physician Global) were determined during each office visit for a community practice RA population. The GAS was calculated from patients’ self-reported pain, functional assessment, and tender joint count. The Physician Global was recorded on a 10-point visual analog scale. The correlation of these 2 disease activity measures was determined for the most recent office visit of 185 patients with RA, and the reasons for discordant results were identified by chart review.Results.The GAS and Physician Global were concordant for active or inactive disease in 126 of 185 patients (68%) and were discordant in 59 (32%). Forty-five of these discordant patients had a high GAS while their Physician Global indicated inactive disease. Their GAS values were high because of osteoarthritis, back pain, soft tissue rheumatism, and/or prior joint damage rather than active RA. The other 14 patients had a low GAS with an uncontrolled Physician Global for a variety of reasons.Conclusion.(1) An RA disease activity score and a quantitative Physician Global can be measured during rheumatology office visits to document patients’ disease status. (2) Disease activity scoring contributes valuable information, but should not replace the Physician Global in guiding RA patient management or reimbursement decisions.

scholarly journals The Localized Scleroderma Skin Severity Index and Physician Global Assessment of Disease Activity: A Work in Progress Toward Development of Localized Scleroderma Outcome Measures

2009 ◽  
Vol 36 (12) ◽  
pp. 2819-2829 ◽  
Author(s):  
THASCHAWEE ARKACHAISRI ◽  
SOAMARAT VILAIYUK ◽  
SUZANNE LI ◽  
KATHLEEN M. O’NEIL ◽  
ELENA POPE ◽  
...  
Keyword(s):  
Disease Activity ◽  
Disease Severity ◽  
Outcome Measures ◽  
Global Assessment ◽  
Severity Index ◽  
Localized Scleroderma ◽  
Second Phase ◽  
Physician Global Assessment ◽  
Intrarater Reliability ◽  
Assessment Of Disease Activity

Objective.To develop and evaluate a Localized Scleroderma (LS) Skin Severity Index (LoSSI) and global assessments’ clinimetric property and effect on quality of life (QOL).Methods.A 3-phase study was conducted. The first phase involved 15 patients with LS and 14 examiners who assessed LoSSI [surface area (SA), erythema (ER), skin thickness (ST), and new lesion/extension (N/E)] twice for inter/intrarater reliability. Patient global assessment of disease severity (PtGA-S) and Children’s Dermatology Life Quality Index (CDLQI) were collected for intrarater reliability evaluation. The second phase was aimed to develop clinical determinants for physician global assessment of disease activity (PhysGA-A) and to assess its content validity. The third phase involved 2 examiners assessing LoSSI and PhysGA-A on 27 patients. Effect of training on improving reliability/validity and sensitivity to change of the LoSSI and PhysGA-A was determined.Results.Interrater reliability was excellent for ER [intraclass correlation coefficient (ICC) 0.71], ST (ICC 0.70), LoSSI (ICC 0.80), and PhysGA-A (ICC 0.90) but poor for SA (ICC 0.35); thus, LoSSI was modified to mLoSSI. Examiners’ experience did not affect the scores, but training/practice improved reliability. Intrarater reliability was excellent for ER, ST, and LoSSI (Spearman’s rho = 0.71–0.89) and moderate for SA. PtGA-S and CDLQI showed good intrarater agreement (ICC 0.63 and 0.80). mLoSSI correlated moderately with PhysGA-A and PtGA-S. Both mLoSSI and PhysGA-A were sensitive to change following therapy.Conclusion.mLoSSI and PhysGA-A are reliable and valid tools for assessing LS disease severity and show high sensitivity to detect change over time. These tools are feasible for use in routine clinical practice. They should be considered for inclusion in a core set of LS outcome measures for clinical trials.

scholarly journals OP0163 COMPARATIVE ANALYSIS OF ETANERCEPT BIOSIMILAR AND ORIGINATOR USE IN CLINICAL PRACTICE: DATA FROM THE GERMAN BIKER-REGISTRY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 98.1-98
Author(s):  
G. Horneff ◽  
D. Windschall ◽  
T. Hospach ◽  
S. Mrusek ◽  
M. Rühlmann ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Adverse Events ◽  
Disease Activity ◽  
Special Interest ◽  
Global Assessment ◽  
Drug Exposure ◽  
Disease Onset ◽  
Injection Site Reaction ◽  
Physician Global Assessment ◽  
First Line

Background:In 2017, 2 Etanercept biosimilars became approved. Comparative studies performed in adult patients with rheumatoid arthritis, ankylosing spondylitis or psoriasis by extrapolation led to approval for juvenile idiopathic arthritis (JIA).Objectives:So far there is limited experience with Etanercept biosimilars in JIA: The large national data base of the BIKER-registry was used to describe experience with Etanercept biosimilars in clinical practice.Methods:In this retrospective analysis patients exposed to ETA were identified in the German BIKER-registry and grouped into cohorts according to initiation of treatment after 2017, use of the originator and of biosimilars. The course of JADAS10, Physician global assessment VAS 0–100-mm, Parent/patient global assessment VAS 0–100-cm, Active joint count 0-71, truncated at 10, ESR and CHAQ-DI was analyzed. Descriptive statistics was used for demographic, clinical data, drug exposure, adverse events (AEs) and events of special interest (ESI).Results:Until 31.10.2020, 2917 JIA patients were reported to have received Etanercept. Since January 1 2017, in 39 centres treatment with Etanercept was started in 439 patients (377 (85.9%) started with the originator and 62 (14.1%) started a Biosimilar). Biosimilars were prescribed n 17 centres (44%). In 12 centres (31%), Etanercept biosimilars were used first line in 62 patients. In 17 centres (44%), 63 patients switched for the originator to a biosimilar. 3 patients reswitched from the biosimilar to the originator. 4 patient switched from a biosimilar to the originator). 22 centres (56%) had not prescribed a biosimilars so far.In not a single centre, initiation of a biosimilar was more frequent than of the originator.The patients’ characteristics and disease activity parameters were widely comparanble. Patients receiving biosimilar first line were slightly older at disease onset and had a longer disease duration. Patients receiving biosimilar first line had more often rheumatoid factor (RF) negative polyarthritis while extended oligoarthritis was more frequent in the originator cohort. In the switching cohort, more patients had extended oligoarthritis and fewer had RF negative polyarthritis and ERA JIA.No difference in disease activity parameters was noted, neither at baseline, during the course of treatment nor at last observation upon treatment. A decrease of the JADAS10 indicates improvement in both groups (Figure 1). At the time of switching, 68% had JADAS minimal disease activity (MDA) and 43% were in JASDAS remission. At month 6 and 12 these numbers increased to 74%/65% and 62%/50%.In total, 66 adverse events (AE) were reported in 45 patients upon biosimilar treatment.33 patients had 1, 5 patients 2, 5 patients had 3 and 2 reported 4 events. Adverse event of special interest were hypersensitivity n=1, injection site reaction n=1, new onset of psoriasis n=1, celiac disease n=1, Crohn‘s diesease n=1, elevated transaminases n=2, depression n=1 and disease deterioration (arthritis flare) in n=21. In 20 patients, the etanercept biosimilar was discontinued.Conclusion:This analysis is the first attempt to present a large data sample on JIA patients exposed to Etanercept biosimilars. Biosimilar were used in a minority of patients and by a minority of centers although no difference in efficacy or safety was noted from our analysis. Until today, the use of the originator is by far exceeding the use of biosimilars. The prescription of a biosimilar either first line or by switching from the originator is limited to a part of centres. Differences in efficacy between first line biosimilar users and originator users could not be observed. Also, after switching, no loss of efficacy was observed.Disclosure of Interests:Gerd Horneff Speakers bureau: Pfizer, Daniel Windschall: None declared, Toni Hospach: None declared, Sonja Mrusek: None declared, Michael Rühlmann: None declared, Ariane Klein: None declared

scholarly journals POS0997 PERFORMANCE OF ASDAS VERSUS BASDAI DURING PREGNANCY

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 767.1-767
Author(s):  
P. Fischer ◽  
A. Zbinden ◽  
F. Foerger
Keyword(s):  
Disease Activity ◽  
Pregnant Women ◽  
Global Assessment ◽  
Signs And Symptoms ◽  
First Trimester ◽  
Point Estimation ◽  
High Disease Activity ◽  
Physician Global Assessment ◽  
Pregnancy And Postpartum ◽  
Pregnant State

Background:Disease activity in patients with axial spondyloarthritis (axSpA) can be measured by BASDAI and ASDAS. Both instruments were validated in non-pregnant patients with cutoff values for active diseases. In pregnant women with axSpA, however, BASDAI and ASDAS scores might be biased by signs and symptoms of pregnancy itself.Objectives:To compare the performance of ASDAS and BASDAI during pregnancyMethods:Patients with axSpA were prospectively followed before pregnancy, at each trimester and 6 to 12 weeks postpartum. Disease activity was assessed by BASDAI, ASDAS, patient global assessment (PGA) and physician global assessment (PhGA). We analysed the disease course throughout pregnancy and postpartum, the correlation between BASDAI and ASDAS and the agreement in the classification of active disease. We applied receiver operating curves (ROC) to evaluate the cut-off points in pregnant patients.Results:The study involved 40 women with axSpA. Disease activity scores were higher during pregnancy (median ASDAS score: 2.5, median BASDAI score 3.1) than during a non-pregnant state (median ASDAS score 2.3, median BASDAI score 2.1). Median BASDAI scores were highest at the first trimester, median ASDAS scores were highest at the second trimester. ASDAS strongly correlated with BASDAI, both in the pregnant and in the non-pregnant state (r=0.796, r=0.727). However, there was a discordance when analysing the proportion of patients with high disease activity using the common cut-off values (ASDAS >2.1, BASDAS >4). More patients had high disease activity when measured by ASDAS (1st trimester (T): 63%, 2nd T: 76%, 3rd T: 61%) compared to those measured by BASDAI (1st T 43%, 2nd T: 39%, 3rd T: 34%). The κ coefficient showed only fair agreement (κ=0.39). ROC analysis among pregnant patients showed that the cut-off point estimation for high disease activity using ASDAS >2.75 corresponded to a BASDAI >4. The ASDAS >2.75 cut-off for high disease activity had a good agreement with BASDAI >4 (κ=0.657). When ASDAS >2.75 was applied in pregnant women with axSpA, about 40% experienced high disease activity.Conclusion:During pregnancy, the majority of women with axSpA experience ongoing disease activity. However, the cut-off values defining low and high disease activity might differ between pregnant and non-pregnant individuals since BASDAI and ASDAS are biased by pregnancy related symptoms like fatigue and mechanical back pain.Disclosure of Interests:None declared.

scholarly journals Discordance between patient and physician global assessment of disease activity in Behçet’s syndrome: a multicenter study cohort

2020 ◽  
Vol 22 (1) ◽  
Author(s):  
Alberto Floris ◽  
◽  
Gerard Espinosa ◽  
Luisa Serpa Pinto ◽  
Nikolaos Kougkas ◽  
...  
Keyword(s):  
Disease Activity ◽  
Global Assessment ◽  
Inactive Disease ◽  
Ocular Involvement ◽  
Behçet’S Syndrome ◽  
Behçet's Syndrome ◽  
Patient Reported ◽  
Behcet’S Syndrome ◽  
Assessment Of Disease Activity ◽  
Behcet's Syndrome

Abstract Background To compare the patients’ and physician’s global assessment of disease activity in Behçet’s syndrome (BS) and investigate the frequency, magnitude, and determinants of potential discordance. Methods A total of 226 adult BS patients with a median (IQR) age of 46.9 (35.6–55.2) years were enrolled across Italy, Greece, Portugal, and Spain. Demographic, clinical, and therapeutic variables, as well as the patient reported outcomes, were collected at the recruitment visit. The physical (PCS) and mental (MCS) component summary scores of the Short Form Questionnaire 36 (SF-36) and the Behçet’s syndrome Overall Damage Index (BODI) were calculated. Disease activity was assessed by the patients’ (PtGA) and physician’s global assessment (PGA) in a 10-cm visual analog scale, as well as the Behçet Disease Current Activity Form (BDCAF). Discordance (∆) was calculated by subtracting the PGA from the PtGA and defined as positive (PtGA>PGA) and negative (PtGA<PGA) discordance using both a more stringent (∆ = ±2) and a less stringent (∆ = ±1) cutoff. Univariate and multivariate logistic regressions were performed. Results Median PtGA and PGA scores were 2.0 (0.3–5.0) and 1.0 (0.0–3.0) cm, respectively. The discordance prevalence varied (from 29.6 to 55.3%) according to the cutoff applied, and the majority (> 80%) of disagreements were due to patients rating higher their disease activity. Higher values of BDCAF were associated to increased rate of positive discordance. When BDCAF = 0, the median (IQR) values of PtGA and PGA were 0.2 (0–2) and 0 (0–1), respectively. PCS (adjusted odds ratio (adjOR) 0.96 per unit, 95% CI 0.93–0.98, p = 0.006) and MCS (adjOR 0.96 per unit, 95% CI 0.93–0.99, p = 0.003) were independently associated with positive discordance using both cutoffs. Active ocular involvement emerged as a potential determinant of negative discordance (adjOR 5.88, 95% CI 1.48–23.30, p = 0.012). Conclusions PtGA and PGA should be considered as complementary measures in BS, as patients and physicians may be influenced by different factors when assessing active disease manifestations. Particularly, PtGA may be a useful tool in the assessment of BS disease activity, as it carries a low risk to misclassify an inactive disease, and may allow to capture aspects of the patient’s health that negatively affect his well-being and the treatment.

Sign in / Sign up

Export Citation Format

Share Document