Physician Global Assessment as a Disease Activity Measure for Relapsing Polychondritis

2021 ◽  
Author(s):  
Emily Rose ◽  
Marcela A. Ferrada ◽  
Kaitlin A. Quinn ◽  
Wendy Goodspeed ◽  
Laurent Arnaud ◽  
...  
Keyword(s):  
Disease Activity ◽  
Global Assessment ◽  
Relapsing Polychondritis ◽  
Physician Global Assessment ◽  
Disease Activity Measure ◽  
Activity Measure

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.

Laboratory investigation results influence Physician’s Global Assessment (PGA) of disease activity in SLE

2020 ◽  
pp. annrheumdis-2019-216753 ◽  
Author(s):  
Cynthia Aranow ◽  
Anca Askanase ◽  
Shereen Oon ◽  
Molla Huq ◽  
Alicia Calderone ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Global Assessment ◽  
Intraclass Correlation ◽  
Physician Global Assessment ◽  
Systemic Lupus ◽  
Laboratory Test Results ◽  
Laboratory Results ◽  
The Impact

ObjectiveTo evaluate the impact of laboratory results on scoring of the Physician Global Assessment (PGA) of disease activity in systemic lupus erythematosus.MethodsFifty clinical vignettes were presented via an online survey to a group of international lupus experts. For each case, respondents scored the PGA pre and post knowledge of laboratory test results (pre-lab and post-lab PGAs). Agreement between individual assessors and relationships between pre-lab and post-lab PGAs, and PGAs and Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) were determined. Respondents were also asked about factors they incorporate into their PGA determinations.ResultsSixty surveys were completed. The inter-rater PGA reliability was excellent (pre-lab intraclass correlation coefficient (ICC) 0.98; post-lab ICC 0.99). Post-lab PGAs were higher than pre-lab PGAs: median (IQR) pre-lab PGA 0.5 (1.05), post-lab PGA 1 (1.3) (p<0.001), with a median (IQR) difference of 0.2 (0.45). In general, all abnormal labs including elevated anti-double stranded DNA antibody level (dsDNA) and low complement impacted PGA assessment. Cases with weakest correlations between pre-lab and post-lab PGA were characterised by laboratory results revealing nephritis and/or haematological manifestations. Both pre-lab and post-lab PGAs correlated with SLEDAI-2K. However, a significantly stronger correlation was observed between post-lab PGA and SLEDAI-2K. Multiple factors influenced PGA determinations. Some factors were considered by an overwhelming majority of lupus experts, with less agreement on others.ConclusionsWe found excellent inter-rater reliability for PGAs in a group of international lupus experts. Post-lab PGA scores were higher than pre-lab PGA scores, with a significantly stronger correlation with the SLEDAI-2K. Our findings indicate that PGA scoring should be performed with knowledge of pertinent laboratory results.

scholarly journals Clinical and associated inflammatory biomarker features predictive of short-term outcomes in non-systemic juvenile idiopathic arthritis

Rheumatology ◽  
2020 ◽  
Vol 59 (9) ◽  
pp. 2402-2411 ◽  
Author(s):  
Elham Rezaei ◽  
Daniel Hogan ◽  
Brett Trost ◽  
Anthony J Kusalik ◽  
Gilles Boire ◽  
...  
Keyword(s):  
Disease Activity ◽  
Clinical Features ◽  
Global Assessment ◽  
Systemic Juvenile Idiopathic Arthritis ◽  
Area Under The Curve ◽  
Inactive Disease ◽  
Physician Global Assessment ◽  
Active Joint ◽  
Short Term ◽  
Prospective Longitudinal

Abstract Objective To identify early predictors of disease activity at 18 months in JIA using clinical and biomarker profiling. Methods Clinical and biomarker data were collected at JIA diagnosis in a prospective longitudinal inception cohort of 82 children with non-systemic JIA, and their ability to predict an active joint count of 0, a physician global assessment of disease activity of ≤1 cm, and inactive disease by Wallace 2004 criteria 18 months later was assessed. Correlation-based feature selection and ReliefF were used to shortlist predictors and random forest models were trained to predict outcomes. Results From the original 112 features, 13 effectively predicted 18-month outcomes. They included age, number of active/effused joints, wrist, ankle and/or knee involvement, ESR, ANA positivity and plasma levels of five inflammatory biomarkers (IL-10, IL-17, IL-12p70, soluble low-density lipoprotein receptor-related protein 1 and vitamin D), at enrolment. The clinical plus biomarker panel predicted active joint count = 0, physician global assessment ≤ 1, and inactive disease after 18 months with 0.79, 0.80 and 0.83 accuracy and 0.84, 0.83, 0.88 area under the curve, respectively. Using clinical features alone resulted in 0.75, 0.72 and 0.80 accuracy, and area under the curve values of 0.81, 0.78 and 0.83, respectively. Conclusion A panel of five plasma biomarkers combined with clinical features at the time of diagnosis more accurately predicted short-term disease activity in JIA than clinical characteristics alone. If validated in external cohorts, such a panel may guide more rationally conceived, biologically based, personalized treatment strategies in early JIA.

Increasing Treatment in Early Rheumatoid Arthritis Is Not Determined by the Disease Activity Score But by Physician Global Assessment: Results from the CATCH Study

2012 ◽  
Vol 39 (11) ◽  
pp. 2081-2087 ◽  
Author(s):  
LONNIE PYNE ◽  
VIVIAN P. BYKERK ◽  
GILLES BOIRE ◽  
BOULOS HARAOUI ◽  
CAROL HITCHON ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Early Rheumatoid Arthritis ◽  
Global Assessment ◽  
Disease Activity Score ◽  
Activity Score ◽  
Joint Involvement ◽  
Tender Joint Count ◽  
Physician Global Assessment ◽  
Treatment Intensification

Objective.To determine the factors most strongly associated with an increase in therapy of early rheumatoid arthritis (ERA).Methods.Data from the Canadian Early Arthritis Cohort (CATCH) were included if the patient had ≥ 2 visits and baseline and 6 months data. A regression analysis was done to determine factors associated with treatment intensification.Results.Of 1145 patients with ERA, 790 met inclusion criteria; mean age was 53.4 years (SD 14.7), mean disease duration 6.1 months (SD 2.8), 75% were female, baseline Disease Activity Score-28 (DAS28) was 4.7 (SD 1.8) and 2.9 (SD 1.8) at 6 months for included patients. Univariate factors for intensifying treatment were physician global assessment (MDGA; OR 7.8 and OR 7.4 at 3 and 6 months, respectively, p < 0.0005), swollen joint count (SJC; OR 4.7 and OR 7.3 at 3 and 6 months, p < 0.0005), and DAS28 (OR 3.0 and OR 4.6 at 3 and 6 months, p < 0.0005). In the regression model only MDGA was strongly associated with treatment intensification (OR 1.5 and OR 1.2 at 3 and 6 months, p < 0.0005); DAS28 was not consistently predictive (OR 1.0, p = 0.987, and OR 1.2, p = 0.023, at 3 and 6 months). DAS28 was the reason for treatment intensification 2.3% of the time, compared to 51.7% for SJC, 49.9% for tender joint count, and 23.8% for MDGA. For the same SJC, larger joint involvement was more likely to influence treatment than small joints at 3 months (OR 1.4, p = 0.027).Conclusion.MDGA was strongly associated with an increase in treatment at 3 and 6 months in ERA, whereas DAS28 was not. Physicians rarely stated that DAS28 was the reason for increasing treatment.

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