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

2019 ◽  
Vol 56 (6) ◽  
pp. 703-708
Author(s):  
D. A. Kusevich ◽  
A. S. Avdeeva ◽  
V. V. Rybakova ◽  
N. V. Chichasova ◽  
E. L. Nasonov
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clinical Efficacy ◽  
Safety Profile ◽  
Active Rheumatoid Arthritis ◽  
Activity Index ◽  
Disease Activity Index ◽  
Eular Response ◽  
American College Of Rheumatology ◽  
Remission Criteria

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<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.

The Role of Depression, Anxiety, Fatigue, and Fibromyalgia on the Evaluation of the Remission Status in Patients with Rheumatoid Arthritis

2014 ◽  
Vol 41 (9) ◽  
pp. 1755-1760 ◽  
Author(s):  
Nevsun Inanc ◽  
Sibel Yilmaz-Oner ◽  
Meryem Can ◽  
Tuulikki Sokka ◽  
Haner Direskeneli
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Psychosocial Factors ◽  
Activity Index ◽  
Disease Activity Index ◽  
American College Of Rheumatology ◽  
Remission Status ◽  
Remission Criteria ◽  
Group 2 ◽  
Definition Of

Objective.To investigate the effect of depression, anxiety, fatigue, and fibromyalgia (FM) on the remission status in patients with rheumatoid arthritis (RA), defined according to the 28-joint count Disease Activity Score (DAS28)-erythrocyte sedimentation rate (ESR) and the Boolean-based new American College of Rheumatology/European League Against Rheumatism remission criteria.Methods.The subjects were patients with RA who participated in a hospital-based observational cohort. Patients who met the DAS28-ESR remission criteria at their latest visit were invited to participate in our study. The patient groups fulfilling or not fulfilling the Boolean remission criteria were identified and compared with each other with regard to the presence of depression, anxiety, fatigue (0–50), and FM. The relationship between psychosocial factors and Simplified Disease Activity Index (SDAI) remission, which is the index-based definition of remission in RA, was also investigated.Results.A total of 87 out of 428 patients (20%) with RA met the DAS28-ESR remission criteria and 32 (37%) of these also met the Boolean remission criteria, while 55 (63%) did not. Forty patients were also in SDAI remission. In the Boolean remission group, 2 patients had depression and 2 had anxiety (p = 0.004). In the Boolean nonremission group, 19 patients had depression and 13 had anxiety (p = 0.04). Continuous scales of anxiety (3.34 ± 3.76 vs 5.83 ± 4.70, p = 0.012) and depression (2.18 ± 2.75 vs 4.63 ± 4.10, p = 0.001) were also lower in the Boolean remission group in comparison with the nonremission group. Though FM syndrome was detected in only 1 patient of the Boolean remission group and in 7 patients of the Boolean nonremission group (p = 0.249), patients’ polysymptomatic distress scores of FM in the Boolean remission group were significantly lower than those of the nonremission group (3.12 ± 3.25 vs 6.27 ± 5.19, p = 0.001). The mean fatigue scores were 9.5 ± 10.6 in the Boolean remission group and 16.8 ± 12.8 in the Boolean nonremission group (p = 0.006). In multivariate analysis, patient’s global assessment (PtGA) and depression were found as the independent discriminators of Boolean-based definition. Similar relationships were also observed between psychosocial factors and SDAI remission.Conclusion.In patients with RA who do not fulfill the Boolean remission criteria, to avoid overtreatment, assessment of anxiety, fatigue, FM, and especially depression must be considered if PtGA scores and disease activity variables are significantly different.

Effect of Remission Definition on Healthcare Cost Savings Estimates for Patients with Rheumatoid Arthritis Treated with Biologic Therapies

2014 ◽  
Vol 41 (8) ◽  
pp. 1600-1606 ◽  
Author(s):  
Cheryl Barnabe ◽  
Nguyen Xuan Thanh ◽  
Arto Ohinmaa ◽  
Joanne Homik ◽  
Susan G. Barr ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Healthcare Cost ◽  
Activity Index ◽  
Cost Savings ◽  
Disease Activity Index ◽  
Disease Status ◽  
Point Estimate ◽  
Sustained Remission ◽  
American College Of Rheumatology

Objective.Sustained remission in rheumatoid arthritis (RA) results in healthcare utilization cost savings. We evaluated the variation in estimates of savings when different definitions of remission [2011 American College of Rheumatology/European League Against Rheumatism Boolean Definition, Simplified Disease Activity Index (SDAI) ≤ 3.3, Clinical Disease Activity Index (CDAI) ≤ 2.8, and Disease Activity Score-28 (DAS28) ≤ 2.6] are applied.Methods.The annual mean healthcare service utilization costs were estimated from provincial physician billing claims, outpatient visits, and hospitalizations, with linkage to clinical data from the Alberta Biologics Pharmacosurveillance Program (ABioPharm). Cost savings in patients who had a 1-year continuous period of remission were compared to those who did not, using 4 definitions of remission.Results.In 1086 patients, sustained remission rates were 16.1% for DAS28, 8.8% for Boolean, 5.5% for CDAI, and 4.2% for SDAI. The estimated mean annual healthcare cost savings per patient achieving remission (relative to not) were SDAI $1928 (95% CI 592, 3264), DAS28 $1676 (95% CI 987, 2365), and Boolean $1259 (95% CI 417, 2100). The annual savings by CDAI remission per patient were not significant at $423 (95% CI −1757, 2602). For patients in DAS28, Boolean, and SDAI remission, savings were seen both in costs directly related to RA and its comorbidities, and in costs for non-RA-related conditions.Conclusion.The magnitude of the healthcare cost savings varies according to the remission definition used in classifying patient disease status. The highest point estimate for cost savings was observed in patients attaining SDAI remission and the least with the CDAI; confidence intervals for these estimates do overlap. Future pharmacoeconomic analyses should employ all response definitions in assessing the influence of treatment.

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

2019 ◽  
Vol 2019 ◽  
pp. 1-7
Author(s):  
María Fernanda Zurita ◽  
Adriana Iglesias ◽  
Emanuel Vanegas ◽  
Adriana Luzuriaga ◽  
Luis Zurita
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Pearson Correlation ◽  
Disease Activity Index ◽  
Chi Square ◽  
Exact Test ◽  
American College Of Rheumatology ◽  
Chi Square Test ◽  
Criteria For Diagnosis

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.

Can Remission in Rheumatoid Arthritis Be Assessed Without Laboratory Tests or a Formal Joint Count? Possible Remission Criteria Based on a Self-report RAPID3 Score and Careful Joint Examination in the ESPOIR Cohort

2013 ◽  
Vol 40 (4) ◽  
pp. 386-393 ◽  
Author(s):  
Isabel Castrejón ◽  
Maxime Dougados ◽  
Bernard Combe ◽  
Francis Guillemin ◽  
Bruno Fautrel ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Self Report ◽  
Tender Joint Count ◽  
Kappa Statistics ◽  
Global Estimate ◽  
Remission Criteria ◽  
Joint Examination

Objective.To explore 5 possible criteria for remission in rheumatoid arthritis (RA) based on a patient self-report index, the Routine Assessment of Patient Index Data (RAPID3), with a careful joint examination and possible physician global estimate (DOCGL), but without a formal joint count or laboratory test.Methods.The ESPOIR early RA cohort of 813 French patients recruited in 2002–2005 was analyzed to identify patients in remission 6 months after enrollment, according to 2 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) criteria: Boolean ≤ 1 for total tender joint count-28, swollen joint count-28, C-reactive protein, and patient global estimate (PATGL), and Simplified Disease Activity Index (SDAI) ≤ 3.3. Agreement with 7 other remission criteria was analyzed — Disease Activity Score-28 (DAS28) ≤ 2.6, Clinical Disease Activity Index (CDAI) ≤ 2.8, and 5 candidate criteria based on RAPID3, joint examination, and DOCGL: “RAPID3R” (RAPID3 ≤ 3.0); “RAPID3R+SJ1” (RAPID3 ≤ 3.0, ≤ 1 swollen joint); “RAPID3R+SJ1+D1” (RAPID3 ≤ 3.0, ≤ 1 swollen joint, DOCGL ≤ 1); “RAPID3R+SJ0” (RAPID3 ≤ 3.0, 0 swollen joints); and “RAPID3R+SJ0+D1” (RAPID3 ≤ 3.0, 0 swollen joints, DOCGL ≤ 1), according to kappa statistics, sensitivity, and specificity. Residual global, articular, and questionnaire abnormalities according to each criteria set were analyzed.Results.Among 813 ESPOIR patients, 720 had complete data to compare all 9 possible criteria. Substantial agreement with the Boolean criteria was seen for SDAI, CDAI, RAPID3R+SJ1, RAPID3R+SJ1+D1, RAPID3R+SJ0, and RAPID3R+SJ0+D1 (92.2%–94.7%, kappa 0.67–0.79), versus only moderate agreement for DAS28 or RAPID3R (79.9%–85.8%, kappa 0.46–0.55).Conclusion.Remission according to CDAI and RAPID3R+SJ1, but not DAS28 or RAPID3R, is similar to that of the ACR/EULAR criteria. RAPID3 scores require a complementary careful joint examination for clinical decisions, do not preclude formal joint counts or other indices, and may be useful in busy clinical settings.

scholarly journals Filgotinib (GLPG0634/GS-6034), an oral selective JAK1 inhibitor, is effective as monotherapy in patients with active rheumatoid arthritis: results from a randomised, dose-finding study (DARWIN 2)

2016 ◽  
Vol 76 (6) ◽  
pp. 1009-1019 ◽  
Author(s):  
A Kavanaugh ◽  
J Kremer ◽  
L Ponce ◽  
R Cseuz ◽  
O V Reshetko ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Active Rheumatoid Arthritis ◽  
Activity Index ◽  
Disease Activity Index ◽  
Rapid Onset ◽  
Janus Kinase ◽  
Inadequate Response ◽  
Onset Of Action ◽  
End Points

ObjectivesTo evaluate the efficacy and safety of different doses of filgotinib, an oral Janus kinase 1 inhibitor, as monotherapy in patients with active rheumatoid arthritis (RA) and previous inadequate response to methotrexate (MTX).MethodsIn this 24-week phase IIb study, patients with moderately to severely active RA were randomised (1:1:1:1) to receive 50, 100 or 200 mg filgotinib once daily, or placebo, after a ≥4-week washout from MTX. The primary end point was the percentage of patients achieving an American College of Rheumatology (ACR)20 response at week 12.ResultsOverall, 283 patients were randomised and treated. At week 12, significantly more patients receiving filgotinib at any dose achieved ACR20 responses versus placebo (≥65% vs 29%, p<0.001). For other key end points at week 12 (ACR50, ACR70, ACR-N, Disease Activity Score based on 28 joints and C reactive protein, Clinical Disease Activity Index, Simplified Disease Activity Index and Health Assessment Questionnaire-Disability Index) significant differences from baseline in favour of filgotinib 100 and 200 mg versus placebo were seen; responses were maintained or improved through week 24. Rapid onset of action was observed for most efficacy end points. Dose-dependent increases in haemoglobin were observed. The percentage of patients with treatment-emergent adverse events (TEAE) was similar in the placebo and filgotinib groups (∼40%). Eight patients on filgotinib and one on placebo had a serious TEAE, and four patients, all of whom received filgotinib, experienced a serious infection. No tuberculosis or opportunistic infections were reported.ConclusionsOver 24 weeks, filgotinib as monotherapy was efficacious in treating the signs and symptoms of active RA, with a rapid onset of action. Filgotinib was generally well tolerated.Trial registration numberNCT01894516.

scholarly journals Validity and Risk of Adopting PGA ≤ 2 As A Remission Criteria of Boolean in Clinical Practice in Patient With Rheumatoid Arthritis

2021 ◽  
Author(s):  
Ichiro Yoshii ◽  
Tatsumi Chijiwa ◽  
Naoya Sawada
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
Disease Activity ◽  
Clinical Remission ◽  
Global Assessment ◽  
Statistical Difference ◽  
Activity Index ◽  
Disease Activity Index ◽  
Remission Criteria ◽  
The Mean

Abstract Validity and risk of setting patient’s global assessment (PGA) ≤ 2 as a Boolean remission criteria substituting PGA ≤ 1 in treating rheumatoid arthritis (RA) was investigatedPatients were recruited from an area cohort, of whom attained Boolean remission (Boolean-1) or near remission with PGA ≤ 2 and the rest components were ≤ 1 (Boolean-2). Simplified disease activity index (SDAI) score was compared according to the criteria variations.A total of 517 patients were studied. Mean SDAI score of patients with Boolean-1 was significantly lower than that of patients with Boolean-2 at acquisition. The trend was evident in the patients who attained Boolean-1 remission. Mean SDAI score at acquisition, 6 months after, and 1 year after of patients who attained Boolean-2 first and then Boolean-1, was significantly inferior to that of patients who attained the remissions at the same time. The mean SDAI score at month 6 in the Boolean-2 was not SDAI remission at all.We concluded that setting PGA ≤ 2 as a remission criteria may not have statistical difference in disease activity from PGA ≤ 1, however, there was an determinant risk to misread that includes patient who losses clinical remission after acquisition.

American College of Rheumatology/European League Against Rheumatism Remission Criteria for Rheumatoid Arthritis Maintain Reliable Performance When Evaluated in 44 Joints

2013 ◽  
Vol 40 (8) ◽  
pp. 1254-1258 ◽  
Author(s):  
Yuko Kaneko ◽  
Harumi Kondo ◽  
Tsutomu Takeuchi
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clinical Remission ◽  
Global Assessment ◽  
Activity Index ◽  
Disease Activity Index ◽  
University Hospital ◽  
Physician Global Assessment ◽  
Remission Criteria ◽  
The Mean

Objective.To investigate the performance of the new remission criteria for rheumatoid arthritis (RA) in daily clinical practice and the effect of possible misclassification of remission when 44 joints are assessed.Methods.Disease activity and remission rate were calculated according to the Disease Activity Score (DAS28), Simplified Disease Activity Index (SDAI), Clinical Disease Activity Index (CDAI), and a Boolean-based definition for 1402 patients with RA in Keio University Hospital. Characteristics of patients in remission were investigated, and the number of misclassified patients was determined — those classified as being in remission based on 28-joint count but as nonremission based on a 44-joint count for each definition criterion.Results.Of all patients analyzed, 46.6%, 45.9%, 41.0%, and 31.5% were classified as in remission in the DAS28, SDAI, CDAI, and Boolean definitions, respectively. Patients classified into remission based only on the DAS28 showed relatively low erythrocyte sedimentation rates but greater swollen joint counts than those classified into remission based on the other definitions. In patients classified into remission based only on the Boolean criteria, the mean physician global assessment was greater than the mean patient global assessment. Although 119 patients had ≤ 1 involved joint in the 28-joint count but > 1 in the 44-joint count, only 34 of these 119 (2.4% of all subjects) were found to have been misclassified into remission.Conclusion.In practice, about half of patients with RA can achieve clinical remission within the DAS28, SDAI, and CDAI; and one-third according to the Boolean-based definition. Patients classified in remission based on a 28-joint count may have pain and swelling in the feet, but misclassification of remission was relatively rare and was seen in only 2.4% of patients under a Boolean definition. The 28-joint count can be sufficient for assessing clinical remission based on the new remission criteria.

Achievement of Remission and Low Disease Activity Definitions in Patients with Rheumatoid Arthritis in Clinical Practice: Results from the NOR-DMARD Study

2016 ◽  
Vol 43 (4) ◽  
pp. 716-723 ◽  
Author(s):  
Till Uhlig ◽  
Elisabeth Lie ◽  
Vibeke Norvang ◽  
Åse Stavland Lexberg ◽  
Erik Rødevand ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Practice ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Joint Disease ◽  
Low Disease Activity ◽  
American College Of Rheumatology ◽  
Short Disease Duration ◽  
High Level

Objective.To examine the frequency of 6 definitions for remission and 4 definitions for low disease activity (LDA) after starting a disease-modifying antirheumatic drug (DMARD) in patients with rheumatoid arthritis (RA) in clinical practice, and to study whether predictors for achieving remission after 6 months are similar for these definitions.Methods.Remission and LDA were calculated according to the 28-joint Disease Activity Score (DAS28), the Clinical Disease Activity Index (CDAI), the Simplified Disease Activity Index (SDAI), the Routine Assessment of Patient Index Data (RAPID3), and both the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) Boolean remission definitions 3 and 6 months after 4992 DMARD prescriptions for patients enrolled in the NOR-DMARD, a 5-center Norwegian register. Prediction of remission after 6 months was also studied.Results.After 3 months, remission rates varied between definitions from 8.7% to 22.5% and for LDA from 35.5% to 42.7%, and increased slightly until 6 months of followup. DAS28 and RAPID3 gave the highest and ACR/EULAR, SDAI, and CDAI the lowest proportions for remission. Positive predictors for remission after 6 months were similar across the definitions and included lower age, male sex, short disease duration, high level of education, current nonsmoking, nonerosive disease, treatment with a biological DMARD, being DMARD-naive, good physical function, little fatigue, and LDA.Conclusion.In daily clinical practice, the DAS28 and RAPID3 definitions identified remission about twice as often as the ACR/EULAR Boolean, SDAI, and CDAI. Predictors of remission were similar across remission definitions. These findings provide additional evidence to follow treatment recommendations and treat RA early with a DMARD.

Do depression and anxiety reduce the likelihood of remission in rheumatoid arthritis and psoriatic arthritis? Data from the prospective multicentre NOR-DMARD study

2017 ◽  
Vol 76 (11) ◽  
pp. 1906-1910 ◽  
Author(s):  
Brigitte Michelsen ◽  
Eirik Klami Kristianslund ◽  
Joseph Sexton ◽  
Hilde Berner Hammer ◽  
Karen Minde Fagerli ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Psoriatic Arthritis ◽  
Disease Activity ◽  
Regression Models ◽  
Activity Index ◽  
Disease Activity Index ◽  
Depression And Anxiety ◽  
Sf 36 ◽  
Remission Criteria

ObjectiveTo investigate the predictive value of baseline depression/anxiety on the likelihood of achieving joint remission in rheumatoid arthritis (RA) and psoriatic arthritis (PsA) as well as the associations between baseline depression/anxiety and the components of the remission criteria at follow-up.MethodsWe included 1326 patients with RA and 728 patients with PsA from the prospective observational NOR-DMARD study starting first-time tumour necrosis factor inhibitors or methotrexate. The predictive value of depression/anxiety on remission was explored in prespecified logistic regression models and the associations between baseline depression/anxiety and the components of the remission criteria in prespecified multiple linear regression models.ResultsBaseline depression/anxiety according to EuroQoL-5D-3L, Short Form-36 (SF-36) Mental Health subscale ≤56 and SF-36 Mental Component Summary ≤38 negatively predicted 28-joint Disease Activity Score <2.6, Simplified Disease Activity Index ≤3.3, Clinical Disease Activity Index ≤2.8, ACR/EULAR Boolean and Disease Activity Index for Psoriatic Arthritis ≤4 remission after 3 and 6 months treatment in RA (p≤0.008) and partly in PsA (p from 0.001 to 0.73). Baseline depression/anxiety was associated with increased patient’s and evaluator’s global assessment, tender joint count and joint pain in RA at follow-up, but not with swollen joint count and acute phase reactants.ConclusionDepression and anxiety may reduce likelihood of joint remission based on composite scores in RA and PsA and should be taken into account in individual patients when making a shared decision on a treatment target.

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