scholarly journals Low-dose rituximab protocol in rheumatoid arthritis—outcome and economic impact

2021 ◽  
Vol 5 (1) ◽  
Author(s):  
Parvathypriya Chandramohan ◽  
Avinash Jain ◽  
Glindow Antony ◽  
Narayanan Krishnan ◽  
Padmanabha Shenoy
Keyword(s):  
Disease Activity ◽  
Clinical Outcomes ◽  
Low Dose ◽  
Lower Cost ◽  
Significant Proportion ◽  
Dosing Regimen ◽  
Eular Response ◽  
Low Disease Activity ◽  
Conventional Dmards ◽  
The Cost

Abstract Objectives A significant proportion of RA patients, particularly those associated with poor prognostic factors, fail on conventional DMARDs (cDMARDs). Although rituximab (RTX) has been effective in these patients, the cost of therapy makes it unaffordable, particularly in poor and developing countries. Numerous, albeit small, studies using lower doses have shown contradictory results. We aimed to analyse the effectiveness of a low-dose RTX protocol based on clinical outcomes in RA patients. Methods Seropositive RA patients with moderate to high disease activity (DAS28-ESR > 3.2) despite combination cDMARDs, treated with RTX, were included in retrospective analysis. All patients were treated according to a predefined protocol, using 500 mg RTX with ongoing cDMARDs at baseline and repeat dosing at 6 weeks or beyond, on lack of moderate to good EULAR response. The B cell count was assessed at baseline, 2 and 24 weeks. Results At 12 weeks, 93% of 166 patients [mean (s.d.) age, 51.5 (11.96) years, 25 men and 141 women, with a disease duration of 10.4 (6.29) years] achieved moderate to good EULAR response. At 24 weeks, 90.8% of patients achieved moderate to good EULAR response, 19.8% achieved low disease activity and 29.5% achieved remission, with a mean change in DAS28-ESR from baseline of 2.9 (1.3). RTX failure and relapse were seen in 5.4% and 3.6%, respectively. The response was maintained for 12.3 (7.2) months with a mean RTX dose 521.1 (100.8) mg. Adverse events were seen in 9.6%. When compared with the standard dosing regimen with the originator molecule, a cost reduction of 90% was achieved. Conclusion A low-dose RTX regimen achieved reasonably good clinical outcomes at the end of 6 months, with a significantly lower cost.

scholarly journals Long-term follow-up of patients in the TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) trial

Rheumatology ◽  
2019 ◽  
Vol 59 (4) ◽  
pp. 807-810 ◽  
Author(s):  
Laura C Coates ◽  
Farrouq Mahmood ◽  
Jane Freeston ◽  
Paul Emery ◽  
Philip G Conaghan ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Drug Use ◽  
Disease Activity ◽  
Clinical Outcomes ◽  
Therapeutic Drug ◽  
Tight Control ◽  
Low Disease Activity ◽  
Clinical Advantage ◽  
Early Psoriatic Arthritis

Abstract Objectives The TIght COntrol of inflammation in early Psoriatic Arthritis (TICOPA) study was the first strategy trial in psoriatic arthritis using an early treat-to-target strategy to improve clinical outcomes. The current study aimed to review a cohort of patients who had completed TICOPA to judge if the clinical advantage gained by participants in the tight control (TC) arm was sustained, and to explore subsequent therapy. Methods A case note review was conducted for a cohort of patients who had participated in TICOPA. Current drug use and clinical status were obtained, with low disease activity judged as no tender or swollen joints, no dactylitis and enthesitis, and no change in treatment required. Results Approximately five years after completion of the TICOPA study, notes were reviewed for 110 patients [TC, n = 54; standard care (StdC), n = 56]. Disease activity was found to be similar in both groups (current low disease activity: TC 69%, StdC 76%). Biologic use at the end of the study was higher in the TC arm (TC 33%, StdC 9%), but at review a similar percentage in both groups were taking biologic drugs (TC 54%, StdC 52%), whereas MTX use diminished. Conclusion After several years, clinical outcomes and therapeutic drug use were similarly good for patients in both arms of the TICOPA study, with no obvious clinical advantage after TC ended. Notably, TC did not result in greater biological use long term, and MTX use decreased in both arms of the study.

scholarly journals Reduction of biologics in rheumatoid arthritis treatment

2019 ◽  
Author(s):  
Leticia Breda e Vasconcelos ◽  
Tais Freire Galvao
Keyword(s):  
Rheumatoid Arthritis ◽  
Systematic Review ◽  
Relative Risk ◽  
Disease Activity ◽  
Clinical Outcomes ◽  
Standard Dose ◽  
Meta Analysis ◽  
Biological Drugs ◽  
Low Disease Activity ◽  
Standardized Mean Difference

This systematic review assesses the effectiveness and safety of reducing the dose of biological drugs in patients with rheumatoid arthritis at low disease activity, compared to standard dose treatment. Clinical outcomes data were collected and summarized in meta-analysis of standardized mean difference or relative risk. Most outcomes were non-significant.

Low disease activity state in juvenile-onset systemic lupus erythematosus

Lupus ◽  
2021 ◽  
pp. 096120332110543
Author(s):  
Kubra Ozturk ◽  
Senğul Caglayan ◽  
Ayse Tanatar ◽  
Esra Baglan ◽  
Gulcin Yener Otar ◽  
...  
Keyword(s):  
Systemic Lupus Erythematosus ◽  
Disease Activity ◽  
Lupus Erythematosus ◽  
Low Dose ◽  
Systemic Lupus ◽  
Juvenile Onset ◽  
Low Disease Activity ◽  
Significant Difference ◽  
Activity State ◽  
Dose Corticosteroid

Objectives To determine the rate of achieving The Lupus Low Disease Activity State (LLDAS) in children with systemic lupus erythematosus (SLE) for tracing pertinent treatment modalities. Methods A total of 122 juvenile-onset SLE (jSLE) patients from six pediatric rheumatology centers in Turkey were enrolled in the study. LLDAS-50 was defined as encountering LLDAS for at least 50% of the observation time. According to the achievement of LLDAS-50, clinical features, immunological profiles, and treatments of patients with jSLE have been revealed. Results LLDAS of any duration was achieved by 82% of the cohort. Although only 10.8% of the patients achieved remission, 68.9% reached LLDAS-50. A significant difference was found between patients who reached LLDAS-50 and those who did not, in terms of the time to reach low-dose corticosteroid treatment ( p = 0.002), the presence of subacute cutaneous findings ( p = 0.007), and the presence of proteinuria ( p = 0.002). Both of the groups were under similar treatment approaches. However, the number of patients being treated with corticosteroids at the last visit was found to be significantly higher in patients who achieved LLDAS-50 ( p<0.001). Conclusion Targeting LLDAS in jSLE, even with long-term, low-dose corticosteroid use, seems to be an achievable goal in clinical practice.

scholarly journals Modelling Cost-Effectiveness of Biologic Treatments Based on Disease Activity Scores for the Management of Rheumatoid Arthritis in Spain

2011 ◽  
Vol 2011 ◽  
pp. 1-9 ◽  
Author(s):  
Ariel Beresniak ◽  
Rafael Ariza-Ariza ◽  
Jose Francisco Garcia-Llorente ◽  
Antonio Ramirez-Arellano ◽  
Danielle Dupont
Keyword(s):  
Cost Effectiveness ◽  
Disease Activity ◽  
Treatment Strategies ◽  
Cost Effective ◽  
Low Disease Activity ◽  
Insufficient Response ◽  
Remission Criteria ◽  
Activity State ◽  
The Cost ◽  
Sequential Strategy

Background. The objective of this simulation model was to assess the cost-effectiveness of different biological treatment strategies based on levels of disease activity in Spain, in patients with moderate to severe active RA and an insufficient response to at least one anti-TNF agent.Methods. Clinically meaningful effectiveness criteria were defined using DAS28 scores: remission and Low Disease Activity State (LDAS) thresholds. Monte-Carlo simulations were conducted to assess cost-effectiveness over 2 years of four biological sequential strategies composed of anti-TNF agents (adalimumab, infliximab), abatacept or rituximab, in patients with moderate to severe active RA and an insufficient response to etanercept as first biological agent.Results. The sequential strategy including etanercept, abatacept and adalimumab appeared more efficacious over 2 years (102 days in LDAS) compared to the same sequence including rituximab as second biological option (82 days in LDAS). Cost-effectiveness ratios showed lower costs per day in LDAS with abatacept (427 €) compared to rituximab as second biological option (508 €). All comparisons were confirmed when using remission criteria.Conclusion. Model results suggest that in patients with an insufficient response to anti-TNF agents, the biological sequences including abatacept appear more efficacious and cost-effective than similar sequences including rituximab or cycled anti-TNF agents.

Comparing Tapering Strategy to Standard Dosing Regimen of Tumor Necrosis Factor Inhibitors in Patients with Spondyloarthritis in Low Disease Activity

2015 ◽  
Vol 42 (9) ◽  
pp. 1638-1646 ◽  
Author(s):  
Chamaida Plasencia ◽  
Eva L. Kneepkens ◽  
Gertjan Wolbink ◽  
Charlotte L.M. Krieckaert ◽  
Samina Turk ◽  
...  
Keyword(s):  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Control Group ◽  
Tnf Inhibitor ◽  
Dosing Regimen ◽  
Standard Regimen ◽  
Low Disease Activity ◽  
Number Of Patients ◽  
Necrosis Factor

Objective.To compare clinical outcomes, incidence of flares, and administered drug reduction between patients with spondyloarthritis (SpA) under TNF inhibitor (TNFi) tapering strategy with patients receiving a standard regimen.Methods.In this retrospective study, 74 patients with SpA from Spain on tapering strategy (tapering group; TG) were compared with 43 patients from the Netherlands receiving a standard regimen (control group; CG). The Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) was measured at visit 0 (prior to starting the TNFi), visit 1 (prior to starting tapering strategy in TG and at least 6 months with BASDAI < 4 after starting the TNFi in the TG and CG), visit 2 (6 mos after visit 1), visit 3 (1 year after visit 1), and visit 4 (the last visit available after visit 1).Results.An overall reduction of the administered drug was seen at visit 4 in the TG [dose reduction of 22% for infliximab (IFX) and an interval elongation of 28.7% for IFX, 45.2% for adalimumab, and 51.5% for etanercept] without significant differences in the BASDAI between the groups at visit 4 (2.15 ± 1.55 in TG vs 2.11 ± 1.31 in CG, p = 0.883). The number of patients with flares was similar in both groups [22/74 (30%) in the TG vs 8/43 (19%) in the CG, p = 0.184].Conclusion.The tapering strategy in SpA results in an important reduction of the drug administered, and the disease control remains similar to that of the patients with SpA receiving the standard regimen.

Patients with Moderate Rheumatoid Arthritis (RA) Achieve Better Disease Activity States with Etanercept Treatment Than Patients with Severe RA

2009 ◽  
Vol 36 (3) ◽  
pp. 522-531 ◽  
Author(s):  
EDWARD KEYSTONE ◽  
BRUCE FREUNDLICH ◽  
MICHAEL SCHIFF ◽  
JUAN LI ◽  
MICHELE HOOPER
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Clinical Outcomes ◽  
Radiographic Progression ◽  
Severe Disease ◽  
High Dose ◽  
Etanercept Treatment ◽  
Low Disease Activity ◽  
Moderate Disease ◽  
Das28 Remission

Objective.This analysis examined clinical and radiographic responses to methotrexate (MTX), etanercept (ETN), and combination ETN and MTX in patients with moderate versus severe rheumatoid arthritis (RA) in both early and late disease.Methods.Data from the Trial of Etanercept and Methotrexate With Radiographic Patient Outcomes (TEMPO) and the Early Rheumatoid Arthritis trials were used. Patients were classified with moderate or severe RA based on Disease Activity Score including 28-joint count (DAS28). Outcomes included DAS28 remission, DAS28 low disease activity, Health Assessment Questionnaire (HAQ), American College of Rheumatology (ACR) scores, Total Sharp Score (TSS) progression, no radiographic progression (annualized change in TSS ≥ 0), change from baseline in TSS, and the change in TSS for patients who had radiographic progression (TSS > 0).Results.Patients with moderate disease generally achieved better clinical outcomes than patients with severe disease, including significant differences in DAS28 remission, low disease activity, and HAQ ≤0.5 at Month 12. Patients with baseline severe disease had higher ACR and DAS responses than patients with moderate disease.Conclusion.Patients with severe RA disease activity achieved substantial clinical improvement with high-dose MTX and/or ETN treatment, but patients with moderate disease were more likely to reach a lower disease activity state. These findings were independent of disease duration. The results support the opportunity for excellent clinical outcomes, particularly with combination therapy, in patients with moderate RA.

scholarly journals AB0223 MODIFIED DOSE RITUXIMAB BIOSIMILAR IN RHEUMATOID ARTHRITIS COMPARING B-CELL DEPLETION EFFECT AND DISEASE ACTIVITY SCORES

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1137.2-1138
Author(s):  
S. Bandyopadhyay
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
B Cell ◽  
Low Dose ◽  
Outcome Measurement ◽  
Eligible Patient ◽  
Cell Depletion ◽  
Individual Choice ◽  
B Cell Depletion ◽  
Eular Response

Background:In emerging economies self-funding patients opt for less costly options, influencing both compliance and maintenance of treatment for chronic illness. Studies comparing originator rituximab 1000mgx2 and 500mgx2 doses in Rheumatoid arthritis (RA) have yielded interesting results1. Evidence of B cell depletion, measured by CD19 count, maybe a marker for disease improvement2. However effect of different dose of biosimilar Rituximab (bRTX) on B cell depletion and disease activity needs exploration.Objectives:To determine correlation of CD19 count defining B cell depletion and disease activity with different dosages of bRTX treatment.Methods:Between April 2019 and March 2020, all RA patients with DMARD failure were screened for eligibility of biologics as routine clinical practice. Depending on individual choice, after full consent, patients received either 1000mgx2 or 500mgx2 bRTX. All patients had CD19 count before and 12 months after the first dose. Effectiveness of bRTX 1000 mg×2 and 500 mg×2 was assessed by DAS28 and EULAR response. Comparative adjusted analysis was performed by analysis of variance (ANOVA).Results:Out of 468 eligible patient, 84 opted for biologic. Of which 27 patients consented for bRTX (17 female, mean age 39.5 years).13 patients opted for 1000mg×2 and 14 for 500mg×2 dose. 74% (20/27) patients were on concomitant methotrexate and 26% on hydroxychloroquine (7/27). Both doses led to significant reduction in ESR, CRP, and DAS28-ESR at 12 months (p<0.001) (Table 1).Table 1.RA outcome-measurement scores at 12 months post biosimilar Rituximab therapy.VariableBaseline12 monthsRTX 1000mg x 2(n=13)RTX 500mg x 2(n=14)RTX 1000mg x 2(n=13)RTX 500mg x 2(n=14)ESR*53.9±23.957.1±24.723.9±2.924.1±4.7CRP*6.1±3.96.9±2.92.1±0.92.3±0.9DAS28-ESR*6.1±0.36.1±0.24.0±0.44.1±0.2CD 19+ Count*# (105/L)1191.6±308.41155±289.6128.8±90.4139±90.6* p<0.0001 as compared to 12 mos vs baseline; # p<0.0001 as compared amongst groupAt the end of 12 months, compared to 1000mg, CD19 count was higher in 500mg group (p=0.25). Percentage of patients achieving EULAR moderate or no response was higher in 500mg group (37%vs29%, p=0.205), both complete and incomplete B cell depletion, but patients achieving good response was same in both groups (14.8%vs18.5%, p = 0.25). (Figure 1).Figure 1.EULAR Response at 12 monthsConclusion:Low dose bRTX is effective in DMARD refractory RA patients with similar improvements as regular dose, although CD19 depletion was less in low dose group. A larger study to establish radiographic regression with CD19 depletion and disease activity score can help in further strengthening the use of lower dose bRTX in RA leading to significant economic advantage.References:[1]Chatzidionysiou K, Lie E, Nasonov E, Lukina G,et al. Rheumatic Diseases Portuguese Register. Effectiveness of two different doses of rituximab for the treatment of rheumatoid arthritis in an international cohort: data from the CERERRA collaboration. Arthritis Res Ther. 2016 Feb 16;18:50.[2]Vital EM, Rawstron AC, Dass S, Henshaw K, Madden J, Emery P, McGonagle D. Reduced-dose rituximab in rheumatoid arthritis: efficacy depends on degree of B cell depletion. Arthritis Rheum. 2011 Mar;63(3):603-8.Disclosure of Interests:None declared

scholarly journals A systematic review of guidelines for managing rheumatoid arthritis

2019 ◽  
Vol 3 (1) ◽  
Author(s):  
Aneela Mian ◽  
Fowzia Ibrahim ◽  
David L. Scott
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Treatment Target ◽  
Low Disease Activity ◽  
Disease Modifying Drugs ◽  
Early Ra ◽  
Core Dataset ◽  
Moderate Disease ◽  
Conventional Dmards ◽  
Current Guidelines

Abstract Background We systematically reviewed current guidelines for managing rheumatoid arthritis (RA) to evaluate their range and nature, assess variations in their recommendations and highlight divergence in their perspectives. Methods We searched Medline and Embase databases using the terms ‘clinical practice guidelines’ and ‘rheumatoid arthritis’ from January 2000 to January 2017 together with publications of national and international bodies. We included guidelines providing recommendations on general RA management spanning a range of treatments and published in English. We undertook narrative assessments due to the heterogeneity of the guidelines. Results We identified 529 articles; 22 met our inclusion criteria. They were primarily developed by rheumatologists with variable involvement of patient and other experts. Three dealt with early RA, one established RA and 18 all patients. Most guidelines recommend regular assessments based on the Outcome Measures in Rheumatology core dataset; 18 recommended the disease activity score for 28 joints. Twenty recommended targeting remission; 16 suggested low disease activity as alternative. All guidelines recommend treating active RA; 13 made recommendations for moderate disease. The 21 guidelines considering early RA all recommended starting disease modifying drugs (DMARDs) as soon as possible; methotrexate was recommended for most patients. Nineteen recommended combination DMARDs when patients failed to respond fully to monotherapy and biologics were not necessarily indicated. Twenty made recommendations about biologics invariably suggesting their use after failing conventional DMARDs, particularly methotrexate. Most did not make specific recommendations about using one class of biologics preferentially. Eight recommended tapering biologics when patients achieved sustained good responses. Conclusions Five general principles transcend most guidelines: DMARDs should be started as soon as possible after the diagnosis; methotrexate is the best initial treatment; disease activity should be regularly monitored; give biologics to patients with persistently active disease who have already received methotrexate; remission or low disease activity are the preferred treatment target.

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