Comparative Effectiveness of Nonbiologic versus Biologic Disease-modifying Antirheumatic Drugs for Rheumatoid Arthritis

2013 ◽  
Vol 40 (2) ◽  
pp. 127-136 ◽  
Author(s):  
ESI MORGAN DEWITT ◽  
YANHONG LI ◽  
JEFFREY R. CURTIS ◽  
HENRY A. GLICK ◽  
JEFFREY D. GREENBERG ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Comparative Effectiveness ◽  
Statistical Power ◽  
Activity Index ◽  
Disease Activity Index ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Treatment Change ◽  
Disease Modifying

Objective.To evaluate the comparative effectiveness of nonbiologic disease-modifying antirheumatic drugs (DMARD) versus biologic DMARD (bDMARD) for treatment of rheumatoid arthritis (RA), using 2 common analytic approaches.Methods.We analyzed change in Clinical Disease Activity Index (CDAI) scores in patients with RA enrolled in a US-based observational registry from 2001 to 2008 using multivariable (MV) regression and propensity score (PS) matching. Among patients who initiated treatment with a nonbiologic DMARD (n = 1729), we compared patients who switched to, or added, another nonbiologic (n = 182) or a bDMARD (n = 342) at 5, 9, and 24 months after treatment change.Results.Both analytic approaches showed that patients switching to or adding another nonbiologic DMARD demonstrated improvement across 9 and 24 months (both p < 0.001). Both approaches also demonstrated greater improvement in CDAI among recipients of bDMARD relative to a second nonbiologic DMARD at 5 months (p < 0.02). The MV regression approach upheld these results at 9 and 24 months (p < 0.03). In contrast, the PS-matching approach did not show a sustained advantage with bDMARD at these later timepoints, possibly because of lower statistical power and/or lower baseline disease activity in the PS-matched cohort.Conclusion.Patients in both treatment groups generally experienced lower CDAI scores across time. Patients switching to bDMARD demonstrated greater improvement than patients switching to nonbiologic DMARD with both analytic approaches at 5 months. Relative advantages with bDMARD were observed at 9 and 24 months only with MV regression. These analyses provide a practical example of how findings in comparative effectiveness research can diverge with different methodological approaches.

Periodontitis Severity Affects the Clinical Response to Biological Disease-Modifying Antirheumatic Drugs in Rheumatoid Arthritis: A 1-Year Follow-up Study

2021 ◽  
Author(s):  
Tetsuo Kobayashi ◽  
Satoshi Ito ◽  
Akira Murasawa ◽  
Hajime Ishikawa ◽  
Koichi Tabeta
Keyword(s):  
Rheumatoid Arthritis ◽  
Clinical Response ◽  
Activity Index ◽  
Disease Activity Index ◽  
Positive Association ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Case Definitions ◽  
Synthetic Dmards ◽  
Disease Modifying

ABSTRACT Objectives To assess whether periodontitis severity affects the clinical response to biological disease-modifying antirheumatic drugs (bDMARDs) for 1 year in rheumatoid arthritis (RA) patients. Methods Data were collected from 50 RA patients who had received corticosteroids, conventional synthetic DMARDs, or non-steroidal anti-inflammatory drugs before (baseline) and after 1 year of bDMARD therapy in a retrospective study. Rheumatologic conditions were compared between the two periodontitis severity groups according to the periodontal inflamed surface area (PISA) or Centers for Disease Control Prevention (CDC)/ American Academy of Periodontology (AAP) case definitions Results Twenty-eight patients with no or mild periodontitis showed significantly greater decreases in changes in Clinical Disease Activity Index (CDAI) and tender and swollen joint count in comparison to 22 patients with moderate and severe periodontitis (p = 0.02, p = 0.01, and p = 0.03). Both bivariate and multivariate analyses revealed a significantly positive association between the baseline CDC/AAP definitions and CDAI changes (p = 0.005 and p = 0.0038). However, rheumatologic conditions were comparable between 25 patients each in the low and high PISA groups. Conclusions Baseline periodontitis severity according to the CDC/AAP definitions is associated with the clinical response to bDMARDs for 1 year in RA patients.

High Levels of Polypharmacy in Rheumatoid Arthritis—A Challenge Not Covered by Current Management Recommendations: Data From a Large Real-Life Study

2019 ◽  
pp. 089719001986915 ◽  
Author(s):  
Ana Paula M. Gomides ◽  
Cleandro P. Albuquerque ◽  
Ana B.V. Santos ◽  
Rodrigo B. C. Amorim ◽  
Manoel B. Bértolo ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Real Life ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Cross Sectional ◽  
Rheumatic Arthritis ◽  
Increased Risk ◽  
Disease Modifying

Background: Rheumatoid arthritis (RA) is associated with high frequency of comorbidities and increased risk of polypharmacy. Although there is a great potential for complications, there is a gap in literature on polypharmacy in patients with rheumatic arthritis. Objective: To evaluate the prevalence and factors associated with polypharmacy in a population in a real-life setting. Methods: A cross-sectional multicenter study was conducted in Brazil. Patients underwent clinical evaluation and medical records analysis. Polypharmacy was considered as a dependent variable. To test independent variables, we used Poisson regression. Results: We evaluated 792 patients (89% female, median age 56.6 years). Median duration of disease was 12.7 years, 78.73% had a positive rheumatoid factor. The median of disease activity score-28 was 3.5 (disease with mild activity), median of the clinical disease activity index score was 9, and median of health assessment questionnaire-disability index was 0.875; 47% used corticosteroids, 9.1% used nonsteroidal anti-inflammatory drugs, 90.9% used synthetic disease-modifying antirheumatic drugs, 35.7% used biologic disease-modifying antirheumatic drugs (DMARDs). In total, 537 (67.9%) patients used 5 or more drugs. Polypharmacy showed a relationship with a number of comorbidities and use of specific drugs (corticosteroids, methotrexate, and biological DMARDs). Conclusion: We found a high prevalence of polypharmacy (67.9%) in RA. Solutions to management this problem should be stimulated.

scholarly journals Comparative effectiveness of tocilizumab versus TNF inhibitors as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs in patients with rheumatoid arthritis after the use of at least one biologic disease-modifying antirheumatic drug: analyses from the pan-European TOCERRA register collaboration

2018 ◽  
Vol 77 (9) ◽  
pp. 1276-1282 ◽  
Author(s):  
Kim Lauper ◽  
Dan C Nordström ◽  
Karel Pavelka ◽  
Maria Victoria Hernández ◽  
Tore K Kvien ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Combination Therapy ◽  
Disease Activity ◽  
Activity Index ◽  
Tnf Inhibitors ◽  
Inadequate Response ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Drug Retention ◽  
Disease Modifying

ObjectiveTo compare the effectiveness of tocilizumab (TCZ) and tumour necrosis factor (TNF) inhibitors (TNFi) as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (DMARDs) in patients with rheumatoid arthritis (RA) after the use of at least one biologic DMARD (bDMARD).MethodsWe included patients with RA having used at least one bDMARD from 10 European registries. We compared drug retention using Kaplan-Meier and Cox models and Clinical Disease Activity Index (CDAI) change over time with mixed-effects models for longitudinal data. The proportions of CDAI remission and low disease activity (LDA) at 1 year were compared using LUNDEX correction.Results771 patients on TCZ as monotherapy (TCZ mono), 1773 in combination therapy (TCZ combo), 1404 on TNFi as monotherapy (TNFi mono) and 4660 in combination therapy (TNFi combo) were retrieved. Crude median retention was higher for TCZ mono (2.31 years, 95% CI 2.07 to 2.61) and TCZ combo (1.98 years, 95% CI 1.83 to 2.11) than TNFi combo (1.37 years, 95% CI 1.30 to 1.45) and TNFi mono (1.31 years, 95% CI 1.18 to 1.47). In a country and year of treatment initiation-stratified, covariate-adjusted analysis, hazards of discontinuation were significantly lower among patients on TCZ mono or combo compared with patients on TNFi mono or combo, and TNFi combo compared with TNFi mono, but similar between TCZ mono and combo. Average adjusted CDAI change was similar between groups. CDAI remission and LDA rates were comparable between groups.ConclusionWith significantly longer drug retention and similar efficacy to TNFi combo, TCZ mono or combo are reasonable therapeutic options in patients with inadequate response to at least one bDMARD.

THU0620-HPR MEASUREMENT OF LOW DISEASE ACTIVITY USING THE CLINICAL DISEASE ACTIVITY INDEX (CDAI) VERSUS THE DISEASE ACTIVITY SCORE 28 (DAS 28): IMPACT OF INFLAMMATION MARKERS ON THE COMPARATIVE EFFECTIVENESS OF BIOLOGICS FOR THE TREATMENT OF RHEUMATOID ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 553.1-553
Author(s):  
K. Janke ◽  
K. Biester ◽  
D. Krause ◽  
B. Richter ◽  
C. Schürmann ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Comparative Effectiveness ◽  
Inflammatory Markers ◽  
Activity Index ◽  
Disease Activity Index ◽  
Signs And Symptoms ◽  
Acute Phase Reactants ◽  
Das 28 ◽  
Effectiveness Studies

Background:Biologics for the treatment of rheumatoid arthritis (RA) have different modes of action to target auto-inflammatory processes causing the signs and symptoms of the disease. Different biologics may thus have different effects on inflammatory markers. For instance, previous studies have shown that the interleukin-6-inhibitor tocilizumab (TOC) decreases the level of acute phase reactants (APRs) [1]. Such direct effects on inflammatory markers may lead to an overestimation of clinical response if disease activity is measured via scores including inflammatory markers, such as the Disease Activity Score 28 (DAS 28). The detected changes in disease activity may not adequately reflect the clinical improvement of signs and symptoms.Objectives:In our study, we compared biologics with each other using two different disease activity scores: the DAS 28 including APRs and the clinical disease activity index (CDAI) excluding APRs. The aim of this study was to assess whether the use of the two different scores affects comparative effectiveness studies on biologics for the treatment of RA.Methods:We compared results on the comparative effectiveness of biologics using the corresponding thresholds for low disease activity (LDA) for the DAS 28 (< 3.2) and the CDAI (≤ 10). We performed two separate network meta-analyses (NMAs) after a thorough step-by-step evaluation of the similarity, homogeneity and consistency assumptions of the patient populations and the study data.Our study formed part of a systematic review (including NMAs) that was largely based on clinical study reports and re-analyses of LDA using individual patient data provided by sponsors for studies conducted up to 2017. Thus, the analyses include hitherto unknown data on LDA analysed by means of the CDAI, especially data from older studies. An extensive comparison of DAS 28 and CDAI in different patient populations was possible.Results:For all analysed patient populations, comparisons of TOC versus other biologics yielded remarkable results: advantages for TOC were found in NMAs using the DAS 28, which were not confirmed in NMAs using the CDAI. For methotrexate (MTX)-naïve patients, using the DAS 28, TOC showed a greater benefit than abatacept (ABA), certolizumab pegol (CZP), and etanercept (ETA), which was not confirmed by the CDAI. In contrast, TOC showed less benefit than adalimumab (ADA) and ETA. For patients after MTX failure and using the DAS 28, TOC showed a greater benefit than ABA, ADA, anakinra (ANA), ETA, golimumab (GOL), and infliximab (INF). With the exception of ANA, these advantages were not confirmed by the CDAI. Similar differences between DAS 28 and CDAI were shown in patients treated with biologics in monotherapy or after failure of biologics.Conclusion:In comparative effectiveness studies of biologics, the assessment of LDA using the DAS 28 instead of the CDAI leads to a consistent overestimation of the benefit of TOC in all patient populations, regardless of pre-treatment or combined therapy with MTX. The inclusion of APRs in disease activity scores may thus introduce bias. A score excluding inflammatory markers should therefore be used to ensure valid results.References:[1]Smolen JS, Aletaha D. Interleukin-6 receptor inhibition with tocilizumab and attainment of disease remission in rheumatoid arthritis: the role of acute-phase reactants. Arthritis Rheum 2011; 63(1): 43-52.Disclosure of Interests:Kirsten Janke: None declared, Katharina Biester: None declared, Dietmar Krause Grant/research support from: Pfizer and AbbVie (Abbott), Bernd Richter: None declared, Christoph Schürmann: None declared, Katharina Hirsch: None declared, Beate Wieseler: None declared

scholarly journals Effect of disease duration and prior disease-modifying antirheumatic drug use on treatment outcomes in patients with rheumatoid arthritis

2019 ◽  
Vol 78 (12) ◽  
pp. 1609-1615 ◽  
Author(s):  
Daniel Aletaha ◽  
Jen-fue Maa ◽  
Su Chen ◽  
Sung-Hwan Park ◽  
Dave Nicholls ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Duration ◽  
Activity Index ◽  
Health Assessment ◽  
Disease Activity Index ◽  
Response To Therapy ◽  
Joint Disease ◽  
Adalimumab Therapy ◽  
Disease Modifying

ObjectivesTo determine if disease duration and number of prior disease-modifying antirheumatic drugs (DMARDs) affect response to therapy in patients with established rheumatoid arthritis (RA).MethodsAssociations between disease duration or number of prior DMARDs and response to therapy were assessed using data from two randomised controlled trials in patients with established RA (mean duration, 11 years) receiving adalimumab+methotrexate. Response to therapy was assessed at week 24 using disease activity outcomes, including 28-joint Disease Activity Score based on C-reactive protein (DAS28(CRP)), Simplified Disease Activity Index (SDAI) and Health Assessment Questionnaire Disability Index (HAQ-DI), and proportions of patients with 20%/50%/70% improvement in American College of Rheumatology (ACR) responses.ResultsIn the larger study (N=207), a greater number of prior DMARDs (>2 vs 0–1) was associated with smaller improvements in DAS28(CRP) (–1.8 vs –2.2), SDAI (–22.1 vs –26.9) and HAQ-DI (–0.43 vs –0.64) from baseline to week 24. RA duration of >10 years versus <1 year was associated with higher HAQ-DI scores (1.1 vs 0.7) at week 24, but results on DAS28(CRP) and SDAI were mixed. A greater number of prior DMARDs and longer RA duration were associated with lower ACR response rates at week 24. Data from the second trial (N=67) generally confirmed these findings.ConclusionsNumber of prior DMARDs and disease duration affect responses to therapy in patients with established RA. Furthermore, number of prior DMARDs, regardless of disease duration, has a limiting effect on the potential response to adalimumab therapy.

scholarly journals Comparison of clinical manifestations of rheumatoid arthritis in patients with moderate or high disease activity depending on the presence or absence of symptoms of neuropathic pain

2021 ◽  
Vol 15 (6) ◽  
pp. 13-18
Author(s):  
E. Yu. Polishchuk ◽  
E. S. Filatova ◽  
A. E. Karateev ◽  
V. N. Amirdzhanova ◽  
V. A. Nesterenko
Keyword(s):  
Rheumatoid Arthritis ◽  
Neuropathic Pain ◽  
Disease Activity ◽  
Pain Intensity ◽  
Clinical Manifestations ◽  
High Disease Activity ◽  
Control Group ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Disease Modifying

Objective: to study the effect of neuropathic pain symptoms (SNP) on the clinical manifestations of rheumatoid arthritis (RA) in patients with moderate or high disease activity.Patients and methods. The 1st (main) group included 58 RA patients (84.5% of women, age 53.0±11.9 years), in whom SNP were identified using the DN4 (≥4) and PainDETECT (≥13) questionnaires. The 2nd (control) group included 43 patients with RA (79.1% women, age 48.8±14.4 years) who did not have SNP (DN4 ≤4 and PainDETECT ≤13). All patients received disease-modifying antirheumatic drugs (mainly methotrexate and leflunomide), 20% – biologic disease-modifying antirheumatic drugs. We compared groups 1 and 2 for RA activity (DAS28, CDAI, SDAI), pain intensity on a visual analogue scale (VAS, 0–100 mm), functional impairment (HAQ), patient global assessment (PGA, VAS), number of painful and swollen joints, quality of life (EQ-5D), signs of anxiety and depression (HADS), CRP level.Results and discussion. The RA activity in patients of the 1st and 2nd groups did not differ statistically significantly. Patients of the 1st group showed significantly higher indicators of the severity of pain, PGA and anxiety than patients of the control group: 71.0±12.5 and 54.7±17.5 mm, respectively (p<0.001); 61.0±13.1 and 53.7±15.3 mm (p=0.045); 62.1 and 28.6% (HADS ≥7; p<0.001), respectively.Conclusion. SNP are associated with higher rates of pain intensity, PGA, and anxiety in RA patients with moderate to high disease activity.

scholarly journals Anti-Cyclic Citrullinated Peptide and Rheumatoid Factor (Prevalence and Association) in Saudi Rheumatoid Arthritis Patients

2018 ◽  
Vol 25 (2) ◽  
pp. 1-10
Author(s):  
Mohammad-Ayman A. Safi ◽  
Dhiya T. Houssien
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Rheumatoid Factor ◽  
Disease Duration ◽  
Direct Impact ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Disease Modifying Drugs ◽  
Disease Modifying ◽  
Citrullinated Peptide

To assess the prevalence and association of anti-cyclic citrullinated peptides and rheumatoid factor in Saudi rheumatoid arthritis patients.Over three years (February 2011 - February 2014). Demographic and clinical features, drugs, rheumatoid factor-positivity, and anti-cyclic citrullinated peptides-positivity were recorded for 205 Saudi rheumatoid arthritis patients (185 females; mean age was 45 years and mean disease duration was 5 years). Anti-cyclic citrullinated peptides and rheumatoid factor were assessed in serum. Disease activity scores for 28 joints was used. There were 36% rheumatoid factor+ve and 45% anti-cyclic citrullinated peptides+ve. 21.5% of the rheumatoid factor-ve subjects were anti-cyclic citrullinated peptides+ve. 13.3% of the rheumatoid factor positive patients were anti-cyclic citrullinated peptides-ve and 86.7% were anti-cyclic citrullinated peptides+ve. Significant association (P < 0.05) of anti-cyclic citrullinated peptides-positivity and rheumatoid factor-positivity with each other, and with gender, use of disease–modifying antirheumatic drugs, hydroxychloroquine and methotrexate. No direct impact of anti-cyclic citrullinated peptides status on the disease activity scores for 28 joints or its constituents (P > 0.5); nevertheless, anti-cyclic citrullinated peptides positive patients appear to represent a greater need for combination disease modifying drugs. 

scholarly journals Optimising Response to Advanced Therapies in Rheumatoid Arthritis – Using Prehabilitation to Improve Success?

2020 ◽  
pp. 87-95
Author(s):  
Alice Mason ◽  
Mariam Malik
Keyword(s):  
Rheumatoid Arthritis ◽  
Physical Activity ◽  
Disease Activity ◽  
Tnf Inhibitors ◽  
Response To Therapy ◽  
Disease Modifying Antirheumatic Drugs ◽  
Antirheumatic Drugs ◽  
Ongoing Research ◽  
Advanced Therapies ◽  
Disease Modifying

In recent years, a new concept of prehabilitation, enhancing an individual’s functional capacity ahead of a medical intervention, has begun to be explored in the fields of surgery and oncology, with positive results. This article explores applying the principle of prehabilitation to patients with rheumatoid arthritis prior to starting advanced therapies, including biologic disease-modifying antirheumatic drugs and targeted synthetic disease-modifying antirheumatic drugs. In this article, the literature is reviewed and the existing evidence is summarised, and the suggestion is that this approach could improve a patient’s chance of achieving low disease activity or remission. There are a number of opportunities for improving the likelihood of patients with rheumatoid arthritis having a good response to therapy. Research shows that smokers starting TNF inhibitors are less likely to achieve a good response compared to non-smokers. Obese patients are also less likely to achieve a good response with TNF inhibitors; female patients with obesity may be less likely to achieve a good response with tocilizumab and early real-world data suggest there may be a reduced response to JAK inhibitors. Rheumatoid arthritis patients experiencing depression are less likely to respond to TNF inhibitors. Increased physical activity is potentially beneficial for all rheumatoid arthritis patients, although the effect on response to specific drugs has been less widely explored. Prehabilitation approaches could include targeting smoking cessation, improving physical activity, providing psychological support, optimising BMI, and dietary changes. A number of studies have shown that each of these interventions can lead to significant improvements in disease activity scores, with some patients potentially benefitting from more than one intervention. The authors identify principles for delivering prehabilitation in practice and suggest that this is an exciting area for ongoing research.

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