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 An observational study on Assessment of disease activity in Rheumatoid Arthritis patients using Patient based Disease Activity Score 2 (PDAS 2)

2021 ◽  
Author(s):  
Harpreet Singh ◽  
Somdatta Giri ◽  
Hemant Kumar ◽  
Pratibha Yonzone ◽  
Mahima Khatkar
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Activity Score ◽  
Activity Index ◽  
Statistical Significance ◽  
Disease Activity Index ◽  
Activity Score ◽  
P Value ◽  
Internal Reliability ◽  
Das 28

Abstract Objective To assess the utility of Patient Based Disease Activity Score 2 (PDAS 2) in assessing the disease activity in Rheumatoid arthritis (RA). Methods A prospective cohort study was conducted on 80 patients of RA. The demographic and clinical characteristics of the patients were recorded. They were assessed for disease activity using “Disease Activity Score 28” (DAS 28), “Clinical Disease Activity Index” (CDAI) and PDAS 2 score at baseline (M0), at 2 months (M2) and at 4 months(M4) while they were on treatment. Data was analyzed for correlation of PDAS-2 with other scores and internal reliability. P < 0.05 was considered for statistical significance. Results The mean age was 40.13\(\pm\) 11.74 years with 70 females and 10 males. There was significant reduction in DAS28, CDAI and PDAS 2 score over 4 month follow up (all scores’ p values < 0.001). Internal reliability (as assessed by Cronbach’s Alpha) of PDAS 2 was 0.578. PDAS 2 showed significant correlation with DAS28 at M0, M2 and M4 (r = 0.792, 0.757 and 0.669 respectively, p value < 0.001) and CDAI (r = 0.861, 0.832 and 0.695 respectively, p value < 0.001). Overall there was a significant agreement between DAS 28 and PDAS 2 (K = 0.788,p < 0.001) and between CDAI and PDAS 2 (K = 0.766,p < 0.001). Conclusion PDAS-2 score can be routinely used in the clinical practice owing to its correlation with DAS-28/CDAI and because of the advantage that it assessed the patients’ daily living activities.

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.

Baseline predictors of different types of treatment success in rheumatoid arthritis

2021 ◽  
pp. annrheumdis-2021-220853
Author(s):  
Dafne Capelusnik ◽  
Daniel Aletaha
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Disease Duration ◽  
Activity Index ◽  
Treatment Success ◽  
Disease Activity Index ◽  
Acute Phase Reactants ◽  
Reactive Protein ◽  
Composite Indices ◽  
Lower Disease Activity

ObjectiveTo perform a comprehensive analysis on predictors of achieving disease activity outcomes by change, response and state measures.MethodsWe used data from three rheumatoid arthritis (RA) trials (one for main analysis, two for validation) to analyse the effect of patient and disease characteristics, core set measure and composite indices on the achievement of different outcomes: response outcomes (% of patients achieving a relative response margin); state outcomes (remission or low disease activity, LDA) and change outcomes (numerical change on metric scales).ResultsWe included patients from the ASPIRE trial (for analysis) and from the ATTRACT and GO-BEFORE trials (for validation). While lower disease activity components at baseline—except acute phase reactants—were associated with achievement of state outcomes (such as LDA by the Simplified Disease Activity Index, SDAI), higher baseline values were associated with change outcomes (such as SDAI absolute change). A multivariate analysis of the identified predictors of state outcomes identified best prediction by a combination of shorter disease duration, male gender and lower disease activity. For prediction of response, no consistently significant predictors were found, again, with exception of C reactive protein, for which higher levels at baseline were associated with better responses.ConclusionPrediction of treatment success is limited in RA. Particularly in early RA, prediction of state targets can be achieved by lower baseline levels of diseases activity. Gender and disease duration may improve the predictability of state targets. In clinical trials, included populations and choice of outcomes can be coordinated to maximise efficiency from these studies.

scholarly journals Relationship Between Disease Activity and Hearing Loss in Rheumatoid Arthritis Patients A Case Control Study

2016 ◽  
Vol 3 (1) ◽  
pp. 1-5
Author(s):  
Ilham Rkain ◽  
Hanan Rkain ◽  
Ilham Bouaddi ◽  
Taoufik Dakka ◽  
Najia Hajjaj-Hassouni ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Hearing Loss ◽  
Disease Activity ◽  
Hearing Impairment ◽  
Activity Index ◽  
Disease Activity Index ◽  
Healthy Controls ◽  
Female Sex ◽  
Das 28 ◽  
Otoscopic Examination

Objectives Rheumatoid arthritis (RA) is well known to affect many different organ systems. Previous work suggests that this includes the auditory system. The objectives of this work are to evaluate the pattern of hearing impairment in patients with rheumatoid arthritis and also to examine the possible associations between hearing impairment and related RA features especially disease activity. Materials and methods Thirty RA patients (mean age of 44.5 ± 9.9 years; female sex (90%)) and 17 healthy controls (mean age of 41.5±9.1 years; female sex (76.4%)) were included in our study. The 2 groups were matched for age and sex (p>0.05). Otoscopic examination was normal in all participants. No subject of the 2 groups has had any abnormalities at otoscopic examination. Hearing impairment was evaluated by pure tone audiometry and tympanometry including the static compliance, middle ear pressure, stapedial reflex threshold test. In all patients the clinical features, laboratory data, X-rays, disease activity index-DAS 28 were performed. Results Hearing loss was more prevalent in RA patients compared to healthy controls (56.7 vs 11.8%; p=0.005). RA patients have conductive, sensorineural and mixed hearing loss in respectively 43.4, 3.3 and 10 % of cases. Association analysis between hearing characteristics and remission in RA patients shows that RA patients in remission have significantly lower mean hearing thresholds (12.8±5.2dB vs 18.8±6.9 dB ; p=0.04). Conclusion This study suggests that hearing loss risk is higher in RA patients and seems to be associated to disease duration. Hearing loss in RA was directly proportional to the disease activity index-DAS 28. Audiological evaluation must be performed periodically to identify possible audiological damage

scholarly journals O08 Development and validation of a new tool to assess inflammatory foot disease activity in RA: the Rheumatoid Arthritis Foot Disease Activity Index

Rheumatology ◽  
2020 ◽  
Vol 59 (Supplement_2) ◽  
Author(s):  
Anika Hoque
Keyword(s):  
Rheumatoid Arthritis ◽  
Construct Validity ◽  
Disease Activity ◽  
Internal Consistency ◽  
Content Validity ◽  
Activity Index ◽  
A Priori ◽  
Disease Activity Index ◽  
Das 28 ◽  
Foot Disease

Abstract Background Rheumatoid arthritis (RA) commonly affects the feet, resulting in pain, walking difficulties, and disability. Omission of foot joints from the disease activity score-28 (DAS-28) may lead to underestimation of foot disease and suboptimal medical and non-medical management. Therefore, the overall objective of this study is to evaluate the measurement properties of the Rheumatoid Arthritis Foot Disease Activity Index-5 (RADAI-F5), a newly developed 5-item (0-10 numerical rating scale) patient-reported outcome measure (PROM) with a summary score (0-10) for measuring foot disease activity in people with RA. Methods Participants with RA recruited from NHS rheumatology outpatient clinics completed the RADAI-F5, a self-modified Rheumatoid Arthritis Disease Activity Index (mRADAI-5) which is a self-reported measure of global disease activity, the Foot function index (FFI), Foot Impact Scale impairment/footwear (FIS-IF) and activity/participation (FIS-AP) subscales. DAS-28 was also recorded for each participant whenever possible. Participants completed RADAI-F5 again at 1 week to allow evaluation of 1-week reproducibility. Construct validity was evaluated using Spearman’s rho to test a priori hypotheses for expected strength of associations between the RADAI-F5 and the alternative disease activity and foot-related disability scales at baseline. Internal consistency was evaluated using Cronbach’s alpha. One-week reproducibility was evaluated using the intraclass correlation coefficient (ICC), 90% smallest detectable change (SDC90), and 95% limits of agreement (LOA). Content validity was evaluated using 5-point Likert scales for readability and relevance. Results Of 142 respondents, 103 were female and 36 were males with a mean (SD) age of 55 years (12.5) and mean (SD) RA disease duration of 39 months (70.4). Mean (SD, range) RADAI-F5 scores for the sample were 5.02 (2.47, 9.2). Associations were largely consistent with a priori hypotheses for construct validity. Strong associations were observed between the RADAI-F5 and MRADAI-5 (0.789, CI 0.73-0.85), the FFI (0.713, CI 0.62-0.79) and FIS-IS (0.695, CI 0.66-0.82) (p &lt; 0.001). Moderate associations were observed with the FFI-AP (0.478, p &lt; 0.001, CI 0.37-0.63). A weak association was observed between the RADAI-F5 and the DAS-28 (0.379, p &lt; 0.001, CI 0.26-0.57). The RADAI-F5 demonstrated high internal consistency (Cronbach’s Alpha=0.82), and floor and ceiling effects were both absent. The RADAI-F5 demonstrated good reproducibility (ICC=0.868, p &lt; 0.001, CI 0.80-0.91) and the value for SDC90 was 2.26. The upper and lower bounds for 95% LOA were -2.57 to 2.80, with 97% of scores observed within these bounds. Content validity was confirmed with 82% and 84% of participants rating the instrument as relevant and easy to understand respectively. The median time for completion was 5 minutes. Conclusion The RADAI-F5 is a highly valid and reliable PROM for measuring foot disease activity in RA patients. Furthermore, the RADAI-F5 appears to be feasible for use in clinical practice and can be used as an adjunct to the DAS28 to measure foot disease activity. Disclosures A. Hoque: Grants/research support; Stipend from Versus Arthritis to complete the Versus Arthritis MSK internship 2019 at Glasgow Caledonian University.

scholarly journals Investigating sirukumab for rheumatoid arthritis: 2-year results from the phase III SIRROUND-D study

RMD Open ◽  
2018 ◽  
Vol 4 (2) ◽  
pp. e000731 ◽  
Author(s):  
Carter Thorne ◽  
Tsutomu Takeuchi ◽  
George Athanasios Karpouzas ◽  
Shihong Sheng ◽  
Regina Kurrasch ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Clinical Signs ◽  
Disease Activity Index ◽  
Signs And Symptoms ◽  
Exposure Period ◽  
Phase Iii ◽  
Double Blind ◽  
Patient Reported

ObjectivesThe phase III, multicentre, randomised, double-blind, placebo-controlled, parallel-group SIRROUND-D study evaluated long-term efficacy and safety of the interleukin (IL)-6 inhibitor, sirukumab, in patients with active rheumatoid arthritis (RA) refractory to disease-modifying antirheumatic drugs (DMARDs).MethodsPatients were randomised 1:1:1 to sirukumab 100  mg every 2 weeks (q2w), 50  mg every 4 weeks or placebo q2w subcutaneously. Patients initially randomised to placebo were rerandomised at Weeks 18, 40 or 52 to one of the sirukumab groups until Week 104.ResultsOf 1670 randomised patients, 1402 were included in the full analysis set and 1269 in the radiographic analysis set at Week 104. American College of Rheumatology scores, Disease Activity Score based on C-reactive protein, Clinical Disease Activity Index and clinically meaningful improvements in patient-reported outcomes were sustained at Week 104 among patients initially randomised to sirukumab. Placebo patients subsequently rerandomised to sirukumab showed clinical improvements at Week 104 that were comparable to results among patients initially randomised to sirukumab. Radiographic progression from Week 52 to Week 104 was comparable between all groups whether initially randomised to sirukumab or subsequently rerandomised to sirukumab from placebo. No new safety signals were identified in the extended exposure period compared with the initial 52 weeks of treatment.ConclusionsSirukumab treatment resulted in sustained reductions in clinical signs and symptoms and minimal progression in radiographic damage over 2 years among patients with RA refractory to DMARDs. The safety profile of sirukumab was as expected for an anti-IL-6 agent, with no new signals reported.

scholarly journals AB0365 COMPARISON OF SUSTAINED CLINICAL REMISSION AND/OR LOW DISEASE ACTIVITY RATE BETWEEN RAPIDLY AND GRADUALLY DE-ESCALATION OF BARICITINIB IN RHEUMATOID ARTHRITIS.

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1483.2-1483
Author(s):  
M. Yamasaki
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Health Assessment ◽  
Disease Activity Index ◽  
Signs And Symptoms ◽  
Janus Kinase ◽  
Biologic Dmards ◽  
Low Disease Activity ◽  
First Line Therapy

Background:However baricitinib, an oral selective inhibitor of Janus kinase (JAK) 1 and 2, improved signs and symptoms of rheumatoid arthritis (RA), it is unknown who can taper or stop baricitinib and strategies for de-escalation.Objectives:We analyze predictors of tapering of withdrawal failure in rheumatoid arthritis (RA) patients treated with baricitinib. This study will assess and compare (1) characteristic of patients who achieve remission (REM) or low disease activity (LDA) as who can taper baricitinib and (2) two de-escalation methods, rapidly and gradually de-escalation in patients who respond first-line therapy.Methods:Cases were recruited to SHin-yokohama Arthritis REgister (SHARE) between 2015 and 2019 (n=3,674). Patients were diagnosed according to ACR/EULAR 2010 classification criteria, and treated with DMARDs which included baricitinib 2mg/day (n=154). In 154 cases, Clinical Disease Activity Index (CDAI), Health Assessment Questionnaire-Disability Index (HAQ-DI), anti-CCP2 and patients clinical parameters were analyzed. Two de-escalation methods were compared in this study. In rapidly de-escalation methods, baricitinib were stopped in patients with stable REM/LDA over 12 weeks. In gradually de-escalation methods, baricitinib were decreased to 50%, 42%, 28%, 14% in order with stable REM/LDA over 12 weeks.Results:In 154 (Male25, Female129 cases, RA duration 11.4+/-8.0 years) cases, CDAI at baricitinib-start was 20.6+/-12.4 and titer of anti-CCP2 was 242.6+/-516.5 U/ml. 126 cases (81.8%) were more than 2 years of RA duration and 49 cases (31.8%) had persistency of signs and/or symptoms suggestive of inflammatory RA disease activitiy, despite prior treatment with csDMARDs and at least two biologic DMARDs. 33 cases (21.4%) were biologic DMARDs naive.(1)”Multivariate logistic regression examined the predictors to detect who can taper baricitinib” However there were no differences in duration of RA, onset age of RA, biologics and/or JAK inhibitors naïve, anti-CCP2 titer and CDAI at the start baricitinib, patients who showed decrease of CDAI at 12 weeks were correlated with achievement of remission (REM) or low disease activity (LDA) in patients treated with baricitinib (OR 0.964, 95%CI 0.934-0.996, p=0.010). ROC analysis of ΔCDAI at 12 weeks is cut-off value of -6.6 (p=0.011).(2)”Comparison of sustained REM and/or LDA rate between rapidly and gradually de-escalation of baricitinib in rheumatoid arthritis” 11 cases were tapered baricitinib with rapidly de-escalation methods and 60 patients were with gradually de-escalation. Mean times to start taper baricitinib in rapidly and gradually de-escalation group were 4.6+/-1.6 months and 5.9+/-2.2 months respectively. Gradually de-escalation methods showed less relapse rate compared with rapidly de-escalation after tapered baricitinib for 6 months (18.3% vs. 54.5%, p=0.018). There were no differences in clinical features such as anti-CCP2, CDAI and administration period of baricitinib between non-relapse and relapse patients in gradually escalation methods.Conclusion:A combination of ΔCDAI at 12 weeks and tapering baricitinib using gradually de-escalation methods may help to predict successful baricitinib deduction in RA patients with sustained clinical REM and/or LDA.References:[1]Ann Rheum Dis. 2019;78:171[2]Rheumatology. 2019;58:110[3]An Rheum Dis. 2015;74:19Disclosure of Interests:None declared

scholarly journals Olokizumab, a monoclonal antibody against interleukin 6, in combination with methotrexate in patients with rheumatoid arthritis inadequately controlled by methotrexate: efficacy and safety results of a randomised controlled phase III study

2021 ◽  
pp. annrheumdis-2021-219876
Author(s):  
Evgeniy Nasonov ◽  
Saeed Fatenejad ◽  
Eugen Feist ◽  
Mariana Ivanova ◽  
Elena Korneva ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Phase Iii ◽  
Double Blind Study ◽  
Efficacy And Safety ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Acr20 Response

ObjectiveTo evaluate the efficacy and safety of olokizumab (OKZ) in patients with active rheumatoid arthritis despite treatment with methotrexate (MTX).MethodsIn this 24-week multicentre, placebo-controlled, double-blind study, patients were randomised 1:1:1 to receive subcutaneously administered OKZ 64 mg once every 2 weeks, OKZ 64 mg once every 4 weeks, or placebo plus MTX. The primary efficacy endpoint was the proportion of patients achieving an American College of Rheumatology 20% (ACR20) response at week 12. The secondary efficacy endpoints included percentage of subjects achieving Disease Activity Score 28-joint count based on C reactive protein <3.2, Health Assessment Questionnaire Disability Index at week 12, ACR50 response and Clinical Disease Activity Index ≤2.8 at week 24. Safety and immunogenicity were assessed throughout the study.ResultsA total of 428 patients were randomised. ACR20 responses were more frequent with OKZ every 2 weeks (63.6%) and OKZ every 4 weeks (70.4%) than placebo (25.9%) (p<0.0001 for both comparisons). There were significant differences in all secondary efficacy endpoints between OKZ-treated arms and placebo. Treatment-emergent serious adverse events (TESAEs) were reported by more patients in the OKZ groups compared with placebo. Infections were the most common TESAEs. No subjects developed neutralising antidrug antibodies.ConclusionsTreatment with OKZ was associated with significant improvement in signs, symptoms and physical function of rheumatoid arthritis without discernible differences between the two regimens. Safety was as expected for this class of agents. Low immunogenicity was observed.Trial registration numberNCT02760368.

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.

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