scholarly journals POS0628 FAILURE TO SUSTAIN TREATMENT TARGET AFTER TAPERING TOCILIZUMAB IN PATIENTS WITH RHEUMATOID ARTHRITIS: 4-YEAR LONGITUDINAL DATA FROM A NATIONWIDE COHORT

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 552.1-552
Author(s):  
J. W. Park ◽  
M. J. Kim ◽  
H. A. Kim ◽  
J. Kim ◽  
E. B. Lee ◽  
...  

Background:Tapering biologic therapy after achieving clinical remission or low disease activity (LDA) has become a viable option in daily clinical practice of treating patients with rheumatoid arthritis (RA). There are yet few studies investigating its effectiveness and safety compared with those of standard biologic treatment, especially with non-tumor necrosis factor inhibitors.Objectives:To investigate the effectiveness and safety of tapering tocilizumab (TCZ) in patients with RA who attained LDA after TCZ therapy.Methods:Data were collected from a nationwide cohort of patients with RA receiving biologic therapy in South Korea (KOBIO-RA). This study included 350 patients who were treated with TCZ and achieved Clinical Disease Activity Index (CDAI)-LDA or remission (CDAI ≤ 10) after one year of treatment. We performed a longitudinal analysis utilizing clinical data measured in all 1-year intervals using generalized estimating equations (GEE). A total of 575 one-year intervals were divided into two groups according to the dose quotient (DQ, 0-100%) of TCZ within the interval (tapering group vs. standard treatment group). The main outcome of this study was loss of CDAI-LDA in the following 1-year interval.Results:Tapering TCZ was conducted in 282 (49.0%) intervals with a mean (SD) DQ of 66.0 (15.5). Loss of CDAI-LDA occurred in 91 (15.1%) intervals. Multivariable GEE showed significantly increased loss of CDAI-LDA (adjusted OR (95% CI): 1.76 [1.01 to 3.07]) in the tapering group after adjusting for previous biologics use, route of TCZ administration, concomitant glucocorticoid use, and CDAI measured in the previous follow-up. In addition, the likelihood to achieve DAS28-deep remission (DAS28-ESR < 1.98) was also significantly lower in the tapering group (adjusted OR 0.68 [0.46 to 0.99]). In contrast, there was no significant difference in the proportion of fulfilling other remission criteria between the two groups (Table 1). Development any adverse drug event or event of special interest was comparable in both groups except for hypercholesterolemia, which was lower in the tapering group.Table 1.Demographic characteristics and csDMARDs before first bDMARDLoss of CDAI-LDADAS28-remissionDAS28-deep remissionCDAI-remissionSDAI-remissionACR/EULAR remissionUnadjusted OR (95% CI)(vs. standard-dose group)1.02 (0.67 to 1.55)1.03 (0.71 to 1.49)0.76 (0.54 to 1.06)1.23 (0.75 to 2.00)0.92 (0.59 to 1.44)0.98 (0.65 to 1.48)Adjusted OR(95% CI)(vs. standard-dose group)1.76 (1.01 to 3.07)0.87 (0.54 to 1.38)0.68 (0.46 to 0.99)0.94 (0.57 to 1.55)0.87 (0.54 to 1.38)0.76 (0.50 to 1.18)CDAI, clinical disease activity index; CI, confidence interval; DAS, disease activity score; LDA, low disease activity; OR, odds ratio; SDAI, simplified disease activity index.Conclusion:Tapering TCZ after achieving LDA in patients with RA increases the risk of losing the benefit of LDA without a significant merit in safety.References:[1]Smolen JS et al. Maintenance, reduction or withdrawal of etanercept after treatment with etanercept and methotrexate in patients with moderate rheumatoid arthritis (PRESERVE): a randomised controlled trial. Lancet. 2013;381:918-29.[2]Schett G et al. Tapering biologic and conventional DMARD therapy in rheumatoid arthritis: current evidence and future directions. Ann Rheum Dis. 2016;75:1428-37.Disclosure of Interests:None declared

2021 ◽  
Vol 80 (Suppl 1) ◽  
pp. 1093.2-1094
Author(s):  
C. Lally ◽  
I. Ali ◽  
C. Silke ◽  
B. Whelan ◽  
M. O’sullivan

Background:Rheumatoid arthritis (RA) is a chronic autoimmune condition which if not treated can lead to joint destruction and long term disability. In RA, the concept of T2T is recommended as the appropriate method to manage early arthritis 1. It has shown promising results to achieve clinical remission (CR) or low disease activity (LDA) 2.Objectives:The objective of this study was to investigate the potential to achieve remission or LDA according to the Clinical Disease Activity Index (CDAI) for RA, during treatment with Disease-Modifying Anti-Rheumatic Drugs (DMARDs) and Biologics, and the factors that affect the remission/LDA outcome.Methods:We performed an observational prospective study on patients’ data available from our Early Arthritis Cohort. All patients with newly diagnosed RA who met the American College of Rheumatology (ACR) criteria were enrolled. Patients are managed by an Advanced Nurse Practitioner (ANP) with consultant supervision. To assess their response to treatment, we used the Clinical Disease Activity Index3. Analysis was performed using SPSS.Results:Out of a total of 459 patients, 353 completed the programme. 217 patients (61.5%) were female and (136) 38.5 % were male. Mean age was 53.98 (SD 14.66). 195 patients were on monotherapy, 40 on combination DMARDs and 115 were on Biologics/Janus Kinase Inhibitors (JAK-Inh). Remission-rates in the monotherapy and combination DMARDs groups were approximately 60%, whilst the remission rate in the Biologics/JAK-Inh group was 41.7%. Amongst female patients 15.9% had erosions on X-ray at the time of diagnosis whilst the equivalent figure for male patients was 29.6%.Conclusion:An association between male gender and the likelihood of erosions on X-Ray was observed. In addition an association between final medication and outcome was observed. An increased likelihood of non-remission was noted in patients that required escalation to Biologics/JAKs. A possible explanation for the lower levels of remission seen throughout the groups is the difficulty in achieving remission under the CDAI score as compared to DAS-28.References:[1]Smolen JS, Breedveld FC, Burmester GR, Bykerk V, Dougados M, Emery P, et al. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Annals of the Rheumatic Diseases. 2016;75(1):3.[2]Scott IC, Ibrahim F, Panayi G, Cope AP, Garrood T, Vincent A, Scott DL, Kirkham B; TITRATE Programme Investigators. The frequency of remission and low disease activity in patients with rheumatoid arthritis, and their ability to identify people with low disability and normal quality of life. Semin Arthritis Rheum. 2019 Aug;49(1):20-26. doi: 10.1016/j.semarthrit.2018.12.006. Epub 2018 Dec 28. PMID: 30685064.Disclosure of Interests:None declared


2021 ◽  
Author(s):  
Jun Won Park ◽  
Min Jung Kim ◽  
Hyoun-Ah Kim ◽  
Jin Hyun Kim ◽  
Eun Bong Lee ◽  
...  

Abstract Background: Although recent guidelines recommend that tapering of biologic disease-modifying anti-rheumatic drugs (bDMARDs) can be considered in patients with rheumatoid arthritis (RA), there has been little evidence supporting the strategy during the non-tumor necrosis factor inhibitor treatment. This study aims to investigate the effectiveness and safety of tapering tocilizumab (TCZ) dose in patients with RA who attain low disease activity (LDA) after TCZ therapy in a nationwide cohort.Methods: Data were collected from a nationwide cohort of patients with RA receiving biologic disease-modifying anti-rheumatic drugs in South Korea (KOBIO-RA). This study included 350 patients who were treated with TCZ and achieved Clinical Disease Activity Index-low disease activity (CDAI)-LDA (CDAI ≤ 10) after 1 year of treatment. We performed longitudinal analysis considering clinical data measured at all 1-year intervals for the included patients using the generalized estimating equation. A total of 575 intervals were classified into two groups according to their dose quotient (DQ) of TCZ (tapering group vs. standard-dose group). The main outcome was maintaining CDAI-LDA in the following 1-year interval.Results: Tapering TCZ dose strategy was used in 282 (49.0%) intervals with a mean (SD) DQ of 66.0 (15.5) %. Loss of CDAI-LDA occurred in 91 (15.1%) intervals. Multivariable GEE showed that the tapering group was associated with more frequent failure to sustain CDAI-LDA (adjusted OR [95% CI]: 0.57 [0.33–0.99]), which subsequently led to impaired functional status. The likelihood of achieving DAS28-deep remission (DAS28-ESR<1.98) was also significantly lower in the tapering group (adjusted OR 0.68 [0.46–0.99]). CDAI remission was achieved in only 69 (12.0%) of the total intervals, with no significant difference in the proportion of intervals achieving the target between the two groups. Incidence of adverse events was comparable in both groups except for hypercholesterolemia, which was lower in the tapering group. Conclusions: Tapering TCZ dose after achieving LDA increases the risk of losing LDA without a significant merit in safety.


2015 ◽  
Vol 42 (7) ◽  
pp. 1090-1098 ◽  
Author(s):  
Leslie R. Harrold ◽  
George W. Reed ◽  
Ashwini Shewade ◽  
Robert Magner ◽  
Katherine C. Saunders ◽  
...  

Objective.To characterize the real-world effectiveness of rituximab (RTX) in patients with rheumatoid arthritis.Methods.Clinical effectiveness at 12 months was assessed in patients who were prescribed RTX based on the Clinical Disease Activity Index (CDAI). Change in CDAI was calculated (CDAI at 12 mos minus at initiation). Achievement of remission or low disease activity (LDA; CDAI ≤ 10) among those with moderate/high disease activity at the time of RTX initiation was compared based on prior anti-tumor necrosis factor agent (anti-TNF) use (1 vs ≥ 2) using logistic regression models.Results.Patients (n = 265) were followed for 12 months with a mean change in CDAI of −8.1 (95% CI −9.8 – −6.4). Of the 218 patients with moderate/high disease activity at baseline, patients with 1 prior anti-TNF (baseline CDAI 25.0) demonstrated a mean change in CDAI of −10.1 (95% CI −13.2 – −7.0); patients with ≥ 2 prior anti-TNF (baseline CDAI 30.0) demonstrated a mean change of −10.5 (95% CI −12.9 – −8.0). The unadjusted OR for achieving LDA/remission in patients with moderate/high disease activity at baseline exposed to ≥ 2 versus 1 prior anti-TNF was 0.40 (95% CI 0.22–0.73), which was robust to 4 different adjusted models (OR range 0.38–0.44).Conclusion.A good clinical response was observed in all patients; however, patients previously treated with 1 anti-TNF, who had lower baseline CDAI and a greater opportunity for clinical improvement compared with patients previously treated with ≥ 2 anti-TNF, were more likely to achieve LDA/remission.


2017 ◽  
Vol 33 (S1) ◽  
pp. 59-60
Author(s):  
Jéssica dos Santos ◽  
Haliton Oliveira ◽  
Francisco Acurcio Michael da Silva ◽  
Alessandra Almeida ◽  
Flávia Rodrigues ◽  
...  

INTRODUCTION:Biological disease-modifying anti-rheumatic drugs (bDMARDs) have become firmly established in the management of patients with rheumatoid arthritis (RA), but some patients do not improve despite therapy. This study evaluated the predictors of effectiveness of the bDMARDs on a cohort of patients with rheumatoid arthritis (RA) in the Brazilian Public Health System.METHODS:RA individuals treated with bDMARDs, were included in the open prospective cohort study. The Clinical Disease Activity Index (CDAI) was used to assess the effectiveness comparing results at baseline and after 6 months of follow-up. The association between socio-demographic and clinical characteristics with the disease activity measured by the CDAI was also investigated. The bDMARDs was considered effective when the patient achieved remission or low disease activity and considered not effective when there was still moderate or high disease activity. Pearson's chi-square was applied for the univariate analysis to evaluate the association of effectiveness measured by the CDAI with the socio-demographic (gender, education, marital status and race) and clinical variables (type of drug, EuroQol (EQ)-5D and Health Assessment Questionnaire (HAQ)). Logistic regression was applied in the multivariate analysis of the variables that presented a p< .20 value during the univariate analysis.RESULTS:All 266 RA patients completed six months of follow-up. The most widely used bDMARDs was adalimumab (57.1 percent), with etanercept used by 22.2 percent, golimumab by 7.5 percent, abatacept by 4.5 percent, tocilizumab by 3.4 percent, infliximab by 2.6 percent, certolizumab by 1.5 percent, and rituximab by 1.1 percent. The bDMARDs reduced disease activity as measured by CDAI at six months of follow-up (p<.001). The percentage of patients achieving remission or low disease activity was 40.6 percent. bDMARDs were more effective in patients with better functionality (Odds Ratio, OR = 2.140 / 95 percent Confidence Interval, CI 1.219 - 3.756) at beginning of treatment and in patients who not had a previous bDMARDs (OR = 2.150 / 95 percent CI 1.144 - 4.042).CONCLUSIONS:In this real-world study, functionality and use of previous bDMARDs are predictors in patients with RA treated with bDMARDs.


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