Incidence and Predictors of Biological Antirheumatic Drug Discontinuation Attempts among Patients with Rheumatoid Arthritis in Remission: A CORRONA and NinJa Collaborative Cohort Study

2015 ◽  
Vol 42 (12) ◽  
pp. 2238-2246 ◽  
Author(s):  
Kazuki Yoshida ◽  
Helga Radner ◽  
Maria D. Mjaavatten ◽  
Jeffrey D. Greenberg ◽  
Arthur Kavanaugh ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Cox Regression ◽  
Activity Index ◽  
Disease Activity Index ◽  
Frailty Models ◽  
National Database ◽  
Drug Discontinuation ◽  
The Us ◽  
Lower Disease Activity

Objective.We conducted a longitudinal observational study of biological disease-modifying antirheumatic drugs (bDMARD) to describe the proportions of patients with rheumatoid arthritis in remission who discontinued these agents, and to assess the potential predictors of the decision to discontinue.Methods.We used data from the US COnsortium of Rheumatology Researchers Of North America (CORRONA) and the Japanese National Database of Rheumatic Diseases by iR-net in Japan (NinJa) registries, and ran parallel analyses. Patients treated with bDMARD who experienced remission (defined by the Clinical Disease Activity Index ≤ 2.8) were included. The outcome of interest was the occurrence of bDMARD discontinuation while in remission. The predictors of discontinuation were assessed in the Cox regression models. Frailty models were also used to examine the effects of individual physicians in the discontinuation decision.Results.The numbers of eligible patients who were initially in remission were 6263 in the CORRONA and 744 in the NinJa. Among these patients, 10.0% of patients in CORRONA and 11.8% of patients in NinJa discontinued bDMARD while in remission over 5 years, whereas many of the remaining patients lost remission before discontinuing bDMARD. Shorter disease duration was associated with higher rates of discontinuation in both cohorts. In CORRONA, methotrexate use and lower disease activity were also associated with discontinuation. In frailty models, physician random effects were significant in both cohorts.Conclusion.Among patients who initially experienced remission while receiving bDMARD, around 10% remained in remission and then discontinued bDMARD in both registries. Several factors were associated with more frequent discontinuation while in remission. Physician preference likely is also an important correlate of bDMARD discontinuation, indicating the need for standardization of practice.

The impact of seropositivity on the effectiveness of biologic anti-rheumatic agents: results from a collaboration of 16 registries

Rheumatology ◽  
2020 ◽  
Author(s):  
Delphine S Courvoisier ◽  
Katarina Chatzidionysiou ◽  
Denis Mongin ◽  
Kim Lauper ◽  
Xavier Mariette ◽  
...  
Keyword(s):  
Disease Activity ◽  
Cox Regression ◽  
Activity Index ◽  
Disease Activity Index ◽  
Pooled Analysis ◽  
Diagnostic Tools ◽  
Drug Discontinuation ◽  
Biologic Dmards ◽  
Low Disease Activity ◽  
The Impact

Abstract Objectives RF and ACPA are used as diagnostic tools and their presence has been associated with clinical response to some biologic DMARDs (bDMARDs) in RA. This study compared the impact of seropositivity on drug discontinuation and effectiveness of bDMARDs in patients with RA, using head-to-head comparisons in a real-world setting. Methods We conducted a pooled analysis of 16 observational RA registries. Inclusion criteria were a diagnosis of RA, initiation of treatment with rituximab (RTX), abatacept (ABA), tocilizumab (TCZ) or TNF inhibitors (TNFis) and available information on RF and/or ACPA status. Drug discontinuation was analysed using Cox regression, including drug, seropositivity, their interaction, adjusting for concomitant and past treatments and patient and disease characteristics and accounting for country and calendar year of bDMARD initiation. Effectiveness was analysed using the Clinical Disease Activity Index evolution over time. Results Among the 27 583 eligible patients, the association of seropositivity with drug discontinuation differed across bDMARDs (P for interaction <0.001). The adjusted hazard ratios for seropositive compared with seronegative patients were 1.01 (95% CI 0.95, 1.07) for TNFis, 0.89 (0.78, 1.02)] for TCZ, 0.80 (0.72, 0.88) for ABA and 0.70 (0.59, 0.84) for RTX. Adjusted differences in remission and low disease activity rates between seropositive and seronegative patients followed the same pattern, with no difference in TNFis, a small difference in TCZ, a larger difference in ABA and the largest difference in RTX (Lundex remission difference +5.9%, low disease activity difference +11.6%). Conclusion Seropositivity was associated with increased effectiveness of non-TNFi bDMARDs, especially RTX and ABA, but not TNFis.

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 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.

scholarly journals Effectiveness of Rituximab for the Treatment of Rheumatoid Arthritis in Patients with Prior Exposure to Anti-TNF: Results from the CORRONA Registry

2015 ◽  
Vol 42 (7) ◽  
pp. 1090-1098 ◽  
Author(s):  
Leslie R. Harrold ◽  
George W. Reed ◽  
Ashwini Shewade ◽  
Robert Magner ◽  
Katherine C. Saunders ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Clinical Effectiveness ◽  
High Disease Activity ◽  
Low Disease Activity ◽  
Logistic Regression Models ◽  
Lower Baseline ◽  
Previously Treated

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.

scholarly journals Rheumatoid arthritis disease activity index-5: Utility in busy clinical settings

2017 ◽  
Vol 12 (2) ◽  
pp. 72
Author(s):  
VikramSingh Tanwar ◽  
Harpreet Singh ◽  
Gagandeep Sukhija ◽  
Rekha Mathur ◽  
Parminder Kaur
Keyword(s):  
Rheumatoid Arthritis ◽  
Disease Activity ◽  
Activity Index ◽  
Disease Activity Index ◽  
Clinical Settings ◽  
Rheumatoid Arthritis Disease Activity ◽  
Rheumatoid Arthritis Disease
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