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Delayed Treatment Acceleration in Patients with Rheumatoid Arthritis Who Have Inadequate Response to Initial Tumor Necrosis Factor Inhibitors: Data from the Corrona Registry.

ABSTRACT: Background:The implementation of treat-to-target principles in rheumatoid arthritis (RA) has not been fully investigated in patients with inadequate response to tumor necrosis factor (TNF) inhibitor treatment. Objectives:To evaluate the prevalence of an inadequate response to initial TNF inhibitor treatment at 6 and 12 months among patients with RA in a real-world patient registry, as well as the delay in therapy adjustment and its impact on disease activity and patient-reported outcome (PRO) measures. Methods:This analysis is based on data of patients with moderate or severe disease activity (Clinical Disease Activity Index [CDAI] score >10) who were included in the Consortium of Rheumatology Researchers of North America (Corrona) RA registry, a prospective, observational database. The patients had never received treatment with a biologic disease-modifying antirheumatic drug (DMARD) and had initiated treatment with a TNF inhibitor (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) between October 2001 and December 2014. We evaluated treatment response (CDAI score ?10), select PRO measures, and treatment changes at 6 months. Patients who had an inadequate response to TNF inhibitor therapy at 6 months and continued to use their initial TNF inhibitor were evaluated again at 12 months. Results:This retrospective analysis included 2282 patients. At 6 months, 1732 (75.9%) of the patients continued to use their initial TNF inhibitor; of these, 803 (46.4%) patients had an inadequate response to treatment. Of the 803 patients who had an inadequate response at 6 months, 488 (60.8%) continued their initial treatment at 12 months. Of these 488 patients, 315 (64.5%) had an inadequate response at 12 months, and 173 (35.5%) had a response. Numerically greater improvements in all PRO measures were observed for patients who responded to therapy compared with patients with an inadequate response. Conclusions:In this real-world analysis of data from the Corrona RA registry, a considerable proportion of patients with RA had an inadequate response to the initial TNF inhibitor therapy at 6 and 12 months. Many patients continued to have moderate or high disease activity, without accelerating treatment (eg, addition or increase in the dose of concurrent conventional synthetic DMARDs or a TNF inhibitor), contrary to treat-to-target principles, thus remaining at risk for accumulating joint damage and disability.

SUBMITTER: Pappas DA

PROVIDER: S-EPMC5973251 | biostudies-literature | 2018 May

REPOSITORIES: biostudies-literature

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Delayed Treatment Acceleration in Patients with Rheumatoid Arthritis Who Have Inadequate Response to Initial Tumor Necrosis Factor Inhibitors: Data from the Corrona Registry.

Pappas Dimitrios A DA Gerber Robert A RA Litman Heather J HJ Gruben David D Geier Jamie J Hua Winnie D WD Chen Connie C Li Youfu Y Kremer Joel M JM Andrews John S JS Bourret Jeffrey A JA

American health & drug benefits 20180501 3

<h4>Background</h4>The implementation of treat-to-target principles in rheumatoid arthritis (RA) has not been fully investigated in patients with inadequate response to tumor necrosis factor (TNF) inhibitor treatment.<h4>Objectives</h4>To evaluate the prevalence of an inadequate response to initial TNF inhibitor treatment at 6 and 12 months among patients with RA in a real-world patient registry, as well as the delay in therapy adjustment and its impact on disease activity and patient-reported o ...[more]

PMID: 29910846

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Project description:IntroductionAnti-citrullinated protein antibodies (ACPAs) are highly specific serological biomarkers that are indicative of a poor prognosis in patients with rheumatoid arthritis (RA). The effectiveness of biologic disease-modifying antirheumatic drugs (bDMARDs) with different mechanisms of action may vary, based on patients' serostatus. The aim of this study is to compare the effectiveness of abatacept versus tumor necrosis factor inhibitors (TNFis) in patients with RA who were anti-cyclic citrullinated peptide antibody positive (anti-CCP+).MethodsAbatacept or TNFi initiators with anti-CCP+ status (≥ 20 U/ml) at or prior to treatment initiation were identified from a large observational US cohort (1 December 2005-31 August 2016). Using propensity score matching (1:1), stratified by prior TNFi use (0, 1 and ≥ 2), effectiveness at 6 months after initiation was evaluated. Primary outcome was mean change in Clinical Disease Activity Index (CDAI) score. Secondary outcomes included achievement of remission (CDAI ≤ 2.8), low disease activity/remission (CDAI ≤ 10), modified American College of Rheumatology 20/50/70 responses and mean change in modified Health Assessment Questionnaire score.ResultsAfter propensity score matching, the baseline characteristics between 330 pairs of abatacept and TNFi initiators (biologic naïve, n = 97; TNFi experienced, n = 233) were well balanced with absolute value standardized differences of ≤ 0.1. Both overall, and in the biologic-naïve cohort, there were no significant differences in mean change in CDAI score at 6 months. However, in the TNFi-experienced cohort, there was a significantly greater improvement in CDAI score at 6 months with abatacept versus TNFi initiators (p = 0.033). Secondary outcomes showed similar trends.ConclusionsImprovements in clinical disease activity were seen in anti-CCP+ abatacept and TNFi initiators. TNFi-experienced anti-CCP+ patients with RA had more improvement in disease activity with abatacept versus TNFis, whereas outcomes were similar between treatments in the overall population and in biologic-naïve patients.Trial registrationClinicalTrials.gov identifier: NCT01625650.FundingThis study is sponsored by Corrona, LLC and funded by Bristol-Myers Squibb. Bristol-Myers Squibb funded the publication of this manuscript.

Project description:IntroductionUnderstanding the durability of response to treatment and factors associated with failure to maintain response in a real-world setting can inform treatment decisions for patients with rheumatoid arthritis (RA). The aim of this study was to analyze durability of response to tocilizumab (TCZ) and factors associated with durability among US patients with RA in routine clinical practice.MethodsTCZ initiators in the Corrona RA Registry were included. Durability of response was defined as maintaining continuous TCZ treatment and either an improvement of at least minimum clinically important difference (MCID) in Clinical Disease Activity Index (CDAI) score or low disease activity (LDA). Secondary analyses included patients treated with intravenous (IV) TCZ and excluded those who discontinued TCZ without reporting reasons for discontinuation. Durability was calculated with Kaplan-Meier survival analysis. Cox proportional hazards modeling identified factors associated with durability.ResultsAmong 1789 TCZ initiators, 466, 272, and 162 were persistent (with or without durable response) with follow-up visits at 1, 2, and 3 years, respectively. Median MCID durability of response in CDAI was > 50% after 36 months overall, 26 months for TCZ-IV, and > 50% after 36 months for those with known reasons for discontinuation; longer durability was associated with increased duration of RA and higher baseline CDAI score and shorter durability with history of malignancy and history of diabetes. Median LDA durability of response was 13.0 months overall, for TCZ-IV, and for those with known reasons for discontinuation; shorter durability was associated with history of malignancy, history of diabetes, and higher baseline CDAI score.ConclusionsMedian durability of response to TCZ in RA was > 3 years when defined as maintenance of MCID in CDAI score and > 1 year with the more stringent criteria of maintenance of LDA.Trial registrationClinicalTrials.gov identifier, NCT01402661.

Project description:Patients with active rheumatoid arthritis (RA) despite anti-tumor necrosis factor(anti-TNF)agent treatment can switch to either a subsequent anti-TNF agent or a biologic with an alternative mechanism of action, such as rituximab; however, there are limited data available to help physicians decide between these 2 strategies. The objective of this analysis was to examine the effectiveness and safety of rituximab versus a subsequent anti-TNF agent in anti-TNF-experienced patients with RA using clinical practice data from the Corrona registry.Rituximab-naive patients from the Corrona registry with prior exposure to ?1 anti-TNF agent who initiated rituximab or anti-TNF agents (2/28/2006-10/31/2012) were included. Two cohorts were analyzed: the trimmed population (excluding patients who fell outside the propensity score distribution overlap) and the stratified-matched population (stratified by 1 vs. ??2 anti-TNF agents, then matched based on propensity score). The primary effectiveness outcome was achievement of low disease activity (LDA)/remission (Clinical Disease Activity Index??10) at 1 year. Secondary outcomes included achievement of modified American College of Rheumatology (mACR) 20/50/70 responses and meaningful improvement (?0.25) in modified Health Assessment Questionnaire (mHAQ) score at 1 year. New cardiovascular, infectious and cancer events were reported.Estimates for LDA/remission, mACR response and mHAQ improvement were consistently better for rituximab than for anti-TNF agent users in adjusted analyses. The odds ratio for likelihood of LDA/remission in rituximab versus anti-TNF patients was 1.35 (95% CI, 0.95-1.91) in the trimmed population and 1.54 (95% CI, 1.01-2.35) in the stratified-matched population. Rituximab patients were significantly more likely than anti-TNF patients to achieve mACR20/50 and mHAQ improvement in the trimmed population and mACR20 and mHAQ in the stratified-matched population. The rate of new adverse events per 100 patient-years was similar between groups.In anti-TNF-experienced patients with RA, rituximab was associated with an increased likelihood of achieving LDA/remission, mACR response and physical function improvement, with a comparable safety profile, versus subsequent anti-TNF agent users.ClinicalTrials.gov NCT01402661 . Registered 25 July 2011.

Dataset Information

Delayed Treatment Acceleration in Patients with Rheumatoid Arthritis Who Have Inadequate Response to Initial Tumor Necrosis Factor Inhibitors: Data from the Corrona Registry.

Publications

Delayed Treatment Acceleration in Patients with Rheumatoid Arthritis Who Have Inadequate Response to Initial Tumor Necrosis Factor Inhibitors: Data from the Corrona Registry.

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