Dataset Information

Assessment on Treatments With Conventional Synthetic Disease-modifying Drugs Before Initiating Biologics in Patients With Rheumatoid Arthritis in Korea: A Population-based Study.

ABSTRACT:

Objective

To assess pre-biologic treatments with conventional synthetic disease-modifying drugs (csDMARDs) prior to biologics initiation among patients with rheumatoid arthritis (RA).

Methods

Using Korea National Health Insurance database, we examined pre-biologic treatments of RA patients on the following four items whether 1) initial methotrexate (MTX) therapy was given, 2) MTX dose was escalated up to ≥15 mg/week within 1-year post-diagnosis, 3) prednisone-equivalent glucocorticoid was used at a dose of ≤7.5 mg/day, and 4) glucocorticoid was discontinued within 6 months of treatment. Multivariable logistic regressions identified predictors of items 2) and 4) fulfillment.

Results

Among 6,986 biologics initiators with RA, 54.9% used MTX as the 1st csDMARD. Within 1-year post-diagnosis, 85.2% used MTX with half of them achieving a dose of ≥15 mg/week. The majority (75.2%) of patients used glucocorticoids initially and 64.5% were still on glucocorticoids at 6 months, mostly at a dose of ≤7.5 mg/day. csDMARD combination was observed in 85.7%. Item 2) fulfillment was associated with males, younger age, glucocorticoid, combination therapy, cyclo-oxygenase-2 inhibitors, and viral hepatitis. Item 4) fulfillment was associated with males, MTX dose of ≥15 mg/week, combination therapy, viral hepatitis, and hospitalizations.

Conclusion

RA patients in Korea were predominantly treated with MTX-based csDMARD combination plus glucocorticoids before initiating biologics, without sufficient MTX dose escalation or glucocorticoid discontinuation. Items 2) and 4) fulfillments were associated with patient age and gender, concomitant treatments, and comorbidities.

SUBMITTER: Kim MJ

PROVIDER: S-EPMC10351359 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature

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Publications

Assessment on Treatments With Conventional Synthetic Disease-modifying Drugs Before Initiating Biologics in Patients With Rheumatoid Arthritis in Korea: A Population-based Study.

Kim Min Jung MJ Park Eun Hye EH Shin Anna A Ha You-Jung YJ Lee Yun Jong YJ Lee Eun Bong EB Baek Han Joo HJ Kang Eun Ha EH

Journal of rheumatic diseases 20220401 2

<h4>Objective</h4>To assess pre-biologic treatments with conventional synthetic disease-modifying drugs (csDMARDs) prior to biologics initiation among patients with rheumatoid arthritis (RA).<h4>Methods</h4>Using Korea National Health Insurance database, we examined pre-biologic treatments of RA patients on the following four items whether 1) initial methotrexate (MTX) therapy was given, 2) MTX dose was escalated up to ≥15 mg/week within 1-year post-diagnosis, 3) prednisone-equivalent glucocorti ...[more]

PMID: 37475897

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Project description:ObjectivesRecent research suggests that rheumatoid arthritis increases the risk of venous thromboembolism. This study compared the risk of venous thromboembolism in patients with newly diagnosed rheumatoid arthritis initiating a biologic disease-modifying antirheumatic drug (DMARD) with those initiating methotrexate or a nonbiologic DMARD.MethodsWe conducted a population-based cohort study using US insurance claims data (2001-2012). Three mutually exclusive, hierarchical DMARD groups were used: (1) a biologic DMARD with and without nonbiologic DMARDs; (2) methotrexate without a biologic DMARD; or (3) nonbiologic DMARDs without a biologic DMARD or methotrexate. We calculated the incidence rates of venous thromboembolism. Cox proportional hazard models stratified by propensity score (PS) deciles after asymmetric PS trimming were used for 3 pairwise comparisons, controlling for potential confounders at baseline.ResultsWe identified 29,481 patients with rheumatoid arthritis with 39,647 treatment episodes. From the pairwise comparison after asymmetric PS trimming, the incidence rate of hospitalization for venous thromboembolism per 1000 person-years was 5.5 in biologic DMARD initiators versus 4.4 in nonbiologic DMARD initiators and 4.8 in biologic DMARD initiators versus 3.5 in methotrexate initiators. The PS decile-stratified hazard ratio of venous thromboembolism associated with biologic DMARDs was 1.83 (95% confidence interval [CI], 0.91-3.66) versus nonbiologic DMARDs and 1.39 (95% CI, 0.73-2.63) versus methotrexate. The hazard ratio of venous thromboembolism in biologic DMARD initiators was the highest in the first 180 days versus nonbiologic DMARD initiators (2.48; 95% CI, 1.14-5.39) or methotrexate initiators (1.80; 95% CI, 0.90-3.62).ConclusionsThe absolute risk for venous thromboembolism was low in patients with newly diagnosed rheumatoid arthritis. Initiation of a biologic DMARD seems to be associated with an increased short-term risk of hospitalization for venous thromboembolism compared with initiation of a nonbiologic DMARD or methotrexate.

Project description:BackgroundTo evaluate the effect of upadacitinib on patient-reported outcomes (PROs) in patients with RA who had an inadequate response to csDMARDs.MethodsPatients in SELECT-NEXT, a randomised controlled trial, were on a background of csDMARDs and received upadacitinib 15 mg and 30 mg or placebo daily for 12 weeks. PROs included Patient Global Assessment of Disease Activity (PtGA), pain, Health Assessment Questionnaire-Disability Index (HAQ-DI), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), duration and severity of morning (AM) joint stiffness, Short Form 36 Health Survey (SF-36), and Work Instability Scale for RA (RA-WIS). Least squares mean (LSM) changes were based on mixed-effect repeated measure models. Percentages of patients reporting improvements ≥ minimum clinically important differences (MCIDs) and scores ≥ normative values and number needed to treat (NNT) were determined; group comparisons used chi-square tests.ResultsData from 661 patients were analysed. Compared with placebo, patients receiving upadacitinib reported statistically significant improvements (both doses, P < 0.05) in PtGA, pain, HAQ-DI, FACIT-F, duration and severity of AM stiffness, SF-36 (PCS and 6/8 domains), and RA-WIS at week 12. Significantly, more upadacitinib-treated patients (both doses, P < 0.05) reported improvements ≥ MCID in PtGA, pain, HAQ-DI, FACIT-F, AM stiffness, SF-36 (PCS and 4 or 7/8 domains), and RA-WIS and scores ≥ normative values in HAQ-DI, FACIT-F, and SF-36 (PCS and 4 or 5/8 domains). For most PROs, the incremental NNT with upadacitinib to report clinically meaningful improvement from baseline ranged from 4 to 8 patients.ConclusionsUpadacitinib 15 mg or 30 mg daily for 12 weeks resulted in significant and clinically meaningful improvements in global disease activity, pain, physical function, fatigue, duration and severity of AM stiffness, HRQOL, and work instability among csDMARD-IR patients with RA.Trial registrationClinicaltrials.gov, NCT02675426. Retrospectively registered 5 February 2016.

Project description:BackgroundTo assess the risks of malignancies, infections and autoimmune diseases in patients with rheumatoid arthritis (RA) treated with abatacept compared with other biologic (b) disease-modifying antirheumatic drugs (DMARDs) or conventional synthetic (cs)DMARDs, in a US-wide observational RA cohort METHODS: Data were reviewed from patients (≥ 18 years) with RA who were registered with FORWARD, the National Databank for Rheumatic Diseases, and who initiated abatacept, other bDMARDs or csDMARDs between 2005 and 2015. Patients who switched treatment during the study could be allocated to more than one group. The incidence rates (IRs) by treatment were calculated for malignancies, hospitalized infections and autoimmune diseases identified by six monthly questionnaires and medical records. The hazard ratios (HRs) (95% confidence intervals [CIs]) for all outcomes with abatacept compared with other bDMARDs or csDMARDs were determined using marginal structural models adjusted for clinical confounders.ResultsIn the study sample, 1496 initiated abatacept, 3490 initiated another bDMARD and 1520 initiated a csDMARD. The risk of malignancies with abatacept was not statistically significant versus other bDMARDs (HR [95% CI)] 1.89 [0.93, 3.84]) or versus csDMARDs (HR [95% CI] 0.93 [0.20, 4.27]). Patients receiving abatacept versus other bDMARDs were at a lower risk of hospitalized infections (HR [95% CI] 0.37 [0.18, 0.75]); the risk versus csDMARDs was lower with wide CIs (HR [95% CI] 0.31 [0.09, 1.05]). The relative risks for psoriasis were similar between treatment groups (HR [95% CI] 1.46 [0.76, 2.81] and HR [95% CI] 2.05 [0.59, 7.16] for abatacept versus other bDMARDs and versus csDMARDS, respectively). The IR (95% CI) of severe infusion/injection reactions was lower with abatacept compared with other bDMARDs (1.57 [1.11, 2.17] vs 2.31 [1.87, 2.82] per 100 patient-years, respectively).ConclusionsIn this analysis, abatacept was well tolerated and did not result in an overall increased risk of malignancies, infections or autoimmune diseases compared with other bDMARDs or csDMARDs.

Dataset Information

Assessment on Treatments With Conventional Synthetic Disease-modifying Drugs Before Initiating Biologics in Patients With Rheumatoid Arthritis in Korea: A Population-based Study.

Objective

Methods

Results

Conclusion

Publications

Assessment on Treatments With Conventional Synthetic Disease-modifying Drugs Before Initiating Biologics in Patients With Rheumatoid Arthritis in Korea: A Population-based Study.

Similar Datasets

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