Browsing by Subject "Rheumatoid arthritis"
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Item Factors associated with the initiation of biologic disease modifying antirheumatic drugs in Texas Medicaid patients with rheumatoid arthritis(2014-05) Kim, Gilwan; Barner, Jamie C.Rheumatoid arthritis (RA) is a progressive autoimmune disorder of joints that is associated with high health care costs and yet lacks guidance on how early to initiate biologic disease-modifying antirheumatic drugs (DMARDs), a class of medications that is the major cost driver in RA management. The main purpose of this study was to examine patient socio-demographics, medication use patterns, and clinical characteristics associated with initiation of biologic DMARDs. This was a retrospective study using Texas Medicaid prescription and medical claims database during the study period of July 1, 2003 – December 31, 2010. Patients (18 – 63 years) with an RA diagnosis (ICD-9-CM code 714.xx), no non-biologic DMARD or biologic DMARD use during the pre-index period, and a minimum of 2 prescription claims for the same non-biologic DMARD during the post-index period were included in the study. The primary study outcomes were time to initiation of biologic DMARDs and likelihood of initiating biologic DMARDs. There was a total of 2,714 subjects included in the study. The majority had claims for pain medications (92.4%), glucocorticoids (64.9%), and non-biologic DMARD monotherapy (86.4%); while 24.3% initiated on biologic DMARDs and 58.9% had a Charlson Comorbidity Index (CCI) score=1. Compared to time to initiation (days) of biologic DMARDs for methotrexate (539.7±276.9) users, it was longer for sulfasalazine (670.2±167.8) and hydroxychloroquine (680.2±158.7) users and similar to leflunomide users (541.6±286.5; p<0.0001). There were no significant differences in time to initiation between non-biologic DMARD mono vs. dual therapy. Younger age, glucocorticoid use, methotrexate user (vs. sulfasalazine, hydroxychloroquine users), and non-biologic DMARD monotherapy user (vs. dual therapy user) were significantly associated with higher likelihood to initiate biologic DMARDs. In conclusion, age, glucocorticoid use, non-biologic DMARD type and therapy were significant factors associated with initiation of biologic DMARDs. Healthcare providers and Texas Medicaid should recognize these potential driving factors and take efforts to achieve optimal therapy for RA patients through thorough RA medication evaluation, well-structured RA monitoring programs, and patient education.Item Identifying the association between health care resource utilization and switching of biologics in rheumatoid arthritis(2014-08) Lu, Jackie Yu-Chen; Rascati, Karen L.; Wilson, James P.Objectives: To identify the predictors of switching from the first biologic to a second biologic in rheumatoid arthritis (RA) patients newly initiated on biologic treatments. Methods: Adult RA patients (18-64 years old) initiated on adalimumab, etanercept, infliximab, certolizumab, golimumab, abatacept, rituximab, tocilizumab, or anakinra between 2009 and 2011 were identified using a commercial claims database. Switching patterns were examined within one year after biologic initiation using descriptive statistics. Health care resource utilization (HCRU) variables (the number of 30-day supplies for steroid and DMARDs, and the claim counts for RA-related outpatient visits, radiographic, laboratory, intra-articular injections, rehabilitation, and surgical procedures) were assessed within one year prior to the switch date for switchers or the end of the study period for non-switchers. Pairwise comparisons of patient characteristics and HCRU variables were conducted using t-tests, Mann-Whitney U tests, and Chi-squared tests. Multiple logistic regressions were used to identify HCRU predictors of switching. Results: A total of 12,370 patients were included in the analysis. The switch rate within one year after biologic initiation was 18.4%, and the median time to switch was 181 days. More females switched compared to males (19.2% vs. 15.9%, p<.001). Switch rates were also higher in patients started on anti-TNFs compared to non-anti-TNFs (19.2% vs. 12.0%, p<.001). Furthermore, switch rates were highest in patients started on golimumab (21.0%) and were lowest in patients started on rituximab (4.8%). Overall, switchers had significantly higher rates and quantities of RA-related HCRU than non-switchers, except in the use of surgical procedures. Logistic regression models revealed that all the HCRU variables were significant predictors of switching, and patients on infliximab, abatacept, tocilizumab, and rituximab had significantly lower odds of switching than patients on etanercept. Combination therapy with DMARDs was also significantly associated with lower odds of switching. Conclusion: Switching of biologics is common in RA patients initiated on biologic therapy. There are marked differences in demographic characteristics and HCRU patterns between switchers and non-switchers. This study demonstrates that patterns of RA-related HCRU can be used to predict switching and thus can potentially serve as useful measures of treatment ineffectiveness.Item Medication adherence, persistence, switching and dose escalation with the use of tumor necrosis factor (TNF) inhibitors among Texas Medicaid patients diagnosed with rheumatoid arthritis(2013-08) Oladapo, Abiola Oluwagbenga; Barner, Jamie C.The main purpose of this study was to evaluate medication use patterns (i.e., dose escalation, medication adherence, persistence, and switching) of rheumatoid arthritis (RA) patients on etanercept (ETN), infliximab (IFX) or adalimumab (ADA) and the associated healthcare utilization costs using Texas Medicaid data. Study participants were Medicaid beneficiaries (18-63 years) with an RA diagnosis (ICD-9-CM code 714.0x) who had no claim for a biologic agent in the 6-month pre-index period (July 1, 2003 - Dec 31, 2010). The index date was the first date when the patient had the first fill for any of the study TNF inhibitors (ETN, ADA or IFX) within the study identification period (Jan 1, 2004 – Aug 31, 2010). Data were extracted from July 1, 2003 to August 31, 2011. Prescription and medical claims were analyzed over an 18-month study period (i.e., 6-month pre-index and 12-month post-index periods). The primary study outcomes were adherence, persistence, dose escalation, switching and cost (i.e., total healthcare, RA-related and TNF inhibitor therapy cost). The study covariates were demographic factors (age, gender, race/ethnicity), pre-index use of other RA-related medications (pain, glucocorticoids and disease modifying antirheumatic drugs), total number of non-study RA-related medications used at index, pre-index RA and non-RA related visits, pre-index healthcare utilization cost and Charlson Comorbidity Index score. Conditional regression analyses, which accounts for matched samples, were used to address the study objectives. After propensity score matching, 822 patients (n=274/group) comprised the final sample. The mean age (±SD) was 48.9(±9.8) years, and the majority of the subjects were between 45 and 63 years (69.2%), Hispanic (53.7%) and female (88.0%). Compared to patients on ETN, the odds of having a dose escalation were ≈ 5 [Odds Ratio= 4.605 [95% CI= 1.605-12.677], p=0.0031] and ≈ 8 [Odds Ratio=7.520, [95% CI= 2.461-22.983], p=0.0004] times higher for IFX and ADA patients, respectively, while controlling for other variables in the model. Compared to ETN, patients on IFX (p=0.0171) were more adherent while adherence was comparable with patients on ADA (p=0.1144). Compared to patients on ETN, the odds of being adherent (MPR ≥ 80%) to IFX was ≈ 2 times higher [Odds Ratio= 2.437, [95% CI=1.592-3.731], p < 0.0001] while controlling for other variables in the model. Persistence to index TNF inhibitor therapy and likelihood to switch or discontinue index TNF inhibitor therapy were comparable among the 3 study groups. In addition, the duration of medication use (i.e., persistence) prior to switching or discontinuation of index therapy was comparable among the 3 study groups. Furthermore, for each of the cost variables (total healthcare, RA-related and TNF inhibitor therapy cost), costs incurred by patients on ETN were significantly lower (p < 0.01) than those incurred by ADA patients but significantly higher (p < 0.01) than those incurred by IFX patients. Finally, a positive and significant relationship (p < 0.0001) was found between RA-related healthcare cost, adherence and persistence to TNF inhibitor therapies. In conclusion, ETN was associated with lower rates of dose escalation compared to ADA or IFX. However, adherence was better and associated healthcare costs were lower with IFX. Clinicians should endeavor to work with each individual patient to identify patient-specific factors responsible for poor medication use behaviors with TNF-inhibitor therapies. Reducing the impact of these factors and improving adherence should be included as a major part of the treatment plan for each RA patient. RA patients need to be adequately educated on the importance of adhering and persisting to their TNF-inhibitor therapy as poor medication adherence/persistence negatively impacts the RA disease process.Item Untargeted metabolomics analysis of Rheumatoid arthritis patient sera before and after rituximab treatment(2015-08) Sweeney, Shannon Renee; Tiziani, Stefano; Guma, MonicaBackground: Rheumatoid arthritis (RA) is an autoimmune disease with no known cure that affects approximately 1.3 million Americans. RA patients suffer from chronic pain and inflammation and are faced with probable disability, reduced life expectancy, and increased risk of several other diseases. In the last decade, biological therapies have revolutionized RA treatment. Although administration of a tumor necrosis factor (TNF) neutralizing agent is the first-line biological therapy, many RA patients show only partial or no clinical response to treatment. Subsequently, anti-B cell, anti-T cell, or anti-IL6 therapies can be evaluated. Streamlining of treatment protocols is necessary to improve patient outcomes. Methods: Serum was collected from 23 active, seropositive RA patients on concomitant methotrexate, at baseline and six months after treatment with rituximab. Based on the American College of Rheumatology improvement criteria, at a level of 20% (ACR20), patients were categorized as either responders or non-responders. An untargeted metabolomics approach was used to characterize the serum metabolome of patients. High resolution one-dimensional ¹H-NMR spectra were acquired using a Bruker Avance 700 MHz spectrometer. In addition, A Thermo Scientific Q Exactive Hybrid Quadrupole-Orbitrap mass spectrometer was used for UPLC-MS/MS of serum lipids. Data processing, statistical analysis, and pathway mapping were performed in MATLAB in conjunction with several metabolomics software packages including, NMRLab, MetaboLab, Chenomx, MetaboAnalyst, MetaboSearch, VANTED, Xcalibur, and Sieve. Results: Based on the ACR20 criteria, at baseline, 14 patients were characterized as responders and 9 patients were considered non-responders. Similarly, 20 patients followed-up at six months, 13 responders and 7 non-responders. Seven polar metabolites and 15 unique lipid species achieved a p-value of less than 0.05 for a two sample t-test prior to treatment with rituximab. Following rituximab therapy, five polar metabolites and 37 lipid species were statistically significant between groups. Pathway analysis of both polar and apolar metabolites revealed metabolic differences between responder and non-responders before and after treatment with rituximab. Conclusion: A clear relationship between blood metabolic profiles and clinical response to rituximab therapy suggests that ¹H-NMR and UPLC-MS/MS are promising tools for RA therapy optimization and acceleration of treatment protocols to improve patient outcomes.