[Show abstract][Hide abstract] ABSTRACT: Introduction While there is a substantial body of literature on the comparative healthcare costs of biologics used to treat rheumatoid arthritis (RA), nearly all of these investigations have been exclusively focused on anti-tumor necrosis factor-α (anti-TNF) agents in the setting of first-line biologic treatment. This study compared healthcare costs between RA patients treated with infused biologics after previously using at least one other biologic agent. Methods Using a large US administrative claims dataset, adult RA patients initiating an infused biologic (abatacept, infliximab, tocilizumab) between January 1, 2010 and January 1, 2012 (initiation = index) were identified. Rituximab was excluded because of unique dosing intervals, which make it difficult to determine treatment discontinuation using a claims database. Patients were required to have used one or more other biologic (infused or injected) at any time before index. Patients could contribute multiple observations to the dataset; one for each infused biologic they initiated between January 1, 2010 and January 1, 2012. A 6-month period before index was used to measure patient characteristics. A variable-length follow-up period after index was used to measure per-patient per-month (PPPM) healthcare costs, including biologic costs, RA-related healthcare costs, and all-cause healthcare costs. Generalized estimating equations models compared healthcare costs between the biologic agents, adjusting for patients’ demographics and clinical characteristics. Results The sample comprised 3,771 infused biologic initiations (abatacept = 1,759; infliximab = 922; tocilizumab = 1,090); the mean age of participants was 55 years, 82 % were female, and the median follow-up ranged from 251 to 280 days. Compared with other patients, patients treated with tocilizumab had significantly lower (all P Conclusions Among RA patients treated with infused biologics after previously using at least one other biologic, patients treated with tocilizumab had the lowest real-world healthcare costs, largely driven by lower costs directly related to biologic treatment. Such biologic-related cost differences may be driven by variations in real-world treatment patterns (e.g., dose, escalation, treatment frequency).
Drugs - Real World Outcomes 03/2015; 2(1). DOI:10.1007/s40801-015-0018-5
[Show abstract][Hide abstract] ABSTRACT: Introduction:
The objective of this study was to investigate clinical effectiveness and incremental lifetime costs associated with first-line bevacizumab in older patients with metastatic colorectal cancer (mCRC).
Patients diagnosed with mCRC in 2004-2007 were identified from the Surveillance, Epidemiology, and End Results-Medicare database and stratified by first-line treatment (no chemotherapy [CTx], CTx alone, CTx plus bevacizumab). The impact of first-line bevacizumab on survival was investigated using a propensity score adjusted multivariate Cox proportional hazards model. Mean lifetime costs for each cohort were calculated using Medicare claims for all services rendered between diagnosis and end of follow-up, adjusting for death and censoring.
A total of 4,414 patients (mean age: 77.3 years) were identified, of whom 15% received first-line bevacizumab. Among first-line-treated patients, bevacizumab receipt was associated with improved overall survival (hazard ratio: 0.85 [95% confidence interval: 0.75-0.97]; p = .013), and this benefit was limited to patients who received >1 month of bevacizumab therapy. Median and mean survival were greatest in patients treated with CTx plus bevacizumab relative to CTx alone (CTx plus bevacizumab median 19.4 months [mean 28.0 months] vs. CTx alone median 15.1 months [mean 22.9 months]; p < .001), as were mean lifetime costs (mean per patient cost $143,284 vs. $111,280). Compared with CTx alone, CTx plus bevacizumab was associated with a 5.1-month increase in mean survival and a $32,004 increase in mean lifetime treatment costs, with an incremental cost of $75,303 per life-year gained.
Bevacizumab use is associated with longer survival than CTx alone in older patients treated in real-world clinical settings, at an incremental cost of $75,303 per life-year gained.
The Oncologist 08/2014; 19(8). DOI:10.1634/theoncologist.2013-0209 · 4.87 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objective
To compare biologics as monotherapy or in combination with methotrexate (MTX) in terms of patient reported outcomes (PROs) in RA patients with an inadequate response to conventional DMARDs (DMARD-IR).
With a systematic literature review 17 RCTs were identified that evaluated adalimumab, certolizumab pegol, etanercept, golimumab, infliximab, abatacept, anakinra or tocilizumab. Treatment effects in terms of pain (0-100 mm), patient’s global assessment of disease activity (PGA; 0-100 mm), Health Assessment-Questionnaire (HAQ) disability index (DI; 0–3), and the physical component summary (PCS) of the SF36 Health Survey (0–100) at 24 weeks were combined by means of Bayesian network meta-analyses.
With tocilizumab monotherapy, greater improvements in pain (difference = -11.1; (95% Credible Interval -21.3, -0.1)) and PGA (-10.3 (-20.4, 0.8)) were observed than with aTNF monotherapy. Tocilizumab was at least as efficacious as aTNF in HAQ-DI improvements (-0.16; (-0.37, 0.05)). aTNF + MTX (-17.9 (-23.1, -13.0) & -19.1 (-24.2, -14.4)), abatacept + MTX (-23.0 (-47.3, 1. 5) & -13.6 (-28.4, 2.0)) and tocilizumab + MTX (-16.0 (-26.3, -6.3) & -15.1 (-25.1, -5.7)) showed comparable reductions in pain and PGA relative to MTX. Efficacy of anakinra + MTX was much smaller as compared to other biologics. The greatest improvements in HAQ-DI relative to MTX were observed with aTNF + MTX (-0.30 (-0.37, -0.22)) and tocilizumab + MTX (-0.27 (-0.42, -0.12)), followed by abatacept + MTX (-0.21 (-0.37, -0.05)) and anakinra + MTX (-0.11 (-0.26, 0.05)). The improvements in SF36-PCS with abatacept + MTX, aTNF + MTX and tocilizumab + MTX were comparable. There is a >90% probability that aTNF + MTX results in a greater improvement in pain (-12.4), PGA (-16.1) and HAQ-DI (-0.21) than aTNF as monotherapy. Efficacy of tocilizumab + MTX showed comparable improvements in PROs as tocilizumab monotherapy.
Based on a network meta-analysis involving indirect comparison of trial findings, the following observations were made for DMARD-IR patients. In monotherapy, tocilizumab was associated with a greater improvement in pain and self-reported disease activity than aTNF, and was at least as efficacious regarding functional ability. The improvements in PROs with aTNF, abatacept and tocilizumab in combination with MTX were comparable. Improvements in PROs with tocilizumab as monotherapy were similar to that of tocilizumab + MTX, whereas aTNF as monotherapy was likely to be less efficacious than aTNF + MTX.
Health and Quality of Life Outcomes 07/2014; 12(1):102. DOI:10.1186/1477-7525-12-102 · 2.12 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background Biologic agents have revolutionised the treatment of rheumatoid arthritis (RA). Few comparative, long-term data on treatment effectiveness and safety in the real world exist for patients typically seen in clinical practice.
Objectives To present the study design and baseline characteristics for 411 patients enrolled in the CORRONA CERTAIN study from 28 Oct 2010 to 30 Sept 2011.
Methods The CORRONA registry is a network of over 100 private and academic rheumatology practices across the US. The CORRONA CERTAIN is a comparative effectiveness prospective cohort study of adult patients with RA conducted across CORRONA participating sites. Patients with moderate disease activity (CDAI score >10) initiating a biologic agent (either for the first time or switching from a previous biologic) are eligible to enroll in CERTAIN. Physician and patient assessments, including lab values and biomarkers, are mandated at baseline, 3-, 6-, 9- and 12-month follow-up visits. A total of 2,750 patients will be enrolled over 3 years. The primary endpoint of CERTAIN is CDAI <10, and comparative safety will also be evaluated.
Results Enrolled patients are 76.7% female, 84.3% Caucasian; median age is 56 (IQR: 47-64). Age, sex and race distributions are similar in TNF and nTNF cohorts. About 62% of the patients were initiated on a TNF and 38% on nTNF. Disease duration was 3 years (IQR: 1-8) for TNF cohort and 9 years (IQR: 3-16) for nTNF cohort. Biologic initiations included: etanercept (17.0%), adalimumab (16.5%), abatacept (16.3%), tocilizumab (15.8%), certolizumab (12.9%), infliximab (10.5%), rituximab (6.1%) and golimumab (4.9%). Monotherapy was used in 34.6% of TNF patients and 37.6% of nTNF patients. Fifty-four percent of TNF and 8.3% of the nTNF initiators were biologic naive. Among patients previously exposed to a different biologic, reasons for discontinuing the previous biologic were failure to maintain response (35%), minor side effect (12%), inadequate initial response (9%) and serious side effect (3%). For the TNF cohort, median baseline values were 25.0 (IQR: 17.0-34.0) for CDAI, 4.5 (IQR: 3.7-5.4) for DAS28 (CRP) and 5.0 (IQR: 1.7-10.8) for CRP. Corresponding values for the nTNF cohort were 29.0 (IQR: 23.0- 37.0), 5.0 (IQR: 4.3- 5.6) and 4.9 (IQR: 1.6-16.0). At baseline 14.9% of the TNF initiators and 9.7% of the nTNF initiators had total cholesterol >240 mg/dl. Among the patients enrolled, 30.4% had HTN, 8.5% had diabetes, 7.3% had a history of CVD and 5.4% reported a history of cancer.
Conclusions The CERTAIN study will generate comparative effectiveness and safety data to improve the quality of care and treatment outcomes for RA patients on biologics.
Disclosure of Interest D. Pappas: None Declared, A. John Employee of: Roche/Genentech, J. Greenberg Shareholder of: CORRONA, Consultant for: AstraZeneca, Novartis, Pfizer, CORRONA, J. Devenport Employee of: Roche/Genentech, J. Kremer Shareholder of: CORRONA, Grant/Research support from: Abbott, Amgen, AstraZeneca, BMS, Genentech, Lilly, Pfizer, Consultant for: Amgen, Genentech, Lilly, Pfizer, Employee of: CORRONA, Speakers Bureau: Abbott, Amgen, BMS, Pfizer, S. Ogale Employee of: Roche/Genentech, G. Reed Grant/Research support from: CORRONA, Consultant for: CORRONA, Employee of: University of Massachusetts Medical School, Paid Instructor for: Harvard Medical School, K. Saunders: None Declared, J. Curtis Grant/Research support from: Roche/Genentech, UCB, Centocor, BMS, Abbott, Amgen, CORRONA, Pfizer, Consultant for: Roche/Genentech, UCB, Centocor, BMS, Abbott, Amgen, CORRONA, Pfizer
Annals of the Rheumatic Diseases 01/2014; 71(Suppl 3):668-668. DOI:10.1136/annrheumdis-2012-eular.524 · 10.38 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Background Switching and discontinuation of biologic disease modifying antirheumatic drugs (DMARDs) may occur due to inadequate response to the current biologic, side effects, or other factors.
Objectives To compare, between biologic agents, persistence (time-to biologic DMARD switching and time-to switching/discontinuation) among patients with rheumatoid arthritis (RA) who have previously used at least one other biologic agent.
Methods Using a large U.S. administrative claims dataset, we conducted a retrospective study of adult RA patients, starting a biologic (abatacept [ABA], adalimumab [ADA], certolizumab [CZP], etanercept [ETA], golimumab [GOL], infliximab [INF], rituximab [RTX], or tocilizumab [TCZ]) between Jan 1, 2010 and Jun 30, 2011. The date of initiation for the biologic used during this period was designated the index, and patients who had used at least one other biologic at any time prior to the index were included. A 6-month pre-index period was used to measure patient characteristics and a variable-length post-index period was used to measure persistence defined in two ways: 1) time-to switch (days from index until switch to a different biologic agent) and 2) time-to switch/discontinuation (days from index until the first occurrence of a 90-day gap in treatment with the initiated biologic agent or a switch to a different biologic agent); for patients who had not switched or discontinued, follow-up was censored at the end of the study period (Jun 30, 2011) or disenrollment from insurance. Patients could contribute multiple observations to the dataset; one for each biologic they initiated sequentially during the study period.
Multivariable Cox proportional hazards models with the Huber-White “sandwich” variance estimator were used to compare persistence between the biologic agents, adjusting for patients’ demographics and pre-index health status, comorbidities, and medication use. Rituximab was excluded from analyses of time-to switch/discontinuation because its long retreatment intervals complicate the definition of discontinuation based on gaps in therapy.
Results The sample comprised 7,515 observations; mean patient age 54 years, 81% female. During the pre-index period 75% of patients used corticosteroids and 53% used methotrexate. Table displays multivariable-adjusted hazard ratios (HRs), with TCZ as the reference category, for the two persistence definitions.
Conclusions Among RA patients initiating biologic agents after previously failing a different biologic, differences in persistence exist between agents. Using time-to switch as a measure of persistence, TCZ had significantly better persistence compared with all studied biologics, except RTX, which was similar; using time-to switch/discontinuation as a measure of persistence, TCZ had significantly better persistence compared with ADA, but similar to the other biologics.
Disclosure of Interest S. Johnston Employee of: Truven Health Analytics, D. McMorrow Employee of: Truven Health Analytics, A. Farr Employee of: Truven Health Analytics, P. Juneau Employee of: Truven Health Analytics, S. Ogale Shareholder of: Genentech, Employee of: Genentech
Annals of the Rheumatic Diseases 01/2014; 72(Suppl 3):A774-A774. DOI:10.1136/annrheumdis-2013-eular.2290 · 10.38 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: To evaluate whether patients with rheumatoid arthritis who did not respond sufficiently to tocilizumab (TCZ) plus disease-modifying antirheumatic drug (DMARD) treatment by Week 8 responded at later timepoints when continuing to take their original dose of TCZ.
In this posthoc analysis of data from phase III randomized controlled trials of inadequate responders (IR) to DMARD or tumor necrosis factor-α inhibitors (anti-TNF), percentages of patients meeting early response criteria were calculated by randomized treatment arm (TCZ 4 mg/kg, 8 mg/kg, or placebo in combination with DMARD). Percentages of patients achieving certain disease activity thresholds at later timepoints were calculated for patients who had/had not achieved response by Week 8.
In DMARD-IR early nonresponders, 29.0%, 17.2%, and 3.7% of TCZ 8 mg/kg-randomized, TCZ 4 mg/kg-randomized, and placebo-randomized patients, respectively, achieved 28-joint Disease Activity Score (DAS28) ≤ 3.2 by Week 24. Among anti-TNF-IR patients without early response, 26.5%, 8.5%, and 1.9% of TCZ 8 mg/kg-randomized, TCZ 4 mg/kg-randomized, and placebo-randomized patients, respectively, achieved DAS28 ≤ 3.2 at Week 24.
A substantial number of DMARD-IR patients taking TCZ 4 or 8 mg/kg and anti-TNF-IR patients taking TCZ 8 mg/kg who failed to respond by 8 weeks benefited from continued TCZ treatment in combination with DMARD. In contrast, the anti-TNF-IR patients without early responses who continued to take TCZ 4 mg/kg were unlikely to experience a cumulative benefit. ClinicalTrials.gov registration numbers: NCT00106548, NCT00106574, NCT00106535, NCT00106522.
The Journal of Rheumatology 01/2014; 41(2). DOI:10.3899/jrheum.130489 · 3.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Objective. To investigate the effect of tocilizumab on patient-reported outcomes (PROs) in RA patients with inadequate responses to TNF inhibitors (TNFis).
Methods. In a Phase III randomized controlled trial, 489 patients received 4 or 8 mg/kg tocilizumab or placebo every 4 weeks plus MTX for 24 weeks. Mean changes from baseline over time and proportions of patients reporting improvements greater than or equal to minimum clinically important differences (MCIDs) in PROs were analyzed.
Results. At week 24, 8 mg/kg resulted in significantly greater improvements vs placebo in pain, global assessment of disease activity (P = 0.001), Health Assessment Questionnaire-Disability Index (HAQ-DI; P < 0.0001), Functional Assessment of Chronic Illness Therapy-Fatigue (P = 0.0150) and Medical Outcomes Survey Short Form 36 (SF-36 v2) Physical Component Summary (PCS; P = 0.0003) scores, all greater than MCID; 4 mg/kg resulted in greater improvements in pain (P = 0.0100), HAQ-DI (P = 0.0030) and SF-36 PCS (P = 0.0020) scores. Tocilizumab-associated improvements were evident as early as week 2. At week 24, more tocilizumab-treated than control patients reported improvements greater than or equal to MCID in SF-36 domain scores and related PROs (50.9–84.9% vs 35.0–51.7%) and achieved ACR50 responses and/or Disease Activity Score 28 (DAS28) remission with PRO improvements greater than or equal to MCID (36.2–51.2% vs 10–20.7% and 10.7–37.5% vs 0.0–3.4%, respectively).
Conclusion. Tocilizumab treatment in patients with inadequate responses to TNFis resulted in rapid and sustained improvements in multiple PROs that were statistically significant and clinically meaningful, consistent with previous efficacy reports.
Trial Registration. ClinicalTrials.gov, http://clinicaltrials.gov/, NCT00106522.
[Show abstract][Hide abstract] ABSTRACT: Improvements in health-related quality of life after treatment with tocilizumab in patients with rheumatoid arthritis refractory to tumour necrosis factor inhibitors: results from the 24-week randomized controlled RADIATE study Abstract Objective. To investigate the effect of tocilizumab on patient-reported outcomes (PROs) in RA patients with inadequate responses to TNF inhibitors (TNFis). Methods. In a Phase III randomized controlled trial, 489 patients received 4 or 8 mg/kg tocilizumab or placebo every 4 weeks plus MTX for 24 weeks. Mean changes from baseline over time and proportions of patients reporting improvements greater than or equal to minimum clinically important differences (MCIDs) in PROs were analyzed. Results. At week 24, 8 mg/kg resulted in significantly greater improvements vs placebo in pain, global assessment of disease activity (P = 0.001), Health Assessment Questionnaire-Disability Index (HAQ-DI; P < 0.0001), Functional Assessment of Chronic Illness Therapy-Fatigue (P = 0.0150) and Medical Outcomes Survey Short Form 36 (SF-36 v2) Physical Component Summary (PCS; P = 0.0003) scores, all greater than MCID; 4 mg/kg resulted in greater improvements in pain (P = 0.0100), HAQ-DI (P = 0.0030) and SF-36 PCS (P = 0.0020) scores. Tocilizumab-associated improvements were evident as early as week 2. At week 24, more tocilizumab-treated than control patients reported improvements greater than or equal to MCID in SF-36 domain scores and related PROs (50.984.9% vs 35.051.7%) and achieved ACR50 responses and/or Disease Activity Score 28 (DAS28) remission with PRO improve-ments greater than or equal to MCID (36.251.2% vs 1020.7% and 10.737.5% vs 0.03.4%, respectively). Conclusion. Tocilizumab treatment in patients with inadequate responses to TNFis resulted in rapid and sustained improvements in multiple PROs that were statistically significant and clinically meaningful, con-sistent with previous efficacy reports.
[Show abstract][Hide abstract] ABSTRACT: The role of biologic therapies in the treatment of rheumatoid arthritis has expanded, but dosing patterns in the first versus subsequent lines of therapy have not been thoroughly explored.
In order to describe patterns of biologic agent utilization among patients with rheumatoid arthritis, health care claims data on use of abatacept, rituximab, or the anti-tumor necrosis factor (TNF) agents etanercept, adalimumab, and infliximab in first- or subsequent-line settings were used to form patient cohorts. Variables included: starting dose (first administration or fill), maintenance dose (third administration or fill), average dose, dose escalation, inter-infusion interval, and discontinuation (gap in therapy > 60 days or switch). Time to discontinuation was assessed with Kaplan-Meier curves and Cox proportional hazards models.
Over 1 year, average (SD) doses of first-line etanercept (N = 1593; 45.4 [8.8] mg/week), adalimumab (N = 1040; 40.7 [10.4] mg/2 weeks), and abatacept (N = 360; 715.4 [214.5] mg/4 weeks) were similar to the starting and maintenance doses; the average infliximab dose (N = 538; 441.0 [209.2] mg/8 weeks) was greater than the starting and maintenance doses. Trends in the subsequent-line anti-TNF cohorts were similar. The percentages with a dose escalation or discontinuation were greater in the subsequent-line anti-TNF cohorts. The proportion with a dose escalation was greatest for the infliximab cohorts (61.2% first-line and 80.2% subsequent-line). The average period between abatacept infusions was 4.8 [1.4] weeks (4-week approved schedule); and 6.8 [2.6] months between rituximab courses (currently approved schedule is 6 months). Time to discontinuation was significantly shorter for subsequent-line than first-line anti-TNF therapy (median 9.7 vs. 12.5 mo; p < 0.001). The hazard ratio for discontinuing subsequent-line versus first-line anti-TNF therapy was 1.177 (p < 0.001).
Subsequent-line anti-TNF therapy cohorts had higher rates of discontinuation, dose escalation, and shorter time to discontinuation than first-line anti-TNF cohorts.
[Show abstract][Hide abstract] ABSTRACT: To assess the effect of rituximab plus methotrexate (MTX) compared with MTX alone on patient-reported outcomes (PROs) and health-related quality of life (HRQOL) in patients with active early rheumatoid arthritis (RA) previously untreated with MTX.
Patients with active early RA were randomized to groups receiving placebo, rituximab 500 mg, or rituximab 1,000 mg. Rituximab was given by intravenous infusion on days 1 and 15. From week 24, patients with a Disease Activity Score in 28 joints-erythrocyte sedimentation rate of ≥2.6 were eligible for retreatment. Physical function was assessed by Health Assessment Questionnaire (HAQ) disability index (DI) and Short Form 36 (SF-36) scores. Patients achieving a minimal clinically important difference (MCID) for PROs were determined. Additional PROs, including fatigue and pain, were assessed.
A total of 748 patients were randomized and received the study drug. Patient characteristics were well balanced. At week 52, treatment with rituximab in both dose groups showed significant improvements in the HAQ DI compared to the MTX alone group (-0.905 and -0.916 in the rituximab 500 mg plus MTX and 1,000 mg plus MTX groups, respectively, versus -0.628 in the MTX alone group; P < 0.0001). Higher proportions of patients achieved MCID in the HAQ DI in the rituximab plus MTX groups compared to MTX alone. Treatment with rituximab plus MTX led to a significant reduction in the SF-36 physical component summary for both rituximab dose groups, but did not show statistically significant differences in the SF-36 mental component summary. Compared to the MTX alone group, both doses of rituximab plus MTX were associated with significant reductions in the patient global assessment of disease activity and pain, and a significantly higher improvement in Functional Assessment of Chronic Illness Therapy-Fatigue scores from baseline to 52 weeks.
Rituximab plus MTX was associated with significant improvement in physical function and HRQOL outcomes compared with MTX alone in patients previously untreated with MTX.
[Show abstract][Hide abstract] ABSTRACT: Fatigue is a common symptom of systemic lupus erythematosus (SLE). Our objective was to validate the 13-item Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale in patients with SLE.
The FACIT-Fatigue, Medical Outcomes Study Short-Form-36 (SF-36) questionnaire, Brief Pain Inventory (BPI), and Patient Global Assessment Visual Analog Scale (Patient-GA) were completed at baseline and at Weeks 12, 24, and 52 by patients with moderately to severely active extrarenal SLE. The patients were participating in a rituximab clinical trial. The British Isles Lupus Assessment Group (BILAG) disease activity index and the Physician Global Assessment Visual Analog Scale (Physician-GA) were completed by physicians at the same visits.
At baseline, 254 patients completed the FACIT-Fatigue scale. Cronbach's α was > 0.95 at all visits. In cross-sectional analyses, FACIT-Fatigue scores differentiated between groups defined by BILAG General domain ratings. FACIT-Fatigue had moderate-high correlations (r = 0.5-0.8) with SF-36, BPI, and Patient-GA, but poor correlations with BILAG total score and Physician-GA (r = 0.1-0.3). At Weeks 12, 24, and 52, mean FACIT-Fatigue scale improvement was higher in patients who improved versus those who remained unchanged on the BILAG General domain. FACIT-Fatigue scale scores remained stable for patients with worsened BILAG General domain ratings compared to baseline. Distribution and anchor-based estimates suggested a minimally important difference (MID) range of 3-6 points.
The FACIT-Fatigue scale is a valid and responsive measure of fatigue in patients with SLE. MID in this SLE sample is similar to that derived previously in other populations. Since few patients experienced worsening BILAG General and Musculoskeletal domains in this study, further research is warranted to evaluate the responsiveness of FACIT-Fatigue to worsening of these domains.
The Journal of Rheumatology 04/2011; 38(4):672-9. DOI:10.3899/jrheum.100799 · 3.19 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: Based on a literature search, there are limited data on the economic burden of systemic lupus erythematosus (SLE), particularly in patients with lupus nephritis.
The objective of this study was to compare health care resource utilization and direct medical care costs over a period of 12 months in patients with a history of SLE with or without nephritis.
Patients aged >or=18 years with >or=1 claim for an immunosuppressive/disease-modifying antirheumatic drug, antimalarial agent, NSAID/cyclooxygenase-2 inhibitor, or other SLE-related treatment (eg, opioid and combination analgesic, antianxiety agent, antihyperlipidemic agent, antihypertensive agent, bisphosphonate, vitamin D) dated between January 1, 2007, and December 31, 2007, were identified using a nationally representative, US commercial insurance claims database. The date of the first dispensation of the treatment represented the index date. Patients were required to have >or=2 claims containing a diagnosis of SLE during a 6-month preindex period through 3 months postindex and to have continuous health plan enrollment for 6 months before and 12 months after the index date. Patients with >or=1 claim containing a diagnosis of nephritis during the preindex period were identified. Health care resource utilization and direct medical care cost data were assessed over a period of 12 months; paid amounts were used as a proxy for costs and were expressed in year-2008 US dollars.
A total of 15,590 patients with SLE were identified (13,828 women, 1762 men; mean age, 48 years); 1068 (6.9%) had a history of nephritis. The mean age of patients with SLE without nephritis was significantly greater compared with the group with nephritis (47.9 vs 46.5 years, respectively; P < 0.001), and a greater proportion of this group were women (89.0% vs 84.7%; P < 0.001). Over a period of 12 months, 30.3% of patients with nephritis were hospitalized compared with 13.6% of those without nephritis (P < 0.001); the mean lengths of hospital stays were 16.52 and 9.69 days (P < 0.001) in patients with and without nephritis, respectively. Patients with nephritis also underwent more outpatient laboratory tests (mean, 64.42 vs 30.96; P < 0.001) and had a significantly higher mean number of intravenous infusions (mean, 1.7 vs 1.1; P < 0.001), and total 12-month follow-up costs were significantly greater in patients with nephritis compared with those without nephritis (mean, $30,652 vs $12,029; P < 0.001). Costs associated with inpatient and outpatient care were 252% and 146% higher in patients with SLE with nephritis, respectively. Outpatient costs were associated with approximately half of the total costs in patients with or without nephritis; pharmacy costs accounted for 20% of the total costs in patients with SLE and nephritis and 27% of total costs among those without nephritis. Significantly higher costs also were found in patients with nephritis when only SLE-related costs were assessed and after differences in patient characteristics and comorbidities were adjusted through multivariate analyses (all, P < 0.05).
The present data analysis found that patients with SLE with nephritis consumed significantly more health care resources, with >2.5-fold the costs, compared with those without nephritis. The majority (84%) of added costs were attributable to inpatient hospitalizations and outpatient services, and 16% were attributable to pharmacy services.