Rheumatoid Arthritis: Woolley JM

Le Loët X, Nordström D, Rodriguez M, Rubbert A, Sarzi-Puttini P, Wouters JM, Woolley JM, Wright N, Lawrence C, Appleton B. · Rouen University Hospital, Rouen, France. · J Rheumatol. · Pubmed #18634163 No free full text.

Abstract: OBJECTIVE: To assess changes in functional status in patients with rheumatoid arthritis (RA) receiving the interleukin-1 receptor antagonist anakinra in addition to a disease modifying antirheumatic drug (DMARD). METHODS: In this large, multicenter, open-label, single-arm study, adult patients with RA receiving methotrexate, sulfasalazine, or hydroxychloroquine for > or = 3 months were given anakinra 100 mg once daily for up to 36 weeks. The primary objective was to evaluate changes from baseline to week 36 in the Health Assessment Questionnaire (HAQ) disability index and subscales. Changes in the 28-joint Disease Activity Score (DAS28), proportion of patients meeting European League Against Rheumatism (EULAR) response criteria, and the safety of each combination regimen were also assessed. RESULTS: A total of 1207 patients were enrolled, received > or = 1 dose of anakinra, and were included in the efficacy and safety analyses. A statistically significant change in the HAQ disability index was observed (p = 0.0001); no significant differences were seen among the 3 DMARD groups. A clinically meaningful improvement in HAQ (> 0.22) was observed in 51% of patients. Mean improvement in DAS28 was 1.5 (p < 0.0001), and 64% of patients achieved a good or moderate EULAR response score. Injection site reaction was the most frequently (62%) reported adverse event. The incidence of infections (24%), most commonly respiratory infection, was similar across treatment groups. No notable changes were observed in laboratory findings and vital signs. CONCLUSION: These findings indicate that anakinra 100 mg/day in combination with DMARD therapy safely improved functional status in patients with active RA.

Cohen SB, Woolley JM, Chan W, Anonymous00297. · St. Paul Medical Center, Dallas, Texas, USA. · J Rheumatol. · Pubmed #12563672 No free full text.

Abstract: OBJECTIVE: This study evaluated the benefit of anakinra, a human recombinant form of interleukin 1 receptor antagonist, on the functional status of patients with active rheumatoid arthritis (RA) despite taking maximally tolerated doses of methotrexate (MTX). METHODS: Patients (n = 419) were randomized to receive, in addition to MTX (15 to 25 mg/wk), placebo or anakinra doses of 0.04, 0.1, 0.4, 1, or 2 mg/kg once daily for 24 weeks. Functional status measured on 8 scales (dressing and grooming, arising, eating, walking, hygiene, reach, grip, and activities) was evaluated at baseline and every 4 weeks with the Health Assessment Questionnaire (HAQ). A weighted sum of the scale scores is the HAQ disability index (HAQ-DI). Primary analysis of the HAQ-DI was based on an omnibus test for a positive dose-response relationship between anakinra treatment and change in HAQ-DI from baseline to week 24. RESULTS: Patients receiving anakinra experienced rapid and sizeable improvements in their HAQ-DI scores in a dose-related fashion. For patients receiving either of the 2 highest doses of anakinra, improvements in the HAQ-DI occurred by week 4 that were of a magnitude considered clinically important and statistically significantly superior to placebo. CONCLUSION: In patients with persistence of RA despite MTX therapy, treatment with anakinra results in a rapid improvement in functional status as measured by the HAQ-DI.

Bullano MF, McNeeley BJ, Yu YF, Quimbo R, Burawski LP, Yu EB, Woolley JM. · Health Outcomes Research, HealthCore, Inc., Wilmington, Delaware 19801, USA. · Manag Care Interface. · Pubmed #17017313 No free full text.

Abstract: A retrospective study of health plan costs related to rheumatoid arthritis (RA) revealed that etanercept was associated with the lowest drug and outpatient costs to the health plan than infliximab and adalimumab. Compared with etanercept, infliximab was related to 55% higher postindex RA-related monthly total health care costs paid by the health plan, based on adjusted analyses (95% confidence interval, 1.47-1.64). Patients receiving adalimumab had 12% higher costs (95% confidence interval, 1.04-1.21). The study showed the average dispensing dose increase was greatest for infliximab (17.4%) and least for etanercept (4.1%).

Schiff MH, Yu EB, Weinblatt ME, Moreland LW, Genovese MC, White B, Singh A, Chon Y, Woolley JM. · Denver Arthritis Clinic, University of Colorado, Denver, Colorado 80230, USA. · Drugs Aging. · Pubmed #16536638 No free full text.

Abstract: BACKGROUND: The impact of long-term therapy for rheumatoid arthritis (RA) in elderly (> or = 65 years of age) and younger (< 65 years of age) patients, especially on patient-reported outcomes, has not been well studied. We evaluated patient-reported outcomes in elderly patients treated with etanercept, in contrast to outcomes in younger patients, using data from multiple controlled and open-label extension studies of patients with early RA (ERA; < or = 3 years) and late RA (LRA; disease-modifying antirheumatic drug [DMARD]-refractory RA). METHODS: This post hoc analysis included adult patients with RA enrolled in controlled, double-blind studies (up to 2 years) and subsequent open-label extension studies (up to 4 years). Patients were evaluated according to age at baseline of the original study. Patients may have received etanercept, placebo or methotrexate during the blinded treatment phases, but all patients had been receiving etanercept 25 mg twice weekly for at least 4 years. Both ERA and LRA extension studies are ongoing. Patient-reported outcome assessments included improvement in Health Assessment Questionnaire-Disability Index (HAQ-DI), proportions of patients achieving an improvement in HAQ-DI > or = 0.22 points, patients exhibiting worsening of HAQ-DI and patients achieving an HAQ-DI score of 0. RESULTS: Elderly patients, with either ERA or LRA, had significantly worse baseline mean HAQ-DI scores than younger patients (p < 0.05, Student's t-test) in most studies, indicating greater disability. Improvement in HAQ-DI was greatest during the first 3 months after starting etanercept treatment in the controlled phase and appeared to be sustained over 3-6 months in patients with early or DMARD-refractory RA. Across the various controlled trials, mean improvements from baseline in HAQ-DI ranged from 0.39 to 0.92 points in elderly patients and from 0.57 to 1.00 points in younger patients. Patients with ERA and LRA, regardless of age group, maintained their improvement in HAQ-DI throughout the open-label extension trials for up to a total of 6 years of etanercept therapy. Change from baseline in HAQ-DI was moderately correlated with 28-joint Disease Activity Score within each age group across the multiple trials. CONCLUSION: Both elderly and younger patients with RA treated with etanercept exhibited similar and rapid improvements in functional status during controlled studies, and these improvements were sustained during open-label extension trials.

Weycker D, Yu EB, Woolley JM, Oster G. · Policy Analysis Inc., Brookline, Massachusetts 02445, USA. · Clin Ther. · Pubmed #15978314 No free full text.

Abstract: OBJECTIVE: The aim of this work was to retrospectively examine the costs of therapy with etanercept and infliximab, among patients aged > or = 65 years with rheumatoid arthritis (RA), from a health-care system perspective. METHODS: Data from 2 large, automated US health-care claims databases (Constella COMPASS and Ingenix LabRx) were pooled for the analyses. Each database is comprised of paid facility, professional service, and retail (ie, outpatient) pharmacy claims from participating health plans. Using the 2 databases, all RA patients aged > =65 years were identified who began therapy with etanercept or infliximab between July 1, 1999 (Constella COMPASS), or January 1, 2001 (Ingenix LabRx), and December 31, 2002. Costs of RA-related care (including study drugs, selected medications, and outpatient encounters for RA) and non-RA-related care (all other medications and services) for patients in the 2 treatment groups were assessed, in US dollars, over a 1-year period after therapy initiation. RESULTS: A total of 280 RA patients aged > or = 65 years initiated therapy with etanercept (n = 99) or infliximab (n = 181) and met all other selection criteria. Etanercept patients were younger than infliximab patients (mean [SD] age, 70.5 [4.6] vs 71.8 [4.6] years; P = 0.04), were less likely to be enrolled in a managed care organization (76.7% vs 87.8%; P < 0.01), and had fewer pretreatment rheumatologist visits (mean [SD], 1.3 [2.3] vs 2.2 [3.8]; P = 0.04). Other characteristics, including pretreatment levels of other types of health-care utilization, were generally similar. Mean (95% CI) total cost of RA-related care was lower for etanercept patients in both databases (US 12,159 dollars [US 10,795 dollars-US 13,380 dollars] for etanercept vs US 22,347 dollars [US 20,808 dollars-US 23,912 dollars] for infliximab in one, and US 14,297 [US 12,238 dollars-US 16,326 dollars] for etanercept vs US 22,154 dollars [US 19,688 dollars-US 24,703 dollars] for infliximab in the other), primarily due to lower costs of anti-tumor necrosis factor therapy (US 10,015 dollars [US 8754 dollars-US 11,224 dollars] for etanercept vs US 18,611 dollars [US 17,169 dollars-US 20,023 dollars] for infliximab in one database; US 11,917 dollars [US 10,128 dollars-US 13,480 dollars] for etanercept vs US 16,759 dollars [US 14,551 dollars-US 19,062 dollars] for infliximab in the other). Mean (95% CI) costs of non-RA-related care were similar among etanercept and infliximab patients in both databases (US 13,100 dollars [US 8956 dollars-US 18,377 dollars] for etanercept vs US 11,789 dollars [US 8326 dollars-US 16,001 dollars] for infliximab in one, and US 16,665 dollars [US 10,329 dollars-US 25,690 dollars] for etanercept vs US 13,959 dollars [US 10,216 dollars-US 18,168 dollars] for infliximab in the other). CONCLUSION: These results suggest that costs of RA-related care during the first year of therapy may be lower among RA patients aged > or =65 years receiving etanercept versus infliximab, a difference attributable primarily to lower costs of drug acquisition.