The health-related quality of life (HRQOL) claims in the current Epoetin alfa label are based on the reanalyses of the exercise and physical function data from the Canadian Erythropoietin Study Group trial. The reanalysis was done to comply with the Food and Drug Administration's requirement of using statistical methods that are currently standard in evaluating clinical trial data. Presented here are HRQOL results associated with anemia. The Canadian Erythropoietin Study Group trial was a multicenter, double blind, randomized, placebo-controlled trial evaluating the effects of Epoetin alfa on HRQOL in anemic hemodialysis patients. A total of 118 patients who were 18-75 years old, on hemodialysis for >3 months, who had a hemoglobin
To describe the longterm effectiveness and safety of etanercept in Canadian patients with psoriatic arthritis (PsA), treated over 24 months in clinical practice.
Patients with active PsA (= 3 tender and = 3 swollen joints) were recruited from 22 centers. Etanercept was administered at 50 mg/week subcutaneously. In addition to clinical assessment of skin and joint disease, conducted at baseline and at Months 6, 12, 18, and 24, regular patient interviews were conducted by telephone. Patient responses related to health status, disability, and work productivity were scored using the patient global assessment tool, the Health Assessment Questionnaire (HAQ), the Health and Labour Questionnaire (HLQ), and the Fatigue Severity Scale.
Out of 110 patients, 71 (65%) maintained etanercept treatment through the end of our study. All clinical measures of disease severity, including joint tenderness/pain, joint swelling, and Psoriasis Area and Severity Index score, improved significantly between baseline and Month 6 of etanercept treatment and remained constant thereafter. By the end of our study, 79% of patients achieved a Psoriatic Arthritis Response Criteria response, and 56% of patients achieved a 0.5-point improvement on HAQ, indicating clinically significant improvement in disability; 14% of patients finished our study free of disability (HAQ = 0). Patients' work productivity and fatigue improved significantly in parallel with these clinical and functional improvements.
Continuous treatment with etanercept over 2 years in a clinical setting improved clinical symptoms of PsA while reducing fatigue, improving work productivity, and ameliorating or eliminating disability.
Very few studies have addressed the etiology of community-acquired pneumonia (CAP) treated in an ambulatory setting.
Patients were recruited from physicians' offices and from Emergency Rooms in Canada. Pneumonia was defined as two or more respiratory symptoms and signs and a new opacity on chest radiograph interpreted by a radiologist as pneumonia. Blood and sputum for culture as well as acute and convalescent serum samples for serology were obtained. Antibodies to Mycoplasma pneumoniae and Chlamydia pneumoniae were determined using enzyme-linked immunosorbent assays.
Five hundred and seven patients were enrolled in the study; 419 (82%) had blood cultures done, seven (1.4%) of which were positive for Streptococcus pneumoniae; 241 (47.5%) had a sputum processed for culture, 31% of which were positive for a potential respiratory pathogen. 437 (86.2%) had both acute and convalescent serum samples obtained, 148 (33.8%) of which gave a positive result. Overall an etiological diagnosis was made in 48.4% of the patients. M. pneumoniae accounted for 15% of the cases, C. pneumoniae 12%, S. pneumoniae 5.9% and Haemophilus influenzae 4.9%.
Despite considerable effort an etiological diagnosis of CAP treated on an ambulatory basis was made in only half the patients. The most commonly identified pathogens were M. pneumoniae, C. pneumoniae, S. pneumoniae,
To determine the amount of intravenous immune globulin (IVIG) used across indications in Canada and which Canadian medical specialties prescribe IVIG. To assess the proportion of IVIG that was used in appropriate off-label and labelled indications versus those deemed to be inappropriate off-label indications.
In Canada, all IVIG is distributed by the Canadian Blood System to Canadian blood banks within the hospital setting. Hospital blood banks then dispense IVIG to individual patients as it is prescribed and, as such, many institutions maintain a comprehensive database inventory on IVIG use. This study is a retrospective review of IVIG use as obtained from 10 teaching and community hospital blood bank databases in Ontario, Quebec, Alberta and British Columbia. Two of these 10 institutions were pediatric teaching hospitals whereas the remaining eight centres were adult care sites. Product usage was assessed between 1997 and 1999 in adult care sites, and 1997 and 1998 in the pediatric hospitals. The information collected included the number of grams of IVIG dispensed, the indications, the prescribing physician's specialty and the number of patients treated for a given indication, all assessed on an annual basis. A separate analysis was performed to determine the appropriateness of IVIG use where appropriateness was based on the published 1997 and 1999 Canadian Consensus Guidelines for IVIG use.
IVIG was prescribed for 90 different indications, six of which are licensed in Canada. When considered as separate populations, adult and pediatric use accounted for 61 and 65 different indications, respectively. Licensed use for all known indications represented approximately 47% and 62% in adult and pediatric settings, respectively. Twenty-nine per cent of IVIG use in adult and 17% in pediatric settings was not reported and is therefore unknown. Although off-label use by definition is approximately 53% in adults and 38% in pediatrics, the majority of overall IVIG use (89% in both populations) is considered appropriate by guideline definition. Hematologists and neurologists were the most prevalent prescribers of IVIG.
Based on guideline definition, appropriate off-label use of IVIG is very high in Canada.
Although etanercept is well tolerated and effective in moderate-to-severe plaque psoriasis, data are limited in Canadian practice settings.
To assess the effectiveness and safety of etanercept in Canadian patients with moderate-to-severe plaque psoriasis (Physician Global Assessment [PGA] = 3) in routine practice.
A 1-year, multicenter, open-label trial of 246 patients enrolled from March 2006 to July 2009 was conducted. Patients received etanercept 50 mg subcutaneously twice weekly for 3 months and then 50 mg once weekly for 9 months. The primary end point was the proportion of patients achieving a PGA score = 2 at month 12. Secondary end points included the proportion of patients achieving PGA score = 2 at months 3, 6, and 9 and change from baseline at month 12 for Patient Global Assessment (PtGA), body surface area, and Dermatology Life Quality Index (DLQI). Adverse events were reported.
At month 12, 73.5% (95% CI 67.2-79.1) achieved a PGA score = 2. The response was similar regardless of the previous response to systemic or phototherapy. The proportion of patients achieving this score improved from 2.2% (95% CI 0.3-4.2) at baseline to 73.5% (95% CI 67.2-79.1) at 12 months. At 12 months, patients with a DLQI score of 0 or = 5-point improvement was 28.8% (95% CI 22.9-34.7) and 47.3% (95% CI 40.8-53.9), respectively. No new safety signals were reported.
The majority of this Canadian population demonstrated a meaningful improvement in PGA and DLQI scores over 1 year.
Work productivity and healthcare resource utilization outcomes for patients on etanercept for moderate-to-severe plaque psoriasis: results from a 1-year, multicentre, open-label, single-arm study in a clinical setting.
Data investigating the effect of etanercept on work productivity and healthcare resource utilization in Canadian patients in a clinical setting is limited.
The aim of the study was to describe work productivity and healthcare resource utilization in patients with psoriasis prescribed etanercept.
A 12-month, phase IV, non-randomized, multicentre, open-label, single-arm prospective trial of patients with moderate-to-severe plaque psoriasis was conducted between March 2006 and July 2009 in 37 community dermatology practice sites across Canada. A total of 246 patients were enrolled. Major eligibility criteria: =18 years of age; diagnosis of moderate-to-severe plaque psoriasis at baseline (Physician Global Assessment [PGA] =3, scale 0-5); able to start etanercept therapy as per product monograph. Patients received etanercept (Enbrel(®)) 50 mg subcutaneously twice weekly for 3 months, then 50 mg once weekly for 9 months. Outcomes were measured by average change and average percent change from baseline at months 3, 6, 9 and 12 on the Work Productivity and Activity Impairment (WPAI) and Healthcare Resource Utilization (HRU) questionnaires.
The mean degree of impairment while working ± standard deviation (SD) in the total population decreased from 22.7% ± 23.2 at baseline to 6.6% ± 14 after 3 months of treatment (p