Validation of new potential targets for remission and low disease activity in psoriatic arthritis in patients treated with golimumab.

OBJECTIVES: Treat to target recommendations for PsA state that the target of treatment should be remission or, at the very least, low disease activity. Different clinical indexes have been proposed to define these disease states including the minimal disease activity criteria and the Disease Activity Index for PsA (DAPSA) scores, which have 7 and 4-5 domains, respectively. Using a Canadian cohort, the objectives were to calculate the proportion of patients achieving these criteria, their prognostic value and the overall patient impact of these disease states. METHODS: BioTRAC is an ongoing, prospective registry of inflammatory arthritis patients. 188 PsA patients treated with golimumab were included. Data collected at baseline, 6 and 12 months were used. RESULTS: Between 15.6% and 38.3% of patients achieved remission, and 37.4-77.7% achieved low disease activity at 6 and 12 months' follow-up. Patients achieving any minimal disease activity target and DAPSA low disease activity had significantly lower swollen joint count, tender joint count, psoriasis area and severity index, dactylitis and enthesitis scores compared with non-achievers (P < 0.05). Higher HAQ scores (P < 0.03) were observed in patients achieving remission with remaining dactylitis or active skin disease. CONCLUSION: Very low disease activity was the most stringent new potential target for remission in PsA. There was a high level of agreement between scores, although residual activity in dactylitis and skin despite DAPSA remission may affect patient function. Patients achieving either DAPSA endpoint, however, did not show a significant reduction in skin disease, indicating that those two criteria are more restricted to joint symptoms.

Post Hoc Analysis of the CONFIDENCE II, PROTECT I, SHAKE THE HABIT I and SHAKE THE HABIT II Observational Studies in Mild to Moderate Hypertensive Patients Treated with Perindopril and Atorvastatin Concomitantly.

BACKGROUND AND OBJECTIVES: Management of hypertension and dyslipidemia is important when considering cardiovascular disease risk; however, achievement of optimal lipid and blood pressure (BP) targets in clinical practice remains inadequate. This analysis sought to estimate the frequency, effectiveness, and safety of co-administrated atorvastatin and perindopril in routine care. METHODS: We conducted a post hoc analysis of four Canadian, prospective, multi-center, observational studies assessing real-life effectiveness and safety of perindopril + atorvastatin in mild-to-moderate hypertensive patients with concomitant dyslipidemia over 16 weeks. The safety population comprised patients receiving one or more doses of free combination perindopril + atorvastatin; the full analysis set (FAS) received perindopril + atorvastatin at baseline, with one or more post-baseline systolic BP measurements while on treatment. RESULTS: A total of 3541 and 3172 patients were included in the safety population and FAS, respectively. At the last observation carried forward, significant reductions in mean systolic BP (- 18.0 mmHg; p < 0.001) and diastolic BP (- 8.9 mmHg; p < 0.001) were observed; target BP was achieved by 73.1% of patients. Emergent adverse events (AEs) were reported in 8.0% of patients, the most common being cough (4.5% of patients), headache (0.9%), and dizziness (0.8%). Four serious AEs were reported among three (0.1%) patients. No differences were observed in effectiveness or safety between studies. CONCLUSIONS: Concomitant perindopril + atorvastatin therapy demonstrated similar efficacy across all studies, with significant reductions in BP and achievement of target BP levels observed in a real-world setting. Results align with known safety profiles of atorvastatin and perindopril, with no unexpected AEs observed when compared with data from treatment with the individual drugs.

Measuring herpes zoster disease burden in São Paulo, Brazil: a clinico-epidemiological single-center study.

OBJECTIVES: Herpes zoster is characterized by acute neuritis and post-herpetic neuralgia. Currently, data concerning the zoster-associated impact on quality of life and healthcare resource utilization in Brazil are scarce. This study measured the zoster-associated burden in a Brazilian population. METHODS: This was a prospective, observational, single-cohort study conducted in a primary hospital's emergency room in São Paulo, Brazil. Patients enrolled at various timepoints during a zoster episode were followed over 180 days. The Zoster Brief Pain Inventory and the Initial Zoster Impact Questionnaire assessed zoster-associated pain. The EuroQoL assessed the impact of herpes zoster and/or zoster-associated pain on quality of life. Healthcare resource utilization was assessed by patient-reported questionnaires. RESULTS: One-hundred forty-six zoster patients were enrolled [mean (SD) age of 69.9 (10.9) years]. Mean (SD) worst pain scores decreased from 5.3 (3.5) at baseline to 1.9 (3.0) 180 days following rash onset. Mean (SD) EuroQoL scores significantly decreased from 0.9 (0.2) before rash appearance to 0.7 (0.2) after rash onset (p<0.001), followed by gradual improvements in quality of life over 180 days, with pre-herpes zoster quality of life achieved at the end of the observation period. The majority of patients purchased prescription medications (89.7%) and required doctor's office visits (65.8%) for zoster episodes. CONCLUSIONS: Herpes zoster is associated with a significant disease burden, including zoster-associated pain, impaired quality of life and increased healthcare resource utilization in Brazil. These results support the implementation of early intervention and prevention programs such as vaccinations to reduce the herpes zoster-associated disease burden in Brazil.

Measuring herpes zoster disease burden in São Paulo, Brazil: a clinico-epidemiological single-center study

OBJECTIVES: Herpes zoster is characterized by acute neuritis and post-herpetic neuralgia. Currently, data concerning the zoster-associated impact on quality of life and healthcare resource utilization in Brazil are scarce. This study measured the zoster-associated burden in a Brazilian population. METHODS: This was a prospective, observational, single-cohort study conducted in a primary hospital's emergency room in São Paulo, Brazil. Patients enrolled at various timepoints during a zoster episode were followed over 180 days. The Zoster Brief Pain Inventory and the Initial Zoster Impact Questionnaire assessed zoster-associated pain. The EuroQoL assessed the impact of herpes zoster and/or zoster-associated pain on quality of life. Healthcare resource utilization was assessed by patient-reported questionnaires. RESULTS: One-hundred forty-six zoster patients were enrolled [mean (SD) age of 69.9 (10.9) years]. Mean (SD) worst pain scores decreased from 5.3 (3.5) at baseline to 1.9 (3.0) 180 days following rash onset. Mean (SD) EuroQoL scores significantly decreased from 0.9 (0.2) before rash appearance to 0.7 (0.2) after rash onset (p<0.001), followed by gradual improvements in quality of life over 180 days, with pre-herpes zoster quality of life achieved at the end of the observation period. The majority of patients purchased prescription medications (89.7%) and required doctor's office visits (65.8%) for zoster episodes. CONCLUSIONS: Herpes zoster is associated with a significant disease burden, including zoster-associated pain, impaired quality of life and increased healthcare resource utilization in Brazil. These results support the implementation of early intervention and prevention programs such as vaccinations to reduce the herpes zoster-associated disease burden in Brazil.

Real-world validation of the minimal disease activity index in psoriatic arthritis: an analysis from a prospective, observational, biological treatment registry.

OBJECTIVE: To describe the minimal disease activity (MDA) rate over time in patients with psoriatic arthritis (PsA) receiving antitumour necrosis factor agents, evaluate prognostic factors of MDA achievement and identify the most common unmet criteria among MDA achievers. DESIGN: Biologic Treatment Registry Across Canada (BioTRAC): ongoing, prospective registry of patients initiating treatment for rheumatoid arthritis, ankylosing spondylitis or PsA with infliximab (IFX), golimumab (GLM) or ustekinumab. SETTING: 46 primary-care Canadian rheumatology practices. PARTICIPANTS: 223 patients with PsA receiving IFX (enrolled since 2005) and GLM (enrolled since 2010) with available MDA information at baseline, 6 months and/or 12 months. PRIMARY AND SECONDARY OUTCOME MEASURES: MDA was defined as ≥5 of the following criteria: 28-item tender joint count (TJC28) ≤1, 28-item swollen joint count (SJC28) ≤1, Psoriasis Area and Severity Index (PASI) ≤1 or body surface area≤3, Pain Visual Analogue Scale (VAS) ≤15 mm, patient's global assessment (PtGA) (VAS) ≤20 mm, Health Assessment Questionnaire (HAQ) ≤0.5, tender entheseal points ≤1. Independent prognostic factors of MDA achievement were assessed with multivariate logistic regression. RESULTS: MDA was achieved by 11.7% of patients at baseline, 43.5% at 6 months, 44.8% at 12 months and 48.8% at either 6 or 12 months. Among MDA achievers at 6 months, 75.7% had sustained MDA at 12 months. Lower baseline HAQ (OR=0.210; 95% CI: 0.099 to 0.447) and lower TJC28 (OR=0.880; 95% CI: 0.804 to 0.964), were significant prognostic factors of MDA achievement over 12 months of treatment. The most commonly unmet MDA criteria among MDA achievers was patient reported pain (25%), PtGA (15%) and PASI (12%). CONCLUSIONS: Almost 50% of patients treated with IFX or GLM in routine clinical care achieved MDA within the first year of treatment. Lower baseline HAQ and lower TJC28, were identified as significant prognostic factors of MDA achievement. The most commonly unmet criteria in patients who achieved MDA were pain, PtGA and PASI. TRIAL REGISTRATION NUMBER: BioTRAC (NCT00741793).

Dolor, calidad de vida relacionada con la salud y utilización de servicios médicos asociados al herpes zoster en Argentina / Herpes zoster-associated pain, health-related quality of life, and healthcare utilization in Argentina

El herpes zoster (HZ) es causado por reactivación del virus varicela-zoster latente. Se caracteriza por exantema vesicular unilateral, neuri-tis aguda y neuralgia posherpética. Aún hay escasos datos sobre el do-lor asociado al HZ (DAZ), su repercusión en la calidad de vida (CdV) y la utilización de recursos sanitarios (URS) asociada en Argentina. En este estudio prospectivo, observacio-nal, de una cohorte, realizado en 3 centros argenti-nos se valuó la carga de morbilidad asociada al HZ en Argentina en contextos clínicos reales. Los pa-cientes fueron enrolados en diversos momentos du-rante un episodio herpético, y seguidos activamen-te los días 14, 21, 30, 60, 90, 120, 150 y 180. Hubo 96 enrolados(edad 70±10,7 años; tiempo desde el inicio del exantema 16±16,9 días[media±DE]). El puntaje del peor dolor (media±DE) disminuyó de 5,5±3,1 en el enrolamiento a 0,2±0,7 a los 180 días de seguimiento. El puntaje del cuestionario de cali-dad de vida EQ-5D (media±DE) disminuyó significa-tivamente de 0,8±0,1 antes del inicio del exantema a 0,6±0,2 tras su inicio (P<0,001), con mejoría gra-dual de la CdV durante 180 días (0,9±0,1), hasta un puntaje similar al previo al inicio del exantema. La URS más frecuente fueron visitas al consultorio mé-dico (96,9%). La gran mayoría de pacientes compró medicamentos recetados (95,8%) y de venta sin receta (83,3%) para los episodios herpéticos. El DAZ estuvo asociado a gran carga de morbili-dad, deterioro de CdV, aumento de URS y costos asociados en Argenti-na. Esto subraya la importancia de estrategias de intervención precoz o prevención para disminuir la carga de morbilidad asociada al HZ

Herpes zoster (HZ) is caused by re-activation of latent varicella zoster virus and is characterized by unilateral, vesicular cutaneous eruptions, acute neuritis, and post-herpetic neuralgia. To date, data on HZ associated pain (ZAP) and its impact on quality of life (QoL) and associated healthcare resource utilization use (HCRU) in Argentina is scarce. This study assessed the burden of illness associated with HZ in Argentina in a real-life clinical setting. This was a prospective, observational, single-cohort study conducted in 3 sites across Argentina. Patients were enrolled at various time points during the course of a zoster episode and were actively followed on days 14, 21, 30, 60, 90, 120, 150, and 180. There were 96 HZ patients enrolled with a mean±SD age and time since rash onset of 70±10. 7 years and 16±16. 9 days, respectively. Mean±SD worst pain score decreased from 5. 5±3. 1 at enrollment to 0. 2±0.7 at 180 days of follow-up. The mean±SD EQ-5D score significantly decreased from 0. 8±0. 1 before rash onset to 0. 6±0. 2 after rash onset (P <0.001) followed by gradual improvement in QoL over 180 days (0. 9±0.) reaching a similar score to that prior to rash onset. The most common HCRU was visits to the doctor's office with 96.9%. The vast majority of patients purchased prescription medications (95.8%) and over-the-counter medications (83.3%) for HZ episodes. ZAP was found to be associated with severe burden of illness, impaired QoL, increased HCRU, and associated cost in Argentina; highlighting the importance of early intervention or prevention strategies to reduce HZ-associated disease burden

Biologic Treatment Registry Across Canada (BioTRAC): a multicentre, prospective, observational study of patients treated with infliximab for ankylosing spondylitis.

OBJECTIVES: To describe the profile of patients with ankylosing spondylitis (AS) treated with infliximab in Canadian routine care and to assess the effectiveness and safety of infliximab in real world. SETTING: 46 primary care rheumatology practices across Canada. PARTICIPANTS: 303 biological-naïve patients with AS or patients previously treated with a biological for <6 months and who were eligible for infliximab treatment as per routine care within the Biologic Treatment Registry Across Canada (BioTRAC). INTERVENTION: Not applicable (non-interventional study). PRIMARY AND SECONDARY OUTCOMES: Effectiveness was assessed with changes in disease parameters (AS Disease Activity Score (ASDAS), Bath AS Disease Activity Index (BASDAI), Bath AS Functional Index (BASFI), Health Assessment Questionnaire Disease Index (HAQ-DI), physician global assessment of disease activity (MDGA), patient global disease activity (PtGA), back pain, C-reactive protein, erythrocyte sedimentation rate (ESR), morning stiffness). Safety was assessed with the incidence of adverse events (AEs). RESULTS: Of the 303 patients included, 44.6% were enrolled in 2005-2007 and 55.4% in 2008-2013. Patients enrolled in 2005-2007 had significantly higher MDGA and ESR at baseline while all other disease parameters examined were numerically higher with the exception of PtGA. Treatment with infliximab significantly (p<0.001) improved all disease parameters over time in both groups. At 6 months, 56% and 31% of patients achieved clinically important (change≥1.1) and major (change≥2.0) improvement in ASDAS, respectively; at 48 months, these proportions increased to 75% and 50%, respectively. Among patients unemployed due to disability at baseline, 12.1% returned to work (mean Kaplan-Meier (KM)-based time=38.8 months). The estimated retention rate at 12 and 24 months was 78.3% and 60.1%, respectively. The profile and incidence of AEs were comparable to data previously reported for tumour necrosis factor-α inhibitors. CONCLUSIONS: Characteristics of patients with AS at infliximab initiation changed over time towards lower disease activity and shorter disease duration. Infliximab treatment significantly reduced disease activity independent of treatment initiation year, although patients enrolled in recent years achieved lower disease activity over 48 months. TRIAL REGISTRATION NUMBER: NCT00741793.

Herpes zoster-associated severity and duration of pain, health-related quality of life, and healthcare utilization in Taiwan: a prospective observational study.

BACKGROUND: To assess the severity and duration of herpes zoster (HZ)-associated pain (ZAP) and its impact on quality of life (QoL) and healthcare utilization (HCRU) from a patient perspective in routine care in Taiwan. METHODS: A prospective, observational, single-cohort study was conducted in five centers across Taiwan. Patients were recruited at different time points during their HZ episode and were followed for ≤180 days. ZAP was assessed with the Initial Zoster Impact Questionnaire and the Zoster Brief Pain Inventory, QoL with the EQ-5D, and HCRU with a simple questionnaire. RESULTS: A total of 150 patients were included with a mean age of 64.9 years and mean time since rash onset of 18.8 days. Prodromal pain was experienced by 64.7% of patients, of whom 91.8% reported moderate-to-severe pain. At enrollment, 98.0% of patients experienced ZAP. Mean ± SD worst pain score decreased from 5.95 ± 3.09 at enrollment to 2.65 ± 2.98 at 30 days and 0.28 ± 0.83 at 180 days. Postherpetic neuralgia was observed in 20.7% of patients. Mean ± SD EQ-5D score significantly decreased (P < 0.001) from 0.91 ± 0.16 before rash onset to 0.67 ± 0.18 after rash onset, showing significant QoL deterioration up to 60 days. The impact of HZ on QoL and pain severity was similar across age groups. Significant HCRU was observed including visits to the doctor (83.3% of patients), specialist (30.7%), emergency department (24.7%), physiotherapist (23.3%), and hospitalizations (20.7%). CONCLUSION: Severe morbidity and significant HCRU are associated with HZ in Taiwan, supporting the need for early intervention and preventive strategies to reduce the HZ-associated burden of illness.

Treating to a target in established active rheumatoid arthritis patients receiving a tumor necrosis factor inhibitor: results from a real-world cluster-randomized adalimumab trial.

OBJECTIVE: In early rheumatoid arthritis (RA), treating to a target is more effective than routine care (RC). Our aim was to determine if treating to a target has better outcomes than RC in established active RA. METHODS: We used a real-world, 18-month cluster-randomized trial in established active RA patients treated with adalimumab. Physicians were randomized to RC, treating to a Disease Activity Score in 28 joints (DAS28) of <2.6 (DAS group), or treating to a 0 of 28 swollen joint count (SJC; 0-SJC group). RESULTS: Among the 308 enrolled patients, 109 (35.4%) were randomized to RC, 100 (32.5%) to the DAS group, and 99 (32.1%) to the 0-SJC group. When adjusting for baseline DAS28, a comparable but significant (P < 0.001) improvement in DAS28 was observed at 12 months for all groups (DAS28 mean score 3.1, 3.4, and 3.2, respectively). There were no significant between-group differences in the improvement of clinical parameters and patient-reported outcomes with the exception of the mean change in patient satisfaction over time (P = 0.020), which was highest in the DAS group. Time to achieving good/moderate European League Against Rheumatism (EULAR) response was significantly shorter in the targeted treatment groups compared to RC (adjusted hazard ratio [HR] for the DAS-group 2.99 [95% confidence interval (95% CI) 1.71-5.24] and HR for the 0-SJC group 1.86 [95% CI 1.09-3.13]). The dropout rate was 52.3% in RC, 27% in the DAS group, and 22.2% in the 0-SJC group (P < 0.001). CONCLUSION: All groups experienced significant improvements at 18 months of treatment with adalimumab. Treating to target in established RA did not differ from RC in terms of therapeutic end point achievement for patients remaining on treatment. However, time to achieving good/moderate EULAR response was significantly shorter in the targeted treatment groups compared to RC and, importantly, the dropout rate was significantly lower with targeted treatment.

Do patients with active RA have differences in disease activity and perceptions if anti-TNF naïve versus anti-TNF experienced? Baseline results of the optimization of adalimumab trial.

BACKGROUND: The chance of a good response in RA is attenuated in previous anti-TNF users who start new anti-TNF therapy compared to biologic naïve patients. In active RA, those with previous anti-TNF exposure compared to anti-TNF naïve may have different baseline disease activity and patient perceptions when starting a new anti-TNF treatment that could explain the observed response differences. MATERIAL/METHODS: The aim of this study was a post hoc analysis of baseline characteristics of patients enrolled in the Optimization of Adalimumab study that was a treat to target vs. routine care study in patients initiating adalimumab. As per the protocol, a maximum of 20% anti-TNF experienced patients were enrolled in the 300 patient trial. Twelve (4.0%) were excluded who previously used other biologics. Baseline characteristics including age, gender, tender and swollen joint counts, disease activity (DAS28), function (HAQ-DI), patient global assessment, patient satisfaction with current treatment, and inflammatory markers (CRP, ESR), were compared between previously anti-TNF experienced [etanercept or infliximab (EXP)], and anti-TNF naïve patients (NAÏVE). RESULTS: The mean (SD) age was 54.8 (13.3) years; 81.0% were female, and 237 (79.0%) were anti-TNF naïve while 51 (17.0%) patients were anti-TNF experienced (29 with etanercept, 16 with infliximab, and 6 for both). The mean (SD) baseline in EXP versus NAÏVE groups respectively was: CRP=21.7(32.9) vs. 17.5(20.7); ESR=28.7(22.5) vs. 29.8(20.4); SJC=10.5(6.0) vs. 10.7(5.6); TJC=12.8(7.1) vs. 12.3(7.3); and DAS28=6.0(1.2) vs. 5.8(1.1). None of the between-group differences were statistically significant, however, the HAQ-DI in EXP was 1.7(0.6) compared to 1.5(0.7) for the NAÏVE (P=0.021). Additionally, EXP patients had a higher patient global score [71.3(26.1) vs. 61.9(26.2), P=0.021]. CONCLUSIONS: Although anti-TNF naïve and experienced patients who initiated adalimumab were similar, with respect to several baseline characteristics, significant differences in subjective measures were observed, which may indicate more severe patient measures (function and global disease activity) in anti-TNF experienced patients.

Comparison of anti-TNF treatment initiation in rheumatoid arthritis databases demonstrates wide country variability in patient parameters at initiation of anti-TNF therapy.

OBJECTIVE: Characteristics of Canadian RA patients started on anti-tumor necrosis factor (TNF) treatment were compared with 12 other countries. METHODS: Data from the Optimization of HUMIRA trial (OH) were compared with Canadian real world studies [Ontario Biologics Research Initiative (OBRI) and the Real-Life Evaluation of Rheumatoid Arthritis in Canadians Receiving HUMIRA (REACH)], and to data from American, Australian, British, Czech, Danish, Dutch, Finnish, German, Italian, Norwegian, Spanish, and Swedish RA databases. Patient characteristics and temporal trends at initiation of anti-TNF therapy were compared between countries. RESULTS: Baseline Disease Activity Scores (DAS28) varied from 5.3 to 6.6. Lower disease severity was noted in databases from countries with less restrictive anti-TNF coverage: Dutch [based on previous disease-modifying antirheumatic drugs (DMARD) use, DAS28, swollen joint count (SJC), tender joint count (TJC), Health Assessment Questionnaire Disability Index (HAQ-DI), Danish (previous DMARD use, DAS28), Norwegian (DAS28, SJC, TJC, visual analog scale (VAS) of global health), and Swedish (DAS28, SJC, TJC, HAQ-DI)]. RA databases showed lower disease scores than did OH (P < 0.05). The US databases also showed lower disease severity (CORRONA: previous DMARD use, SJC, TJC; National Data Bank for Rheumatic Diseases: HAQ, P < 0.001). The UK and Czech Republic had restrictive coverage and higher mean baseline DAS28 than OH (P < 0.001). Baseline DAS28 in the registries with published data lowered over time (British, Norwegian, Danish, and Swedish) but less for the British (P < 0.001). CONCLUSIONS: These results confirm that regional variation exists between the 13 countries analyzed in the initiation of treatment with anti-TNF agents among RA patients and suggest that in some cases this variation may be increasing. In some countries the mean baseline disease severity declined over time and regional reimbursement policies and differences in physician preferences may be influencing initiation of anti-TNF therapy in RA.

Canadian variation by province in rheumatoid arthritis initiating anti-tumor necrosis factor therapy: results from the optimization of adalimumab trial.

OBJECTIVE: We compared variations among Canadian provinces in rheumatoid arthritis (RA) initiating anti-tumor necrosis factor (TNF) therapy. METHODS: Data were obtained from the Optimization of Humira trial (OH) and from the Ontario Biologics Research Initiative (OBRI). Baseline characteristics were compared between regions: Ontario (ON), Quebec (QC), and other provinces (OTH). We compared Ontario OH to OBRI patients who were initiating anti-TNF therapy. RESULTS: In 300 OH patients, mean age was 54.8 years (13.3). There were 151 (50.3%) ON patients, 57 from QC (19%), and 92 from OTH (30.7%). Regional differences were seen in the number of disease-modifying antirheumatic drugs (DMARD) ever taken (ON: 3.8 ± 1.4, QC: 3.1 ± 1.1, OTH: 3.3 ± 1.4; p < 0.001); swollen joint count (SJC; ON: 10.9 ± 5.9, QC: 9.0 ± 4.4, OTH: 11.3 ± 5.6; p = 0.033); tender joint count (TJC; ON: 12.2 ± 7.5, QC: 10.3 ± 5.7, OTH: 14.4 ± 7.6; p = 0.003); 28-joint Disease Activity Score (DAS28; ON: 5.8 ± 1.2, QC: 5.6 ± 1.0, OTH: 6.0 ± 1.1; p = 0.076); and Health Assessment Questionnaire (ON: 1.4 ± 0.7, QC: 1.7 ± 0.7, OTH: 1.5 ± 0.7; p = 0.060). DMARD-ever use differed: methotrexate (ON: 94.7%, QC: 93%, OTH: 84.8%; p = 0.025); leflunomide (ON: 74.8%, QC: 21.1%, OTH: 51.1%; p < 0.001); sulfasalazine (ON: 51%, QC: 38.6%, OTH: 25%; p < 0.001); myochrysine (ON: 9.3%, QC: 0%, OTH: 15.2%; p = 0.008); and hydroxychloroquine (ON: 67.5%, QC: 86%, OTH: 66.3%; p = 0.018). In comparison to ON OH patients, 95 OBRI patients initiating first anti-TNF had lower SJC (p = 0.017), TJC (p = 0.008), and DAS28 (p = 0.05). CONCLUSION: In Quebec, where access to anti-TNF is less restrictive, patients had lower SJC and TJC. ON used more DMARD, especially leflunomide, as mandated by the provincial government. Both provincial funding criteria and prescribing habits may contribute to differences. Canadian rheumatologists may vary in treatment decisions, but patients generally have similar DAS28 when initiating anti-TNF therapy.

Efficacy of BIO K+ CL1285 in the reduction of antibiotic-associated diarrhea - a placebo controlled double-blind randomized, multi-center study.

INTRODUCTION: Antibiotic associated diarrhea (AAD) is a frequently encountered adverse event following antibiotic administration. Evidence suggests that probiotics may be beneficial in preventing and decreasing the severity of AAD. MATERIAL AND METHODS: Adult patients who were prescribed antibiotics for 3-14 days were enrolled from eight Canadian centers. Study treatment was randomized at a 1 : 1 ratio of BIO-K+CL1285( (®) ) or placebo and was administered within 24 h of initiation to 5 days after termination of antibiotherapy. Patients were followed for 21 days after last dose of study treatment. The primary outcome was severity and incidence of AAD. Severity was measured by the total number of days with diarrhea and incidence was defined as the number of patients with at least one day with diarrhea over the total number of patients enrolled in the study. RESULTS: 216 patients were randomized to BIO-K+ and 221 to placebo. The mean (SD) number of days with diarrhea was 1.19. (3.20) days for the placebo and 0.67 (2.05) days for BIO-K+CL1285( (®) ) (p = 0.040). Adjusted multivariate linear regression results showed that the duration of diarrhea for BIO-K+CL1285 (®)vs. placebo was reduced by 51.5% (b[SE] = 0.515 [0.256], p = 0.045). The incidence of diarrhea was 21.8% for the BIO-K+ and 29.4% for the placebo group (OR = 0.667, p = 0.067). Multivariate logistic regression, showed that the adjusted odds ratio of AAD in patients receiving BIO-K+ vs. placebo was 0.627 (p = 0.037). Study treatment was well tolerated. CONCLUSIONS: BIO-K+ is effective for preventing and reducing the severity of AAD in patients receiving antibiotic therapy in a hospital setting.

Montelukast as add-on therapy to inhaled corticosteroids in the management of asthma (the SAS trial).

AIM: To evaluate the effectiveness of montelukast as add-on therapy for asthmatic patients who remain uncontrolled with low, moderate or high doses of inhaled corticosteroid monotherapy. DESIGN: An eight-week, multicentre, open-label, observational study. RESULTS: Of 320 patients enrolled, 288 (90.0%) completed the study. Of patients who had uncontrolled asthma symptoms (Canadian Asthma Consensus Guidelines Update, 2003) but were controlled according to the Asthma Control Questionnaire (ACQ score of less than 1.5), 93.9% maintained asthma control at week 8. Of patients with uncontrolled asthma at baseline for both definitions, 63.5% achieved asthma control by week 8. The mean +/- SD ACQ score decreased from 1.13+/-0.28 to 0.57+/-0.50 (P<0.001) for controlled patients at baseline and from 2.38+/-0.73 to 1.03+/-0.80 (P<0.001) for patients who were uncontrolled at baseline, each representing a clinically significant improvement. CONCLUSION: Montelukast add-on therapy is an effective alternative to inhaled corticosteroid monotherapy.

Montelukast as add-on therapy with inhaled corticosteroids alone or inhaled corticosteroids and long-acting beta-2-agonists in the management of patients diagnosed with asthma and concurrent allergic rhinitis (the RADAR trial).

OBJECTIVE: To evaluate the effectiveness of montelukast as add-on therapy for patients diagnosed with asthma and concurrent allergic rhinitis who remain uncontrolled while receiving inhaled corticosteroid (ICS) monotherapy or ICS/long-acting beta-2-agonist (LABA) therapy in a community practice setting. DESIGN: An eight-week, multicentre, open-label, observational study. Patients were 15 years of age or older and, while treated with an ICS or ICS/LABA, had allergic rhinitis and uncontrolled asthma symptoms by at least two criteria as per the Canadian Asthma Consensus Guidelines. The primary outcome measure was the percentage of patients with controlled asthma symptoms after eight weeks of treatment with montelukast 10 mg once daily added to ICS or ICS/LABA therapy. RESULTS: In total, 1004 patients participated in the survey phase of the study. Of these patients, 319 continued in the treatment phase and 301 (94.4%) completed the eight-week assessment. At baseline, all patients had uncontrolled asthma symptoms based on the Canadian Asthma Consensus Guidelines; at the eight-week assessment, 229 patients (76.1%) achieved asthma control. According to the Asthma Control Questionnaire (as determined by scores of 0.75 or less), 164 patients (54.7%) achieved well-controlled asthma at week 8. The mean (+/- SD) Asthma Control Questionnaire score decreased from 2.03+/-0.80 to 0.92+/-0.80 (P<0.001) for all patients, representing a clinically significant improvement. A statistically and clinically significant reduction in the overall Mini Rhinitis Quality of Life Questionnaire score was achieved with a decrease from 2.57+/-1.20 to 1.12+/-1.00 (-1.45+/-1.35; P<0.001). Patient and physician satisfaction rates with montelukast add-on therapy were also significantly increased when compared with baseline treatment. CONCLUSION: Montelukast add-on therapy is effective for managing asthma and allergic rhinitis symptoms in patients who were previously uncontrolled with ICS or ICS/LABA treatment.

Assessment of mortality in older trauma patients sustaining injuries from falls or motor vehicle collisions treated in regional level I trauma centers.

OBJECTIVE: To compare mortality in elderly trauma patients sustaining fall or motor vehicle collision (MVC) related injuries and who are subsequently treated at regional Level I (tertiary) trauma centers. SUMMARY BACKGROUND DATA: An increase in the mean age of the Canadian population is leading to a higher proportion of older patients injured in falls who are subsequently treated at Level 1 trauma centers in Quebec. The Level 1 centers were designed to treat younger patients injured in MVCs and violent acts. As a result, discordance may exist between the type of care supplied at these centers and the increased demand for care tailored to older trauma patients. METHODS: A retrospective cohort study comprised of 4,717 patients over the age of 65; 606 (12.8%) injured in MVCs and 4,111 (87.2%) in falls. The mean (SD) age was 79.6 (8.0) years and 67.9% were female. The mean (SD) Injury Severity Score (ISS) was 10.8 (7.4). Data were obtained from the Quebec Trauma Registry (QTR) for patients treated at 3 Level I trauma centers in the province of Quebec, Canada. The primary outcome measure in this study was mortality. RESULTS: Being injured in a fall was a strong predictor for mortality, with an odds ratio of 5.11 (95% C.I. = 1.84-14.17, P = 0.002). Additionally, the adjusted mortality rate was 25.3% among fall victims, versus 7.8% for MVC patients. Female gender, older age, higher ISS and an increasing number of injuries were all associated with heightened mortality. In contrast, the number of body regions injured, experiencing complications, sustaining a hip fracture, the Revised Trauma Score, the Prehospital Index and the Charlson (comorbidity) Index had no association with mortality in the Level I centers. CONCLUSIONS: Elderly patients sustaining fall-related injuries and treated at Level I trauma centers are at risk for excess mortality when compared with those injured in MVCs. Effective and efficient methods for treating this population must be determined.