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1.
Rheumatol Ther ; 11(2): 443-455, 2024 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-38416391

RESUMO

INTRODUCTION: The APPRAISE study was conducted to better understand the 12-month effectiveness, tolerability, and patient satisfaction with apremilast treatment for patients with psoriatic arthritis (PsA) in real-world settings. METHODS: APPRAISE (NCT03608657), a prospective, multicenter, observational study, enrolled adults with active PsA prescribed apremilast per routine care between July 2018 and March 2020. Patients were followed for 12 months with visits suggested every 4 months. The primary outcome measure was achievement of remission (REM) or low disease activity (LDA), defined as a Clinical Disease Activity Index for Psoriatic Arthritis (cDAPSA) score ≤ 13. RESULTS: Of the 102 patients who enrolled, 45 (44.1%) discontinued the study by 12 months. Most patients (75.5%) had moderate or high disease activity, and 24.5% were in REM/LDA at baseline based on cDAPSA score. Achievement of cDAPSA REM/LDA was 63.7%, 67.2%, and 53.8% at months 4, 8, and 12, respectively. In those continuing in the study, significant improvements were seen in swollen and tender joint counts, pain visual analog scale, psoriasis body surface area, and complete dactylitis resolution. Enthesitis reduction was also observed. Improvements in treatment satisfaction and patient-reported outcomes, including Health Assessment Questionnaire-Disability Index and the 36-item Short Form physical and mental component scores, were observed over 12 months. The proportion of patients achieving a Patient-Acceptable Symptom State (PASS) increased significantly from baseline at months 4, 8, and 12 (P < 0.001). Apremilast was well tolerated; the most frequent adverse events (AEs) leading to discontinuation were diarrhea (9/102 [8.8%]), nausea (4/102 [3.9%]), and migraine (4/102 [3.9%]). CONCLUSION: In this real-world study conducted in Canadian rheumatology clinics, apremilast demonstrated clinical effectiveness in patients with active PsA, along with patient satisfaction with treatment. Safety findings were consistent with previously reported clinical data. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT03608657.

2.
J Cosmet Dermatol ; 22(9): 2382-2390, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37424173

RESUMO

BACKGROUND: Hollowing of the infraorbital region represents a common concern among aesthetic patients. In the past decade, an increasing number of patients have resorted to noninvasive aesthetic procedures to treat these concerns. The objective of this study was to evaluate the safety profile of infraorbital hyaluronic acid injections for aesthetic rejuvenation. METHODS: Through a systematic review and meta-analysis of prospective clinical trials, investigators sought to answer the research question "Does the use of needle versus cannula during infraorbital HA injections result in the same incidence rate of adverse events?" The primary outcomes of interest were the incidence rates of ecchymosis and edema in subject groups treated with a needle or cannula. RESULTS: Subjects treated with needles had a statistically significant greater incidence rate of ecchymosis, compared to those treated with cannula. Conversely, subjects treated with cannula had a statistically significant greater incidence rate of edema, compared to those treated with needles. CONCLUSIONS: The incidence rates of adverse events following the administration of hyaluronic acid injections in the infraorbital region vary depending on whether a needle or cannula is used; with needles being associated with a greater risk of ecchymosis and cannulas being associated with a greater risk of edema. These findings should be discussed with patients prior to treatment consultation. Finally, as with most techniques, it is usually prudent to develop expertise with one technique before using a second, especially in cases where both approaches can be used and have different adverse event profiles.


Assuntos
Contusões , Técnicas Cosméticas , Preenchedores Dérmicos , Envelhecimento da Pele , Humanos , Ácido Hialurônico/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Técnicas Cosméticas/efeitos adversos , Equimose/induzido quimicamente , Equimose/epidemiologia , Estudos Prospectivos , Contusões/etiologia , Edema/induzido quimicamente , Edema/epidemiologia
3.
Arthritis Care Res (Hoboken) ; 75(2): 240-251, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-35678771

RESUMO

OBJECTIVE: The Canadian Tofacitinib for Rheumatoid Arthritis Observational (CANTORAL) is the first Canadian prospective, observational study assessing tofacitinib. The objective was to assess effectiveness and safety for moderate to severe rheumatoid arthritis (RA). Coprimary and secondary outcomes are reported from an interim analysis. METHODS: Patients initiating tofacitinib from October 2017 to July 2020 were enrolled from 45 Canadian sites. Coprimary outcomes (month 6) included the Clinical Disease Activity Index (CDAI)-defined low disease activity (LDA) and remission. Secondary outcomes (to month 18) included the CDAI and the 4-variable Disease Activity Score in 28 joints (DAS28) using the erythrocyte sedimentation rate (ESR)/C-reactive protein (CRP) level to define LDA and remission; the proportions of patients achieving mild pain (visual analog scale <20 mm), and moderate (≥30%) and substantial (≥50%) pain improvements; and the proportions of patients achieving a Health Assessment Questionnaire disability index (HAQ DI) score greater or equal to normative values (≤0.25) and a HAQ DI score greater or equal to minimum clinically important difference (MCID) (≥0.22). Safety was assessed to month 36. RESULTS: Of 504 patients initiating tofacitinib, 44.4% received concomitant methotrexate. At month 6, 52.9% and 15.4% of patients were in CDAI-defined LDA and remission, respectively; a similar proportion of patients achieved outcomes by month 3 (first post-baseline assessment). By month 3, 27.2% and 41.7% of patients, respectively, were in DAS28-ESR-defined LDA and DAS28-CRP <3.2; 14.7% and 25.8% achieved DAS28-ESR remission and DAS28-CRP <2.6. By month 3, mild pain and moderate and substantial pain improvements occurred in 29.6%, 55.6%, and 42.9% of patients, respectively; 19.9% and 53.7% of patients achieved a HAQ DI score greater than or equal to normative values and a HAQ DI score greater than or equal to MCID, respectively. Outcomes were generally maintained to month 18. Incidence rates (events per 100 patient-years) for treatment-emergent adverse events (AEs), serious AEs, and discontinuations due to AEs were 126.8, 11.9, and 14.5, respectively, and AEs of special interest were infrequent. CONCLUSION: Tofacitinib was associated with early and sustained improvement in RA signs and symptoms in real-world patients. Effectiveness and safety were consistent with the established tofacitinib clinical profile.


Assuntos
Antirreumáticos , Artrite Reumatoide , Humanos , Estudos Prospectivos , Resultado do Tratamento , Pirróis/efeitos adversos , Canadá , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/tratamento farmacológico , Artrite Reumatoide/epidemiologia , Antirreumáticos/efeitos adversos
4.
Clin Exp Rheumatol ; 40(11): 2147-2152, 2022 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-35383561

RESUMO

OBJECTIVES: The Clinical Disease Activity Index (CDAI) is routinely used in clinical care when treating-to-target RA patients. Previous validation studies have looked at CDAI's overall performance; this analysis aimed at evaluating its properties by disease state and identifying drivers of variance. METHODS: RA patients enrolled in the OBRI registry, with available follow-up of ≥6 months were included. Construct validity of CDAI was assessed with principal component analysis; internal consistency with Cronbach's alpha (α); correlational validity with Spearman's rho (ρ); agreement in disease state classification with the kappa statistic. Stratification by disease states was performed. RESULTS: CDAI correlation with DAS28 was strong when CDAI>10 (ρ=0.79), moderate when CDAI≤10 (ρ=0.56) or 2.810, CDAI was able to be reduced to a single component with patient global assessment (PtGA) having the lowest loading. When CDAI≤10, two distinct components were identified: (1) PtGA and physician global assessment; (2) SJC28 and TJC28. Moderate levels (α=0.71) of internal consistency were observed when CDAI>10 but low when CDAI≤10 (α=0.23), 2.8

Assuntos
Antirreumáticos , Artrite Reumatoide , Humanos , Ontário , Índice de Gravidade de Doença , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/tratamento farmacológico , Sistema de Registros , Antirreumáticos/uso terapêutico , Resultado do Tratamento
5.
J Arthroplasty ; 37(7S): S524-S529, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35241321

RESUMO

BACKGROUND: The aim of this study is to assess the independent effect of age on the risk of postsurgical complications and death in patients undergoing total hip arthroplasty (THA). METHODS: The National Surgical Quality Improvement Program was used to identify all patients aged 65 years and older who underwent primary THA from 2011 to 2017. Study outcomes were minor complications, major life-threatening complications, and 30-day mortality. Predictors of outcomes were identified using bivariate analyses and age was added into the final logistic regression models with stepwise selection. RESULTS: A total of 74,361 patients were included in the analysis. Mean (standard deviation) age was 735 years (6.46), median 72.0 years; 1,119 (1.50%) patients were ≥90 years. Females comprised 60.6% of the patient sample. The incidence of major life-threatening complications, minor complications, and death was 939/74,361 (1.3%), 2,098 (2.8%) and 154 (0.2%) respectively. When added to the final models, age was significantly associated with an increased risk of postoperative complications and mortality. CONCLUSION: Elective THA in relatively healthy nonagenarians should only be considered among patients with disabling osteoarthritis demonstrating a restricted quality of life. Although THA can substantially improve patient wellbeing, our findings suggest that surgeons and patients must consider the impact of age on patient course and outcomes regardless of the presence of comorbidities. LEVEL OF EVIDENCE: Level II, prognostic study.


Assuntos
Artroplastia de Quadril , Idoso de 80 Anos ou mais , Artroplastia de Quadril/efeitos adversos , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Feminino , Humanos , Masculino , Nonagenários , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Melhoria de Qualidade , Qualidade de Vida , Estudos Retrospectivos , Fatores de Risco
6.
Clin Exp Rheumatol ; 39 Suppl 130(3): 115-119, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33938797

RESUMO

OBJECTIVES: Medications have only small to moderate effects on symptoms in fibromyalgia (FM). Cannabinoids, including medical cannabis (MC) may have potential to fill this gap. Since recreational legalisation of cannabis in Canada, patients have easier access and may be self-medicating with cannabis. We have examined the prevalence and characteristics of MC use in FM patients. METHODS: During a two-month period (June-August 2019), consecutive attending rheumatology patients participated in an onsite survey comprising 2 questionnaires: 1) demographic and disease information completed by the rheumatologist, 2) patient anonymous questionnaire of health status, cannabis use (recreational and/or medicinal) and characteristics of use. RESULTS: In a cohort of 1000 rheumatology attendees, 117 (11.7%) were diagnosed with FM. Ever use of MC was reported by 28 (23.9%; 95%CI: 16.5%-32.7%) FM patients compared to 98 (11.1%; 95%CI: 9.1%-13.4%) non-FM patients. Among FM ever users, 17 (61%) patients continued use of MC. FM ever users vs. FM nonusers tended to be younger, 53 vs. 58 years (p=0.072), were more likely unemployed or disabled 39% vs. 17% (p=0.019) and used more medication types (p=0.013) but did not differ in symptom severity parameters. Cigarette smoking and recreational cannabis were more common in ever users. Global symptom relief on a VAS (1-10) was 7.0±2.3. CONCLUSIONS: FM patients have commonly used MC, with more than half continuing use. Reported symptom relief was substantial. Cigarette smoking and recreational cannabis use may play a facilitatory role in MC use in FM. Adjunctive MC may be a treatment consideration for some FM patients.


Assuntos
Cannabis , Fibromialgia , Maconha Medicinal , Canadá/epidemiologia , Cannabis/efeitos adversos , Estudos Transversais , Fibromialgia/epidemiologia , Humanos , Maconha Medicinal/uso terapêutico
7.
Curr Rheumatol Rev ; 17(3): 349-359, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-33308132

RESUMO

OBJECTIVE: For patients with Rheumatoid Arthritis (RA) who do not achieve adequate clinical response with combined conventional synthetic disease-modifying anti-rheumatic drugs (cs- DMARDs), initiation of advanced therapies such as biologic DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) is recommended. Tumour necrosis factor inhibitors (TNFi) are the oldest and most commonly used subgroup of advanced therapies. In the last decade, new non-TNFi advanced therapy options have become available. We described the relative use of TNFi vs. non-TNFi in Ontario-based practices from 2008-2017. METHODS: Adult patients with RA enrolled in the Ontario Best Practices Research Initiative (OBRI) database who started bDMARDs or tsDMARDs anytime during or within 30 days prior to enrollment were included. The proportion of patients treated with TNFi vs. non-TNFi agents between 2008 and 2017 was described for all patients and those initiating their first bDMARD/tsDMARD. All TNFi therapies were included. Non-TNFi included Abatacept, Rituximab, Tocilizumab, and Tofacitinib. RESULTS: A total of 1,057 patients were included, of whom 72.0% were bDMARD/tsDMARD naïve. In 2008, the relative non-TNFi use was 5.4% in all patients while it was 0% in bDMARD/ts- DMARD-naïve patients. In 2017, the proportion of patients using non-TNFi increased to 33.8% among all patients and 33.3% in bDMARD/tsDMARD-naïve patients. CONCLUSION: This descriptive analysis of data from the OBRI cohort reveals that TNFi are still used in the majority of cases; however, there has been an increase in the use of non-TNFi therapies both overall and as first-line advanced therapy. This trend towards non-TNFi therapies as first-line advanced therapy may be partially explained by the shift in guideline recommendations from TNFi as first-line to any of the advanced therapeutics.


Assuntos
Antirreumáticos , Artrite Reumatoide , Produtos Biológicos , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Bases de Dados Factuais , Humanos , Ontário
8.
Rheumatology (Oxford) ; 60(5): 2434-2439, 2021 05 14.
Artigo em Inglês | MEDLINE | ID: mdl-33221911

RESUMO

BACKGROUND: Yttrium-90 (90Y) is approved in several countries as a radiosynoviorthesis agent in the intra-articular treatment of synovitis, however, no such radiopharmaceuticals are approved in Canada. The aim of this Health Canada-approved study was to examine the safety and efficacy of 90Y synovectomy among patients with refractory synovitis. METHODS: We performed a subset analysis of a prospective, phase III, single-arm, pan-Canadian trial. Large and medium-sized joints of adults with refractory inflammatory mono- or oligo-arthritis and minimal cartilage/bone destruction who failed treatment with two intra-articular corticosteroid injections were eligible. Patient follow-up was at 3, 6 and 12 months. Outcome measures included joint tenderness, swelling, effusion, joint function and bone scans. RESULTS: A total of 79 joints were included (90% knees). The underlying diagnosis included SpA (35.2% of patients), RA (26.8%), JIA (8.5%) and other (29.6%). Non-biologic DMARDs were concurrently used in 59.2% of patients and biologic/targeted synthetic DMARDs in 31%. Five adverse events occurred, including one serious radiation burn requiring surgery. All events were non-life-threatening and resolved. Significant improvements in joint tenderness, swelling and effusion were achieved at 3 months (P < 0.001), which were maintained until 12 months. During follow-up, 92.3% of joints did not show radiographic progression. Per the treating physician, clinically important improvement in joint function was observed in 90% of joints. CONCLUSION: Our results confirm the safety of 90Y radiosynoviorthesis in refractory synovitis and provide preliminary evidence supporting its clinical efficacy with sustained benefit at 12 months, suggesting that it is a safe alternative to surgical synovectomy in such cases. This is the first such study in a Canadian cohort.


Assuntos
Sinovite/radioterapia , Radioisótopos de Ítrio/uso terapêutico , Adulto , Canadá , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
9.
Rheumatology (Oxford) ; 60(2): 717-727, 2021 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-32789456

RESUMO

OBJECTIVES: RA patients are often not in remission due to patient global assessment of disease activity (PtGA) included in disease activity indices. The aim was to assess the lag of patient-reported outcomes (PROs) after remission measured by clinical disease activity index (CDAI) or swollen joint count (SJC28). METHODS: RA patients enrolled in the Ontario Best Practices Research Initiative registry not in low disease state at baseline with at ≥6 months of follow-up, were included. Low disease state was defined as CDAI ≤ 10, SJC28 ≤ 2, PtGA ≤ 2cm, pain score ≤ 2cm, or fatigue ≤ 2cm. Remission included CDAI ≤ 2.8, SJC28 ≤ 1, PtGA ≤ 1cm, pain score ≤ 1cm, or fatigue ≤ 1cm. Time to first low disease state/remission based on each definition was calculated overall and stratified by early vs established RA. RESULTS: A total of 986 patients were included (age 57.4 (12.9), disease duration 8.3 (9.9) years, 80% women). The median (95% CI) time in months to CDAI ≤ 10 was 12.4 (11.4, 13.6), SJC28 ≤ 2 was 9 (8.2, 10), PtGA ≤ 2cm was 18.9 (16.1, 22), pain ≤ 2cm was 24.5 (19.4, 30.5), and fatigue ≤ 2cm was 30.4 (24.8, 31.7). For remission, the median (95% CI) time in months to CDAI ≤ 2.8 was 46.5 (42, 54.1), SJC28 ≤ 1 was 12.5 (11.4, 13.4), PtGA ≤ 1cm was 39.6 (34.6, 44.8), pain ≤ 1cm was 54.7 (43.6, 57.5) and fatigue ≤ 1cm was 42.6 (36.8, 48). Time to achieving low disease state and remission was generally significantly shorter in early RA compared with established RA with the exception of fatigue. CONCLUSION: Time to achieving low disease state or remission based on PROs was considerably longer compared with swollen joint count. Treating to a composite target in RA could lead to inappropriate changes in DMARDs.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Edema/tratamento farmacológico , Articulações/diagnóstico por imagem , Medidas de Resultados Relatados pelo Paciente , Artrite Reumatoide/complicações , Artrite Reumatoide/diagnóstico , Proteína C-Reativa/metabolismo , Edema/diagnóstico , Edema/etiologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Ontário , Estudos Prospectivos , Indução de Remissão , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do Tratamento
11.
Clin Infect Dis ; 71(10): e665-e671, 2020 12 17.
Artigo em Inglês | MEDLINE | ID: mdl-32253431

RESUMO

BACKGROUND: Influenza antigens may undergo adaptive mutations during egg-based vaccine production. In the 2017-2018 influenza season, quadrivalent, inactivated cell-derived influenza vaccine (ccIIV4) vaccine was produced using A(H3N2) seed virus propagated exclusively in cell culture, thus lacking egg adaptive changes. This United States study estimated relative vaccine effectiveness (rVE) of ccIIV4 vs egg-derived quadrivalent vaccines (egg-derived IIV4) for that season. METHODS: Vaccination, outcome, and covariate data were ascertained retrospectively from a electronic medical record (EMR) dataset and analyzed. The study cohort included patients ≥ 4 years of age. rVE was estimated against influenza-like illness (ILI) using diagnostic International Classification of Diseases, Ninth or Tenth Revision codes. The adjusted odds ratios used to derive rVE estimates were estimated from multivariable logistic regression models adjusted for age, sex, race/ethnicity, geographic region, and health status. RESULTS: Overall, 92 187 individuals had a primary care EMR record of ccIIV4 and 1 261 675 had a record of egg-derived IIV4. In the ccIIV4 group, 1705 narrowly defined ILI events occurred, and 25 645 occurred in the standard egg-derived IIV4 group. Crude rVE was 9.2% (95% confidence interval [CI], 4.6%-13.6%). When adjusted for age, sex, health status, comorbidities, and geographic region, the estimated rVE changed to 36.2% (95% CI, 26.1%-44.9%). CONCLUSIONS: ccIIV4, derived from A(H3N2) seed virus propagated exclusively in cell culture, was more effective than egg-derived IIV4 in preventing ILI during the 2017-2018 influenza season. This result suggests that cell-derived influenza vaccines may have greater effectiveness than standard egg-derived vaccines.


Assuntos
Vacinas contra Influenza , Influenza Humana , Técnicas de Cultura de Células , Humanos , Vírus da Influenza A Subtipo H3N2 , Influenza Humana/epidemiologia , Influenza Humana/prevenção & controle , Padrões de Referência , Estudos Retrospectivos , Estados Unidos/epidemiologia , Vacinas Combinadas , Vacinas de Produtos Inativados
12.
Rheumatology (Oxford) ; 59(10): 2746-2753, 2020 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-32011706

RESUMO

OBJECTIVES: Since the creation of the Canadian Rheumatology Ultrasonography Society, an increasing number of rheumatologists has been trained in the use of musculoskeletal US (MSUS). We compared the effectiveness of MSUS to routine care (RC) as a disease management tool in patients with moderate-to-severe RA requiring a treatment change due to lack of efficacy. The predictive value of MSUS was also assessed. METHODS: This was a prospective, two-cohort, quasi-experimental study. Patients were managed either with MSUS (within the Canadian Rheumatology Ultrasonography Society) or as per RC for up to 1 year. Main outcomes included Clinical Disease Activity Index low disease activity/remission, DAS28 low disease activity/remission, MSUS scores, patient satisfaction and perception of participation in disease management. RESULTS: A total of 383 patients were enrolled (MSUS: n = 171; RC: n = 212). At baseline, a greater proportion of MSUS patients were treated with a biologic DMARD (50.3 vs 36.8%; P = 0.008) while more patients treated per RC received a non-biologic DMARD (84.2 vs 91.5%; P = 0.027). During follow-up, a greater number of RA treatment modifications was applied in the MSUS group compared with RC [adjusted incidence rate ratio (95% CI): 1.4 (1.1, 1.8)], including steroids, non-biologic DMARDs and biologic DMARDs. Regarding clinical and patient-reported outcomes, no remarkable differences were observed between groups. However, throughout the study, 50-80% of MSUS patients in clinical remission has a MSUS synovitis score of ≥1, and 37-73% an erosion score of ≥1. Significant associations were observed between baseline synovitis and joint erosion during follow-up. CONCLUSION: MSUS assessments can be useful in detecting subclinical levels of inflammation and predicting future joint deterioration, thus allowing optimization of RA treatment and patient care.


Assuntos
Artrite Reumatoide/tratamento farmacológico , Sistema Musculoesquelético/diagnóstico por imagem , Reumatologia/organização & administração , Ultrassonografia/métodos , Idoso , Antirreumáticos/uso terapêutico , Canadá/epidemiologia , Gerenciamento Clínico , Feminino , Seguimentos , Humanos , Inflamação/diagnóstico por imagem , Inflamação/patologia , Masculino , Pessoa de Meia-Idade , Ensaios Clínicos Controlados não Aleatórios como Assunto/métodos , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente , Percepção , Valor Preditivo dos Testes , Estudos Prospectivos , Sinovite/diagnóstico por imagem , Sinovite/patologia
13.
J Rheumatol ; 47(4): 510-517, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-31263067

RESUMO

OBJECTIVE: Although most patients with rheumatoid arthritis (RA) respond to anti-tumor necrosis factor (anti-TNF) treatment, some present with initial nonresponse (1ry nonresponse) or lose initial responsiveness (2ry nonresponse). We compared the rate of real-world "nonresponse" to first anti-TNF as reported by treating physicians to the nonresponse rate per accepted definitions and recommended treat-to-target strategies. METHODS: Patients were included from the Biologic Treatment Registry Across Canada (BioTRAC) and Ontario Best Practices Research Initiative (OBRI) registries who were taking their first anti-TNF, with ≥ 1 followup visit. Posthoc reclassification of physician-reported nonresponse was based on prior achievement of 28-joint count Disease Activity Score based on erythrocyte sedimentation rate (DAS28-ESR) low disease activity (LDA), Clinical Disease Activity Index (CDAI) LDA, or good/moderate European League Against Rheumatism (EULAR) response, and actual time of physician-reported nonresponse. RESULTS: Among 736 BioTRAC and 640 OBRI patients, 13.7% and 18%, respectively, discontinued their anti-TNF because of physician-reported nonresponse. Based on reclassification using disease activity, 65.6% (BioTRAC) and 87.2% (OBRI) of 1ry nonresponders did not achieve DAS28-ESR LDA, 65.6%/90.7% CDAI LDA, and 46.9%/61.5% good/moderate EULAR response. Among 2ry nonresponders, 50.7%/47.8% did not achieve DAS28-ESR LDA, 37.7%/52.9% CDAI LDA, and 15.9%/19.6% good/moderate EULAR response before treatment discontinuation. Regarding actual time of nonresponse, 18.8% of BioTRAC and 60.8% of OBRI 1ry nonresponders discontinued at ≤ 6 months. In both registries, a high proportion of 2ry nonresponders discontinued their anti-TNF after 12 months (87.0% BioTRAC, 60.9% OBRI). CONCLUSION: Physician-reported 1ry nonresponse was more correlated with non-achievement of DAS28-ESR LDA or CDAI LDA, whereas 2ry nonresponse with actual time of discontinuation. Further work is needed to confirm the importance of response and type of response to the initial anti-TNF in identifying patients most likely to benefit from a second biologic agent treatment.


Assuntos
Antirreumáticos , Artrite Reumatoide , Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Humanos , Ontário , Sistema de Registros , Índice de Gravidade de Doença , Resultado do Tratamento , Inibidores do Fator de Necrose Tumoral
14.
Rheumatology (Oxford) ; 59(7): 1522-1528, 2020 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-31628486

RESUMO

OBJECTIVES: The objective of this trial was to compare effectiveness of certolizumab pegol added to conventional synthetic DMARDs (csDMARDs) in RA patients, followed by continuing vs discontinuing background csDMARDs after treatment response. METHODS: Patients with active RA who had certolizumab pegol added to their existing csDMARD regimen due to inadequate response were eligible. At 3 or 6 months, patients who achieved a change (Δ) in DAS28 of ⩾1.2 were randomized to continue combination therapy (COMBO) or withdraw csDMARD therapy (MONO) (unblinded). The primary outcome was non-inferiority of stopping vs continuing csDMARD(s) in terms of maintaining ΔDAS28 ⩾ 1.2 or achieving DAS28 low disease activity at 18 months (non-inferiority margin: 15 percentile units). RESULTS: A total of 125 patients were enrolled, 88 randomized to COMBO (n = 43) or MONO (n = 45). No significant differences were observed between groups in baseline age, gender, race, RF status or prior biologics (16% vs 11%). Although the rate of ΔDAS28 ⩾ 1.2 and/or DAS28 low disease activity achievement at 18 months was clinically comparable between the two groups (72% vs 69%), non-inferiority assumptions were not met [absolute risk difference (upper limit of 90% CI): 2.6% (19.1%)]. Similar baseline-adjusted improvements were seen in DAS28 (COMBO vs MONO: -2.3 vs -2.1; P = 0.49) and all endpoints were not statistically different including 59% vs 56% achieved DAS28 low disease activity, 69% vs 59% ΔDAS28 ⩾ 1.2, and 41% each remission. CONCLUSION: Among RA patients achieving a therapeutic response on combination therapy with certolizumab pegol and csDMARDs, withdrawing csDMARDs was not non-inferior to maintaining csDMARDs but improvements were sustained in both groups at 18 months.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Certolizumab Pegol/uso terapêutico , Desprescrições , Inibidores do Fator de Necrose Tumoral/uso terapêutico , Adulto , Idoso , Quimioterapia Combinada , Feminino , Humanos , Hidroxicloroquina/uso terapêutico , Leflunomida/uso terapêutico , Masculino , Metotrexato/uso terapêutico , Pessoa de Meia-Idade , Sulfassalazina/uso terapêutico
15.
BMC Dermatol ; 19(1): 9, 2019 06 21.
Artigo em Inglês | MEDLINE | ID: mdl-31226985

RESUMO

BACKGROUND: Treatment options for the management of moderate to severe plaque psoriasis include phototherapy, oral systemic agents, and biologic therapy. Secukinumab, a fully human monoclonal antibody that selectively targets IL-17A, is the first IL-17 antagonist approved for this patient population. Long-term observational data are required for establishing the true population-based benefit-risk ratio of approved treatments. PURE is a multinational registry that will assess the real-world safety and effectiveness of secukinumab and other approved therapies in the management of patients with moderate to severe psoriasis. METHODS: This is a multinational (Canadian and Latin American), prospective, observational study of adult patients with moderate to severe psoriasis that initiate treatment with secukinumab or other approved therapies as per local standard of care. A total of 2500 patients (1250 per cohort) will be recruited in the practices of hospital and community dermatologists. Decision regarding treatment must have been reached prior to and independent of patient enrollment in the study. The study includes a 5-year follow-up with recommended assessments at Baseline, 3 and 6 months post-Baseline, and every 6 months thereafter. The primary objective of the study is safety. Secondary outcome measures relate to effectiveness (Investigator's Global Assessment -IGA mod 2011-, Psoriasis Areas and Severity Index, Body Surface Area), patient reported outcomes (Dermatology Life Quality Index, Work Productivity and Activity Impairment Questionnaire, Hospital Anxiety and Depression Scale, Psoriasis Epidemiology Screening Tool, Psoriasis Symptom Diary, and Treatment Satisfaction Questionnaire), and healthcare resource utilization. DISCUSSION: This is the first observational study in Canada and Latin America assessing the real-world safety and effectiveness of secukinumab in the management of moderate to severe psoriasis. The extensive clinical, patient-reported and health economic outcomes collected will allow the comprehensive evaluation of this new treatment in comparison to other approved therapies. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02786186 ; date of registration: May 30, 2016.


Assuntos
Estudos Observacionais como Assunto , Psoríase/terapia , Sistema de Registros , Adulto , Anticorpos Monoclonais Humanizados/administração & dosagem , Anticorpos Monoclonais Humanizados/efeitos adversos , Produtos Biológicos/administração & dosagem , Produtos Biológicos/efeitos adversos , Canadá , Fármacos Dermatológicos/administração & dosagem , Fármacos Dermatológicos/efeitos adversos , Feminino , Humanos , Cooperação Internacional , América Latina , Masculino , Estudos Multicêntricos como Assunto , Fototerapia/efeitos adversos , Fototerapia/métodos , Psoríase/complicações , Psoríase/diagnóstico , Qualidade de Vida , Projetos de Pesquisa , Medição de Risco/métodos , Índice de Gravidade de Doença , Resultado do Tratamento
16.
Medicine (Baltimore) ; 98(20): e15517, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31096451

RESUMO

Access to care and management of Rheumatoid Arthritis (RA) patients may differ based on residential area. We described differences in the profile of patients initiating their first biologic disease modifying antirheumatic drug (bDMARD) based on their residential area type.Cross-sectional analysis of 793 adult RA patients in the longitudinal Ontario Best Practices Research Initiative (OBRI) registry initiating their first bDMARD <30 days prior to or anytime post-enrolment. Patient residential and clinic areas (rural vs. urban) were classified using 2 methods: postal codes and Statistics Canada population centres. Sociodemographics, disease characteristics, and RA medications (tumor necrosis factor inhibitor [TNFi] vs. non-TNFi, concurrent use of conventional synthetic DMARDs [csDMARDs], and intravenous [IV] vs. subcutaneous [SC] bDMARD) at initiation of first bDMARD were contrasted between residential area types.Other than marital status, first language, and race (higher proportion of married, English speaking, Caucasian patients in rural areas), no significant differences were observed in the demographic and disease characteristics of patients living in rural and urban areas. In multivariate analysis, there was no association between residential area type and type of bDMARD use, concurrent csDMARD(s) use or route of bDMARD. However, patients living farther from their treating clinic were significantly less likely to initiate IV bDMARD. Female rheumatologist and rural clinic location were independently associated with lower odds of IV bDMARD use.The use of SC vs. IV bDMARD was associated with being seen in a clinic located in a rural area, being treated by a female rheumatologist, and living farther from treating clinic. These results suggest possible prescription bias in bDMARD selection and/or patient preferences due to convenience.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Padrões de Prática Médica/estatística & dados numéricos , Características de Residência/estatística & dados numéricos , Adulto , Fatores Etários , Idoso , Antirreumáticos/administração & dosagem , Produtos Biológicos/administração & dosagem , Estudos Transversais , Vias de Administração de Medicamentos , Feminino , Acessibilidade aos Serviços de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Ontário , População Rural/estatística & dados numéricos , Índice de Gravidade de Doença , Fatores Sexuais , Fatores Socioeconômicos , Fator de Necrose Tumoral alfa/antagonistas & inibidores , População Urbana/estatística & dados numéricos
17.
Pediatr Infect Dis J ; 38(3): 253-257, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30763284

RESUMO

BACKGROUND: Invasive meningococcal disease (IMD) is associated with significant morbidity and mortality, thus remaining a concern for healthcare providers and the public. Evidence of the longitudinal burden of IMD and associated costs are scarce. Here we have evaluated the healthcare utilization and cost associated with hospitalized IMD cases in Ontario, Canada. METHODS: Observational cohort study utilizing the Ontario provincial claims databases, comprising: (1) individuals hospitalized with IMD between January 1995 and June 2012 and (2) age-, gender- and area-matched non-IMD controls (1:20 ratio). IMD cases were identified through diagnostic codes from hospitalization data and medical services claims. Costs are presented in Canadian dollars. RESULTS: Nine-hundred twelve IMD cases and 18,221 non-IMD controls were included. Over 5 years of follow-up, 27% of IMD cases (excluding initial hospitalization and 30-day acute phase) versus 15% of non-IMD controls (P < 0.001) were hospitalized. Compared with controls, IMD cases were more likely to receive alternative level of care (6.7% vs. 1.1%; P < 0.001) or visit the intensive care unit (49.2% vs. 2.4%; P < 0.001), and were associated with significantly higher mean hospitalization cost per case ($40,075 vs. $2827; P < 0.001). The hospitalization cost per case remained significantly higher when excluding the initial hospitalization and acute phase ($9867 vs. $3312; P < 0.001). The mean total cost per IMD case, including medications, hospitalization and medical services, was $45,768-$52,631 ($13,520-$23,789 excluding initial hospitalization and acute phase), for an overall cost (all cases during total follow-up) of $41,740,142-$47,999,289. CONCLUSIONS: In addition to its clinical burden, IMD is associated with significant economic burden to the public health system.


Assuntos
Custos de Cuidados de Saúde , Recursos em Saúde/economia , Infecções Meningocócicas/economia , Aceitação pelo Paciente de Cuidados de Saúde , Adolescente , Adulto , Estudos de Casos e Controles , Criança , Pré-Escolar , Feminino , Recursos em Saúde/estatística & dados numéricos , Custos Hospitalares , Hospitalização/economia , Humanos , Masculino , Infecções Meningocócicas/epidemiologia , Pessoa de Meia-Idade , Ontário/epidemiologia , Estudos Retrospectivos , Adulto Jovem
18.
Reprod Biomed Online ; 38(3): 321-329, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30660602

RESUMO

RESEARCH QUESTION: Does autologous endometrial cell co-culture (AECC) improve the number of good-quality blastocysts obtained by IVF/intracytoplasmic sperm injection (ICSI), compared with conventional embryo culture medium in a broad group of patients referred to assisted reproductive technology (ART)? DESIGN: This interventional, randomized, double-blind study took place at Clinique Ovo from March 2013 to October 2015 and included 207 healthy patients undergoing an IVF or ICSI protocol, of which 71 were excluded before randomization. On the previous cycle, all participants underwent an endometrial biopsy at D5 to D7 post-ovulation, following which the endometrial cells were prepared for AECC. RESULTS: The data demonstrated that AECC significantly increased the incidence of good-quality blastocysts compared with culture in conventional media (42.6% vs 28.4%, P < 0.001). No significant differences were found in pregnancy and live birth rates. CONCLUSION: This study demonstrated the benefits of AECC on blastocyst quality compared with conventional embryo culture medium, in a broader category of patients referred to ART as opposed to other studies that concentrated on specific causes of infertility only. However, limitations of the study design should be taken into consideration; the analysis was performed using embryos rather than patients and a follow-up of children born following the treatments could not be conducted.


Assuntos
Blastocisto/citologia , Técnicas de Cocultura , Técnicas de Cultura Embrionária/métodos , Desenvolvimento Embrionário/fisiologia , Endométrio/citologia , Fertilização in vitro/métodos , Adulto , Método Duplo-Cego , Transferência Embrionária/métodos , Feminino , Humanos , Nascido Vivo , Oócitos/citologia , Gravidez , Resultado da Gravidez , Taxa de Gravidez , Resultado do Tratamento
19.
Drugs R D ; 18(4): 283-293, 2018 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-30448890

RESUMO

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.


Assuntos
Anti-Hipertensivos/farmacologia , Atorvastatina/farmacologia , Pressão Sanguínea/efeitos dos fármacos , Hipertensão/tratamento farmacológico , Perindopril/farmacologia , Administração Oral , Idoso , Anti-Hipertensivos/administração & dosagem , Atorvastatina/administração & dosagem , Canadá , Estudos de Coortes , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Perindopril/administração & dosagem , Estudos Prospectivos , Resultado do Tratamento
20.
RMD Open ; 4(2): e000738, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30487995

RESUMO

OBJECTIVES: This study evaluated the interaction of anticitrullinated protein antibody (ACPA) and rheumatoid factor (RF) in predicting sustained clinical response in an observational registry of patients with rheumatoid arthritis (RA) followed in routine practice. METHODS: Patients with RA enrolled in the Ontario Best Practices Research Initiative registry, with ≥1 swollen joint, autoantibody information and ≥1 follow-up assessment were included. Sustained clinical remission was defined as Clinical Disease Activity Index (CDAI) ≤2.8 in at least two sequential visits separated by 3-12 months. Time to sustained remission was assessed using cumulative incidence curves and multivariate cox regression. RESULTS: Among 3251 patients in the registry, 970 were included, of whom 262 (27%) were ACPAneg/RFneg, 60 (6.2%) ACPApos /RFneg, 117 (12.1%) ACPAneg/RFpos and 531 (54.7%) ACPApos /RFpos at baseline. Significant between group differences were observed in age (p=0.02), CDAI (p=0.03), tender joint count (p=0.02) and Health Assessment Questionnaire (p=0.002), with ACPApos patients being youngest with lowest disease activity and disability. No difference in biologic use was found between groups (20.2% of patients).Over a mean follow-up of 3 years, sustained remission was achieved by 43.5% of ACPApos/RFpos patients, 43.3% of ACPApos /RFneg patients, 31.6 % of ACPAneg/RFpos patients and 32.4% of ACPAneg/RFneg patients (p=0.01). Significant differences were observed in CDAI improvement based on ACPA and RF status where ACPApos/RFpos had a shorter time to achieving sustained remission (HR 1.30; 95% CI 1.01 to 1.67) and experienced significantly higher improvements compared with ACPAneg/RFneg patients. CONCLUSIONS: Combined ACPA and RF positivity were associated with improved and faster response to antirheumatic medications in patients with RA.

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