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1.
Ann Rheum Dis ; 77(2): 221-227, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-28970213

RESUMO

OBJECTIVE: To compare 2 years of radiographic sacroiliac joint (SIJ) changes in patients with recent onset axial spondyloarthritis (axSpA) receiving etanercept in a clinical trial (EMBARK) to similar patients not receiving biologics in a cohort study (DESIR). METHODS: Endpoints were changes at week 104 per the modified New York (mNY) grading system in total SIJ score (primary endpoint) and net percentage of patients with progression defined three ways. Treatment effect was analysed with and without adjustment for baseline covariates. RESULTS: At 104 weeks, total SIJ score improved in the etanercept group (n=154, adjusted least-squares mean change: -0.14) and worsened in the control group (n=182, change: 0.08). The adjusted difference between groups (etanercept minus control) was -0.22 (95% CI -0.38 to -0.06), p=0.008. The net percentage of patients with progression was significantly lower in the etanercept versus the control group for two of three binary endpoints: -1.9% versus 1.6% (adjusted difference for etanercept minus control: -4.7%,95% CI -9.9 to 0.5, p=0.07) for change in mNY criteria; -1.9% versus 7.8% (adjusted difference: -18.2%,95% CI -30.9 to -5.6, p=0.005) for change ≥1 grade in ≥1 SIJ; and -0.6% versus 6.7% (adjusted difference: -16.4%,95% CI -27.9 to -5.0, p=0.005) for change ≥1 grade in ≥1 SIJ, with shift from 0 to 1 or 1 to 0 considered no change. CONCLUSION: Despite the slow radiographic SIJ progression rate over 2 years in axSpA, this study suggests a lower rate of progression in the SIJ with etanercept than without anti-tumour necrosis factor therapy. TRIAL REGISTRATION NUMBERS: NCT01258738, NCT01648907; Post-results.


Assuntos
Antirreumáticos/uso terapêutico , Etanercepte/uso terapêutico , Articulação Sacroilíaca/diagnóstico por imagem , Espondilartrite/tratamento farmacológico , Adolescente , Adulto , Estudos de Coortes , Progressão da Doença , Método Duplo-Cego , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Articulação Sacroilíaca/patologia , Índice de Gravidade de Doença , Coluna Vertebral/patologia , Espondilartrite/complicações , Adulto Jovem
2.
Clin Exp Rheumatol ; 35 Suppl 105(3): 50-53, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-28240587

RESUMO

OBJECTIVES: Differentiating between pain from spondyloarthritis (SpA) and pain from fibromyalgia is challenging. We evaluated patients with non-radiographic axial SpA (nr-axSpA) to determine the percentage of patients with extremely high enthesitis and/or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores, the relationship between extreme scores and depression, and the effect of extreme scores on treatment outcomes with etanercept. METHODS: Patients with nr-axSpA received double-blind etanercept 50 mg or placebo weekly and were divided into those who did vs did not have extreme scores at baseline. Extreme scores were defined as the highest quintile for enthesitis score (≥6), and/or scores ≥8 on three of five BASDAI items (excluding morning stiffness duration). Depression was assessed with the Hospital Anxiety and Depression Scale, depression subscale (HADS-D) and medication use. Week 12 outcomes included Assessment of SpondyloArthritis (ASAS) 40 and ASAS partial remission. RESULTS: At baseline, 35/213 (16.4%) patients met extreme enthesitis criteria, 31 (14.6%) met extreme BASDAI criteria, 12 (5.6%) met both, and 135 (63.4%) met neither. More patients with extreme scores than without met the HADS-D definition of depression: 35/68 (51.5%) vs. 27/118 (22.9%), p<0.0001. For patients with vs. without extreme scores who received etanercept, no significant difference existed in week 12 ASAS 40: 13/41 (31.7%) vs. 21/60 (35.0%), respectively, or ASAS partial remission: 8/41 (19.5%) vs. 19/60 (31.7%). CONCLUSIONS: Extreme enthesitis and/or BASDAI scores were associated with measurements of depression, but did not affect week 12 ASAS 40 or ASAS partial remission.


Assuntos
Fibromialgia/diagnóstico , Espondiloartropatias/diagnóstico , Adulto , Antirreumáticos/uso terapêutico , Depressão/psicologia , Diagnóstico Diferencial , Método Duplo-Cego , Intervenção Médica Precoce , Etanercepte/uso terapêutico , Feminino , Fibromialgia/fisiopatologia , Fibromialgia/psicologia , Humanos , Masculino , Ensaios Clínicos Controlados Aleatórios como Assunto , Espondiloartropatias/tratamento farmacológico , Espondiloartropatias/fisiopatologia , Espondiloartropatias/psicologia , Fator de Necrose Tumoral alfa/antagonistas & inibidores
3.
Clin Exp Rheumatol ; 35(2): 209-213, 2017.
Artigo em Inglês | MEDLINE | ID: mdl-27749225

RESUMO

OBJECTIVES: To assess symptomatic outcomes associated with flare after discontinuation of non-steroidal anti-inflammatory drugs (NSAIDs) in axial spondyloarthritis (axSpA). METHODS: Patients with NSAID-refractory axSpA discontinued NSAIDs, restarted if symptoms recurred, and self-recorded Bath Ankylosing Spondylitis Disease Activity Index (BASDAI). 75th percentiles were calculated for changes in BASDAI total and components from NSAID discontinuation to resumption. RESULTS: 75th percentiles for absolute/relative changes: BASDAI total (0-10)=1.5/28%; fatigue=2.0/25%; spinal pain=2.0/33%; joint pain/swelling=2.0/50%; enthesitis=2.0/43%; morning stiffness=1.5/27%. CONCLUSIONS: No single score threshold applied but absolute change ≥2 or relative change ≥30% indicated symptomatic deterioration for most BASDAI components.


Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Articulações/efeitos dos fármacos , Coluna Vertebral/efeitos dos fármacos , Espondilartrite/tratamento farmacológico , Adulto , Anti-Inflamatórios não Esteroides/efeitos adversos , Progressão da Doença , Método Duplo-Cego , Esquema de Medicação , Feminino , Humanos , Articulações/fisiopatologia , Masculino , Pessoa de Meia-Idade , Recidiva , Indução de Remissão , Índice de Gravidade de Doença , Coluna Vertebral/fisiopatologia , Espondilartrite/diagnóstico , Espondilartrite/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
4.
Ann Rheum Dis ; 75(7): 1328-35, 2016 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-26269397

RESUMO

OBJECTIVE: To evaluate the efficacy and safety of etanercept (ETN) after 48 weeks in patients with early active non-radiographic axial spondyloarthritis (nr-axSpA). METHODS: Patients meeting Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axSpA, but not modified New York radiographic criteria, received double-blind ETN 50 mg/week or placebo (PBO) for 12 weeks, then open-label ETN (ETN/ETN or PBO/ETN). Clinical, health, productivity, MRI and safety outcomes were assessed and the 48-week data are presented here. RESULTS: 208/225 patients (92%) entered the open-label phase at week 12 (ETN, n=102; PBO, n=106). The percentage of patients achieving ASAS40 increased from 33% to 52% between weeks 12 and 48 for ETN/ETN and from 15% to 53% for PBO/ETN (within-group p value <0.001 for both). For ETN/ETN and PBO/ETN, the EuroQol 5 Dimensions utility score improved by 0.14 and 0.08, respectively, between baseline and week 12 and by 0.23 and 0.22 between baseline and week 48. Between weeks 12 and 48, MRI Spondyloarthritis Research Consortium of Canada sacroiliac joint (SIJ) scores decreased by -1.1 for ETN/ETN and by -3.0 for PBO/ETN, p<0.001 for both. Decreases in MRI SIJ inflammation and C-reactive protein correlated with several clinical outcomes at weeks 12 and 48. CONCLUSIONS: Patients with early active nr-axSpA demonstrated improvement from week 12 in clinical, health, productivity and MRI outcomes that was sustained to 48 weeks. TRIAL REGISTRATION NUMBER: NCT01258738.


Assuntos
Antirreumáticos/uso terapêutico , Etanercepte/uso terapêutico , Imageamento por Ressonância Magnética , Espondilartrite/tratamento farmacológico , Adulto , Vértebra Cervical Áxis/diagnóstico por imagem , Vértebra Cervical Áxis/patologia , Método Duplo-Cego , Feminino , Humanos , Masculino , Articulação Sacroilíaca/diagnóstico por imagem , Articulação Sacroilíaca/patologia , Índice de Gravidade de Doença , Espondilartrite/diagnóstico por imagem , Espondilartrite/patologia , Fatores de Tempo , Resultado do Tratamento
5.
Rheumatology (Oxford) ; 51(9): 1687-96, 2012 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-22653382

RESUMO

OBJECTIVE: To evaluate the longer-term efficacy of etanercept in patients with severe and advanced active AS. METHODS: Seventy-seven patients who completed the randomized, double-blind, placebo-controlled 12-week SPINE study enrolled in a 12-week open-label extension and received s.c. etanercept 50 mg once weekly. The etanercept/etanercept group received a total of 24 weeks treatment with etanercept (n = 38); the placebo/etanercept group received placebo during the double-blind study then 12 weeks' etanercept treatment during the open-label extension (n = 39). RESULTS: At the end of the open-label extension, BASDAI scores in the etanercept/etanercept group had further decreased beyond reductions observed during the double-blind study [mean (s.d.) change from baseline -37.6 (22.4) at end of extension vs -27.4 (23.8) at end of double-blind study]. Mean (s.d.) BASDAI scores also improved in the placebo/etanercept group once switched to etanercept [-28.6 (24.3) vs -15.0 (20.0)]. Similar trends were observed in BASFI and BASMI scores. In the placebo/etanercept group, total back pain decreased to similar levels achieved in the etanercept group in the double-blind study. Pain levels continued to decrease with longer-term etanercept therapy in the etanercept/etanercept group. CONCLUSION: Despite the improvements in symptoms and inflammatory markers observed shortly after initiation of once-weekly etanercept, there was no notable plateauing effect on patient-reported outcomes. Indeed, signs and symptoms of severe and advanced active AS continued to improve after up to 24 weeks, treatment with etanercept.


Assuntos
Antirreumáticos/uso terapêutico , Imunoglobulina G/uso terapêutico , Receptores do Fator de Necrose Tumoral/uso terapêutico , Espondilite Anquilosante/tratamento farmacológico , Dor nas Costas/tratamento farmacológico , Dor nas Costas/fisiopatologia , Etanercepte , Feminino , Nível de Saúde , Humanos , Masculino , Pessoa de Meia-Idade , Radiografia , Índice de Gravidade de Doença , Coluna Vertebral/diagnóstico por imagem , Coluna Vertebral/patologia , Espondilite Anquilosante/fisiopatologia , Fatores de Tempo , Resultado do Tratamento
6.
Clin Exp Rheumatol ; 30(2): 266-8, 2012.
Artigo em Inglês | MEDLINE | ID: mdl-22325048

RESUMO

BACKGROUND: Onset of action is considered to be a key characteristic of the treatment of rheumatoid arthritis. The efficacy of TNF blockers is usually evaluated after 2 to 4 weeks of therapy. EULAR-RAID is a valid patient-reported outcome composite index. OBJECTIVES: To evaluate the onset of action of etanercept in rheumatoid arthritis patients according to the EULAR-RAID score. METHODS: An open-label, single-arm (etanercept 50 mg/week), 12-week study was carried out in patients with active rheumatoid arthritis. Patients were asked to fill in the RAID score questionnaire each day for the first 14 days of the study and at the 4-week and 12-week visits. Onset of action was evaluated by considering: a) changes over time of the EULAR-RAID score; b) the percentage of patients achieving an 'acceptable' condition according to the EULAR-RAID score (e.g. a score ≤3.00). RESULTS: Of the 120 screened patients, 108 (female: 75%), age 54±13 years, disease duration 8±7 years) were enrolled. At baseline, patients had active rheumatoid arthritis (DAS: 5.4±0.8; CRP: 18.±30mg/l). Eleven patients dropped out of the study. A statistically significant decrease in the EULAR-RAID score was observed by day 1 of therapy. Kaplan-Meier estimates of the proportion of patients achieving an acceptable RAID score were 29.8 [% 95% C.I. 23.8-X42.6], 50 % [95% C.I. 41-60.9], 51.9% [95% C.I. 43.8-63.7], 56% [95% C.I. 49.5-69.1, after 1, 2, 4 and 12 weeks of therapy respectively. The median time to achieve an acceptable EULAR-RAID score was 14.5 days. CONCLUSIONS: This open-label study suggests that patients can perceive a clinically relevant improvement by the first week of etanercept therapy.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Imunoglobulina G/uso terapêutico , Receptores do Fator de Necrose Tumoral/uso terapêutico , Adulto , Idoso , Análise de Variância , Artrite Reumatoide/diagnóstico , Artrite Reumatoide/psicologia , Avaliação da Deficiência , Etanercepte , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Paris , Pacientes/psicologia , Percepção , Valor Preditivo dos Testes , Estudos Prospectivos , Índice de Gravidade de Doença , Inquéritos e Questionários , Fatores de Tempo , Resultado do Tratamento
7.
Ann Rheum Dis ; 70(5): 740-6, 2011 May.
Artigo em Inglês | MEDLINE | ID: mdl-21149497

RESUMO

OBJECTIVES: (1) To investigate the psychometric properties of a patient-reported numerical rating scale (NRS) for evaluating functional disability in osteoarthritis (OA), in comparison with the WOMAC function scale and with a physician-reported function NRS; (2) to estimate the patient acceptable symptomatic state (PASS) and the minimal clinically important improvement (MCII) values for treatment with non-steroidal anti-inflammatory drugs (NSAIDs). METHODS: Data were extracted from a prospective multicentre study involving 1186 patients with knee or hip OA. The psychometric properties assessed were feasibility: percentage of responses, floor and ceiling effects; construct validity by examining the correlations with classically used OA outcomes measures; responsiveness by comparing the results of before and 1 month after treatment with NSAIDs using standardised response mean (SRM) and effect size (ES). The MCII and PASS values of each function scale were calculated by an anchoring method. RESULTS: No floor or ceiling effect was observed. High correlations were observed as expected between the patient NRS and WOMAC function, pain visual analogue scale and patient global assessment. The responsiveness was moderate to large, with SRM and ES ranging from 0.6 (hip OA) to 0.9 (knee OA) and higher than that of the WOMAC function scale. The PASS was close to 3 for the NRS scales. The MCII appears to be the change that makes the OA functional disability decrease from baseline to the PASS. CONCLUSION: The patient-reported NRS demonstrated good psychometric properties, similar to the WOMAC function scale and can be regarded as a promising tool in therapeutic evaluation and decision-making in OA.


Assuntos
Osteoartrite do Quadril/fisiopatologia , Osteoartrite do Joelho/fisiopatologia , Índice de Gravidade de Doença , Idoso , Avaliação da Deficiência , Métodos Epidemiológicos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Psicometria
8.
Ann Rheum Dis ; 69(8): 1430-5, 2010 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-20511606

RESUMO

OBJECTIVE: Inflammation at the entheses is a distinguishing feature of spondyloarthritis (SpA). Enthesitis at the heel is the most common location and is often chronic, refractory to standard treatment and may have socioeconomic consequences. The objective of this study was to investigate the efficacy of etanercept in refractory heel enthesitis related to SpA. METHODS: The present work was a 12-week, randomised, double-blind, placebo-controlled study compared etanercept with placebo in patients with SpA according to Amor's criteria, and heel enthesitis proven by MRI. The primary efficacy end point was the normalised net incremental area under the curve (AUC) between randomisation and week 12 for the patient's global assessment (PGA) of disease activity. Secondary end points included change from baseline in PGA, heel pain, the Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) function subscale and improvement in enthesitis as measured by MRI. RESULTS: A total of 24 patients were randomised. Mean normalised net incremental AUC for PGA of disease activity over 12 weeks was significantly greater in the etanercept versus placebo group: -28.5 versus -11.1, respectively (p=0.029). Significant improvements were also reported in the etanercept versus placebo group for PGA, -37.6 versus -11.6 (p=0.007); heel pain, -36.7 versus -13.1 (p=0.022); and WOMAC function, -23.2 versus -7.8 (p=0.024). No significant changes were observed in the MRI findings between groups. No unexpected adverse events or changes in laboratory values or vital signs. CONCLUSIONS: This trial is the first randomised placebo-controlled study of an anti-tumour necrosis factor (TNF) agent in refractory heel enthesitis in patients with SpA. It demonstrates that etanercept has a statistically significant and clinically relevant benefit in such patients. ClinicalTrials.gov identifier NCT00420303.


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Antirreumáticos/uso terapêutico , Calcâneo , Imunoglobulina G/uso terapêutico , Receptores do Fator de Necrose Tumoral/uso terapêutico , Espondilartrite/tratamento farmacológico , Tendinopatia/tratamento farmacológico , Adulto , Anti-Inflamatórios não Esteroides/efeitos adversos , Antirreumáticos/efeitos adversos , Métodos Epidemiológicos , Etanercepte , Feminino , Humanos , Imunoglobulina G/efeitos adversos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adulto Jovem
9.
Arthritis Care Res (Hoboken) ; 69(10): 1590-1598, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28482137

RESUMO

OBJECTIVE: To evaluate the long-term clinical and imaging efficacy of etanercept in patients with early, active nonradiographic axial spondyloarthritis (SpA). METHODS: Adult patients who satisfied the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA (but not the modified New York radiographic criteria), with symptom duration >3 months to <5 years, and who were unresponsive to ≥2 nonsteroidal antirheumatic drugs (NSAIDs) received double-blind etanercept 50 mg/week or placebo for 12 weeks, followed by open-label etanercept 50 mg/week to week 104. Clinical, magnetic resonance imaging (MRI; Spondyloarthritis Research Consortium of Canada [SPARCC] scores), and safety outcomes at 104 weeks were analyzed. RESULTS: Of 215 randomized patients (etanercept: n = 106; placebo: n = 109), 205 entered the study (etanercept/etanercept: n = 100; placebo/etanercept: n = 105) and 169 completed the open-label period (etanercept/etanercept: n = 83; placebo/etanercept: n = 86). At week 104, 61 of 81 (75%), 49 of 81 (61%), 48 of 80 (60%), and 57 of 81 (70%) patients who received etanercept throughout the trial achieved ASAS20, ASAS40, Ankylosing Spondylitis Disease Activity Score (ASDAS) inactive disease, and Bath Ankylosing Spondylitis Disease Activity Index criteria for 50% improvement (BASDAI 50) scores, respectively (observed). From baseline to week 104, continued improvements in clinical outcomes (ASDAS-C-reactive protein: -1.5 and -1.7; BASDAI: -3.3 and -3.8 [last observation carried forward]), and SPARCC MRI scores (sacroiliac joint: -6.0 and -3.4; spinal: -2.1 and -0.8 [observed]) were seen in patients receiving etanercept/etanercept and placebo/etanercept. During the study, 8% in the etanercept/etanercept group and 7% in the placebo/etanercept group had serious adverse events; no new safety signals were seen. CONCLUSION: Patients with early, active nonradiographic axial SpA and an inadequate response to at least 2 NSAIDs demonstrated improvement in clinical and imaging outcomes that were sustained through 104 weeks of etanercept treatment.


Assuntos
Antirreumáticos/administração & dosagem , Produtos Biológicos/administração & dosagem , Etanercepte/administração & dosagem , Coluna Vertebral/efeitos dos fármacos , Espondilartrite/tratamento farmacológico , Fator de Necrose Tumoral alfa/antagonistas & inibidores , Adulto , Anti-Inflamatórios não Esteroides/uso terapêutico , Antirreumáticos/efeitos adversos , Produtos Biológicos/efeitos adversos , Avaliação da Deficiência , Método Duplo-Cego , Substituição de Medicamentos , Etanercepte/efeitos adversos , Feminino , Humanos , Imageamento por Ressonância Magnética , Masculino , Indução de Remissão , Coluna Vertebral/diagnóstico por imagem , Coluna Vertebral/imunologia , Espondilartrite/diagnóstico por imagem , Espondilartrite/imunologia , Fatores de Tempo , Resultado do Tratamento , Fator de Necrose Tumoral alfa/imunologia
10.
J Rheumatol ; 43(9): 1680-6, 2016 09.
Artigo em Inglês | MEDLINE | ID: mdl-27307522

RESUMO

OBJECTIVE: To establish cutoffs for the minimum clinically important improvement (MCII) and the patient-acceptable symptom state (PASS) for the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) and the Bath Ankylosing Spondylitis Functional Index (BASFI) in patients with ankylosing spondylitis (AS). METHODS: Patients with AS who started nonsteroidal antiinflammatory drugs were included. After 4 weeks, the PASS and the MCII were defined using external anchor questions (for the PASS, patients considering their condition of AS over the prior 48 h as "acceptable" forever; and for the MCII, those reporting moderate or slightly important improvement). Consistency of the MCII and PASS were tested according to HLA-B27 status, presence/absence of SpA extraarticular manifestations, age, sex, disease duration, and baseline BASDAI/BASFI score. The 75th percentile of the cumulative distribution was used to determine the MCII and PASS. RESULTS: In total, 283 patients from a multinational cohort were included. Overall cutoffs for the PASS were 4.1 in the BASDAI and 3.8 in the BASFI. Cutoffs for the MCII were 0.7 and 0.4 for the BASDAI and BASFI, respectively. Subgroup analyses revealed that disease duration and baseline BASDAI/BASFI were significantly associated with the PASS and MCII. In a subanalysis limited to patients with active disease (baseline BASDAI ≥ 4), the MCII was 1.1 for the BASDAI and 0.6 for the BASFI. CONCLUSION: The conceptual viability of the PASS for the BASDAI is questionable because levels approach those required for the start of biological therapy. Because the MCII is less variable than the PASS, we propose its exclusive use, with cutoffs of 1.1/0.6 for the BASDAI/BASFI in patients with active disease. Because these values are based on a subset of the study population, we recommend confirmation in larger studies focused on patients with baseline BASDAI ≥ 4.


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Espondilite Anquilosante/diagnóstico , Espondilite Anquilosante/tratamento farmacológico , Adulto , Avaliação da Deficiência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Índice de Gravidade de Doença , Avaliação de Sintomas , Resultado do Tratamento
11.
J Rheumatol ; 42(12): 2361-8, 2015 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-26568588

RESUMO

OBJECTIVE: Using data from a randomized, double-blind, placebo-controlled study, we assessed the capacity of clinical and nonsteroidal antiinflammatory drug (NSAID)-sparing endpoints, alone and in combination, to discriminate between treatment effects in axial spondyloarthritis (axSpA). METHODS: Patients with active NSAID-resistant axSpA received etanercept (ETN) 50 mg/week or placebo for 8 weeks and tapered/discontinued NSAID. In posthoc logistic regression analyses, OR were calculated that indicated the capacity of the following endpoints to discriminate between the effects of ETN and placebo at Week 8: Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50; BASDAI ≤ 3; Assessment of Spondyloarthritis international Society (ASAS) 20; ASAS40; Ankylosing Spondylitis Disease Activity Score (ASDAS) with C-reactive protein (CRP) < 1.3 and ASDAS-CRP < 2.1; ≥ 50% decrease from baseline in ASAS-NSAID score, score < 10, and score = 0; and each clinical and/or each NSAID measure. RESULTS: In 90 randomized patients (ETN, n = 42; placebo, n = 48), disease activity was similar between groups at baseline: mean (± SD) BASDAI (ETN vs placebo) 6.0 ± 1.6 versus 5.9 ± 1.5. NSAID intake was high: ASAS-NSAID score 98.2 ± 39.0 versus 93.0 ± 23.4. OR ranged from 1.6 (95% CI 0.5-5.4) for ASDAS-CRP < 1.3 to 5.8 (95% CI 1.2-29.1) for BASDAI50 and NSAID score of 0; most measures (34/45) reached statistical significance (α = 0.05) favoring ETN. Most combined outcome variables using OR were more discriminant than single outcome measures. CONCLUSION: These findings suggest that changes in NSAID intake during treatment do not prevent demonstration of clinically relevant effects of biologic treatment, and combined (i.e., clinical with NSAID-sparing) endpoints were frequently more discriminant than single (i.e., clinical) endpoints. ClinicalTrials.gov (NCT01298531).


Assuntos
Anti-Inflamatórios não Esteroides/administração & dosagem , Etanercepte/administração & dosagem , Espondilartrite/tratamento farmacológico , Espondilartrite/fisiopatologia , Adulto , Intervalos de Confiança , Relação Dose-Resposta a Droga , Método Duplo-Cego , Esquema de Medicação , Feminino , Seguimentos , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Radiografia , Medição de Risco , Índice de Gravidade de Doença , Espondilartrite/diagnóstico por imagem , Resultado do Tratamento
12.
Arthritis Care Res (Hoboken) ; 67(7): 972-80, 2015 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-25581339

RESUMO

OBJECTIVE: The ability to interpret scores from patient-reported outcome measures at the individual patient level depends on the availability of valid, clinically meaningful benchmarks of response and state attainment. The goal was to develop multinational estimates for minimal clinically important improvement (MCII) and patient acceptable symptomatic state (PASS). METHODS: A multinational sample of patients with osteoarthritis (OA) was evaluated before and 4 weeks after treatment with nonsteroidal antiinflammatory drugs. Patients completed either the Western Ontario and McMaster Osteoarthritis Index (WOMAC) numerical rating scale 3.1 (hip and knee OA) or the Australian/Canadian Index (AUSCAN) numerical rating scale 3.1 (hand OA) before and after treatment. Patients rated the clinical importance of their response to treatment and their satisfaction with the health state achieved, from which multinational MCII and PASS estimates were calculated for both the WOMAC and AUSCAN indices. RESULTS: A total of 609 patients from 7 countries participated in the study. MCII and PASS estimates varied slightly by instrument and subscale. Absolute (percentage) change for MCII ranged 6-9 (10% to 17%) for WOMAC and 4-9 (8% to 15%) for AUSCAN. PASS estimates ranged 39-48 for WOMAC and 38-45 for AUSCAN. Some between-country variation was observed in MCII and PASS. CONCLUSION: Preliminary multinational estimates for MCII and PASS have been developed for several countries. Further research is required to evaluate the robustness, temporal consistency, and age- and sex-dependency of the preliminary estimates as well as their generalizability to other countries, languages, cultures, regions, and other condition-specific outcome measures.


Assuntos
Internacionalidade , Osteoartrite/diagnóstico , Osteoartrite/terapia , Medição da Dor/normas , Satisfação do Paciente , Anti-Inflamatórios não Esteroides/uso terapêutico , Austrália/epidemiologia , Europa (Continente)/epidemiologia , Feminino , Humanos , Líbano/epidemiologia , Estudos Longitudinais , Masculino , Marrocos/epidemiologia , Osteoartrite/epidemiologia , Medição da Dor/métodos , Estudos Prospectivos , Resultado do Tratamento
13.
Joint Bone Spine ; 70(3): 219-25, 2003 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-12814765

RESUMO

OBJECTIVE AND METHODS: To evaluate patients' opinions about the gastrointestinal safety and areas for improvement of conventional nonsteroidal antiinflammatory drug (NSAID) therapy for musculoskeletal pain, the Louis Harris Institute conducted a survey in 401 patients selected in France using a quota sampling method. RESULTS: Three hundred and five patients (76%) described their pain as incapacitating. Nearly, one-third of the patients (125/401, 31%) reported gastrointestinal side effects, which prompted endoscopy in 24 (24/125, 20%) and gastroprotective drug treatment (usually by a proton pump inhibitor) in 100 (100/125, 82%). NSAID discontinuation or dosage reduction because of gastrointestinal side effects occurred in 55 patients (55/125, 45%), at the cost of symptom exacerbation, including worse pain, in over half the cases. Among the 401 patients, 304 (76%) wanted more effective NSAIDs and 174 (43%) wanted better gastrointestinal tolerability. CONCLUSION: Under everyday conditions, the use and effectiveness of conventional NSAID therapy are limited by gastrointestinal side effects. Furthermore, patients want NSAIDs with better risk/benefit ratios to control musculoskeletal pain.


Assuntos
Anti-Inflamatórios não Esteroides/efeitos adversos , Gastroenteropatias/induzido quimicamente , Inquéritos Epidemiológicos , Doenças Musculoesqueléticas/tratamento farmacológico , Dor/tratamento farmacológico , Satisfação do Paciente , Feminino , Gastroenteropatias/fisiopatologia , Humanos , Masculino , Pessoa de Meia-Idade , Doenças Musculoesqueléticas/complicações , Dor/etiologia , Medição da Dor
14.
J Rheumatol ; 41(10): 1922-34, 2014 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-25128520

RESUMO

OBJECTIVE: The objective of these posthoc analyses was to evaluate short-term clinical outcomes as predictors of poor response after 1 year of treatment with combination etanercept/methotrexate (ETN/MTX) therapy versus MTX monotherapy in patients with early rheumatoid arthritis (RA). METHODS: Participants with moderate to severe RA [28-joint Disease Activity Score-Erythrocyte Sedimentation Rate (DAS28-ESR) ≥ 3.2] of 3-24 months' duration received ETN 50 mg weekly plus MTX or MTX monotherapy for 52 weeks. Regression analyses were performed to evaluate the likelihood of remission (DAS28-ESR < 2.6) after 1 year despite poor clinical short-term treatment effects (e.g., absolute or changes from baseline in DAS28-ESR after 4, 8, 12, 20, and 24 weeks of therapy). RESULTS: The magnitude of disease activity and its improvement and timing influenced remission probability in both treatment groups; remission rate was diminished with higher disease activity levels and lower response levels over time from weeks 4 to 24. The rate of DAS28-ESR remission at 1 year was generally greater with ETN/MTX than with MTX alone at most timepoints from weeks 4 to 24. Despite persistent high disease activity (DAS28-ESR > 5.1) after 4, 8, 12, and 24 weeks of therapy, 35%, 27%, 25%, and 22% of patients, respectively, in the ETN/MTX group achieved DAS28-ESR remission after 1 year of continuous treatment; the respective proportions were 33%, 27%, 8%, and 13% in the MTX group. CONCLUSION: High disease activity and less improvement with treatment over time in the initial 24 weeks of treatment, particularly after 12 weeks, were predictive of a lower remission rate after 1 year.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Etanercepte/uso terapêutico , Metotrexato/uso terapêutico , Adulto , Idoso , Artrite Reumatoide/diagnóstico , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Indução de Remissão , Retratamento , Índice de Gravidade de Doença , Resultado do Tratamento
15.
Arthritis Res Ther ; 16(6): 481, 2014 Nov 27.
Artigo em Inglês | MEDLINE | ID: mdl-25428762

RESUMO

INTRODUCTION: In clinical practice, nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly discontinued after response to biologic therapy is achieved in patients with axial spondyloarthritis (axSpA), but the impact of NSAID discontinuation has not been assessed in prospective controlled trials. The aim of the SPARSE study was to evaluate the effects of the anti-tumor necrosis factor agent etanercept on NSAID intake and conventional clinical outcomes in axSpA patients. METHODS: In the double-blind, placebo-controlled period, patients with active (mini Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4) axSpA despite optimal NSAID intake were randomized to receive etanercept 50 mg or placebo once weekly for 8 weeks. All patients were advised to taper/discontinue their NSAID intake during the treatment period. NSAID intake was self-reported by diary and Assessment of SpondyloArthritis International Society (ASAS)-NSAID scores calculated based on ASAS recommendations. The primary endpoint was change from baseline to week 8 in ASAS-NSAID score (analysis of covariance). RESULTS: In 90 randomized patients at baseline, mean age (standard deviation) was 38.9 (11.8) years; disease duration, 5.7 (8.1) years; 59/90 (66%) were human leukocyte antigen-B27 positive; 51/90 (57%) had radiographic sacroiliitis; and 45/90 (50%) were magnetic resonance imaging sacroiliitis-positive. Mean ASAS-NSAID scores were similar between etanercept and placebo groups at baseline (98.2 (39.0) versus 93.0 (23.4)), as were BASDAI (6.0 (1.7) versus 5.9 (1.5)), and Bath Ankylosing Spondylitis Functional Index (5.2 (2.1) versus 5.1 (2.2)). Mean changes (SE) in ASAS-NSAID score from baseline to week 8 were -63.9 (6.1) and -36.6 (5.9) in the etanercept and placebo groups (between-group difference, -27.3; P = 0.002). Significantly higher proportions of patients receiving etanercept versus placebo had an ASAS-NSAID score <10 (46% versus 17%; P = 0.008) and ASAS-NSAID score of 0 (41% versus 14%; P = 0.013) at this time point. Significantly more patients in the etanercept versus placebo group achieved BASDAI50 (39% versus 18%; P = 0.032) and ASAS40 (44% versus 21%; P = 0.028) at week 8. CONCLUSIONS: In patients with axSpA, etanercept was associated with clinically relevant NSAID-sparing effects in addition to significant improvements in conventional clinical outcomes. TRIAL REGISTRATION: ClinicalTrials.gov NCT01298531. Registered 16 February 2011.


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Antirreumáticos/uso terapêutico , Imunoglobulina G/uso terapêutico , Receptores do Fator de Necrose Tumoral/uso terapêutico , Espondilite Anquilosante/diagnóstico , Espondilite Anquilosante/tratamento farmacológico , Adulto , Método Duplo-Cego , Etanercepte , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
16.
Joint Bone Spine ; 81(4): 352-9, 2014 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-24721422

RESUMO

OBJECTIVES: To compare retention rates of adalimumab, etanercept and infliximab as first-line biotherapy in rheumatoid arthritis (RA), to determine causes of discontinuation, retention-associated factors, and retention rates of possible second-line TNF-α inhibitors (TNFi). METHODS: In this retrolective, multicentric study, medical charts of RA patients starting TNFi between March 2005 and April 2009 were reviewed, with follow-up between two and six years. The retention rate was estimated using the Kaplan-Meier method. Comparison between TNFi was done after adjustment using a Cox model. Factors associated with better retention were identified by multivariate analysis. RESULTS: Of the 706 patients included, the percentage continuing treatment after two years was 54.9, 61.9 and 48.7%, and the median retention was 31, 45 and 23 months for adalimumab, etanercept and infliximab, respectively. The hazard ratios (HRs) for discontinuation were greater with adalimumab and infliximab than etanercept (1.315, 95% CI [1.050-1.648] and 1.380, 95% CI [1.041-1.828], respectively). The HR for discontinuation due to inefficacy was significantly higher with adalimumab than etanercept. Adverse events were significantly higher with infliximab than etanercept. Past use of more DMARDs and higher baseline ESR were associated with better retention. The median retention of the second-line TNFi was 11, 43 and 19.1 months for adalimumab, etanercept, and infliximab, respectively. HRs for adalimumab discontinuation due to all causes were significantly greater than for etanercept. CONCLUSIONS: Etanercept had a better retention rate than adalimumab and infliximab as first-line biotherapy in RA, and than adalimumab as second-line biotherapy.


Assuntos
Anticorpos Monoclonais Humanizados/uso terapêutico , Anticorpos Monoclonais/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Imunoglobulina G/uso terapêutico , Receptores do Fator de Necrose Tumoral/uso terapêutico , Adalimumab , Adulto , Antirreumáticos/uso terapêutico , Etanercepte , Feminino , Humanos , Infliximab , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos
17.
Arthritis Rheumatol ; 66(8): 2091-102, 2014 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-24891317

RESUMO

OBJECTIVE: To assess the efficacy of etanercept in the treatment of early active nonsteroidal antiinflammatory drug (NSAID)-refractory nonradiographic axial spondyloarthritis (SpA). METHODS: The study population consisted of patients who met the Assessment of SpondyloArthritis international Society (ASAS) classification criteria for axial SpA but not the modified New York radiographic criteria for ankylosing spondylitis (as assessed by a radiologist at the central trial site), had a symptom duration of >3 months but <5 years, had a score of ≥4 on the Bath Ankylosing Spondylitis Disease Activity Index, and had been treated unsuccessfully with ≥2 NSAIDs. Patients were randomized to receive etanercept 50 mg/week or placebo and continued background NSAID treatment for 12 weeks (double-blind study); during the subsequent open-label period, all patients received etanercept 50 mg/week. The primary study end point was meeting the ASAS criteria for 40% improvement (ASAS40) at week 12. Magnetic resonance imaging (MRI) of the sacroiliac joints and spine was performed at baseline and week 12. RESULTS: One hundred six patients were randomized to the etanercept group and 109 to the placebo group. Of the 215 patients, the mean ± SD age at baseline was 32.0 ± 7.8 years, 154 (72%) were HLA-B27 positive, and 174 (81%) had MRI-confirmed sacroiliitis. At 12 weeks, the proportion of patients with improvement according to the ASAS40 was significantly higher in the etanercept group than in the placebo group (34 of 105 [32%] versus 17 of 108 [16%]; P = 0.006). Patients who received etanercept exhibited a greater reduction in MRI-based scores for sacroiliac joint inflammation (-46.9% versus -10.9%; P < 0.001) and spinal inflammation (-45.4% versus -33.4%; P = 0.04) compared with placebo-treated patients at week 12. Post hoc analyses suggested a possible association between higher baseline C-reactive protein levels or MRI sacroiliac joint inflammation scores and higher rates of ASAS40 response to etanercept. At week 24, patients in the placebo group who had switched to etanercept at 12 weeks exhibited improvement similar to that observed in patients who had received etanercept for 24 weeks. CONCLUSION: In patients with nonradiographic axial SpA, etanercept treatment was associated with rapid, significant improvement in symptomatic disease activity, function, and systemic and skeletal inflammation over 12 weeks; clinical/functional improvement was sustained over 24 weeks.


Assuntos
Imunoglobulina G/uso terapêutico , Fatores Imunológicos/uso terapêutico , Receptores do Fator de Necrose Tumoral/uso terapêutico , Espondilartrite/tratamento farmacológico , Adulto , Método Duplo-Cego , Etanercepte , Feminino , Humanos , Masculino , Indução de Remissão , Espondilartrite/diagnóstico , Espondilartrite/imunologia
18.
J Rheumatol ; 40(10): 1650-7, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23950185

RESUMO

OBJECTIVE: To report the 5-year outcome of a large prospective cohort of patients with very early rheumatoid arthritis (RA), and to identify factors predictive of outcome. METHODS: Patients were recruited if they had early arthritis of < 6 months' duration, had a high probability of developing RA, and had never been prescribed disease-modifying antirheumatic drugs (DMARD) or steroids. Logistic regression analysis was used to determine factors that predict outcome. RESULTS: We included 813 patients from December 2002 to April 2005. Age was 48.1 ± 12.6 years, delay before referral 103.1 ± 52.4 days, 28-joint Disease Activity Score (DAS28) 5.1 ± 1.3, Health Assessment Questionnaire (HAQ) 1.0 ± 0.7; 45.8% and 38.7% had rheumatoid factor or antibodies to cyclic citrullinated peptide (anti-CCP), respectively; 22% had hand or foot erosions; 78.5% fulfilled the American College of Rheumatology/European League Against Rheumatism criteria for RA at baseline and 93.8% during followup. At 5 years, 573 patients were evaluated. The outcome was mild for most patients: disease activity (median DAS28 = 2.5) and HAQ disability (median 0.3) were well controlled over time; 50.6% achieved DAS28 remission and 64.7% low disease activity. Radiographic progression was low (2.9 Sharp unit/year) and only a few patients required joint surgery. Nevertheless, some patients developed new comorbidities. During the 5 years, 82.7% of patients had received at least 1 DMARD (methotrexate, 65.9%), 18.3% a biological DMARD, and about 60% prednisone at least once. Anti-CCP was the best predictor of remaining in the cohort for 5 years, of prescription of synthetic or biologic DMARD, and of radiographic progression. CONCLUSION: The 5-year outcome of an early RA cohort in the 2000s was described. Anti-CCP was a robust predictor of outcome. The generally good 5-year outcome could be related to early referral and early effective treatment, key processes in the management of early RA in daily practice.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Produtos Biológicos/uso terapêutico , Metotrexato/uso terapêutico , Adulto , Idoso , Artrite Reumatoide/diagnóstico por imagem , Artrografia , Progressão da Doença , Feminino , Seguimentos , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Indução de Remissão/métodos , Fator Reumatoide , Índice de Gravidade de Doença , Resultado do Tratamento
19.
Arthritis Care Res (Hoboken) ; 64(2): 290-4, 2012 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-22006544

RESUMO

OBJECTIVE: To evaluate the interest of the Assessment of SpondyloArthritis international Society (ASAS) nonsteroidal antiinflammatory drug (NSAID) score as a quality indicator and a potential outcome measure in clinical studies. METHODS: We used data from patients with active, advanced, axial ankylosing spondylitis refractory to NSAIDs. The study design was a 12-week, randomized, placebo-controlled period followed by a 12-week open-label extension. The ASAS-NSAID score was collected during 3 periods of interest (i.e., the 12 weeks preceding baseline, the 12 weeks of the placebo-controlled trial, and the 12 weeks of the open-label trial). RESULTS: For the 82 enrolled patients, the mean ± SD ASAS-NSAID score at baseline was similar between the 2 groups: 93 ± 76 and 74 ± 54 in the etanercept and placebo groups, respectively. There was no significant change in the ASAS-NSAID score during the first part of the trial, as recommended by the protocol. There was a statistically significant decrease in the ASAS-NSAID score during the second part of the trial with a relevant effect size (-0.56) in the placebo to etanercept group. CONCLUSION: This study confirms the feasibility and simplicity of the ASAS-NSAID score and suggests that such a score be integrated in all studies in spondylarthritis either to check the quality of the observed data (i.e., intergroup baseline characteristics) or to evaluate the NSAID-sparing effect of other therapies.


Assuntos
Anti-Inflamatórios não Esteroides/uso terapêutico , Monitoramento de Medicamentos/métodos , Uso de Medicamentos/estatística & dados numéricos , Imunoglobulina G/uso terapêutico , Receptores do Fator de Necrose Tumoral/uso terapêutico , Espondilite Anquilosante/tratamento farmacológico , Esquema de Medicação , Etanercepte , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Espondilite Anquilosante/fisiopatologia
20.
Arthritis Res Ther ; 14(3): R129, 2012 May 30.
Artigo em Inglês | MEDLINE | ID: mdl-22647431

RESUMO

INTRODUCTION: The Rheumatoid Arthritis Impact of Disease (RAID) is a patient-reported outcome measure evaluating the impact of rheumatoid arthritis (RA) on patient quality of life. It comprises 7 domains that are evaluated as continuous variables from 0 (best) to 10 (worst). The objective was to define and identify cut-off values for disease activity states as well as improvement scores in order to present results at the individual level (for example, patient in acceptable state, improved patient). METHODS: Patients with definite active RA requiring anti-tumour necrosis factor (anti-TNF) therapy were seen at screening, baseline and after 4 and 12 weeks of etanercept therapy. Answers to "Gold standard" questions on improvement (MCII: Minimum Clinically Important Improvement) and an acceptable status (PASS: Patient Acceptable Symptom State) were collected as well as the RAID score and Disease Activity Score 28- erythrocyte sedimentation rate (DAS28-ESR). Cut-offs were defined by different techniques including empirical, measurement error and gold standard anchors. The external validity of these cut-offs was evaluated using the positive likelihood ratio (LR) based on the patient's perspective (for example, patient's global) and on low disease activity status (such as DAS28-ESR). RESULTS: Ninety-seven (97) of the 108 recruited patients (age: 54 ± 13 years old, female gender: 75%, rheumatoid factor positive: 81%, disease duration: 8 ± 7 years, CRP: 18 ± 30 mg/l, DAS28-ESR: 5.4 ± 0.8) completed the 12 weeks of the study. The different techniques suggested thresholds ranging from 0.2 to 3 (absolute change) and from 6 to 50% (relative change) for defining MCII and thresholds from less than 1 to less than 4.2 for defining PASS. The evaluation of external validity (LR+) showed the highest LR+ was obtained with thresholds of 3 for absolute change; 50% for relative change and less than 2 for an acceptable status. CONCLUSIONS: This study showed that thresholds defined for continuous variables are closely related to the methodological technique, justifying a systematic evaluation of their validity. Our results suggested that a change of at least 3 points (absolute) or 50% (relative) in the RAID score should be used to define a MCII and that a maximal value of 2 defines an acceptable status. TRIAL REGISTRATION: Clinicaltrial.gov: NCT004768053.


Assuntos
Antirreumáticos/uso terapêutico , Artrite Reumatoide/tratamento farmacológico , Imunoglobulina G/uso terapêutico , Avaliação de Resultados em Cuidados de Saúde/métodos , Qualidade de Vida , Receptores do Fator de Necrose Tumoral/uso terapêutico , Índice de Gravidade de Doença , Etanercepte , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Inquéritos e Questionários , Resultado do Tratamento
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