Evaluation of the change in structural radiographic sacroiliac joint damage after 2 years of etanercept therapy (EMBARK trial) in comparison to a contemporary control cohort (DESIR cohort) in recent onset axial spondyloarthritis.

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.

Effects of Long-Term Etanercept Treatment on Clinical Outcomes and Objective Signs of Inflammation in Early Nonradiographic Axial Spondyloarthritis: 104-Week Results From a Randomized, Placebo-Controlled Study.

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.

Evaluation of whether extremely high enthesitis or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) scores suggest fibromyalgia and confound the anti-TNF response in early non-radiographic axial spondyloarthritis.

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.

Flare in axial spondyloarthritis: investigation of meaningful changes in symptomatic outcome measures.

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.

The Minimum Clinically Important Improvement and Patient-acceptable Symptom State in the BASDAI and BASFI for Patients with Ankylosing Spondylitis.

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).

Discriminant Capacity of Clinical Efficacy and Nonsteroidal Antiinflammatory Drug-sparing Endpoints, Alone or in Combination, in Axial Spondyloarthritis.

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.

Clinical and MRI responses to etanercept in early non-radiographic axial spondyloarthritis: 48-week results from the EMBARK study.

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.

Development of multinational definitions of minimal clinically important improvement and patient acceptable symptomatic state in osteoarthritis.

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.

Evaluation of the nonsteroidal anti-inflammatory drug-sparing effect of etanercept in axial spondyloarthritis: results of the multicenter, randomized, double-blind, placebo-controlled SPARSE study.

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.

When to adjust therapy in patients with rheumatoid arthritis after initiation of etanercept plus methotrexate or methotrexate alone: findings from a randomized study (COMET).

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.

Symptomatic efficacy of etanercept and its effects on objective signs of inflammation in early nonradiographic axial spondyloarthritis: a multicenter, randomized, double-blind, placebo-controlled trial.

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.

Retention rates of adalimumab, etanercept and infliximab as first and second-line biotherapy in patients with rheumatoid arthritis in daily practice.

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.

Continuous efficacy of etanercept in severe and advanced ankylosing spondylitis: results from a 12-week open-label extension of the SPINE study.

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.

Defining cut-off values for disease activity states and improvement scores for patient-reported outcomes: the example of the Rheumatoid Arthritis Impact of Disease (RAID).

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).

Onset of action of etanercept in rheumatoid arthritis based on patient-reported outcomes.

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.

Nonsteroidal antiinflammatory drug intake according to the Assessment of SpondyloArthritis International Society Score in clinical trials evaluating tumor necrosis factor blockers: example of etanercept in advanced ankylosing spondylitis.

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 influence of the definition of patient global assessment in assessment of disease activity according to the Disease Activity Score (DAS28) in rheumatoid arthritis.

Objective: Patient global assessment (PGA) is one of the 4 items included in the Disease Activity Score (DAS28) for evaluation of activity of rheumatoid arthritis (RA). We studied the influence of the use of 3 different techniques of PGA on the assessment of disease activity.

Methods: We evaluated 3 different DAS28 according to the technique of PGA in 108 patients with active RA before and after 12 weeks of etanercept therapy.

The DESIR cohort: a 10-year follow-up of early inflammatory back pain in France: study design and baseline characteristics of the 708 recruited patients.

Objectives: The French Society of Rheumatology has initiated a large national multicenter, longitudinal, prospective follow-up of patients presenting with early inflammatory back pain in order to set up a database to facilitate several investigations on diagnosis, prognosis, epidemiology, pathogenesis and medico-economics in the field of early inflammatory back pain and spondyloarthritis.

Methods: Patients were recruited if they had inflammatory back pain of more than 3 months and less than 3 years. Patients will be followed every 6 months during the first 2 years then every year during at least 5years.

Validation of a numerical rating scale to assess functional impairment in hip and knee osteoarthritis: comparison with the WOMAC function scale.

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).

A randomised, multicentre, double-blind, placebo-controlled trial of etanercept in adults with refractory heel enthesitis in spondyloarthritis: the HEEL trial.

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.

The ESPOIR cohort: a ten-year follow-up of early arthritis in France: methodology and baseline characteristics of the 813 included patients.

Objectives: The French Society of Rheumatology initiated a large national multicenter, longitudinal and prospective cohort, the so-called "ESPOIR cohort study" in order to set up databases to allow various investigations on diagnosis, prognostic markers, epidemiology, pathogenesis and medico-economic factors in the field of early arthritis and rheumatoid arthritis.

Methods: Patients were recruited if they had undifferentiated arthritis or rheumatoid arthritis, of less than 6 months disease duration and if they were DMARD and steroids naïve. Patients have then to be followed every 6 months during the first 2 years then every year during at least 10 years.

Validation of a short form of the Western Ontario and McMaster Universities Osteoarthritis Index function subscale in hip and knee osteoarthritis.

Objective: A short version of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function scale has recently been developed to enhance the applicability of the scale in routine practice and clinical research for patients with hip and knee osteoarthritis. The goal of the present study was to validate this short form.

Methods: We conducted a prospective 4-week cohort study of 1,036 outpatients.

Short-term efficacy of rofecoxib and diclofenac in acute shoulder pain: a placebo-controlled randomized trial.

Objectives: To evaluate the short-term symptomatic efficacy of rofecoxib and diclofenac versus placebo in acute episodes of shoulder pain.

Design: Randomized controlled trial of 7 days.

Setting: Rheumatologists and/or general practitioners totaling 47.

Feeling good rather than feeling better matters more to patients.

Objective: To determine the most appropriate means to assess the response to treatment in terms of pain and functional impairment in a chronic rheumatic condition (knee osteoarthritis [OA]) and an acute rheumatic condition (rotator cuff syndrome [RCS]).

Methods: Two prospective studies were conducted consisting of 1,019 outpatients with knee OA and 271 patients with acute RCS. The minimal clinically important improvement and the patient acceptable symptom state were determined for knee OA pain using a visual analog scale, and for knee OA function using the Western Ontario and McMaster Universities Osteoarthritis Index function subscale; for acute RCS pain, a numeral rating scale was used, and the Neer function subscale was used for RCS function.