The health assessment questionnaire 1992. Status and review

157

Objective. To compare work disability and job loss in early rheumatoid arthritis (RA) patients receiving adalimumab plus methotrexate (adalimumab ؉ MTX) versus MTX alone. Methods. In this multicenter, randomized, controlled trial, patients with RA for <2 years who had never taken MTX and who self-reported work impairment were randomized to adalimumab ؉ MTX or placebo ؉ MTX for 56 weeks. Primary outcome was job loss of any cause and/or imminent job loss at or after week 16. Secondary outcomes included disease activity, function (Health Assessment Questionnaire [HAQ] score), and RA quality of life (RAQoL) questionnaire score. Work was evaluated with work diaries and the RA Work Instability Scale. Results. Although job loss during the 56-week study was significantly lower with adalimumab ؉ MTX (14 of 75 patients) compared with MTX alone (29 of 73 patients; P ‫؍‬ 0.005), the primary end point was not met (12 of 75 versus 20 of 73 patients; P ‫؍‬ 0.092), likely owing to early drop out in the MTX group. There were significant improvements in American College of Rheumatology 20% response criteria, 28-joint Disease Activity Score, ⌬HAQ, ⌬RAQoL, and working time lost in the adalimumab ؉ MTX group. Twenty-four serious adverse events were reported in 17 participants, with no differences between groups. Conclusion. Adalimumab ؉ MTX reduced job loss and improved productivity in early RA when compared with MTX alone, which supports the early use of anti-tumor necrosis factor therapy and suggests its cost efficacy.

Section: Methodsmentioning

confidence: 99%

Effect of the early use of the anti–tumor necrosis factor adalimumab on the prevention of job loss in patients with early rheumatoid arthritis

Bejarano

Quinn

Conaghan

et al. 2008

157

“…The outcome measures used to assess disease response consisted of the following set of 6 response variables (the JRA core criteria) (13,14): 1) global assessment of disease severity by the physician, 2) global assessment of overall well-being by the patient or the patient's parent or guardian, 3) number of joints with active disease (joints with swelling not due to deformity or joints with limitation of motion and with pain, tenderness, or both), 4) number of joints with limitation of motion, 5) functional ability, assessed in this study by the Childhood Health Assessment Questionnaire (C-HAQ) (15,16), and 6) a laboratory marker of inflammation, defined in this study as the ESR during the first year and as the C-reactive protein (CRP) level thereafter. The fourth criterion was modified to "number of joints with limitation of motion and with pain, tenderness, or both" to eliminate counting joints with contractures that might not have improved during the course of treatment.…”

Section: Methodsmentioning

confidence: 99%

Long‐term efficacy and safety of etanercept in children with polyarticular‐course juvenile rheumatoid arthritis: Interim results from an ongoing multicenter, open‐label, extended‐treatment trial

Lovell

Giannini

Reiff

et al. 2003

224

Objective. To evaluate the long-term efficacy and safety of etanercept in children with juvenile rheumatoid arthritis (JRA) participating in an ongoing multicenter, open-label, extended-treatment trial. All patients had been participants in an initial randomized efficacy and safety trial of etanercept.Methods. Etanercept was administered at a dosage of 0.4 mg/kg (maximum 25 mg) subcutaneously twice each week. Safety and efficacy evaluations were performed every 3-4 months. The JRA 30% definition of improvement (DOI) was defined as improvement of >30% in at least 3 of 6 response variables used to assess disease activity, with no more than 1 variable worsening by more than 30%.Results. At the time of analysis, 48 of the 58 patients (83%) were still enrolled in the study; 43 of them (74%) had completed 2 years of treatment. Of these 43 patients, 81% met the JRA 30% DOI, 79% met the JRA 50% DOI, and 67% met the JRA 70% DOI. Ten children started low-dose methotrexate after year 1. Of the 32 children taking prednisone, the dosage was decreased to <5 mg/day in 26 (81%). Two children had serious infections (varicella with aseptic meningitis in one and complicated sepsis in the other). In general, adverse events were of the types seen in a general pediatric patient population.Conclusion. Children with severe, longstanding, methotrexate-resistant polyarticular JRA demonstrated sustained clinical improvement with >2 years of continuous etanercept treatment. Etanercept was generally well-tolerated. There were no increases in the rates of adverse events over time. However, children taking etanercept should be monitored closely for infections.Juvenile rheumatoid arthritis (JRA) is the most common rheumatic disease in children (1,2). The proinSupported by Immunex Corporation, Seattle, WA, who provided the study drug and grants to investigational sites.

“…Physical function was assessed using the Health Assessment Questionnaire (HAQ) (23). Clinical response was evaluated using the American College of Rheumatology (ACR) criteria for improvement (24).…”

Section: Clinical Outcome Measurementsmentioning

confidence: 99%

Infliximab treatment maintains employability in patients with early rheumatoid arthritis

Smolen

Han²,

Heijde

et al. 2006

108

Objective. To evaluate the impact of infliximab therapy on the employment status of patients with early rheumatoid arthritis (RA).Methods. Methotrexate (MTX)-naive patients with active early RA were randomly allocated to receive MTX plus placebo or MTX plus infliximab (3 mg/kg or 6 mg/kg) at weeks 0, 2, and 6 and then every 8 weeks through week 46. Data for patients younger than age 65 years were included in the analyses. A patient was categorized as employable if he or she was employed or felt well enough to work if a job were available.Results. The change in actual employment was not significantly different between patients receiving MTX plus infliximab and those receiving MTX plus placebo (0.5% versus 1.3%; P > 0.5). However, the proportion of patients whose status changed from employable at baseline to unemployable at week 54 was smaller in the group receiving MTX plus infliximab compared with that in the group receiving MTX alone (8% versus 14%; P ‫؍‬ 0.05). Patients who were treated with infliximab plus MTX had a significantly greater likelihood of improvement rather than deterioration in employability (odds ratio 2.4; P < 0.001); this likelihood was not significantly greater in patients receiving MTX alone. The proportion of employed patients who lost workdays during the trial was smaller in the MTX plus infliximab group than in the MTX-alone group (P ‫؍‬ 0.010). Conclusion. The actual employment rates among patients in the 2 treatment groups were not different. However, patients with early RA who were treated with MTX plus infliximab had a higher probability of maintaining their employability compared with those who were treated with MTX alone.