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Measures of arthritis activity associated with patient-reported improvement in rheumatoid arthritis when assessed prospectively versus retrospectively.

ABSTRACT: OBJECTIVE:The patient global assessment (PGA) is intended to provide an integrated summary of all symptoms of arthritis, but it is not clear which disease features most impact patients' assessments of changes in their overall status. We investigated what aspects of rheumatoid arthritis (RA) activity correlated best with prospectively measured changes in the PGA and with patients' retrospective judgments of improvement. METHODS:We studied 250 patients with active RA in a prospective longitudinal study. Disease activity measures were collected before and after treatment escalation. Prospectively measured changes in PGA and patients' judgments of improvement or worsening at the followup visit were tested for correlations with changes in patient-reported measures of symptoms and functioning, joint counts, and laboratory tests. RESULTS:Patients improved during the study, with the mean?±?SD PGA decreasing from 55.6?±?25.2 to 37.6?±?24.0. At the followup visit, 167 patients (66.8%) reported improvement in overall arthritis status. Changes in pain severity, stiffness severity, and fatigue were the only significant correlates of changes in PGA. In contrast, changes in the Health Assessment Questionnaire, tender joint count or Disease Activity Score in 28 joints (DAS28), and stiffness severity were associated with retrospective judgments of improvement. CONCLUSION:Prospectively measured changes in PGA in RA were related solely to other patient-reported measures, but patients' retrospective judgments of improvement were related to functional limitations, tender joint count, and DAS28. Patients' subjective judgments of improvement reflect aspects of RA different from the PGA and may be a simple complementary measure of treatment efficacy.

SUBMITTER: Ward MM

PROVIDER: S-EPMC4556344 | biostudies-literature | 2015 May

REPOSITORIES: biostudies-literature

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Measures of arthritis activity associated with patient-reported improvement in rheumatoid arthritis when assessed prospectively versus retrospectively.

Ward Michael M MM Guthrie Lori C LC Alba Maria I MI

Arthritis care & research 20150501 6

<h4>Objective</h4>The patient global assessment (PGA) is intended to provide an integrated summary of all symptoms of arthritis, but it is not clear which disease features most impact patients' assessments of changes in their overall status. We investigated what aspects of rheumatoid arthritis (RA) activity correlated best with prospectively measured changes in the PGA and with patients' retrospective judgments of improvement.<h4>Methods</h4>We studied 250 patients with active RA in a prospectiv ...[more]

PMID: 25370806

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Project description:BACKGROUND:The phase III MONARCH randomized controlled trial (NCT02332590) demonstrated that in patients with rheumatoid arthritis (RA), sarilumab (anti-interleukin-6 receptor monoclonal antibody) monotherapy is superior to adalimumab monotherapy in reducing disease activity and signs and symptoms of RA, as well as in improving physical function, with similar rates of adverse and serious adverse events. We report the effects of sarilumab versus adalimumab on patient-reported outcomes (PROs). METHODS:Patients with active RA intolerant of, or inadequate responders to, methotrexate were randomized to sarilumab 200 mg plus placebo every 2 weeks (q2w; n?=?184) or adalimumab 40 mg plus placebo q2w (n?=?185). Dose escalation to weekly administration of adalimumab or matching placebo was permitted at week 16. PROs assessed at baseline and weeks 12 and 24 included patient global assessment of disease activity (PtGA), pain and morning stiffness visual analogue scales (VASs), Health Assessment Questionnaire Disability Index (HAQ-DI), 36-item Short Form Health Survey (SF-36), Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), Rheumatoid Arthritis Impact of Disease (RAID), and rheumatoid arthritis-specific Work Productivity Survey (WPS-RA). Between-group differences in least-squares mean (LSM) changes from baseline were analyzed. p?<?0.05 was considered significant for PROs in a predefined hierarchy. For PROs not in the hierarchy, nominal p values are provided. Proportions of patients reporting improvements greater than or equal to the minimal clinically important difference (MCID) and achieving normative values were assessed. RESULTS:At week 24, sarilumab treatment resulted in significantly greater LSM changes from baseline than adalimumab monotherapy in HAQ-DI (p?<?0.005), PtGA (p?<?0.001), pain VAS (p?<?0.001), and SF-36 Physical Component Summary (PCS) (p?<?0.001). Greater LSM changes were reported for sarilumab than for adalimumab in RAID (nominal p?<?0.001), morning stiffness VAS (nominal p?<?0.05), and WPS-RA (nominal p?<?0.005). Between-group differences in FACIT-F and SF-36 Mental Component Summary (MCS) were not significant. More patients reported improvements greater than or equal to the MCID in HAQ-DI (nominal p?<?0.01), RAID (nominal p?<?0.01), SF-36 PCS (nominal p?<?0.005), and morning stiffness (nominal p?<?0.05), as well as greater than or equal to the normative values in HAQ-DI (p?<?0.05), with sarilumab versus adalimumab. CONCLUSIONS:In parallel with the clinical efficacy profile previously reported, sarilumab monotherapy resulted in greater improvements across multiple PROs than adalimumab monotherapy. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02332590 . Registered on 5 January 2015.

Dataset Information

Measures of arthritis activity associated with patient-reported improvement in rheumatoid arthritis when assessed prospectively versus retrospectively.

Publications

Measures of arthritis activity associated with patient-reported improvement in rheumatoid arthritis when assessed prospectively versus retrospectively.

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