30 research outputs found

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    ABSTRACT. Objective. To evaluate the effects of intravenous (IV) golimumab 2 mg/kg + methotrexate (MTX) on patient-reported measures of health-related quality of life (HRQOL) in patients with active rheumatoid arthritis (RA) despite prior MTX therapy. Methods. In this randomized, multicenter, double-blind, placebo-controlled, phase III trial, adults with RA were randomly assigned to receive IV placebo (n = 197) or golimumab 2 mg/kg (n = 395) infusions at Week 0, Week 4, and every 8 weeks thereafter. Results. Mean HAQ-DI improvements from baseline were significantly greater with golimumab + MTX than placebo + MTX at Week 14 and Week 24 (p < 0.001). Significantly greater improvements in all 8 individual SF-36 subscores and both the SF-36 PCS and MCS scores (p < 0.001) also accompanied golimumab + MTX therapy. Improved EQ-5D and EQ-5D VAS (p < 0.001) and FACIT-Fatigue (p < 0.001) scores were also observed for golimumab + MTX-treated patients at Week 12, Week 16, and Week 24, and greater proportions of golimumab + MTX-treated patients had clinically meaningful improvements in these measures. Greater reductions in disease effect on productivity were observed with golimumab + MTX versus placebo + MTX at Week 24 (p < 0.001)

    Reliability and Validity of Selected PROMIS Measures in People with Rheumatoid Arthritis

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    These data provide preliminary evidence of reliability and construct validity of PROMIS CATs to assess RA symptoms and impacts, and feasibility of use in clinical care. PROMIS instruments captured the experiences of RA patients across the broad continuum of RA symptoms and function, especially at low disease activity levels. Future research is needed to evaluate performance in relevant subgroups, assess responsiveness and identify clinically meaningful changes

    The effect of tofacitinib on residual pain in patients with rheumatoid arthritis and psoriatic arthritis

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    Objective: Post hoc analysis of pooled data from 9 randomised controlled trials to assess the effect of tofacitinib (oral Janus kinase inhibitor for treatment of rheumatoid arthritis [RA] and psoriatic arthritis [PsA]) on residual pain in patients with RA or PsA with abrogated inflammation. Methods: Patients who received ≥1 dose of tofacitinib 5 mg twice daily (BID), adalimumab or placebo with/without background conventional synthetic disease-modifying antirheumatic drugs and had abrogated inflammation (swollen joint count [SJC]=0 and C reactive protein [CRP]<6 mg/L) after 3 months’ therapy were included. Assessments included Patient’s Assessment of Arthritis Pain at Month 3 (Visual Analogue Scale [VAS] 0–100 mm). Scores were summarised descriptively; treatment comparisons assessed by Bayesian network meta analyses (BNMA). Results: From the total RA/PsA population, 14.9% (382/2568), 17.1% (118/691) and 5.5% (50/909) of patients receiving tofacitinib, adalimumab and placebo, respectively, had abrogated inflammation after 3 months’ therapy. RA/PsA patients with abrogated inflammation receiving tofacitinib/adalimumab had higher baseline CRP versus placebo; RA patients receiving tofacitinib/adalimumab had lower SJC and longer disease duration versus placebo. Median residual pain (VAS) at Month 3 was 17.0, 19.0 and 33.5 in RA patients treated with tofacitinib, adalimumab or placebo, and 24.0, 21.0 and 27.0 in PsA patients, respectively. Residual pain reductions with tofacitinib/adalimumab versus placebo were less prominent in PsA versus RA patients, with no significant differences between tofacitinib/adalimumab, per BNMA. Conclusion: Patients with RA/PsA with abrogated inflammation receiving tofacitinib/adalimumab had greater residual pain reduction versus placebo at Month 3. Results were similar between tofacitinib/adalimumab

    More than just minutes of stiffness in the morning: Report from the OMERACT rheumatoid arthritis flare group stiffness breakout sessions

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    The Journal of Rheumatology Copyright © 2015. All rights reserved. Objective. Stiffness was endorsed within the rheumatoid arthritis (RA) flare core domain set at the previous Outcome Measures in Rheumatology meeting (OMERACT 11). Two stiffness breakout groups at the present OMERACT 12 RA flare workshop discussed results of new qualitative studies in RA stiffness. Methods. Results from 2 independent studies of RA stiffness were presented to breakout group participants, followed by group discussions about stiffness measurement. Results. Both studies identified stiffness as complex, variable with the level of disease activity, and as encompassing concepts of impact, intensity, timing, location, and duration. That stiffness has an effect on multiple dimensions of health was a common finding. Participants agreed that stiffness is an important aspect of RA flare. Whether measuring only morning stiffness duration, the traditional approach in RA, was sufficient in coverage of the concept was unclear. Groups agreed that more research on stiffness measurement is needed considering the importance patients place on the effect of stiffness. Conclusion. Results from independent studies highlight stiffness effect as an important feature of RA, in addition to intensity, timing, location, and duration. Additional work is needed to identify optimal ways to assess stiffness in RA and other rheumatologic diseases

    PROMIS and legacy scores by CDAI disease activity levels.

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    <p>Note: Values in the same row not sharing the same subscript are significantly different at p< .05. SD = Standard deviation. All PROMIS measures are computerized adapted tests, except the Pain Intensity 3a which is a short form.</p><p>*N = 66 for MHAQ, Pain VAS and Fatigue VAS;</p><p><sup><b>†</b></sup>N = 38 for Depression, Anxiety, Anger, and Ability to Participate Social scales.</p><p>PROMIS and legacy scores by CDAI disease activity levels.</p
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