Optimization of flare management in patients with rheumatoid arthritis: results of a randomized controlled trial
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To evaluate the effect of a flare management intervention guided by non-physician providers versus usual care between rheumatology visits on flare occurrence and rheumatoid arthritis (RA) disease activity.
Adult patients with established RA (per 2010 ACR criteria, n = 150) were randomized to the intervention arm (n = 75) versus usual care (n = 75). The Flare Assessment in Rheumatoid Arthritis (FLARE-RA) questionnaire was administered monthly during 24 months to all patients in the intervention arm to assess flare status. Telephone nurse-led counseling or an expedited visit with a rheumatology provider was offered to patients in the intervention arm who indicated they were in flare.
Patients in the intervention arm completed a median of 8.5 (range 1–24) questionnaires. RA flare was reported on 122 (19%) of these questionnaires; average FLARE-RA score, 4.72 on 0 (no flare) to 10 (maximum flare) scale. Patients preferred an expedited clinic visit with a rheumatology provider during 39 (32%) of flares. The majority of patients preferred to self-manage their flare (76, 62%); some patients received nursing advice on flare management over the phone (7, 6%). There were no differences in RA flare by OMERACT9 definition, DAS28-CRP, CDAI, SDAI, anti-rheumatic treatment change by rheumatology provider, or remission by CDAI between the study arms over 24-month follow-up.
The flare management intervention did not have any major effect on flare occurrence or RA disease activity metrics over the 24-month follow-up. The majority of patients in the intervention arm preferred self-management to an expedited visit with their rheumatology provider.
• The flare management intervention had no effect on rheumatoid arthritis (RA) disease activity.
• Patients preferred self-management of their RA flares to expedited rheumatology provider visits.
KeywordsFlare Randomized controlled trial Rheumatoid arthritis
This work was financially supported by a grant from Pfizer (Grant ID 15322005).
Compliance with ethical standards
The study was approved by the Institutional Review Board of Mayo Clinic and was registered at the ClinicalTrials.gov Identifier: NCT02382783 (https://clinicaltrials.gov/ct2/show/NCT02382783). All patients included in the study signed a written informed consent for participation in this study.
Elena Myasoedova: no disclosures or COI
Cynthia S. Crowson: no disclosures or COI
Rachel E. Giblon: no disclosures or COI
Kathleen McCarthy-Fruin: no disclosures or COI
Daniel E. Schaffer: no disclosures or COI
Kerry Wright: no disclosures or COI
Eric L. Matteson: Grant/Research/Clinical Trial Support (rheumatoid arthritis)
Genentech, Mesoblast, Novartis, Pfizer, Sun Pharmaceutical Industries, Ltd
Editorial functions: UpToDate
John M. Davis, III: Grant/Research/Clinical Trial Support (rheumatoid arthritis) Pfizer
Funders reviewed the protocol for the study but had no role in study conduct or interpretation of the results.
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