FRI0018 USING SELF-REPORTED OUTCOMES TO DETECT NEW-ONSET FLARE IN A REAL-WORLD STUDY OF PARTICIPANTS WITH RHEUMATOID ARTHRITIS - INTERIM RESULTS FROM THE DIGITAL TRACKING OF ARTHRITIS LONGITUDINALLY (DIGITAL) STUDY

Background:Patients with rheumatoid arthritis (RA) experience fluctuating symptoms, increased pain, decreased function and variable quality of life; such changes often occur between visits to clinicians. Digital Tracking of Arthritis Longitudinally (DIGITAL) study2is evaluating the use of electronically captured patient-reported outcomes (ePRO) and passive data collection from a Fitbit device to identify disease worsening in a real-world study of participants (pts) with RA.Objectives:Evaluate agreement between self-reported new-onset flare and ePROs in an interim analysis from DIGITAL using a classification model.Methods:Members of the ArthritisPower registry with RA were invited to participate in DIGITAL. Pts who successfully completed a two-week Lead-in period entered the Main Study in which they wore a smartwatch and provided daily (pain and fatigue numeric rating scales (NRS)) and weekly ePROs, including the OMERACT RA Flare Questionnaire (FLARE) and PROMIS measures. This interim analysis is of ePRO data from pts who completed at least 30 days of the Main Study. A “Yes” response to the FLARE item, “Are you having a flare now?” identified flare. For modeling association between new-onset flare and ePRO, the dataset was split into training (the first 30 days of the Main Study) and test data (Day 31 and following). Within each dataset, repeated binary outcomes (Flare/No Flare) per pt were defined each week. To focus on new-onset flare, within each dataset, outcomes for patient weeks for which flare was present in the previous week were excluded.Candidate variables for the model included baseline and current FLARE score (0-50 scale) and each of its 5 items, daily pain, daily fatigue, and several PROMIS weekly instruments and their lagged values (last week or last 6 days for daily). ‘Baseline’ was calculated in non-flare weeks. Training data was used for logistic regression model selection combining clinical expertise with backward elimination. Performance of the final model was evaluated using test data.Results:The training data was composed of outcomes from 128 pts who reported 388 weekly flare assessments as no flare or onset flare over 2800 days during the first month of the Main Study. Of pts in the training dataset, 92.2% were female, 87.5% white, with mean age (SD) 52.7 (11.0) and years since RA diagnosis 10.4 (10.3); 62.5% were on a biologic. Among those in the training dataset, 58 flare outcomes occurred in 50 (39.1%) unique pts.The test data comprised outcomes from 123 pts who reported 442 weekly flare assessments as no flare or onset flare over 3366 days in which 64 flare outcomes occurred, and primarily included continued observations from pts who contributed to the training dataset.The best-performing model to classify flare in training data included the current and baseline FLARE instrument activity question (i.e. “Considering how active your rheumatoid arthritis has been, how much difficulty have you had when taking part in activities such as work, family life, social events that are typical for you during the last week”), current daily pain, and baseline daily pain average and standard deviation. In test data, this model had an area under the receiver operator curve of 0.81 (Figure). At a cut point requiring specificity to be ≥0.80, sensitivity to detect flare was 0.62 and overall accuracy was 0.78.Conclusion:New-onset flare is common among RA patients, and the FLARE instrument and daily pain scores appear effective to classify it. Evaluation of passive data as a proxy for self-reported new-onset flare is ongoing.References:[1]Bartlett SJ, et al. JRheumatol, 2017;44:1536-43.[2]Nowell WB, et al. JMIR Res Protoc, 2019;8:e14665.Disclosure of Interests:Virginia S. Haynes Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jeffrey Curtis Grant/research support from: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB, Consultant of: AbbVie, Amgen, Bristol-Myers Squibb, Corrona, Janssen, Lilly, Myriad, Pfizer, Regeneron, Roche, UCB, Fenglong Xie: None declared, Ilya Lipkovich Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Hong Zhao: None declared, Carol L. Kannowski Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Jiat-Ling Poon Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, Kelly Gavigan: None declared, David Curtis: None declared, Sandra K. Nolot Shareholder of: Eli Lilly and Company, Employee of: Eli Lilly and Company, W. Benjamin Nowell: None declared

AB1241 EVALUATION OF A PATIENT COMPLETED DISEASE FLARE QUESTIONNAIRE IN PSORIATIC DISEASE

Background:Psoriatic Disease (PsD) is a chronic inflammatory disease of the skin, nails, joints, and entheses. A number of composite disease activity measures have been developed though there is yet consensus as to which to use in the clinic and in clinical trials. A patient completed disease flare questionnaire, covering multiple domains of disease impact, has been developed but has yet to be fully validated.Objectives:To validate the FLARE questionnaire in PsD.Methods:The 10 question FLARE instrument1was administered to 141 patients in an observational study of treatment change in PsD over 6 months follow up. Disease activity was measured by the PASDAS and the gold standard of flare was based on patient opinion. ROC curve was constructed to examine the optimum cut-off for disease flare. Agreement between the FLARE instrument and patient opinion was assessed by Cohen’s kappa. Test-retest was assessed in 28 patients with stable disease who underwent repeat assessment within 2 weeks and evaluated by intra-class correlation coefficient (ICC).Results:The FLARE questionnaire was administered at 367 patient encounters. ROC analysis indicated that the optimum cut-off for a flare of disease was 4 (sensitivity 82%, specificity 76%; area under curve 0.85: figure). Mean PASDAS scores were 2.7 and 6.3 for no-flare (4) and flare (≥4) respectively (p = < 0.0001). For those patients who were having a flare the frequency of response to each question is given in the table. Agreement between patient opinion and questionnaire was 0.57, and between patient opinion and physician (based on treatment escalation) 0.43. ICC for the questionnaire was 0.87 (95% CI 0.72 – 0.94).Conclusion:In PsD a flare represents escalation of symptoms and signs across multiple domains, as measured by the FLARE instrument; a score of 4 or more has external validity both in terms of composite disease activity and overall patient opinion of the state of their condition.References:[1]Moverley A, Waxman R, de Wit M, Parkinson A, Campbell W, Brooke M, et al J Rheum May 2016, 43 (5) 974-978TableFLARE item response for those in flare vs not in flareItemFLARE instrument score <4FLARE instrument score ≥4N (%)N (%)Worsening Itch35 (19)108 (58)Worsening skin area27 (15)91 (49)Increasing joint pain34 (19)161 (86)Increasing number of tender joints20 (11)142 (76)Decrease in ability to perform activities3 (2)81 (43)Worsening in ability to move easily8 (4)126 (67)Increase in frustration14 (8)142 (76)Worsening in depression8 (4)90 (48)Worsening in feeling of tiredness all the time37 (21)148 (79)Worsening in the number or combination of symptoms from your disease7 (4)134 (72)Figure.ROC analysis of FLARE questionnaireAcknowledgments:This report is independent research funded by the National Institute for Health Research, Programme Grants for Applied Research [Early detection to improve outcome in patients with undiagnosed PsA (‘PROMPT’), RP-PG-1212-20007]. The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social CareDisclosure of Interests:Philip Helliwell: None declared, William Tillett Grant/research support from: AbbVie, Celgene, Eli Lilly, Janssen, Novartis, Pfizer Inc, UCB, Consultant of: AbbVie, Amgen, Celgene, Lilly, Janssen, Novartis, MSD, Pfizer Inc, UCB, Speakers bureau: AbbVie, Amgen, Celgene, Lilly, Janssen, Novartis, Pfizer Inc, UCB, Robin Waxman: None declared, Laura C Coates: None declared, Oliver FitzGerald: None declared, Jon Packham: None declared, Neil McHugh: None declared

GRAPPA 2016 Project Report

At the 2016 annual meeting of the Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA), members received updates on several ongoing research and educational efforts. Among them were updates on the FLARE instrument, the Biomarker Project, GRAPPA’s logo and Website, continuing progress on the video training project, and numerous educational project efforts in 2016.

Development of a Flare Instrument for Use in Psoriatic Disease: A Report from the 2015 GRAPPA Annual Meeting

Objective.The objective of this Group for Research and Assessment of Psoriasis and Psoriatic Arthritis (GRAPPA) initiative is to develop a questionnaire to determine the presence of a flare of disease activity in psoriatic disease (PsD), for use in clinical care and research settings.Methods.In 2014 and 2015, 2 online Delphi surveys of patients and physicians attempted to achieve consensus about items that might discriminate a flare of disease. In the first round, items were derived from previous qualitative studies with patients; in the second round, new items, suggested by both patients and physicians, were added. Survey results were discussed at the 2015 GRAPPA annual meeting, and 8 breakout groups discussed specific aspects of PsD flares.Results.Survey participants were patients (n = 103 and n = 57 in rounds 1 and 2) and physicians (n = 125 and n = 81). Items for flare covered 6 domains (joints, skin, emotion, participation, fatigue, and unclassified). Patients agreed that 20 items were important (10 joints, 1 participation, 8 fatigue, 1 unclassified), and physicians agreed on 23 items (5 skin, 11 joints, 4 participation, 3 unclassified). Eight items were selected as important by both groups: 7 joint items and 1 unclassified. Patients emphasized fatigue and physicians emphasized skin and participation. Breakout groups concluded that the components of a flare instrument should be derived from patients. A flare should be defined as a change in disease state requiring intervention.Conclusion.The concept of flare in PsD covers articular, skin, emotional, participation, and fatigue domains. Further work is required to specify items that represent these domains.