1965: Discordance Between Patient and Physician Perception of Disease Activity Among Patients with Idiopathic Inflammatory Myopathies: Results from the COVAD Study

Mrinalini Dey¹, Rudra Prosad Goswami², Parikshit Sen³, Samuel Shinjo⁴, Nelly Ziade⁵, Ioannis Parodis⁶, Mrudula Joshi⁷, Marcin Milchert⁸, Abraham Edgar Gracia-Ramos⁹, Lorenzo Cavagna¹⁰, Vishwesh Agarwal¹¹, Johannes Knitza¹², Jessica Day¹³, Hector Chinoy¹⁴, COVAD Study Group¹⁵, Vikas Agarwal¹⁶, Rohit Aggarwal¹⁷ and Latika Gupta¹⁸, ¹Queen Elizabeth Hospital, London, United Kingdom; University of Liverpool, Liverpool, United Kingdom, ²Department of Rheumatology, All India Institute of Medical Sciences, New Delhi, India, ³Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, Delhi-110002, India., Dalhi, India, ⁴Faculdade de Medicina FMUSP, Universidade de Sao Paulo, São Paulo, Brazil, ⁵Saint-Joseph University, Beirut, Lebanon, ⁶Karolinska Institutet, Stockholm, Sweden, ⁷Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India, ⁸Department of Internal Medicine, Rheumatology, Diabetology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, Szczecin, Poland, ⁹Department of Internal Medicine, General Hospital, National Medical Center "La Raza", Instituto Mexicano del Seguro Social, Av. Jacaranda S/N, Col. La Raza, Del. Azcapotzalco, C.P. 02990, Mexico City, Mexico, ¹⁰Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, ¹¹Mahatma Gandhi Missions Medical College, Lucknow, India, ¹²Department of Internal Medicine 3 Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg, University Hospital Erlangen, Erlangen, Germany, ¹³Walter and Eliza Hall Institute, Melbourne, Australia, ¹⁴The University of Manchester, Sale, United Kingdom, ¹⁵-, -, ¹⁶Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow, India, ¹⁷University of Pittsburgh, Pittsburgh, PA, ¹⁸Royal Wolverhampton Trust, Wolverhampton/University of Manchester, United Kingdom

Background/Purpose: Disease activity assessment is key in the management of patients with idiopathic inflammatory myopathies (IIM). However, patients' perception of disease may differ from clinicians. We tried to understand what factors lead to discrepancy between patients' and physicians' perception of disease activity in IIMs from the COVID-19 Vaccination in Autoimmune Diseases (COVAD) study.

Methods: The COVAD-1 study collected global cross-sectional data from adults with autoimmune diseases and healthy controls by a team of 106 experts from 94 countries from April-December 2021, on demographics; disease characteristics, treatment and glucocorticoid (GC) dose; and validated patient reported outcomes (PROs), including PROMIS SF10 physical function, VAS-pain and VAS-fatigue. Patient-perceived active disease was self-reported. Physician-reported active disease was defined as presence of joint swelling, active rash or worsened muscle weakness and/or GC dose ≥10mg prednisolone equivalents. Discordant and concordant pairs of patient-physician reported disease activity were compared, and predictors of discordance were analysed using multivariate regression models.

Results: Among 16328 respondents, 1217 patients with IIM were included (median age 59 years (IQR 45-73), 70% females and 81.6% Caucasians, details in Table 1). Dermatomyositis (DM; 30.9%) was the most common subtype. Moderate concordance was seen between patient and physician disease activity. Discordance was identified in 38.8% (n=472) responses. Poorest concordance was observed in inclusion body myositis (IBM), overlap myositis (OM) and necrotising autoimmune myopathy (NAM) subgroups. Among patients with DM and OM, those with higher PROMIS physical function scores (i.e. better physical function) were more likely to be concordant (DM: OR=1.03, 95% CI: 1.01-1.05, p=0.012; OM: OR=1.04, 95% CI: 1.01-1.06, p=0.012) while older patients with DM were prone to discordance (OR =0.98, 95% CI: 0.97-0.99, p=0.03) PROMIS scores varied significantly among the four groups of perceived disease activity (active or inactive by patient and/or physician) and disease subgroups except IBM (Figure 1). Pain and Fatigue VAS scores also varied significantly among the four groups. Multivariable analysis, controlling for age, gender, fatigue and pain, showed respondents with higher PROMIS physical function scores were more likely to belong to one of the active disease perception groups, compared to concordant inactive groups, for all disease subgroups except IBM (Table 2). Addition of PROMIS increased area under the curve by 8-10% in model fitting. Simple cut-off scores based on PROMIS scores could be developed to distinguish active from inactive disease.

Conclusion: Our study provides invaluable insights into the factors determining patents' perception of self-reported disease activity, and the disease groups where these measures may be less reliable for remote monitoring and virtual trials. Patient-reported assessment might be discordant in IBM while likely to be fairly concordant in DM and younger individuals irrespective of pain and fatigue.








M. Dey: None; R. Goswami: None; P. Sen: None; S. Shinjo: None; N. Ziade: Abbvie, 6, Boehringer-Ingelheim, 6, Eli Lilly, 6, Janssen, 6, Newbridge, 6, Novartis, 6, Pfizer, 6, Pierre Fabre, 6, Roche, 6, sanofi, 6; I. Parodis: Amgen, 5, 6, AstraZeneca, 5, 6, Aurinia Pharmaceuticals, 5, 6, Bristol-Myers Squibb(BMS), 5, 6, Elli Lilly and Company, 5, 6, F. Hoffmann-La Roche AG, 5, 6, Gilead Sciences, 5, 6, GSK, 5, 6, Janssen Pharmaceuticals, 5, 6, Novartis, 5, 6, Otsuka Pharmaceutical, 5, 6; M. Joshi: None; M. Milchert: None; A. Gracia-Ramos: None; L. Cavagna: None; V. Agarwal: None; J. Knitza: None; J. Day: CSL limited, 5; H. Chinoy: AstraZeneca, 1, Biogen, 2, Eli Lilly, 5, GlaxoSmithKlein(GSK), 6, Novartis, 2, Orphazyme, 2, Pfizer, 1, UCB, 6; C. Study Group: None; V. Agarwal: None; R. Aggarwal: Actigraph, 2, Alexion, 2, ANI Pharmaceuticals, 2, Argenx, 2, AstraZeneca, 2, Boehringer-Ingelheim, 2, 5, Bristol-Myers Squibb(BMS), 2, 5, CabalettaBio, 2, Capella Bioscience, 2, Corbus, 2, CSL Behring, 2, EMD Serono, 2, 5, Galapagos, 2, Horizon Therapeutics, 2, I-Cell, 2, Janssen, 2, 5, Kezar, 2, Kyverna, 2, Mallinckrodt, 5, Merck, 2, Octapharma, 2, Pfizer, 2, 5, Q32, 5, Roivant, 2, Sanofi, 2, Teva, 2; L. Gupta: None.