1970: Impaired Health-Related Quality of Life in Patients with Idiopathic Inflammatory Myopathies: A Cross-Sectional Analysis from the COVAD Dataset

Akira Yoshida¹, Yuan Li², Vahed Maroufy², Masataka Kuwana¹, Naveen R³, Ashima Makol⁴, Parikshit Sen⁵, James Lilleker⁶, Vishwesh Agarwal⁷, Sinan Kardes⁸, Jessica Day⁹, Marcin Milchert¹⁰, Mrudula Joshi¹¹, Tamer A Gheita¹², Babur Salim¹³, Tsvetelina Velikova¹⁴, Abraham Edgar Gracia-Ramos¹⁵, Ioannis Parodis¹⁶, Elena Nikiphorou¹⁷, Ai Lyn Tan¹⁸, Arvind Nune¹⁹, Lorenzo Cavagna²⁰, Miguel Angel Saavedra Salinas²¹, Samuel Shinjo²², Nelly Ziade²³, Johannes Knitza²⁴, Oliver Distler²⁵, Hector Chinoy²⁶, Vikas Agarwal³, Rohit Aggarwal²⁷, Latika Gupta²⁸ and COVAD Study Group²⁹, ¹Nippon Medical School Graduate School of Medicine, Tokyo, Japan, ²University of Texas Health Science Center at Houston, Houston, TX, ³Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS), Lucknow, India, ⁴Mayo Clinic, Rochester, MN, Rochester, MN, ⁵Maulana Azad Medical College, 2-Bahadurshah Zafar Marg, New Delhi, Delhi-110002, India., Dalhi, India, ⁶Centre for Musculoskeletal Research, Division of Musculoskeletal and Dermatological Sciences, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre, The University of Manchester, Manchester, UK; Manchester Centre for Clinical Neurosciences, Salford Royal NHS Foundation Trust, Salford, UK. Orcid ID: 0000-0002-9230-4137., Manchester, United Kingdom, ⁷Mahatma Gandhi Missions Medical College, Lucknow, India, ⁸Istanbul University, Istanbul, Turkey, ⁹Walter and Eliza Hall Institute, Melbourne, Australia, ¹⁰Department of Internal Medicine, Rheumatology, Diabetology, Geriatrics and Clinical Immunology, Pomeranian Medical University in Szczecin, Szczecin, Poland, ¹¹Byramjee Jeejeebhoy Government Medical College and Sassoon General Hospitals, Pune, India, ¹²Kasr Al Ainy School of Medicine, Cairo University, Cairo, Egypt, ¹³Fauji foundation hospital Rawalpindi, Rawalpindi, Pakistan, ¹⁴Department of Clinical Immunology, Medical Faculty, University Hospital "Lozenetz", Sofia University St. Kliment Ohridski, Sofia, Bulgaria, ¹⁵Department 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, ¹⁶Karolinska Institutet, Stockholm, Sweden, ¹⁷King's College London, London, United Kingdom, ¹⁸University of Leeds, Leeds, United Kingdom, ¹⁹Southport & Ormskirk NHS Foundation Trust, Liverpool, United Kingdom, ²⁰Fondazione IRCCS Policlinico San Matteo, Pavia, Italy, ²¹IMSS, Mexico City, Mexico, ²²Faculdade de Medicina FMUSP, Universidade de Sao Paulo, São Paulo, Brazil, ²³Saint-Joseph University, Beirut, Lebanon, ²⁴Department of Internal Medicine 3 Rheumatology and Immunology, Friedrich-Alexander-University Erlangen-Nürnberg, University Hospital Erlangen, Erlangen, Germany, ²⁵Department of Rheumatology, University Hospital Zurich, University of Zurich, Zurich, Switzerland, ²⁶The University of Manchester, Sale, United Kingdom, ²⁷University of Pittsburgh, Pittsburgh, PA, ²⁸Royal Wolverhampton Trust, Wolverhampton/University of Manchester, United Kingdom, ²⁹-, -

Background/Purpose: The significance of Health-related quality of life (HRQoL) in patients with autoimmune diseases is well acknowledged. Unfortunately, there is dearth of data on the HRQoL in patients with idiopathic inflammatory myopathies (IIMs)and factors adversely impacting it.

Methods: HRQoL was measured in patients classifiable as IIMs and compared with non-IIM autoimmune inflammatory rheumatic diseases (AIRDs), non-rheumatic autoimmune inflammatory diseases (NRAIDs), and healthy controls, using Patient-Reported Outcome Measurement Information System (PROMIS) instrument data obtained through the 2nd COVID-19 vaccination in autoimmune disease (COVAD-2), a global patient reported e-survey that was extensively validated and pilot tested by a team of experts (160 collaborators, 100 countries).

Demographics, diagnoses, comorbidities, disease activity, treatments, and PROMIS instrument data were extracted from the COVAD-2 database. (Fig. 1D) Primary outcomes were PROMIS Global Physical Health (GPH) and Mental Health (GMH). Secondary outcomes were PROMIS Physical Function 10a (PF-10a), Fatigue-4a scores, and Pain Visual Analog Scores (VAS).

Independent factors affecting GPH and GMH scores in IIMs, also in the whole population were identified using multivariable regression analysis (Fig. 2) Each PROM was stratified by IIM subgroups. (Fig. 3)

Results: Complete responses from 1582 IIMs, 4700 non-IIM AIRDs, 545 NRAIDs, and 3675 controls as of May 22 were analysed. (Fig. 1A)

Notably GPH scores were the lowest in IIMs (Fig. 2A). GMH scores in IIMs were also substantially lower than in controls (Fig. 2B) PROMIS PF-10a scores were the lowest in IIMs. (Fig. 2C) pain VAS scores were the highest in patients with non-IIM AIRDs (Fig. 2D) PROMIS Fatigue-4a scores were the highest in IIMs (Fig. 2E) indicating increased fatigue in patients with IIMs.

Among IIM subsets, PROMIS GPH and PF-10a scores were the lowest in patients with IBM. (Fig. 3A & 3C) PROMIS GMH scores were lower in patients with ASSD or OM compared to other subtypes (Fig. 3B). Pain VAS (Fig. 3D) andPROMIS Fatigue-4a scores were the highest in patients with OM (Fig. 3E).

Older age, IBM, hypertension, diabetes, active disease, glucocorticoid use, and higher fatigue scores were the factors for lower GPH scores in IIMs (Fig. 1B), whereas interstitial lung disease, mental disorders, active disease, higher pain VAS, and fatigue scores were independently associated with lower GMH scores in IIMs (Fig. 1C).

Multivariable regression analysis in the overall population identified older age, women, longer disease duration, diagnosis of autoimmune inflammatory diseases including IIMs, and comorbidities as independent factors for lower PROMIS GPH scores. (Fig. 1E) On the contrary, younger age, women, Asian ethnicity, diagnosis of autoimmune inflammatory diseases including IIMs, and comorbidities were independently associated with lower PROMIS GMH scores (Fig. 1F)

Conclusion: Both physical and mental health are significantly impaired in patients with IIMs particularly the elderly, IBM and those with specific comorbidities, calling for greater attention and optimized multidisciplinary care to enhance patient-reported experience and global well-being in this population.








A. Yoshida: None; Y. Li: None; V. Maroufy: None; M. Kuwana: AbbVie/Abbott, 6, Asahi-Kasei, 5, 6, Astellas, 6, AstraZeneca, 2, Boehringer-Ingelheim, 2, 5, 6, Chugai, 2, 5, 6, Corbus, 2, Eisai, 6, GlaxoSmithKlein(GSK), 2, Horizon, 2, Janssen, 6, Kissei, 2, MBL, 2, 5, Mitsubishi Tanabe, 2, 5, 6, Mochida, 2, 6, Nippon Shinyaku, 6, Ono, 5, 6; N. R: None; A. Makol: Boehringer-Ingelheim, 1, Sanofi-Genzyme, 1; P. Sen: None; J. Lilleker: None; V. Agarwal: None; S. Kardes: None; J. Day: CSL limited, 5; M. Milchert: None; M. Joshi: None; T. Gheita: None; B. Salim: None; T. Velikova: AstraZeneca, 6, Pfizer, 6; A. Gracia-Ramos: None; 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; E. Nikiphorou: AbbVie/Abbott, 6, Celltrion, 6, Eli Lilly, 6, fresenius, 6, Galapagos, 6, Gilead, 1, 6, Pfizer, 6, Sanofi, 6; A. Tan: Abbvie, 1, 6, Gilead, 6, Janssen, 6, Lilly, 6, Novartis, 6, Pfizer, 6, UCB, 6; A. Nune: None; L. Cavagna: None; M. Saavedra Salinas: 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; J. Knitza: None; O. Distler: 4P-Pharma, 2, 5, 6, AbbVie, 2, 5, 6, Acceleron, 2, 5, 6, Alcimed, 2, 5, 6, Altavant Sciences, 2, 5, 6, Amgen, 2, 5, 6, AnaMar, 2, 5, 6, Arxx, 2, 5, 6, AstraZeneca, 2, 5, 6, Bayer, 2, 5, 6, Blade Therapeutics, 2, 5, 6, Boehringer Ingelheim, 2, 5, 6, Citus AG, 12, Co-Founder, Corbus Pharmaceuticals, 2, 5, 6, CSL Behring, 2, 5, 6, Galapagos, 2, 5, 6, Galderma, 2, 5, 6, Glenmark, 2, 5, 6, Gossamer, 2, 5, 6, Horizon Therapeutics, 2, 5, 6, Janssen, 2, 5, 6, Kymera, 2, 5, 6, Lupin, 2, 5, 6, Medscape, 2, 5, 6, Miltenyi Biotec, 2, 5, 6, Mitsubishi Tanabe, 2, 5, 6, MSD, 2, 5, 6, Novartis, 2, 5, 6, Patent issued “mir-29 for the treatment of systemic sclerosis” (US8247389, EP2331143), 10, Prometheus Biosciences, 2, 5, 6, Redx Pharma, 2, 5, 6, Roivant, 2, 5, 6, Topadur, 2, 5, 6; H. Chinoy: AstraZeneca, 1, Biogen, 2, Eli Lilly, 5, GlaxoSmithKlein(GSK), 6, Novartis, 2, Orphazyme, 2, Pfizer, 1, UCB, 6; 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; C. Study Group: None.