Flares in IIMs and the timeline following COVID-19 vaccination: a combined analysis of the COVAD-1 and -2 surveys

Author:

R Naveen1ORCID,Sen Parikshit2ORCID,Griger Zoltán3ORCID,Day Jessica456ORCID,Joshi Mrudula7ORCID,Nune Arvind8ORCID,Nikiphorou Elena910ORCID,Saha Sreoshy11ORCID,Tan Ai Lyn1213ORCID,Shinjo Samuel Katsuyuki14ORCID,Ziade Nelly1516ORCID,Velikova Tsvetelina17ORCID,Milchert Marcin18ORCID,Jagtap Kshitij19ORCID,Parodis Ioannis2021ORCID,Gracia-Ramos Abraham Edgar22ORCID,Cavagna Lorenzo23ORCID,Kuwana Masataka24ORCID,Knitza Johannes25ORCID,Chen Yi Ming2627ORCID,Makol Ashima28ORCID,Agarwal Vishwesh29ORCID,Patel Aarat30,Pauling John D3132ORCID,Wincup Chris3334ORCID,Barman Bhupen35,Zamora Tehozol Erick Adrian36ORCID,Rojas Serrano Jorge37ORCID,García-De La Torre Ignacio38ORCID,Colunga-Pedraza Iris J39ORCID,Merayo-Chalico Javier40ORCID,Chibuzo Okwara Celestine41,Katchamart Wanruchada42ORCID,Akarawatcharangura Goo Phonpen43,Shumnalieva Russka44ORCID,Hoff Leonardo Santos45ORCID,El Kibbi Lina46ORCID,Halabi Hussein47ORCID,Vaidya Binit48ORCID,Shaharir Syahrul Sazliyana49ORCID,Hasan A T M Tanveer50ORCID,Dey Dzifa51,Toro Gutiérrez Carlos Enrique52ORCID,Caballero-Uribe Carlo V53,Lilleker James B5455ORCID,Salim Babur56ORCID,Gheita Tamer57ORCID,Chatterjee Tulika58ORCID,Distler Oliver59ORCID,Saavedra Miguel A60ORCID,Chinoy Hector546162ORCID,Agarwal Vikas1ORCID,Aggarwal Rohit63ORCID,Gupta Latika546465ORCID,Kardes Sinan,Andreoli Laura,Lini Daniele,Screiber Karen,Vince Melinda Nagy,Singh Yogesh Preet,Ranjan Rajiv,Jain Avinash,Pandya Sapan C,Pilania Rakesh Kumar,Sharma Aman,Manesh Manoj M,Gupta Vikas,Kavadichanda Chengappa G,Patro Pradeepta Sekhar,Ajmani Sajal,Phatak Sanat,Goswami Rudra Prosad,Chowdhury Abhra Chandra,Mathew Ashish Jacob,Shenoy Padnamabha,Asranna Ajay,Bommakanti Keerthi Talari,Shukla Anuj,Pande Arunkumar R,Chandwar Kunal,Ghodke Akanksha,Boro Hiya,Fazal Zoha Zahid,Cansu Döndü Üsküdar,Yıldırım Reşit,Gasparyan Armen Yuri,Del Papa Nicoletta,Sambataro Gianluca,Fabiola Atzeni,Govoni Marcello,Parisi Simone,Bocci Elena Bartoloni,Sebastiani Gian Domenico,Fusaro Enrico,Sebastiani Marco,Quartuccio Luca,Franceschini Franco,Sainaghi Pier Paolo,Orsolini Giovanni,De Angelis Rossella,Danielli Maria Giovanna,Venerito Vincenzo,Grignaschi Silvia,Giollo Alessandro,Alluno Alessia,Ioannone Florenzo,Fornaro Marco,Traboco Lisa S,Wibowo Suryo Anggoro Kusumo,Loarce-Martos Jesús,Prieto-González Sergio,Gonzalez Raquel Aranega,Yoshida Akira,Nakashima Ran,Sato Shinji,Kimura Naoki,Kaneko Yuko,Gono Takahisa,Tomaras Stylianos,Proft Fabian Nikolai,Holzer Marie-Therese,Gromova Margarita Aleksandrovna,Aharonov Or,Griger Zoltán,Hmamouchi Ihsane,El Bouchti Imane,Baba Zineb,Giannini Margherita,Maurier François,Campagne Julien,Meyer Alain,Langguth Daman,Limaye Vidya,Needham Merrilee,Srivastav Nilesh,Hudson Marie,Landon-Cardinal Océane,Zuleta Wilmer Gerardo Rojas,Arbeláez Álvaro,Cajas Javier,Silva José António Pereira,Fonseca João Eurico,Zimba Olena,Bohdana Doskaliuk,Ima-Edomwonyi Uyi,Dedeke Ibukunoluwa,Airenakho Emorinken,Madu Nwankwo Henry,Yerima Abubakar,Olaosebikan Hakeem,Becky A,Koussougbo Oruma Devi,Palalane Elisa,So Ho,Ugarte-Gil Manuel Francisco,Chinchay Lyn,Bernaola José Proaño,Pimentel Victorio,Fathi Hanan Mohammed,Mohammed Reem Hamdy A,Harifi Ghita,Fuentes-Silva Yurilís,Cabriza Karoll,Losanto Jonathan,Colaman Nelly,Cachafeiro-Vilar Antonio,Bautista Generoso Guerra,Ho Enrique Julio Giraldo,González Raúl,Nunez Lilith Stange,Cristian Vergara M,Báez Jossiell Then,Alonzo Hugo,Pastelin Carlos Benito Santiago,Salinas Rodrigo García,Obiols Alejandro Quiñónez,Chávez Nilmo,Ordóñez Andrea Bran,Llerena Gil Alberto Reyes,Sierra-Zorita Radames,Arrieta Dina,Hidalgo Eduardo Romero,Saenz Ricardo,Idania Escalante M,Calapaqui Wendy,Quezada Ivonne,Arredondo Gabriela,

Affiliation:

1. Department of Clinical Immunology and Rheumatology, Sanjay Gandhi Postgraduate Institute of Medical Sciences , Lucknow, India

2. Maulana Azad Medical College , New Delhi, Delhi, India

3. Division of Clinical Immunology, Department of Internal Medicine, Faculty of Medicine, University of Debrecen , Debrecen, Hungary

4. Department of Rheumatology, Royal Melbourne Hospital , Parkville, VIC, Australia

5. Walter and Eliza Hall Institute of Medical Research , Parkville, VIC, Australia

6. Department of Medical Biology, University of Melbourne , Parkville, VIC, Australia

7. Byramjee Jeejeebhoy Government Medical College, and Sassoon General Hospitals , Pune, India

8. Southport and Ormskirk Hospital NHS Trust , Southport, UK

9. Centre for Rheumatic Diseases, King’s College London , London, UK

10. Rheumatology Department, King’s College Hospital , London, UK

11. Mymensingh Medical College , Mymensingh, Bangladesh

12. NIHR Leeds Biomedical Research Centre, Leeds Teaching Hospitals Trust , Leeds, UK

13. Leeds Institute of Rheumatic and Musculoskeletal Medicine, University of Leeds , Leeds, UK

14. Division of Rheumatology, Faculdade de Medicina FMUSP, Universidade de Sao Paulo , Sao Paulo, SP, Brazil

15. Rheumatology Department, Saint-Joseph University , Beirut, Lebanon

16. Rheumatology Department, Hotel-Dieu de France Hospital , Beirut, Lebanon

17. Medical Faculty, Sofia University St Kliment Ohridski , Sofia, Bulgaria

18. Department of Internal Medicine, Rheumatology, Diabetology, Geriatrics and Clinical Immunology, Pomeranian Medical University , Szczecin, Poland

19. Seth Gordhandhas Sunderdas Medical College and King Edwards Memorial Hospital , Mumbai, Maharashtra, India

20. Division of Rheumatology, Department of Medicine Solna, Karolinska Institutet and Karolinska University Hospital , Stockholm, Sweden

21. Department of Rheumatology, Faculty of Medicine and Health, Örebro University , Örebro, Sweden

22. Department of Internal Medicine, General Hospital, National Medical Center, “La Raza”, Instituto Mexicano del Seguro Social , Mexico City, Mexico

23. Rheumatology Unit, Dipartimento di Medicine Interna e Terapia Medica, Università degli Studi di Pavia , Pavia, Lombardy, Italy

24. Department of Allergy and Rheumatology, Nippon Medical School Graduate School of Medicine , Tokyo, Japan

25. Medizinische Klinik 3—Rheumatologie und Immunologie, Universitätsklinikum Erlangen, Friedrich-Alexander-Universität Erlangen-Nürnberg , Erlangen, Germany

26. Division of Allergy, Immunology and Rheumatology, Department of Internal Medicine, Taichung Veterans General Hospital , Taichung City, Taiwan

27. Department of Medical Research, Taichung Veterans General Hospital , Taichung, Taiwan

28. Division of Rheumatology, Mayo Clinic , Rochester, MN, USA

29. Mahatma Gandhi Mission Medical College , Navi Mumbai, Maharashtra, India

30. Bon Secours Rheumatology Center, and Division of Pediatric Rheumatology, Department of Pediatrics, University of Virginia School of Medicine , Charlottesville, VA, USA

31. Bristol Medical School Translational Health Sciences, University of Bristol , UK

32. Department of Rheumatology, North Bristol NHS Trust , Bristol, UK

33. Department of Rheumatology, Division of Medicine, Rayne Institute, University College London , London, UK

34. Centre for Adolescent Rheumatology Versus Arthritis at UCL, UCLH, GOSH , London, UK

35. Department of General Medicine, All India Institute of Medical Sciences (AIIMS) , Guwahati, India

36. Rheumatology, Medical Care & Research, Centro Medico Pensiones Hospital, Instituto Mexicano del Seguro Social Delegación Yucatán , Yucatán, Mexico

37. Rheumatologist and Clinical Investigator, Interstitial Lung Disease and Rheumatology Unit, Instituto Nacional de Enfermedades Respiratorias , Mexico City, Mexico

38. Departamento de Inmunología y Reumatología, Hospital General de Occidente and Universidad de Guadalajara , Guadalajara, Jalisco, Mexico

39. Rheumatology, Hospital Universitario Dr Jose Eleuterio Gonzalez , Monterrey, Mexico

40. Department of Immunology and Rheumatology, Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán , Mexico City, Mexico

41. Department of Medicine, University of Nigeria Teaching Hospital, Ituku-Ozalla/University of Nigeria , Enugu, Nigeria

42. Division of Rheumatology, Department of Medicine, Faculty of Medicine Siriraj Hospital, Mahidol University , Bangkok, Thailand

43. Department of Medicine, Queen Savang Vadhana Memorial Hospital , Chonburi, Thailand

44. Department of Rheumatology, Clinic of Rheumatology, University Hospital “St Ivan Rilski”, Medical University-Sofia , Sofia, Bulgaria

45. School of Medicine, Universidade Potiguar (UnP) , Natal, Brazil

46. Rheumatology Unit, Internal Medicine Department, Specialized Medical Center , Riyadh, Saudi Arabia

47. Department of Internal Medicine, Section of rheumatology, King Faisal Specialist Hospital and Research Center , Jeddah, Saudi Arabia

48. National Center for Rheumatic Diseases (NCRD) , Ratopul, Kathmandu, Nepal

49. Faculty of Medicine, Universiti Kebangsaan Malaysia , Kuala Lumpur, Malaysia

50. Department of Rheumatology, Enam Medical College & Hospital , Dhaka, Bangladesh

51. Rheumatology Unit, Department of Medicine and Therapeutics, University of Ghana Medical School, College of Health Sciences , Accra, Ghana

52. General Director, Reference Center for Osteoporosis, Rheumatology and Dermatology, Pontifica Universidad Javeriana Cali , Cali, Colombia

53. Department of Medicine, Hospital Universidad del Norte , Barranquilla, Atlantico, Colombia

54. Division of Musculoskeletal and Dermatological Sciences, Centre for Musculoskeletal Research, School of Biological Sciences, Faculty of Biology, Medicine and Health, Manchester Academic Health Science Centre The University of Manchester , Manchester, UK

55. Manchester Centre for Clinical Neurosciences, Salford Royal NHS Foundation Trust , Salford, UK

56. Rheumatology Department, Fauji Foundation Hospital , Rawalpindi, Pakistan

57. Rheumatology Department, Kasr Al Ainy School of Medicine, Cairo University , Cairo, Egypt

58. Department of Internal Medicine, University of Illinois College of Medicine , Peoria, IL, USA

59. Department of Rheumatology, University Hospital Zurich, University of Zurich , Zurich, Switzerland

60. Departamento de Reumatología Hospital de Especialidades Dr. Antonio Fraga Mouret IMSS, Centro Médico Nacional La Raza , Mexico City, Mexico

61. National Institute for Health Research Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, The University of Manchester , Manchester, UK

62. Department of Rheumatology, Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust , Salford, UK

63. Division of Rheumatology and Clinical Immunology, University of Pittsburgh School of Medicine , Pittsburgh, PA, USA

64. Department of Rheumatology, Royal Wolverhampton Hospitals NHS Trust , Wolverhampton, UK

65. City Hospital, Sandwell and West Birmingham Hospitals NHS Trust , Birmingham, UK

Abstract

Abstract Objectives Disease flares in the post–coronavirus disease 2019 (COVID-19) vaccination period represent a prominent concern, though risk factors are poorly understood. We studied these flares among patients with idiopathic inflammatory myopathies (IIMs) and other autoimmune rheumatic diseases (AIRDs). Methods The COVAD-1 and -2 global surveys were circulated in early 2021 and 2022, respectively, and we captured demographics, comorbidities, AIRDs details, COVID-19 infection history and vaccination details. Flares of IIMs were defined as (a) patient self-reported, (b) immunosuppression (IS) denoted, (c) clinical sign directed and (d) with >7.9-point minimal clinically significant improvement difference worsening of Patient-Reported Outcomes Measurement Information System (PROMIS) PROMISPF10a score. Risk factors of flares were analysed using regression models. Results Of 15 165 total respondents, 1278 IIMs (age 63 years, 70.3% female, 80.8% Caucasians) and 3453 AIRDs were included. Flares of IIM were seen in 9.6%, 12.7%, 8.7% and 19.6% patients by definitions (a) to (d), respectively, with a median time to flare of 71.5 (10.7–235) days, similar to AIRDs. Patients with active IIMs pre-vaccination (OR 1.2; 95% CI 1.03, 1.6, P = 0.025) were prone to flares, while those receiving rituximab (OR 0.3; 95% CI 0.1, 0.7, P = 0.010) and AZA (OR 0.3, 95% CI 0.1, 0.8, P = 0.016) were at lower risk. Female gender and comorbidities predisposed to flares requiring changes in IS. Asthma (OR 1.62; 95% CI 1.05, 2.50, P = 0.028) and higher pain visual analogue score (OR 1.19; 95% CI 1.11, 1.27, P < 0.001) were associated with disparity between self-reported and IS-denoted flares. Conclusion A diagnosis of IIMs confers an equal risk of flares in the post–COVID-19 vaccination period to AIRDs, with active disease, female gender and comorbidities conferring a higher risk. Disparity between patient- and physician-reported outcomes represents a future avenue for exploration.

Publisher

Oxford University Press (OUP)

Subject

Pharmacology (medical),Rheumatology

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