Flares in IIMs and the timeline following COVID-19 vaccination: a combined analysis of the COVAD-1 and -2 surveys
Authors: R Naveen , Sen Parikshit , Griger Zoltán , Day Jessica , Joshi Mrudula , Nune Arvind , Nikiphorou Elena , Saha Sreoshy , Tan Ai Lyn , Shinjo Samuel Katsuyuki , Ziade Nelly , Velikova Tsvetelina , Milchert Marcin , Jagtap Kshitij , Parodis Ioannis , Gracia-Ramos Abraham Edgar , Cavagna Lorenzo , Kuwana Masataka , Knitza Johannes , Chen Yi Ming , Makol Ashima , Agarwal Vishwesh , Patel Aarat , Pauling John D , Wincup Chris , Barman Bhupen , Zamora Tehozol Erick Adrian , Rojas Serrano Jorge , García-De La Torre Ignacio , Colunga-Pedraza Iris J , Merayo-Chalico Javier , Chibuzo Okwara Celestine , Katchamart Wanruchada , Akarawatcharangura Goo Phonpen , Shumnalieva Russka , Hoff Leonardo Santos , El Kibbi Lina , Halabi Hussein , Vaidya Binit , Shaharir Syahrul Sazliyana , Hasan A T M Tanveer , Dey Dzifa , Toro Gutiérrez Carlos Enrique , Caballero-Uribe Carlo V , Lilleker James B , Salim Babur , Gheita Tamer , Chatterjee Tulika , Distler Oliver , Saavedra Miguel A , Chinoy Hector , Agarwal Vikas , Aggarwal Rohit , Gupta Latika ,   COVAD Study Group, 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 
Published: April 2023

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 &gt;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 &lt; 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.