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

Naveen, R.; Sen, P.; Griger, Z.; Day, J.; Joshi, M.; Nune, A.; Nikiphorou, E.; Saha, S.; Tan, A. L.; Shinjo, S. K.; Ziade, N.; Velikova, T.; Milchert, M.; Jagtap, K.; Parodis, I.; Gracia-Ramos, A. E.; Cavagna, L.; Kuwana, M.; Knitza, J.; Chen, Y. M.; Makol, A.; Agarwal, V.; Patel, A.; Pauling, J. D.; Wincup, C.; Barman, B.; Zamora Tehozol, E. A.; Rojas Serrano, J.; Garcia-De La Torre, I.; Colunga-Pedraza, I. J.; Merayo-Chalico, J.; Chibuzo, O. C.; Katchamart, W.; Akarawatcharangura Goo, P.; Shumnalieva, R.; Hoff, L. S.; El Kibbi, L.; Halabi, H.; Vaidya, B.; Shaharir, S. S.; Hasan, A. T. M. T.; Dey, D.; Toro Gutierrez, C. E.; Caballero-Uribe, C. V.; Lilleker, J. B.; Salim, B.; Gheita, T.; Chatterjee, T.; Distler, O.; Saavedra, M. A.; Chinoy, H.; Agarwal, V.; Aggarwal, R.; Gupta, L.; Kardes, S.; Andreoli, L.; Lini, D.; Screiber, K.; Vince, M. N.; Singh, Y. P.; Ranjan, R.; Jain, A.; Pandya, S. C.; Pilania, R. K.; Sharma, A.; Manesh Manoj, M.; Gupta, V.; Kavadichanda, C. G.; Patro, P. S.; Ajmani, S.; Phatak, S.; Goswami, R. P.; Chowdhury, A. C.; Mathew, A. J.; Shenoy, P.; Asranna, A.; Bommakanti, K. T.; Shukla, A.; Pande, A. R.; Chandwar, K.; Ghodke, A.; Boro, H.; Fazal, Z. Z.; Cansu, D. U.; Ylldlrlm, R.; Gasparyan, A. Y.; Del Papa, N.; Sambataro, G.; Fabiola, A.; Govoni, M.; Parisi, S.; Bocci, E. B.; Sebastiani, G. D.; Fusaro, E.; Sebastiani, M.; Quartuccio, L.; Franceschini, F.; Sainaghi, P. P.; Orsolini, G.; De Angelis, R.; Danielli, M. G.; Venerito, V.; Grignaschi, S.; Giollo, A.; Alluno, A.; Ioannone, F.; Fornaro, M.; Traboco, L. S.; Wibowo, S. A. K.; Loarce-Martos, J.; Prieto-Gonzalez, S.; Gonzalez, R. A.; Yoshida, A.; Nakashima, R.; Sato, S.; Kimura, N.; Kaneko, Y.; Gono, T.; Tomaras, S.; Proft, F. N.; Holzer, M. -T.; Gromova, M. A.; Aharonov, O.; Griger, Z.; Hmamouchi, I.; El Bouchti, I.; Baba, Z.; Giannini, M.; Maurier, F.; Campagne, J.; Meyer, A.; Langguth, D.; Limaye, V.; Needham, M.; Srivastav, N.; Hudson, M.; Landon-Cardinal, O.; Zuleta, W. G. R.; Arbelaez, A.; Cajas, J.; Silva, J. A. P.; Fonseca, J. E.; Zimba, O.; Bohdana, D.; Ima-Edomwonyi, U.; Dedeke, I.; Airenakho, E.; Madu, N. H.; Yerima, A.; Olaosebikan, H.; Becky, A.; Koussougbo, O. D.; Palalane, E.; So, H.; Ugarte-Gil, M. F.; Chinchay, L.; Bernaola, J. P.; Pimentel, V.; Fathi, H. M.; Mohammed, R. H. A.; Harifi, G.; Fuentes-Silva, Y.; Cabriza, K.; Losanto, J.; Colaman, N.; Cachafeiro-Vilar, A.; Bautista, G. G.; E. J. G., Ho; Gonzalez, R.; Nunez, L. S.; Cristian Vergara, M.; Baez, J. T.; Alonzo, H.; Pastelin, C. B. S.; Salinas, R. G.; Obiols, A. Q.; Chavez, N.; Ordonez, A. B.; Llerena, G. A. R.; Sierra-Zorita, R.; Arrieta, D.; Hidalgo, E. R.; Saenz, R.; Idania Escalante, M.; Calapaqui, W.; Quezada, I.; Arredondo, G.

doi:10.1093/rheumatology/kead180

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.

Flares in IIMs and the timeline following COVID-19 vaccination: a combined analysis of the COVAD-1 and -2 surveys / Naveen, R., Sen, P., Griger, Z., Day, J., Joshi, M., Nune, A., Nikiphorou, E., Saha, S., Tan, A.L., Shinjo, S.K., Ziade, N., Velikova, T., Milchert, M., Jagtap, K., Parodis, I., Gracia-Ramos, A.E., Cavagna, L., Kuwana, M., Knitza, J., Chen, Y.M., et al.. - In: RHEUMATOLOGY. - ISSN 1462-0324. - 63:1(2024), pp. 127-139. [10.1093/rheumatology/kead180]

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

Naveen R.;Sen P.;Griger Z.;Day J.;Joshi M.;Nune A.;Nikiphorou E.;Saha S.;Tan A. L.;Shinjo S. K.;Ziade N.;Velikova T.;Milchert M.;Jagtap K.;Parodis I.;Gracia-Ramos A. E.;Cavagna L.;Kuwana M.;Knitza J.;Chen Y. M.;Makol A.;Agarwal V.;Patel A.;Pauling J. D.;Wincup C.;Barman B.;Zamora Tehozol E. A.;Rojas Serrano J.;Garcia-De La Torre I.;Colunga-Pedraza I. J.;Merayo-Chalico J.;Chibuzo O. C.;Katchamart W.;Akarawatcharangura Goo P.;Shumnalieva R.;Hoff L. S.;El Kibbi L.;Halabi H.;Vaidya B.;Shaharir S. S.;Hasan A. T. M. T.;Dey D.;Toro Gutierrez C. E.;Caballero-Uribe C. V.;Lilleker J. B.;Salim B.;Gheita T.;Chatterjee T.;Distler O.;Saavedra M. A.;Chinoy H.;Agarwal V.;Aggarwal R.;Gupta L.;Kardes S.;Andreoli L.;Lini D.;Screiber K.;Vince M. N.;Singh Y. P.;Ranjan R.;Jain A.;Pandya S. C.;Pilania R. K.;Sharma A.;Manesh Manoj M.;Gupta V.;Kavadichanda C. G.;Patro P. S.;Ajmani S.;Phatak S.;Goswami R. P.;Chowdhury A. C.;Mathew A. J.;Shenoy P.;Asranna A.;Bommakanti K. T.;Shukla A.;Pande A. R.;Chandwar K.;Ghodke A.;Boro H.;Fazal Z. Z.;Cansu D. U.;Ylldlrlm R.;Gasparyan A. Y.;Del Papa N.;Sambataro G.;Fabiola A.;Govoni M.;Parisi S.;Bocci E. B.;Sebastiani G. D.;Fusaro E.;Sebastiani M.;Quartuccio L.;Franceschini F.;Sainaghi P. P.;Orsolini G.;De Angelis R.;Danielli M. G.;Venerito V.;Grignaschi S.;Giollo A.;Alluno A.;Ioannone F.;Fornaro M.;Traboco L. S.;Wibowo S. A. K.;Loarce-Martos J.;Prieto-Gonzalez S.;Gonzalez R. A.;Yoshida A.;Nakashima R.;Sato S.;Kimura N.;Kaneko Y.;Gono T.;Tomaras S.;Proft F. N.;Holzer M. -T.;Gromova M. A.;Aharonov O.;Griger Z.;Hmamouchi I.;El Bouchti I.;Baba Z.;Giannini M.;Maurier F.;Campagne J.;Meyer A.;Langguth D.;Limaye V.;Needham M.;Srivastav N.;Hudson M.;Landon-Cardinal O.;Zuleta W. G. R.;Arbelaez A.;Cajas J.;Silva J. A. P.;Fonseca J. E.;Zimba O.;Bohdana D.;Ima-Edomwonyi U.;Dedeke I.;Airenakho E.;Madu N. H.;Yerima A.;Olaosebikan H.;Becky A.;Koussougbo O. D.;Palalane E.;So H.;Ugarte-Gil M. F.;Chinchay L.;Bernaola J. P.;Pimentel V.;Fathi H. M.;Mohammed R. H. A.;Harifi G.;Fuentes-Silva Y.;Cabriza K.;Losanto J.;Colaman N.;Cachafeiro-Vilar A.;Bautista G. G.;Ho E. J. G.;Gonzalez R.;Nunez L. S.;Cristian Vergara M.;Baez J. T.;Alonzo H.;Pastelin C. B. S.;Salinas R. G.;Obiols A. Q.;Chavez N.;Ordonez A. B.;Llerena G. A. R.;Sierra-Zorita R.;Arrieta D.;Hidalgo E. R.;Saenz R.;Idania Escalante M.;Calapaqui W.;Quezada I.;Arredondo G.

2024

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.

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	Anno di pubblicazione
	
				2024
			
	Rivista
	
				RHEUMATOLOGY
			
	N° del Volume
	
				63
			
	Fascicolo
	
				1
			
	Pagina iniziale
	
				127
			
	Pagina finale
	
				139
			
	Codice DOI
	
				https://dx.doi.org/10.1093/rheumatology/kead180
			
	Codice WoS
	
				WOS:000999243100001
			
	Codice Scopus
	
				2-s2.0-85180733005
			
	Codice PubMed
	
				37084267
			
	Citazione
	
				Flares in IIMs and the timeline following COVID-19 vaccination: a combined analysis of the COVAD-1 and -2 surveys / Naveen, R., Sen, P., Griger, Z., Day, J., Joshi, M., Nune, A., Nikiphorou, E., Saha, S., Tan, A.L., Shinjo, S.K., Ziade, N., Velikova, T., Milchert, M., Jagtap, K., Parodis, I., Gracia-Ramos, A.E., Cavagna, L., Kuwana, M., Knitza, J., Chen, Y.M., et al.. - In: RHEUMATOLOGY. - ISSN 1462-0324. - 63:1(2024), pp. 127-139. [10.1093/rheumatology/kead180]
			
	Tutti gli autori
	
						Naveen, R.; Sen, P.; Griger, Z.; Day, J.; Joshi, M.; Nune, A.; Nikiphorou, E.; Saha, S.; Tan, A. L.; Shinjo, S. K.; Ziade, N.; Velikova, T.; Milchert,...espandi
						
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