Factors associated with disease flare following SARS-CoV-2 vaccination in people with inflammatory rheumatic and musculoskeletal diseases: results from the physician-reported EULAR Coronavirus Vaccine (COVAX) Registry.

Objectives: To investigate the frequency and factors associated with disease flare following vaccination against SARS-CoV-2 in people with inflammatory/autoimmune rheumatic and musculoskeletal diseases (I-RMDs).
Methods: Data from the European Alliance of Associations for Rheumatology Coronavirus Vaccine physician-reported registry were used. Factors associated with flare in patients with I-RMDs were investigated using multivariable logistic regression adjusted for demographic and clinical factors.
Results: The study included 7336 patients with I-RMD, with 272 of 7336 (3.7%) experiencing flares and 121 of 7336 (1.6%) experiencing flares requiring starting a new medication or increasing the dosage of an existing medication. Factors independently associated with increased odds of flare were: female sex (OR=1.40, 95% CI=1.05 to 1.87), active disease at the time of vaccination (low disease activity (LDA), OR=1.45, 95% CI=1.08 to 1.94; moderate/high disease activity (M/HDA), OR=1.37, 95% CI=0.97 to 1.95; vs remission), and cessation/reduction of antirheumatic medication before or after vaccination (OR=4.76, 95% CI=3.44 to 6.58); factors associated with decreased odds of flare were: higher age (OR=0.90, 95% CI=0.83 to 0.98), non-Pfizer/AstraZeneca/Moderna vaccines (OR=0.10, 95% CI=0.01 to 0.74; vs Pfizer), and exposure to methotrexate (OR=0.57, 95% CI=0.37 to 0.90), tumour necrosis factor inhibitors (OR=0.55, 95% CI=0.36 to 0.85) or rituximab (OR=0.27, 95% CI=0.11 to 0.66), versus no antirheumatic treatment. In a multivariable model using new medication or dosage increase due to flare as the dependent variable, only the following independent associations were observed: active disease (LDA, OR=1.47, 95% CI=0.94 to 2.29; M/HDA, OR=3.08, 95% CI=1.91 to 4.97; vs remission), cessation/reduction of antirheumatic medication before or after vaccination (OR=2.24, 95% CI=1.33 to 3.78), and exposure to methotrexate (OR=0.48, 95% CI=0.26 to 0.89) or rituximab (OR=0.10, 95% CI=0.01 to 0.77), versus no antirheumatic treatment.
Conclusion: I-RMD flares following SARS-CoV-2 vaccination were uncommon. Factors associated with flares were identified, namely higher disease activity and cessation/reduction of antirheumatic medications before or after vaccination.
Competing Interests: Competing interests: BF does not report conflicts of interest. SL-T does not report conflicts of interest. KLH reports non-personal speaker's fees from AbbVie and grant income from BMS and Pfizer, all unrelated to this manuscript; and her institute was supported by EULAR for COVAX database management. LG reports research grants from Amgen, Galapagos, Lilly, Pfizer and Sandoz; and consulting fees from AbbVie, Amgen, BMS, Celltrion, Galapagos, Gilead, GSK, Janssen, Lilly, Novartis, Pfizer, Samsung Bioepis, Sanofi-Aventis and UCB, all unrelated to this manuscript. LC has not received fees or personal grants from any laboratory, but her institute works by contract for laboratories among other institutions, such as Galapagos, Pfizer, Lilly, MSD, Novartis, Roche, Sanofi Aventis, BMS and Sandoz; she also reports safety board participation, not paid personally. AS reports personal fees from lectures for AbbVie, Galapagos, Lilly, Pfizer and Takeda. EFM does not report conflicts of interest. MS does not report conflicts of interest. AR does not report conflicts of interest. EH does not report conflicts of interest. JAG-P does not report conflicts of interest. MM reports having received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, all unrelated to this manuscript. PD reports speaker's fees from AbbVie, Lilly, Galapagos, Janssen and Biogen, all unrelated to this manuscript. LT does not report conflicts of interest. TG does not report conflicts of interest. MC does not report conflicts of interest. ES reports receiving grants from AbbVie; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Novartis, AbbVie, Pfizer, Eli Lilly, UCB, Sobi, Roche, Sanofi, Boehringer-Ingelheim, Viatris, Sandoz, Mylan, MSD, Amgen and Janssen-Johnson & Johnson; support for attending meetings and/or travel from AbbVie and Janssen-Johnson & Johnson; participation in a data safety monitoring board or advisory board from AbbVie, Eli Lilly, UCB, Sobi, Boehringer-Ingelheim and Janssen-Johnson & Johnson; and is a committee member of Slovak Society of Rheumatology, all unrelated to this manuscript. IB reports receiving speaker's fees from AbbVie, Pfizer, Boehringer Ingelheim and Janssen; and has received support for attending meetings and/or travel from AbbVie, all unrelated to this manuscript. ES does not report conflicts of interest. JZ reports consulting fees from AbbVie, Janssen, Novartis and Boehringer-Ingelheim; speaker's fees from AbbVie, Janssen, Novartis, Boehringer Ingelheim Latvia and UAB Viasana; receiving support for attending meetings and/or travel from AbbVie, UAB Viasana and Johnson & Johnson; and is a board member of Latvian Society of Adult Rheumatology; all unrelated to this manuscript. NR has nothing to disclose. OB has nothing to disclose. EV has nothing to disclose. BR has nothing to disclose. GRB has nothing to disclose. XM reports personal consultant fees from BMS, Galapagos, GSK, Novartis and Pfizer; and having received support for attending meetings and/or travel from Novartis, all unrelated to this manuscript. PMM has received consulting/speaker’s fees from AbbVie, BMS, Celgene, Eli Lilly, Galapagos, Janssen, MSD, Novartis, Orphazyme, Pfizer, Roche and UCB, all unrelated to this manuscript.
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