Table I.

COVID-19 vaccine safety outcomes in patients with immune-mediated inflammatory disease

Study	Vaccine given	Population	Therapies used at the time of vaccination	Response to COVID-19 vaccine
Connolly et al16	BNT162b2 or mRNA-1273	325 IMID patients surveyed about side effects in first week after initial dose of vaccine	DMARDs (44%) Biologics (19%) Combination therapy (37%)	•Local and systemic reactions were transient, mild, and similar to those reported in vaccine trials •89% reported local symptoms (most commonly pain) •69% reported systemic symptoms (most commonly fatigue) •No allergic reactions requiring epinephrine •One case of PCR-confirmed COVID 19 infection •One case of peripheral neuropathy
Watad et al17	ChAdOx1 nCoV-19, BNT162b2, or mRNA-1273	Collection of cases (n = 27, 17 flares, and 10 new-onset IMID) in patients with IMID in 28 days following COVID vaccination	Mixed group including biologics, steroids, and DMARDs Biologics included: infliximab, certolizumab, adalimumab, tocilizumab, apremilast, vedolizumab	•Findings of new-onset disease rare and likely close to the background incidence of these conditions •Flares were temporally associated with vaccination, but no way to determine causation •Most (81%) of cases treated with glucocorticoids; no cases of severe, resistant, or progressive disease
Damiani et al18	All BNT162b2	4 patients with psoriasis	Biologics included: secukinumab, risankizumab, ixekiuzmab	•All patients developed detectable anti-SARS-CoV-2 receptor-binding domain antibodies •No patients modified or discontinued their biologic in preparation for vaccination •Patients experienced pain at the injection site but no psoriatic flares or other cutaneous manifestations
Boekel et al19	ChAdOx1 nCoV-19, BNT162b2, or mRNA-1273	505 patients with IMID; 203 healthy controls	No treatment (31%) Methotrexate (33%) Glucocorticoids (15%) Biologics (29%) - predominately TNFi and BCDT	•No significant difference in frequency of adverse events between patients with IMID and controls (51% of patients vs 52% of controls experienced mild AEs; 21% patients vs 19% controls reported moderate AEs) •44% of patients and 40% of controls reported systemic AEs, most commonly fatigue and headache •Patients with IMID more frequently reported joint pain than controls (10% vs 1%) •Only 5% of patients reported worsening of their IMID up to 2 months post vaccination

AEs, Adverse events; BCDT, B-cell–depleting therapy; DMARDs, disease-modifying antirheumatic drugs; IMID, immune-mediated inflammatory disease; PCR, polymerase chain reaction; TNFi, tumor necrosis factor inhibitor.