ABSTRACT
INTRODUCTION: We determined adverse events after 4 doses of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) vaccine in those with inflammatory bowel disease (IBD), associations between antibodies and injection site reactions (ISR), and risk of IBD flare. METHODS: Individuals with IBD were interviewed for adverse events to SARS-CoV-2 vaccine. Multivariable linear regression assessed the association between antibody titers and ISR. RESULTS: Severe adverse events occurred in 0.03%. ISR were significantly associated with antibody levels after the fourth dose (geometric mean ratio = 2.56; 95% confidence interval 1.18-5.57). No cases of IBD flare occurred. DISCUSSION: SARS-CoV-2 vaccines are safe for those with IBD. ISR after the fourth dose may indicate increased antibodies.
ABSTRACT
Introduction: The rapid development and distribution of SARS-CoV-2 vaccines has raised concerns surrounding vaccine safety in immunocompromised populations, such as those with inflammatory bowel disease (IBD). Analysis found elevated GMT levels in those with injection site reactions compared to those without injection site reactions following all four doses, with second dose serological responses being statistically significantly different (8614/mL vs 6841 AU/mL [p< 0.05], respectively) (Figure). Participant characteristics and adverse events following first, second, third, and fourth dose of a SARS-CoV-2 vaccine Characteristics Dose 1 (/331) Dose 2 (/331) Dose 3 (/195) Dose 4 (/100) Sex, n (%) Male Female 155 (46.8%) 176 (53.2%) 155 (46.8%) 176 (53.2%) 86 (44.1%) 109 (55.9%) 49 (49.0%) 51 (51.0%) Mean age (SD) 52.05 (14.52) 52.05 (14.52) 51.81 (15.20) 57.98 (14.01) IBD Type, n (%) Crohn’s Disease Ulcerative Colitis & IBD-U 238 (71.9%) 93 (28.1%) 238 (71.9%) 93 (28.1%) 150 (76.9%) 45 (23.1%) 75 (75.0%) 25 (25.0%) Medication, n (%) No immunosuppressives Anti-TNF only† Immunomodulators only Vedolizumab only Ustekinumab only Tofacitinib only Combination therapy‡ Oral Corticosteroids 33 (10.0%) 118 (35.7%) 7 (2.1%) 37 (11.2%) 76 (23.0%) 5 (1.5%) 49 (14.8%) 6 (1.8%) 32 (9.7%) 119 (36.0%) 7 (2.1%) 39 (11.8%) 74 (22.4%) 5 (1.5%) 47 (14.2%) 8 (2.4%) 14 (7.2%) 74 (38.0%) 5 (2.6%) 19 (9.7%) 42 (21.5%) < 5 36 (18.5%) < 5 27 (27.0%) 20 (20.0%) < 5 9 (9.0%) 16 (16.0%) — 18 (18.0%) 7 (7.0%) Vaccine Type, n (%) Pfizer Moderna AstraZeneca 271 (81.9%) 45 (13.6%) 15 (4.5%) 275 (83.1%) 49 (14.8%) 7 (2.1%) 179 (91.8%) 16 (8.2%) — 82 (82.0%) 18 (18.0%) — Adverse Events Dose 1 (/331) Dose 2 (/331) Dose 3 (/195) Dose 4 (/100) Injection site, n (%) 250 (75.5%) 231 (70%) 138 (70.8%) 55 (55.0%) Lymph node swelling, n (%) 1 (0.3%) 9 (2.7%) 14 (7.2%) 1 (1.0%) Gastrointestinal, n (%) 17 (5.1%) 16 (4.8%) 6 (3.1%) 2 (2.0%) Fatigue or malaise, n (%) 86 (26.0%) 87 (26.3%) 45 (23.1%) 22 (22.0%) Fever or chills, n (%) 27 (8.2%) 35 (10.6%) 19 (9.7%) 5 (5.0%) Musculoskeletal, n (%) 34 (10.3%) 41 (12.4%) 25 (12.8%) 9 (9.0%) Headache or migraine, n (%) 34 (10.3%) 46 (13.9%) 23 (11.8%) 11 (11.0%) Other, n (%) 16 (4.8%)α 14 (4.2%)β 7 (3.6%)γ 2 (2.0%)δ Any symptoms, n (%) 275 (83.3%) 261 (79.1%) 151 (77.4%) 67 (67.0%) †One of golimumab, adalimumab, or infliximab (originator or biosimilar) ‡Any combination of anti-TNF and one or more of the following therapies: vedolizumab, ustekinumab, tofacitinib, azathioprine, 6-mercaptopurine, or methotrexate αParesthesia, chin swelling, dysgeusia, numbness, hot flashes, irritability, ennui, hyperactivity, brain fog, congestion, dry eyes, sleep trouble, testicular swelling, angioedema, sinus swelling, throat swelling βShingles, hot flashes, brain fog, sleep troubles, rapid heartbeat, forced breathing, congestion, angioedema, throat swelling, leg swelling γHot flashes, brain fog, sleep troubles, sore throat, congestion, angioedema, ITP δParesthesia, sleep troubles