Patients with inflammatory bowel disease (IBD) experience fewer and milder SARS-CoV-2 mRNA postvaccination symptoms, compared with individuals without IBD, according to a study published in Inflammatory Bowel Diseases.
Vaccination against COVID-19 is recommended for individuals with IBD. Real-world studies support postvaccination safety and tolerability. However, a substantial amount of IBD patients remain unvaccinated likely due to the lack of inclusion of individuals with chronic immune-mediated diseases in studies during vaccine development. In an effort to strengthen vaccination adherence among those with IBD, study authors aimed to characterize postvaccination symptoms in a cohort of individuals with IBD relative to a non-IBD control population.
A cohort of adults with IBD undergoing SARS-CoV-2 vaccination and a control group of health care workers (HCW)were enrolled in a prospective registry. Study participants were tasked with documenting frequency, severity, and duration of postvaccine symptoms. Inclusion criteria consisted of adults with a self-reported diagnosis of IBD (Crohn disease [CD], ulcerative colitis [UC], IBD unclassified [IBD-U]), who completed at least 1 online survey on postvaccine symptoms a week after administration of an mRNA vaccine (BNT162b2 [Pfizer-BioNTech] or mRNA- 1273 [Moderna]). Patients who received the Ad26.CoV.2 (Johnson & Johnson) vaccination were excluded from the study.
The primary outcome of the study was the proportion of patients who experienced any symptom (local or systemic) after a vaccine dose. Secondary outcomes included organ-specific symptoms stratified by disease type and immune-modifying therapies (IMT).
Online surveys collected information on injection site reactions, generalized systemic symptoms, as well as systems-based effects. Symptom severity was categorized according to the degree of interference with daily activities (mild, moderate, extreme, or severe).
Web-based surveys were completed by 2,910 subjects after 1 dose and 2,746 subjects after 2 doses. Study participants had a mean [SD] age of 43.3[13.8] years, 66.4% were women, and 22.6% identified as non-White. Mostly all HCWs received the BNT162b2 vaccine, but only 60% of IBD patients received BNT162b2. The IBD cohort included individuals with CD (65%) and UC or IBD-U (35%).
HCWs vs patients with IBD were found to experience a greater frequency of postvaccination symptoms, both after dose 1 (D1) and dose 2 (D2; 57.4% vs 35.0%, P <.001) and (73.2% vs 50.2%, P <.001), respectively. The most common frequent symptoms after D1 included local injection site symptoms (57% vs 33%, P <.001), fatigue or malaise (28% vs 21%, P <.001), and headache, dizziness or lightheadedness (21% vs 14%, P <.001). After D2, HCWs experienced greater frequency of injection site reactions (70% vs 46%, P <.001), fatigue or malaise (60% vs 39%, P <.001), and headache, dizziness, or lightheadedness (43% vs 28%, P <.001). The IBD group experienced a higher frequency of gastrointestinal (GI) symptoms after D1 (5.5% vs 3%, P =.003), but not after D2 (10% vs 13%, P =.07).
In reference to IBD diagnosis, patients with CD reported a higher frequency of GI symptoms, compared with UC and IBD-U after D1 (6.3% vs 3.9%, P = .03). However, there was no observed difference after D2 (11.2% vs 8.5%, P =.09).
Postvaccine symptoms were generally well-tolerated and mild between both groups, lasting on average 2 days or fewer after both doses. HCWs experienced more postvaccination symptoms overall after the first and second dose, relative to the IBD group (D1: 57% vs 35%, P <.001; D2: 73% vs 50%, P <.001). In reference to GI symptoms, the IBD group reported more moderate (2% vs 1%, P =.002) and severe symptoms (1.6% vs 0.2%, P =.002), compared with HCWs.
Among subjects with IBD, 1672 were on at least 1 IMT, while 298 were not on any IMT at time of vaccination. Symptoms were generally similar between both groups after D1 and D2. However, those on IMT experienced slightly higher musculoskeletal and rheumatologic symptoms after D1 (8% vs 5%, P =.05) and more GI symptoms after D2 (8% vs 5%, P =.03).
Study limitations include recall bias, since survey responses were self-reported. Additionally, the varying proportion of type of vaccine administered (40% of IBD receiving mRNA-1273 vs almost all HCWs receiving BNT162b2) may have influenced differences seen in symptoms after doses.
“Overall, our study findings should reassure IBD patients and providers that postvaccination symptoms after mRNA SARS-CoV-2 vaccination are generally less frequent among those with IBD relative to HCWs without IBD and that those on IMT might expect an even lower likelihood of postvaccination symptoms than those not on IMT,” the study authors noted. “Although a small proportion of IBD patients reported increased abdominal pain and diarrhea, these symptoms were mostly mild to moderate and of short duration.”
Mujukian A, Kumar R, Li D, et al. Postvaccination symptoms after SARS-COV-2 mRNA vaccination among patients with inflammatory bowel disease: a prospective, comparative study. Inflamm Bowel Dis. Published online August 9, 2023. doi:10.1093/ibd/izad114