The Impact of COVID-19 Vaccination on Autoimmune Rheumatic Diseases: Patient Reported Outcomes

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Patients with autoimmune rheumatic diseases due to the treatments they receive and immunological alterations constitute a group with a higher risk of presenting infectious complications, including severe COVID-19. Although vaccination seems to be an effective strategy to prevent complications from this infection, a significant percentage of patients have decided not to receive it.^[1] One of the most frequently mentioned reasons is the fear that the vaccine will trigger the activity of the underlying disease.

It has been reported that up to 5% of patients have a disease flare that requires a change in immunosuppressive treatment.^[2] However, it is important to note that there is no universal definition of an activity flare, so patients may report an exacerbation of symptoms that does not warrant a therapeutic change, but that alters the reported outcomes.

Outbreaks in patients with autoimmune diseases after vaccination

In order to assess the incidence of outbreaks reported by patients after vaccination against COVID-19, a group of researchers conducted an international, cross-sectional study, with data from electronic questionnaires.^[3]

Two questionnaires assessed short-term and long-term adverse events after vaccination against COVID-19. In these, information on the disease, demographics on comorbidities, treatment, and outcomes reported by patients, as well as on disease activity and other adverse events, were collected.

3,453 questionnaires from patients with autoimmune rheumatic diseases were included. The median age was 48 years (37 to 59) and 84.8% of the participants were female. Autoimmune rheumatic diseases included: rheumatoid arthritis (32.7%), generalized lupus erythematosus (20.9%), axial spondylitis (9.7%), systemic sclerosis (5.5%), mixed connective tissue disease (2 3%), some overlap syndrome (14.5%) and 14% another pathology.

Thirty-seven percent of the patients received steroid treatment and 60.7% reported active disease, most received the Pfizer/BioNTech (43.2%); 11.3% of patients reported having a disease flare with a median time to flare of 57.5 days (10.7 to 188.0); 14.8% had a flare that required an increase in immunosuppressive drugs. The most frequently reported symptoms included arthritis (61.6%), fatigue (58.8%), and muscle pain (53.4%).

The patients who reported outbreaks of activity more frequently had some comorbidity (51.9% vs. 45.3%; p = 0.013), mental health disorders (39.9% vs. 26.6%; p <0,001) y síndromes de sobreposición de enfermedades reumáticas autoinmunes (36,4% frente a 26,9%; p <0,001), en comparación con aquellos que no reportaron un brote de actividad.

Reported disease outbreaks were decreasing, with 16.9% reported in the second dose, 8.6% in the third, and 6.7% in the fourth. The regression analysis found a higher risk of reporting a flare in patients with overlap (odds ratio [OR]:1.4; 95% CI: 1.1 to 1.7), mental health conditions (OR: 1.7; 95% CI: 1.1 to 2.6), and in those who received the Modern (OR: 1.5; 95% CI: 1.09 to 2.2). The use of mycophenolate mofetil and glucocorticosteroids had a protective effect against disease flare-ups.

The authors mentioned that it is difficult to have a definition of a disease outbreak, so different indicators could alter the incidence reported in different studies. However, this research highlights the outcome from the point of view of the patients. Although a significant percentage presented an outbreak of activity, there is no control group, so this effect cannot be definitively attributed to the vaccine.

Expert opinion

Until now, it is not known why some patients achieve sustained disease remission and how the vaccine alters this state of new homeostasis.

Another interesting point was the relationship between the flare-ups and changes in the mental health of the patients, which could be attributed to a worse perception of the disease due to mental stressors or a lower therapeutic compliance associated with these disorders.^[4] It is possible that the use of immunosuppressants, such as mycophenolate or steroids, decreased the immunogenicity of the vaccine and, therefore, its association with disease outbreaks.

This study provides important information on the safety of vaccination against COVID-19 in this group of patients who may be uncertain about the effects of the vaccine on their underlying disease. This is why having a large study, with long-term follow-up and an emphasis on patient-reported outcomes helps guide the conversation with them. Although vaccination is the most recommended in all cases, we must be clear about the risks and adverse events that it can entail. As physicians, it is our duty to provide relevant information to help make joint decisions that support the preferences and priorities of our patients.

Follow Dr. Javier Merayo Chalico from Medscape in Spanish on Twitter @merayo_dr.

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