The Pfizer-BioNTech mRNA vaccine (Comirnaty) showed a good safety profile with minimal short-term side effects and no negative impact on disease activity in a cohort of adolescents and young adults with rheumatic diseases, according to research presented at the annual scientific meeting of the Childhood Arthritis and Rheumatology Research Alliance, held virtually this year.
Only 3% of patients experience a severe transient adverse event, according to Merav Heshin-Bekenstein, MD, of Dana-Dwek Children’s Hospital at the Tel Aviv Sourasky Medical Center in Israel. The findings were published in Rheumatology.
Courtesy Dr. Heshin-Bekenstein
Dr. Merav Heshin-Bekenstein
“We found that the mRNA Pfizer vaccine was immunogenic and induced an adequate humoral immune response in adolescent patients,” Dr. Heshin-Bekenstein told CARRA attendees. “It was definitely comparable to healthy controls and practically all patients were seropositive following the second vaccine, except for one patient with long-standing systemic sclerosis.”
The findings were not necessarily surprising but were encouraging to Melissa S. Oliver, MD, assistant professor of clinical pediatrics in the division of pediatric rheumatology at Indiana University, Indianapolis. Dr. Oliver wasn’t part of the study team.
“We know that the COVID vaccines in healthy adolescents have shown good efficacy with minimal side effects, and it’s good to see that this study showed that in those with rheumatic diseases on immunosuppressive therapy,” Dr. Oliver told this news organization.
Dr. Melissa S. Oliver
Until now, the data on COVID-19 vaccines in teens with rheumatic illnesses has been limited, she said, so “many pediatric rheumatologists only have the data from adult studies to go on or personal experience with their own cohort of patients.”
But the high immunogenicity seen in the study was a pleasant surprise to Beth H. Rutstein, MD, assistant professor of clinical pediatrics in the division of rheumatology at Children’s Hospital of Philadelphia and the Perelman School of Medicine at the University of Pennsylvania.
“I was both surprised and thrilled with Dr. Heshin-Bekenstein’s findings suggesting near-universal seroconversion for patients with rheumatic disease regardless of underlying diagnosis or immunomodulatory therapy regimen, as much of the adult data has suggested a poorer seroconversion rate” and lower antibody titers in adults with similar illnesses, Dr. Rutstein said in an interview.
The study “provides essential reassurance that vaccination against COVID-19 does not increase the risk of disease flare or worsen disease severity scores,” said Dr. Rutstein, who was not associated with the research. “Rather than speaking purely anecdotally with our patients and their families, we can refer to the science – which is always more reassuring for both our patients and ourselves.”
Study included diverse conditions and therapies
Risk factors for poor outcomes with COVID-19 in children include obesity, cardiovascular disease, chronic lung disease, diabetes, and asthma, Dr. Heshin-Bekenstein told CARRA attendees. Multisystem inflammatory syndrome in children (MIS-C) and long COVID are also potential complications of COVID-19 with less understood risk factors.
Although COVID-19 is most often mild in children, certain severe, systemic rheumatic diseases increase hospitalization risk, including systemic lupus erythematosus (SLE) and vasculitis. Evidence has also shown that COVID-19 infection increases the risk of disease flare in teens with juvenile-onset rheumatic diseases, so it’s “crucial to prevent COVID-19 disease in this population,” Dr. Heshin-Bekenstein said.
Her study therefore aimed to assess the safety and immunogenicity of the Pfizer mRNA vaccine for teens with juvenile-onset rheumatic diseases and those taking immunomodulatory medications. The international prospective multicenter study ran from April to November 2021 at three pediatric rheumatology clinics in Israel and one in Slovenia. Endpoints included short-term side effects, vaccination impact on clinical disease activity, immunogenicity at 2-9 weeks after the second dose, and, secondarily, efficacy against COVID-19 infection.
The 91 participants included adolescents aged 12-18 and young adults aged 18-21. Nearly half of the participants (46%) had juvenile idiopathic arthritis (JIA), and 14% had SLE. Other participants’ conditions included systemic vasculitis, idiopathic uveitis, inflammatory bowel disease–related arthritis, systemic or localized scleroderma, juvenile dermatomyositis, or an autoinflammatory disease. Participants’ mean disease duration was 4.8 years.
The researchers compared the patients with a control group of 40 individuals with similar demographics but without rheumatic disease. The researchers used the LIAISON quantitative assay to assess serum IgG antibody levels against the SARS-CoV-2 spike protein in both groups.
Eight in 10 participants with rheumatic disease were taking an immunomodulatory medication, including a conventional synthetic disease-modifying antirheumatic drug (csDMARD) in 40%, a biologic DMARD in 37%, tumor necrosis factor (TNF) inhibitors in 32%, hydroxychloroquine (HCQ) in 19%, glucocorticoids in 14%, and mycophenolate in 11%. A smaller proportion were on other biologics: JAK inhibitors in 6.6%, anti-CD20 drugs in 4.4%, and an IL-6 inhibitor in 1%.