Vaccination reduces risk for severe COVID-19 in patients using rituximab
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Although the breakthrough infection rate has been high in patients using rituximab during the later stages of the COVID-19 pandemic, a small proportion of those who are fully vaccinated develop severe outcomes, according to data.
“Our findings offer assurance to other clinicians who treat their patients with rituximab that this treatment appears to be generally safe in the context of a pandemic, as long as their patients are fully vaccinated,” Md Yuzaiful Md Yusof, PhD, MRCP, of the Leeds Institute of Rheumatic and Musculoskeletal Medicine, at the University of Leeds, in the United Kingdom, told Healio. “This is important since these patients often have limited other therapies to treat their conditions. We also demonstrated the effectiveness of COVID-19 and booster vaccination in preventing poor outcomes including deaths.”
To examine the incidence of breakthrough COVID-19, compare the rate of moderate-to-severe disease with that of any infection event, and assess key predictors of moderate-to-severe COVID-19 outcomes in patients using rituximab (Rituxan, Genentech), Yusof and colleagues conducted a retrospective cohort study. The researchers included 400 adults — at a mean age of 58.9 years — with rheumatic and musculoskeletal diseases who received at least one rituximab infusion at a single center in Leeds between Sept. 1, 2019, and April 1, 2022.
SARS-CoV-2 infection was confirmed through antigen or PCR test. COVID-19 outcomes were categorized as either mild — with patients ranging from from ambulatory to hospitalized but not requiring oxygen — or moderate-to-severe — defined as hospitalization with required oxygen support or death. The primary outcome was breakthrough SARS-CoV-2 infection, defined as a COVID-19 case occurring 14 days or more following the second vaccine dose. The researchers used Cox regression proportional hazards to analyze predictors of moderate-to-severe outcomes.
Among the included patients, 398 had vaccine data available, of whom 93% were fully vaccinated. Among the 400 total included participants, 68% rheumatoid arthritis, 12% had systemic lupus erythematosus, 12% had anti-neutrophil cytoplasmic antibody-associated vasculitis, 12% had other rheumatic and musculoskeletal diseases. There were a total of 774.6 patient-years of follow-up.
According to the researchers, of the 370 patients who were fully vaccinated and had complete data, 30% demonstrated any breakthrough infection, 4% had a moderate-to-severe breakthrough case and 1 patient died. Following the vaccination phase of the pandemic that began on Dec. 18, 2020, COVID-19 incidence rates of any severity were “substantially lower” in fully vaccinated patients (22.83 per 100 person-years; 95% CI, 18.94-27.52), compared with those who were unvaccinated or partially vaccinated (89.46 per 100 person-years; 95% CI, 52.98.151.05), the researchers wrote.
Incidence rates were similarly lower in vaccinated patients in terms of moderate-to-severe disease, at 3.32 per 100 person-years (95% CI, 2.03-5.42), compared with 25.56 per 100 person-years (95% CI, 9.59-68.1) among those partially vaccinated or unvaccinated. The rate of moderate-to-severe COVID-19 was “broadly similar” to other severe infection events in patients receiving rituximab (5.68 per 100 person-years; 95% CI, 4.22-7.63), the researchers wrote.
The most predictive factors of an increased risk for moderate-to-severe COVID-19 were number of comorbidities (HR = 1.46; 95% CI, 1.13-1.89) and hypogammaglobulinemia (HR = 3.22; 95% CI, 1.27-8.19).
“Breakthrough SARS-CoV-2 infection was common in rituximab-treated patients, but most COVID-19 cases were mild,” Yusof and colleagues wrote in The Lancet Rheumatology. “Later in the pandemic, there have been less severe SARS-CoV-2 variants, increased use of vaccination, less social restrictions, and new therapies. The risk-benefit ratio might favor rituximab in vaccinated patients with severe rheumatic and musculoskeletal diseases who have few other treatment options. Increased vigilance is needed in the presence of comorbidities and low IgG concentrations for all infection types.”
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Yusof MYM, et al. Lancet Rheumatol. 2022;doi:10.1016/S2665-9913(22)00340-X.
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