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Sufferers with systemic autoimmune rheumatic illnesses (SARDs) have frequent breakthrough COVID-19 following remedy with tixagevimab/cilgavimab, however the variety of sufferers who expertise extreme COVID-19 is low, in keeping with examine outcomes printed in The Journal of Rheumatology.
Mixture tixagevimab/cilgavimab has been authorized to be used amongst immunosuppressed sufferers, together with these with SARDs. Attributable to considerations about breakthrough SARS-CoV-2 infections, it’s usually reserved for these receiving B cell-depleting remedy. Nevertheless, little real-world knowledge can be found on remedy with tixagevimab/cilgavimab amongst this inhabitants. Researchers aimed to find out the incidence of and danger elements for breakthrough COVID-19 after remedy with tixagevimab/cilgavimab amongst immunocompromised sufferers with SARDs.
A retrospective cohort examine was carried out, together with sufferers who obtained tixagevimab/cilgavimab as pre-exposure prophylaxis (PrEP) between January 2, 2022, and November 16, 2022.
Among the many 444 sufferers included, 78.2% have been girls, imply affected person age was 62 years, and 79.3% have been White.
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Presently (as of July 2023), there is no such thing as a pre-exposure prophylaxis in opposition to SARS-CoV2 for severely immunocompromised sufferers reminiscent of SARD sufferers utilizing CD20 inhibitors or different potent immunosuppressive brokers.
Through the follow-up interval of 2637.6 person-months, 83 instances of breakthrough COVID-19 have been recognized, accounting for 18.7% of whole instances.
The incidence fee of breakthrough COVID-19 was 31.5 per 1000 person-months (95% CI, 24.7-38.2). The median time from first administration of tixagevimab/cilgavimab to symptomatic COVID-19 amongst these sufferers was 146 days (interquartile vary, 98-209 days).
Among the many 83 breakthrough instances, 7 sufferers (1.6%) had extreme COVID-19.
Older age (adjusted hazard ratio [aHR], 0.86 per 12 months; 95% CI, 0.75-0.99) and better baseline spike antibody ranges (aHR, 0.42; 95% CI, 0.18-0.99 for spike antibody ranges >200 vs <0.4 items) have been related to a decrease danger for breakthrough an infection.
Apparently, a previous COVID-19 an infection was not related to the chance for breakthrough an infection (aHR, 0.66; 95% CI, 0.35-1.25).
Research outcomes demonstrated no proof of a better danger for breakthrough an infection with CD20 inhibitor customers in contrast in opposition to sufferers handled with conventional-synthetic disease-modifying antirheumatic medicine (aHR, 1.05; 95%, CI 0.44-2.49).
Research limitations included the dearth of a comparator group of sufferers with SARDs who didn’t obtain tixagevimab/cilgavimab. Moreover, sufferers with SARDs who sought PrEP might have unmeasured variations associated to well being behaviors and entry to care. As a result of examine’s retrospective nature, circulating B cells or immunoglobulin ranges weren’t clinically examined.
Research authors famous, “Presently (as of July 2023), there is no such thing as a pre-exposure prophylaxis in opposition to SARS-CoV2 for severely immunocompromised sufferers reminiscent of SARD sufferers utilizing CD20 inhibitors or different potent immunosuppressive brokers.”
“Our findings spotlight the excessive scientific want for PrEP to stop COVID-19 amongst significantly weak sufferers,” they concluded.
Disclosure: Some examine authors declared affiliations with biotech, pharmaceutical, and/or system firms. Please see the unique reference for a full checklist of authors’ disclosures.
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