Support for Prophylactic Anti-SARS-CoV-2 Monoclonal Antibodies in Patients With Immune-Mediated Disease

By Reuters Staff

April 25, 2022

NEW YORK (Reuters Health) - Severely immunocompromised patients with immune-mediated inflammatory diseases often do not mount an adequate antibody response to SARS-CoV-2 vaccination and treatment with anti-SARS-CoV-2 monoclonal antibodies before exposure lowers the risk of COVID-19, report researchers in France.

"Our study is, to our knowledge, the first to report on the real-world clinical use of prophylactic anti-SARS-CoV-2 monoclonal antibodies in patients with immune-mediated inflammatory diseases, with initial evidence for clinical benefit," write Dr. Tiphaine Goulenok of Assistance Publique Hopitaux de Paris and colleagues in The Lancet Rheumatology.

They studied 165 patients fully vaccinated against SARS-CoV-2 who had immune-mediated inflammatory diseases and were taking immunosuppressive drugs, including 70 who were severely immunocompromised.

Forty-four patients were screened for humoral response after vaccination and 17 (39%) had an inadequate humoral response to vaccine, defined by a serum SARS-CoV-2 anti-spike IgG (anti-S) titer of less than 264 binding antibody units (BAU)/mL at two to four weeks after receiving a fourth vaccine dose.

These 17 patients were eligible for pre-exposure prophylaxis with anti-SARS-CoV-2 monoclonal antibodies (tixagevimab plus cilgavimab) and 10 received it.

PCR-confirmed COVID-19 occurred in eight (47%) of the 17 patients, with infection occurring a median of 49 days after the fourth vaccine dose.

Seven of the eight patients with PCR-confirmed COVID-19 did not receive prophylactic monoclonal antibodies. The patient who received prophylactic tixagevimab and cilgavimab and developed COVID-19 had only mild disease and did not require admission to hospital.

"Our findings support the use of timely pre-exposure administration of prophylactic anti-SARS-CoV-2 monoclonal antibodies to prevent COVID-19 in patients with immune-mediated inflammatory diseases who are severely immunocompromised and do not generate an adequate humoral response to vaccination," the researchers write.

"All patients with immune-mediated inflammatory diseases who are receiving immunosuppressive drugs should be screened for humoral response to vaccination based on anti-S titers. The absence of anti-SARS-Cov-2 antibodies after full vaccination identifies patients who are at high risk and are eligible for anti-COVID-19 monoclonal antibody prophylaxis," they advise.

"Successful administration of anti-SARS-CoV-2 monoclonal antibodies requires accurate identification of high-risk patients, rapid assessment of humoral responses to vaccination based on anti-S titers, and an easily accessible site for anti-SARS- CoV-2 monoclonal antibody administration," they note.

SOURCE: The Lancet Rheumatology, online April 11, 2022.