Article ID: e24008
We conducted a general drug use investigation to assess the real-world safety and clinical outcomes of sotrovimab treatment in Japan. Patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection were included in the investigation if they had risk factors for severe SARS-CoV-2 infection, did not require oxygen supplementation for SARS-CoV-2 infection, and would receive sotrovimab for the first time. The maximum observation period per patient was 29 days, starting from the day of sotrovimab administration: inpatients who were discharged or transferred to another hospital before day 29 were observed until the day of discharge or transfer, and outpatients were observed on the day of sotrovimab administration. Safety was evaluated through reports for any adverse drug reactions, and the clinical outcome endpoint was the percentage of patients who showed progression of SARS-CoV-2 infection (progressors) among the inpatients. Between January 31, 2022, and February 28, 2023, a total of 635 patients were enrolled in this investigation within 14 days of sotrovimab administration via a central enrollment method. During the median follow-up of 7.5 days, adverse drug reactions were reported in 1.6% (10/635) of the patients in the safety analysis set (including 142 outpatients): pyrexia in 7 patients, COVID-19 pneumonia in 2 patients, and dyspnoea, respiratory disorder, oropharyngeal pain, and eczema in 1 patient each. The percentage of progressors in the clinical outcome analysis set was 1.2% (6/489), with 1.5% (2/132) during the Omicron BA.1 dominant period, 1.0% (2/209) in the Omicron BA.2 dominant period, and 1.4% (2/148) in the Omicron BA.5 dominant period. This investigation found no new safety or clinical outcome concerns for sotrovimab treatment in the real-world setting during the Omicron BA.1, BA.2, and BA.5 dominant periods.
