Drug products: EVUSHELD
ATC code: J06BD03
The efficacy of tixagevimab-cilgavimab is similar in men and women in clinical phase 3 trials.
Pharmacokinetics and dosing
Women have slightly lower exposure of tixagevimab-cilgavimab, according to the manufacturer’s population pharmacokinetic analysis (1338 men, 1220 women). Weight-adjusted clearance were comparable in men and women. Patient’s sex was not considered to have a clinically relevant effect on the pharmacokinetics for tixagevimab and cilgavimab .
The efficacy of tixagevimab-cilgavimab in patients with increased risk of an inadequate response to covid-19 vaccination or exposure to SARS-CoV-2 was analyzed in the pivotal phase 3 trial PROVENT (2800 men, 2397 women). Prevention of covid-19 was better in men than women, although the sex difference did not reach statistical significance (relative risk reduction 93.9% (95%CI 73.7-98.6) vs 70.3% (95% CI 32.4-87.0)) .Protection against progression of severe COVID-19 from a single dose of tixagevimab-cilgavimab in unvaccinated non-hospitalized individuals with a SARS-CoV-2 infection was analyzed in the phase 3 trial TACKLE (448 men, 455 women). Men and women had similar response rates (relative risk reduction 44.9% (95%CI -12.8-73.1) vs 52.9% (95%CI -7.5-79.4)) .Another phase 3 trial evaluated tixagevimab-cilgavimab (823 men, 594 women), in addition to remdesivir and other standard treatment, in patients hospitalized with COVID-19. Treatment did not improve time to sustained recovery and there were no sex differences in recovery rate ratios (1.06 vs 1.10) .
No sex-divided data of adverse effects were reported in the trials PROVENT and TACKLE [2, 3]. Among reports of suspected adverse reactions for tixagevimab-cilgavimab registered in the European database EudraVigilance, the majority of individual cases were women (>50%) . The most common adverse reactions reported were the same in men and women: reactions at the injection site .
Reproductive health issues
Regarding teratogenic aspects, please consult Janusmed Drugs and Birth Defects (in Swedish, Janusmed fosterpåverkan).
Date of litterature search: 2022-08-11
- Evusheld (tixagevimab, cilgavimab). AstraZeneca AB. EMA EPAR Scientific Discussion. Published 28/04/2022.
- Levin MJ, Ustianowski A, De Wit S, Launay O, Avila M, Templeton A et al. Intramuscular AZD7442 (Tixagevimab-Cilgavimab) for Prevention of Covid-19. N Engl J Med. 2022;386(23):2188-2200. PubMed
- Montgomery H, Hobbs FDR, Padilla F, Arbetter D, Templeton A, Seegobin S et al. Efficacy and safety of intramuscular administration of tixagevimab-cilgavimab for early outpatient treatment of COVID-19 (TACKLE): a phase 3, randomised, double-blind, placebo-controlled trial. Lancet Respir Med. 2022. PubMed
- ACTIV-3–Therapeutics for Inpatients with COVID-19 (TICO) Study Group. Tixagevimab-cilgavimab for treatment of patients hospitalised with COVID-19: a randomised, double-blind, phase 3 trial. Lancet Respir Med. 2022. PubMed
- EudraVigilance. Amsterdam: European Medicines Agency (EMA). 2022 [updated 2022-08-13, cited 2022-08-17.] länk
Reviewed by: Diana Rydberg, Pauline Raaschou
Approved by: Karin Schenck-Gustafsson