Tezepelumab for severe asthma : final report Rind, David M., author. Campbell, Jonathan D., author. Herce-Hagiwara, Belén, author. Herron-Smith, Serina, author. Fluetsch, Noemi, author. Pearson, Steven D., author. McQueen, R. Brett, author. Gutierrez, Eric (Of University of Colorado), author. Antibodies, Monoclonal, Humanized -- therapeutic use Asthma -- drug therapy In the overall population of adults and adolescents with severe, uncontrolled asthma, tezepelumab added to standard-of-care therapy without biologics (as estimated by the placebo arm of the clinical trials) substantially reduces annualized asthma exacerbation rate (AAER). This is the case even in patients without eosinophilic asthma. However, in both eosinophilic and non-eosinophilic asthma patients the average effects of tezepelumab on daily symptoms and quality of life are small and generally smaller than the minimal clinically important difference (MCID) on scales measuring such outcomes. Improvements in AAER without large improvements in daily symptoms have been seen with other biologic therapies as well. Tezepelumab has a new mechanism of action, targeting thymic stromal lymphopoietin (TSLP). We do not find important safety signals in the clinical trials, but as noted above, new biologic therapies are frequently found to have safety concerns even after drug approval. This uncertainty is balanced by the severity of disease in the patients for whom tezepelumab is intended such that we think net harm is unlikely. Additionally, in the absence of longer-term trials, it is uncertain whether benefits may increase or decrease over time. [Boston, Massachusetts] : Institute for Clinical and Economic Review, February 13, 2023 Institute for Clinical and Economic Review, issuing body. Midwest Comparative Effectiveness Public Advisory Council, issuing body. Technical Report Text Illustrations 1 online resource (1 PDF file (various pages)) nlm:nlmuid-9918697385006676-pdf 9918697385006676 http://resource.nlm.nih.gov/9918697385006676 English United States Reproduced with permission of the copyright holder. Further use of the material is subject to CC BY license. http://creativecommons.org/licenses/by/4.0