Tezepelumab for the treatment of severe asthma: a plain language summary of the PATHWAY and NAVIGATOR studies
Abstract
What is this summary about?
This is a summary of the results of 2 clinical studies that looked at a medicine called tezepelumab. Tezepelumab is approved in the United States of America (USA), the European Union (EU) and several other countries for the treatment of severe, uncontrolled asthma in people aged 12 and above. The results of these 2 studies, called PATHWAY and NAVIGATOR, formed the basis for tezepelumab's approval for use.
Tezepelumab is a type of biologic treatment called an antibody. Biologics are treatments that target certain cells or proteins in the body and often in the immune system - the body's natural defence system against infections and diseases - to reduce patients' disease. It works by blocking a key first step in the body's chain reaction leading to inflammation in the airways of people with severe asthma.
The clinical studies were done to learn if tezepelumab can be used to treat people with severe, uncontrolled asthma and to find out about its safety. In both studies, tezepelumab was compared to placebo. A placebo is a dummy treatment that looked like tezepelumab but did not have any medicine in it.
What were the main conclusions reported by the researchers?
In both studies, tezepelumab reduced the number of severe asthma attacks that the participants had per year compared with placebo. It also increased the volume of air that the participants could breathe out in 1 second compared with placebo.
Tezepelumab was well-tolerated, and a similar number of participants had health issues in the tezepelumab and placebo treatment groups.
The most common health issues that the participants had during the PATHWAY study were: Worsening of asthma, common cold, headache, and inflammation of the airways.
The most common health issues that the participants had during the NAVIGATOR study were: Common cold, infection of the sinuses, throat and airways, headache, worsening of asthma, and inflammation of the airways.
What are the key takeaways?
The results showed that participants who had monthly doses of tezepelumab had fewer severe asthma attacks and better lung function than those who had placebo. In both studies, the health issues that the participants had were similar between the tezepelumab and placebo treatment groups.
Overall, the studies showed that tezepelumab worked in a broad population of people with severe asthma and that the study participants had an acceptable level of health issues during the studies. These results led to the approval of tezepelumab for people with severe asthma aged 12 and above in the USA, EU and other countries.
Clinical Trial Registration: PATHWAY study: NCT02054130; NAVIGATOR study: NCT03347279 (ClinicalTrials.gov)
This is an abstract of the Plain Language Summary of Publication article.
To read the full Plain Language Summary of this article, click here to view the PDF.
Link to original PATHWAY article here
Link to original NAVIGATOR article here
Acknowledgments
AstraZeneca and Amgen Inc. would like to thank the clinical study participants and their family members and carers. They would also like to thank the investigators and staff at the study centres who cared for the participants in the clinical studies.
Editorial review was provided by Luke Kennedy Burke, PhD, of AstraZeneca UK. Medical writing and editorial assistance were provided by Claudia Brockmeyer, PhD, and Emma Wescott, respectively, of Oxford PharmaGenesis, UK, and was supported by AstraZeneca UK. Andrew Menzies-Gow, MD, has an additional affiliation with Respiratory and Immunology, BioPharmaceuticals Medical, AstraZeneca, Cambridge, UK.
Financial & competing interests disclosure
Jonathan Corren, MD, has received grants and personal fees from AstraZeneca, Genentech and Vectura, and has received grants from Optinose, Sanofi and Teva Pharmaceuticals. Andrew Menzies-Gow, MD, Gun Almqvist, MSc, Karin Bowen, MSc, Janet M Griffiths, PhD, and Sandhia Ponnarambil, MD, are employees of AstraZeneca and may own stocks or stock options in AstraZeneca. Andrew Menzies-Gow, MD, has attended advisory board meetings for AstraZeneca, GSK, Novartis, Regeneron Pharmaceuticals, Sanofi and Teva Pharmaceuticals; has received speaker fees from AstraZeneca, Novartis, Sanofi and Teva Pharmaceuticals; has participated in research with AstraZeneca, for which his institution has been remunerated; has attended international conferences with Teva Pharmaceuticals; and has consultancy agreements with AstraZeneca and Sanofi. Arnaud Bourdin, MD, has received grants from AstraZeneca, Boehringer Ingelheim, Cephalon/Teva Pharmaceuticals, GlaxoSmithKline, Novartis and Sanofi-Regeneron Pharmaceuticals; has provided consultancy for Actelion, AstraZeneca, Boehringer Ingelheim, Chiesi, GlaxoSmithKline, MedinCell, Merck, Novartis, Roche and Sanofi-Regeneron Pharmaceuticals; and has acted as an investigator or co-investigator for trials sponsored by Actelion, AstraZeneca, Boehringer Ingelheim, Chiesi, Galapagos, GlaxoSmithKline, Merck, Novartis, Roche, Sanofi-Regeneron Pharmaceuticals and Vertex. Elliot Israel, MD, has served as a consultant to and received personal fees from 4D Pharma, AB Science, Amgen, AstraZeneca, Avillion, Biometry, Cowen, Equillium, Genentech, GlaxoSmithKline, Merck, Novartis, Pneuma Respiratory, PPS Health, Regeneron Pharmaceuticals, Sanofi, Sienna Biopharmaceuticals and Teva Pharmaceuticals; has received non-financial support from Circassia, Teva Pharmaceuticals and Vorso Corp; and has received clinical research grants from AstraZeneca, Avillion, Genentech, Gossamer Bio, Novartis and Sanofi. Gene Colice, MD, was an employee of AstraZeneca at the time of the study. Christopher E Brightling, MD, FMedSci, is an asthma doctor in the UK and has received grants and consultancy fees from 4D Pharma, AstraZeneca, Chiesi, Genentech, GlaxoSmithKline, Mologic, Novartis, Regeneron Pharmaceuticals, Roche and Sanofi. Michael E Wechsler, MD, is an employee of National Jewish Health and has received consultancy fees from AstraZeneca, Equillium, Genentech, GlaxoSmithKline, Novartis, Regeneron Pharmaceuticals, resTORbio, Sanofi, and Teva Pharmaceuticals.
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