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Previously reported placebo-response-associated variants do not predict patient outcomes in inflammatory disease Phase III trial placebo arms.

ABSTRACT: In clinical trials, a placebo response refers to improvement in disease symptoms arising from the psychological effect of receiving a treatment rather than the actual treatment under investigation. Previous research has reported genomic variation associated with the likelihood of observing a placebo response, but these studies have been limited in scope and have not been validated. Here, we analyzed whole-genome sequencing data from 784 patients undergoing placebo treatment in Phase III Asthma or Rheumatoid Arthritis trials to assess the impact of previously reported variation on patient outcomes in the placebo arms and to identify novel variants associated with the placebo response. Contrary to expectations based on previous reports, we did not observe any statistically significant associations between genomic variants and placebo treatment outcome. Our findings suggest that the biological origin of the placebo response is complex and likely to be variable between disease areas.

SUBMITTER: Haug-Baltzell A

PROVIDER: S-EPMC6515143 | biostudies-literature | 2019 Feb

REPOSITORIES: biostudies-literature

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Previously reported placebo-response-associated variants do not predict patient outcomes in inflammatory disease Phase III trial placebo arms.

Haug-Baltzell Asher A Bhangale Tushar R TR Chang Diana D Dressen Amy A Yaspan Brian L BL Ortmann Ward W Brauer Matthew J MJ Hunkapiller Julie J Reeder Jens J Mukhyala Kiran K Cuenco Karen T KT Tom Jennifer A JA Cowgill Amy A Vogel Jan J Forrest William F WF Behrens Timothy W TW Graham Robert R RR Wuster Arthur A

Genes and immunity 20180318 2

In clinical trials, a placebo response refers to improvement in disease symptoms arising from the psychological effect of receiving a treatment rather than the actual treatment under investigation. Previous research has reported genomic variation associated with the likelihood of observing a placebo response, but these studies have been limited in scope and have not been validated. Here, we analyzed whole-genome sequencing data from 784 patients undergoing placebo treatment in Phase III Asthma o ...[more]

PMID: 29550837

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Previously reported placebo-response-associated variants do not predict patient outcomes in inflammatory disease Phase III trial placebo arms.

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Previously reported placebo-response-associated variants do not predict patient outcomes in inflammatory disease Phase III trial placebo arms.

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