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The objective of this investigation was to identify the baseline characteristics predictive of treatment response, measured by improvement in motor symptom severity, in advanced PD patients treated with LCIG during a 54-week, open-label phase 3 study. Patients with \u22651\u2009h improvement from baseline in \u201cOff\u201d time were categorized as \u201cResponders\u201d; whereas those with &lt;1\u2009h improvement, any worsening, or no post-baseline assessment were \u201cNon-Responders\u201d. A subgroup of Responders with \u22653\u2009h improvement in \u201cOff\u201d time was also examined; this subgroup was identified as \u201cRobust Responders\u201d. Baseline demographics and disease characteristics were analyzed and their predictive relationship to change from baseline in normalized \u201cOff\u201d time was assessed. Out of the 324 patients included in the analysis, 272 (84.0%) were categorized as Responders and 52 (16.0%) were Non-Responders. A majority of patients (65.7%) had \u22653\u2009h improvement in \u201cOff\u201d time. In general, baseline characteristics were similar between Non-responders, Responders, and the subgroup of Robust Responders. A conditional tree-structured regression analysis identified baseline \u201cOff\u201d time as the only factor that had significant effect on Responder and Robust Responder status. The safety profile of LCIG was similar between patient groups. Overall, this analysis showed that 84% of LCIG-treated advanced PD patients had \u22651\u2009h improvement in \u201cOff\u201d time and the number-needed-to-treat to observe one patient responder was 1.19 patients. Notably, Responders and Robust Responders to LCIG were observed across the range of baseline demographics and clinical characteristics examined.<\/jats:p>","DOI":"10.1038\/s41531-017-0040-2","type":"journal-article","created":{"date-parts":[[2018,1,18]],"date-time":"2018-01-18T14:37:07Z","timestamp":1516286227000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":8,"title":["Systematic evaluation of levodopa-carbidopa intestinal gel patient-responder characteristics"],"prefix":"10.1038","volume":"4","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-2921-8348","authenticated-orcid":false,"given":"David G.","family":"Standaert","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"James T.","family":"Boyd","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Per","family":"Odin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Weining Z.","family":"Robieson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jorge","family":"Zamudio","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-4326-2612","authenticated-orcid":false,"given":"Krai","family":"Chatamra","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2018,1,24]]},"reference":[{"key":"40_CR1","doi-asserted-by":"publisher","first-page":"448","DOI":"10.1002\/mds.1090","volume":"16","author":"JE Ahlskog","year":"2001","unstructured":"Ahlskog, J. 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G. S. is a member of the faculty of the University of Alabama at Birmingham and is supported by endowment and University funds. D. G. S. is an investigator in studies funded by Abbvie, Inc., the American Parkinson Disease Association, the Michael J. Fox Foundation for Parkinson Research, Alabama Department of Commerce, and NIH grants P01NS087997, P20NS087997, R25NS079188, P2CHD086851, and P30NS047466. He has a clinical practice and is compensated for these activities through the University of Alabama Health Services Foundation. In addition, since 1st January 2016 he has served as a consultant for or received honoraria from Serina Therapeutics, Abbvie, Voyager Therapeutics, the Michael J. Fox Foundation for Parkinson Research, The International Parkinson Disease and Movement Disorder Society, the National Institutes of Health, The American Institute for Biological Sciences, Rush University, Huntsville Hospital, UCSD, Voyager Therapeutics, and he has received royalties for publications from McGraw Hill, Inc. J. T. B. served as a consultant and\/or scientific advisor for AbbVie Inc., Auspex, Teva, Lundbeck, Chronos Therapeutics, Neurocrine, and Medical Education Resources. He has received research support from the Michael J. Fox Foundation for Parkinson Research, NIH\/NINDS, Auspex, Biotie, Cure Huntington\u2019s Disease Initiative, Vaccinex, Teva, AbbVie Inc., NeuroDerm, and Roche. P. O. was a study investigator and has received compensations for consultancy and speaker related activities from AbbVie, Britannia, Boehringer-Ingelheim, Nordic Infucare, UCB, and Zambon. P. O. has received royalties from Uni-Med Verlag. W. Z. R. and J. Z. are employees of AbbVie and hold AbbVie stock and\/or stock options. K. C. is a former employee of AbbVie and and holds AbbVie stock and\/or stock options.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"4"}}