TY - JOUR
T1 - Early improvements of individual symptoms as a predictor of treatment response to asenapine in patients with schizophrenia
AU - Ogyu, Kamiyu
AU - Noda, Yoshihiro
AU - Yoshida, Kazunari
AU - Kurose, Shin
AU - Masuda, Fumi
AU - Mimura, Yu
AU - Nishida, Hana
AU - Plitman, Eric
AU - Tarumi, Ryosuke
AU - Tsugawa, Sakiko
AU - Wada, Masataka
AU - Miyazaki, Takahiro
AU - Uchida, Hiroyuki
AU - Graff-Guerrero, Ariel
AU - Mimura, Masaru
AU - Nakajima, Shinichiro
N1 - Funding Information:
Dr Ogyu has received grants from Inokashira Hospital Research Fund. Dr Noda has received an investigator‐initiated clinical study grant from TEIJIN PHARMA LIMITED and research grants from Japan Health Foundation, Meiji Yasuda Mental Health Foundation, Mitsui Life Social Welfare Foundation, Takeda Science Foundation, SENSHIN Medical Research Foundation, Health Science Center Foundation, Mochida Memorial Foundation for Medical and Pharmaceutical Research, and Daiichi Sankyo Scholarship Donation Program. He receives equipment‐in‐kind supports for an investigator‐initiated study from Magventure Inc, Inter Reha Co., Ltd, Rogue Resolutions Ltd, and Miyuki Giken Co., Ltd. Dr Yoshida has received manuscript fees from Sumitomo Dainippon Pharma, fellowship grants from the Japan Research Foundation for Clinical Pharmacology, and consultant fees from Bracket and VeraSci within the past 3 years. Dr Graff‐Guerrero has received support from the United States National Institute of Health, CIHR, OMHF, Consejo Nacional de Ciencia y Tecnología, the Instituto de Ciencia y Tecnología del DF, the Brain & Behavior Research Foundation (Formerly NARSAD), the Ontario Ministry of Health and Long‐Term Care, the Ontario Ministry of Research and Innovation Early Research Award, and Janssen. Dr Uchida has received grants from Eisai, Otsuka Pharmaceutical, Dainippon‐Sumitomo Pharma, Mochida Pharmaceutical, Meiji‐Seika Pharmaceutical, and Novartis; speaker's honoraria from Otsuka Pharmaceutical, Eli Lilly, Shionogi, Pfizer, Yoshitomi Yakuhin, Dainippon‐Sumitomo Pharma, Meiji‐Seika Pharma, MSD, and Janssen Pharmaceutical; and advisory panel payments from Dainippon‐Sumitomo Pharma within the past 3 years. Dr Mimura has received grants or speaker's honoraria from Asahi Kasei Pharma, Astellas Pharmaceutical, Daiichi Sankyo, Dainippon‐Sumitomo Pharma, Eisai, Eli Lilly, GlaxoSmithKline, Janssen Pharmaceutical, Meiji‐Seika Pharma, Mochida Pharmaceutical, MSD, Novartis Pharma, Otsuka Pharmaceutical, Pfizer, Shionogi, Takeda, Tanabe Mitsubishi Pharma, and Yoshitomi‐Yakuhin within 3 years. Dr Nakajima has received fellowship grants from CIHR, research support from Japan Society for the Promotion of Science, Japan Research Foundation for Clinical Pharmacology, Naito Foundation, Uehara Memorial Foundation, Takeda Science Foundation, Daiichi Sankyo, and MSD, manuscript fees or speaker's honoraria from Dainippon Sumitomo Pharma and Yoshitomi Yakuhin within the past 3 years. Other authors have no financial or other relationship relevant to the subject of this manuscript.
Funding Information:
Meiji Seika Pharma provided phase III data for the study.
Publisher Copyright:
© 2020 The Authors. Neuropsychopharmacology Reports published by John Wiley & Sons Australia, Ltd on behalf of The Japanese Society of Neuropsycho Pharmacology
PY - 2020/6/1
Y1 - 2020/6/1
N2 - Aim: It is well accepted that early improvement with antipsychotics predicts subsequent response in patients with schizophrenia. However, no study has examined the contribution of individual symptoms rather than overall symptom severity as the predictors. Thus, we aimed to detect individual symptoms whose improvements could predict subsequent response in patients with schizophrenia during treatment with asenapine and examine whether a prediction model with individual symptoms would be superior to a model using overall symptom severity. Methods: This study analyzed a dataset including 532 patients with schizophrenia enrolled in a 6-week double-blind, placebo-controlled, randomized trial of asenapine. Response to asenapine was defined as a ≥30% decrease in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 6. Stepwise logistic regression analyses were performed to investigate the associations among response and PANSS total/individual item score improvements at week 1 or week 2. Results: Response was associated with early improvement in the following PANSS items: disturbance of volition, active social avoidance, poor impulse control at week 1; and active social avoidance, poor attention, lack of judgment and insight at week 2. Prediction accuracy was almost compatible between the model with individual symptoms and the model with PANSS total score both at weeks 1 and 2 (Nagelkerke R2:.51,.42 and.55,.54, respectively). Conclusion: Early improvement in negative symptoms, poor attention and impulse control, and lack of insight, in particular predicted subsequent treatment response in patients with schizophrenia during treatment with asenapine as accurately as prediction based on overall symptom severity.
AB - Aim: It is well accepted that early improvement with antipsychotics predicts subsequent response in patients with schizophrenia. However, no study has examined the contribution of individual symptoms rather than overall symptom severity as the predictors. Thus, we aimed to detect individual symptoms whose improvements could predict subsequent response in patients with schizophrenia during treatment with asenapine and examine whether a prediction model with individual symptoms would be superior to a model using overall symptom severity. Methods: This study analyzed a dataset including 532 patients with schizophrenia enrolled in a 6-week double-blind, placebo-controlled, randomized trial of asenapine. Response to asenapine was defined as a ≥30% decrease in Positive and Negative Syndrome Scale (PANSS) total score from baseline to week 6. Stepwise logistic regression analyses were performed to investigate the associations among response and PANSS total/individual item score improvements at week 1 or week 2. Results: Response was associated with early improvement in the following PANSS items: disturbance of volition, active social avoidance, poor impulse control at week 1; and active social avoidance, poor attention, lack of judgment and insight at week 2. Prediction accuracy was almost compatible between the model with individual symptoms and the model with PANSS total score both at weeks 1 and 2 (Nagelkerke R2:.51,.42 and.55,.54, respectively). Conclusion: Early improvement in negative symptoms, poor attention and impulse control, and lack of insight, in particular predicted subsequent treatment response in patients with schizophrenia during treatment with asenapine as accurately as prediction based on overall symptom severity.
KW - antipsychotic
KW - asenapine
KW - early improvement
KW - prediction
KW - response
KW - schizophrenia
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U2 - 10.1002/npr2.12103
DO - 10.1002/npr2.12103
M3 - Article
C2 - 32180369
AN - SCOPUS:85081739115
SN - 1340-2544
VL - 40
SP - 138
EP - 149
JO - Neuropsychopharmacology Reports
JF - Neuropsychopharmacology Reports
IS - 2
ER -