The Clinical Relevance of Pain Severity Changes: Is There Any Difference Between Asian and Caucasian Patients With Osteoarthritis Pain?

Li Yue, Jianing Wang, Hiroyuki Enomoto, Shinji Fujikoshi, Levent Alev, Yan Yolanda Cheng, Vladimir Skljarevski, Li Yue, Jianing Wang, Hiroyuki Enomoto, Shinji Fujikoshi, Levent Alev, Yan Yolanda Cheng, Vladimir Skljarevski

Abstract

The objective of the present analysis was to determine whether changes in Brief Pain Inventory (BPI) average pain scores by patient global impression of improvement (PGI-I) category and the cut-off for clinically important difference (CID) were different between Asian and Caucasian patients with chronic pain due to osteoarthritis. This analysis used data from 3 (Caucasian) and 2 (Asian) randomized, placebo-controlled, 10- to 14-week duloxetine studies for the treatment of patients ≥40 years of age with osteoarthritis pain. The receiver operating characteristic (ROC) analysis was used to characterize the association between changes in BPI average pain scores and PGI-I levels at study endpoint. The CID was characterized by PGI-I, and the cut-off point for CID in BPI average pain scores was determined by the intersection of a 45-degree tangent line with each ROC curve. Data from 668 Asian and 868 Caucasian patients were available for analysis. Baseline BPI average pain ratings including worst and least pain were comparable between Asians and Caucasians. Ratings for percentage change from baseline to endpoint for BPI average pain scores in Asian patients and Caucasian patients were similar across the 7 PGI-I categories, regardless of age, gender, study, and treatment. The ROC analysis results of cut-off points in BPI average pain scores demonstrated the raw change cut-off was -3.0, and percentage change cut-off was -40% for both Asian and Caucasian patients. Overall, the present analysis concludes changes in BPI average pain scores by PGI-I category and the cut-off for CID were similar for Asian and Caucasian patients with chronic pain due to osteoarthritis.

Trial registration: ClinicalTrials.gov NCT00408421 NCT01018680 NCT00433290 NCT01931475 NCT02248480.

Keywords: Asian patient; Caucasian patient; chronic pain; clinical improvement; duloxetine; osteoarthritis; pain severity; racial difference.

Conflict of interest statement

All authors are Eli Lilly and Company employees, except for Li Yue. Hiroyuki Enomoto, Shinji Fujikoshi, Levent Alev, Yan Yolanda Cheng, and Vladimir Skljarevski are minor stakeholders. Li Yue and Jianing Wang have no conflicts of interest to declare.

© 2019 The Authors. Pain Practice published by Wiley Periodicals, Inc. on behalf of World Institute of Pain.

Figures

Figure 1
Figure 1
Reduction of Brief Pain Inventory (BPI) average pain scores from baseline to endpoint by Patient Global Impression of Improvement (PGI‐I) category according to race. N, number of subjects in analysis population. Data presented are median values.
Figure 2
Figure 2
Reduction of Brief Pain Inventory (BPI) average pain scores from baseline to endpoint by Patient Global Impression of Improvement (PGI‐I) category according to age group in Asian (A) and Caucasian (B) patients. Data presented are median values.
Figure 3
Figure 3
Reduction of Brief Pain Inventory (BPI) average pain scores from baseline to endpoint by Patient Global Impression of Improvement (PGI‐I) category according to gender in Asian (A) and Caucasian (B) patients. Data presented are median values.
Figure 4
Figure 4
Reduction of Brief Pain Inventory (BPI) average pain scores from baseline to endpoint by Patient Global Impression of Improvement (PGI‐I) category according to study participation. N, number of subjects in analysis population for each study. Data presented are median values. Clinical trial identifiers: Study 1, NCT01931475; Study 2, NCT02248480; Study 3, NCT00408421; Study 4, NCT00433290; Study 5, NCT01018680.
Figure 5
Figure 5
Reduction of Brief Pain Inventory (BPI) average pain from baseline to endpoint by Patient Global Impression of Improvement (PGI‐I) category according to treatment in Asian (A) and Caucasian (B) patients. tx, treatment. Data presented are median values.
Figure 6
Figure 6
Reduction of Brief Pain Inventory (BPI) average pain from baseline to endpoint by Patient Global Impression of Improvement (PGI‐I) category according to race in duloxetine‐treated patients (N = 751, where Asian = 328; Caucasian = 423). Data presented are median values.

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