Relationship Between Pain Reduction and Improvement in Health-Related Quality of Life in Patients with Knee Pain Due to Osteoarthritis Receiving Duloxetine: Exploratory Post Hoc Analysis of a Japanese Phase 3 Randomized Study

Hiroyuki Enomoto, Shinji Fujikoshi, Kei Ogawa, Toshinaga Tsuji, Sakae Tanaka, Hiroyuki Enomoto, Shinji Fujikoshi, Kei Ogawa, Toshinaga Tsuji, Sakae Tanaka

Abstract

Purpose: This post hoc analysis of a Japanese phase 3 randomized study (ClinicalTrials.gov identifier: NCT02248480) investigated relationships between changes in pain severity and changes in health-related quality of life (HRQoL) in duloxetine-treated patients with knee osteoarthritis (OA).

Patients and methods: Patients with knee OA and Brief Pain Inventory (BPI) average pain score ≥4 received duloxetine 60 mg/day or placebo for 14 weeks. Spearman rank correlation coefficients were calculated for change in pain severity, as assessed by the BPI, and change in HRQoL, as assessed by the items of the (i) 36-item Short-Form Health Survey (SF-36; a generic measure of HRQoL) and (ii) Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; an OA-specific measure of HRQoL).

Results: After 14 weeks of treatment, there was a significantly greater improvement (p<0.001) for duloxetine (n=177) vs placebo (n=176) in BPI average pain severity score and significantly greater improvements (p<0.01) for duloxetine vs placebo for 5 of the 8 SF-36 domains (including the Role-Physical, Bodily Pain, and Physical Functioning domains) and all 24 individual WOMAC items. The correlation between BPI change from baseline and SF-36 item change from baseline was statistically significant (p<0.05) for 2 of the 8 SF-36 items (Bodily Pain, Physical Functioning) in duloxetine-treated patients. The correlation between BPI change from baseline and WOMAC item change from baseline was statistically significant for 22 of the 24 WOMAC items in duloxetine-treated patients.

Conclusion: This post hoc analysis suggested that the pain reduction observed in duloxetine-treated patients with knee OA was associated with improvements in OA-specific aspects of HRQoL, ie, pain and physical functioning.

Keywords: 36-item Short-form Health Survey; Brief Pain Inventory; Western Ontario and McMaster Universities Osteoarthritis Index; placebo effect.

Conflict of interest statement

TT is an employee of Shionogi & Co., Ltd. and owns stock in Shionogi & Co., Ltd. and Takeda Pharmaceutical Company Ltd. HE, SF, and KO are employees of Eli Lilly Japan K.K. HE, SF, and KO own stock in Eli Lilly and Company. ST has received research grants from Eli Lilly Japan K.K. The authors report no other conflicts of interest in this work.

© 2020 Enomoto et al.

References

    1. Neogi T. The epidemiology and impact of pain in osteoarthritis. Osteoarthritis Cartilage. 2013;21(9):1145–1153. doi:10.1016/j.joca.2013.03.018
    1. Mora JC, Przkora R, Cruz-Almeida Y. Knee osteoarthritis: pathophysiology and current treatment modalities. J Pain Res. 2018;11:2189–2196. doi:10.2147/JPR
    1. Muraki S, Oka H, Akune T, et al. Prevalence of radiographic knee osteoarthritis and its association with knee pain in the elderly of Japanese population-based cohorts: the ROAD study. Osteoarthritis Cartilage. 2009;17(9):1137–1143. doi:10.1016/j.joca.2009.04.005
    1. Brown JP, Boulay LJ. Clinical experience with duloxetine in the management of chronic musculoskeletal pain. A focus on osteoarthritis of the knee. Ther Adv Musculoskelet Dis. 2013;5(6):291–304. doi:10.1177/1759720X13508508
    1. Rahman MM, Kopec JA, Cibere J, Goldsmith CH, Anis AH. The relationship between osteoarthritis and cardiovascular disease in a population health survey: a cross-sectional study. BMJ Open. 2013;3(5). doi:10.1136/bmjopen-2013-002624
    1. Wang H, Bai J, He B, Hu X, Liu D. Osteoarthritis and the risk of cardiovascular disease: a meta-analysis of observational studies. Sci Rep. 2016;6:39672. doi:10.1038/srep39672
    1. Hochberg MC, Altman RD, April KT, et al. American College of Rheumatology 2012 recommendations for the use of nonpharmacologic and pharmacologic therapies in osteoarthritis of the hand, hip, and knee. Arthritis Care Res. 2012;64(4):465–474. doi:10.1002/acr.21596
    1. Jevsevar DS. Treatment of osteoarthritis of the knee: evidence-based guideline, 2nd edition. J Am Acad Orthop Surg. 2013;21(9):571–576. doi:10.5435/JAAOS-21-09-571
    1. McAlindon TE, Bannuru RR, Sullivan MC, et al. OARSI guidelines for the non-surgical management of knee osteoarthritis. Osteoarthritis Cartilage. 2014;22(3):363–388. doi:10.1016/j.joca.2014.01.003
    1. Walsh DA, Stocks J. New therapeutic targets for osteoarthritis pain. SLAS Discov. 2017;22(8):931–949. doi:10.1177/2472555217716912
    1. Krebs EE, Gravely A, Nugent S, et al. Effect of opioid vs nonopioid medications on pain-related function in patients with chronic back pain or hip or knee osteoarthritis pain: the SPACE randomized clinical trial. JAMA. 2018;319(9):872–882. doi:10.1001/jama.2018.0899
    1. Chappell AS, Ossanna MJ, Liu-Seifert H, et al. Duloxetine, a centrally acting analgesic, in the treatment of patients with osteoarthritis knee pain: a 13-week, randomized, placebo-controlled trial. Pain. 2009;146(3):253–260. doi:10.1016/j.pain.2009.06.024
    1. Chappell AS, Desaiah D, Liu-Seifert H, et al. A double-blind, randomized, placebo-controlled study of the efficacy and safety of duloxetine for the treatment of chronic pain due to osteoarthritis of the knee. Pain Pract. 2011;11(1):33–41. doi:10.1111/ppr.2011.11.issue-1
    1. Frakes EP, Risser RC, Ball TD, Hochberg MC, Wohlreich MM. Duloxetine added to oral nonsteroidal anti-inflammatory drugs for treatment of knee pain due to osteoarthritis: results of a randomized, double-blind, placebo-controlled trial. Curr Med Res Opin. 2011;27(12):2361–2372. doi:10.1185/03007995.2011.633502
    1. Wang G, Bi L, Li X, et al. Efficacy and safety of duloxetine in Chinese patients with chronic pain due to osteoarthritis: a randomized, double-blind, placebo-controlled study. Osteoarthritis Cartilage. 2017;25(6):832–838. doi:10.1016/j.joca.2016.12.025
    1. Uchio Y, Enomoto H, Alev L, et al. A randomized, double-blind, placebo-controlled Phase III trial of duloxetine in Japanese patients with knee pain due to osteoarthritis. J Pain Res. 2018;11:809–821. doi:10.2147/JPR
    1. Zhang W, Robertson J, Jones AC, Dieppe PA, Doherty M. The placebo effect and its determinants in osteoarthritis: meta-analysis of randomised controlled trials. Ann Rheum Dis. 2008;67(12):1716–1723. doi:10.1136/ard.2008.092015
    1. Altman R, Asch E, Bloch D, et al. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Diagnostic and therapeutic criteria committee of the American Rheumatism Association. Arthritis Rheum. 1986;29(8):1039–1049. doi:10.1002/art.1780290816
    1. Sheehan D, Lecrubier Y. M.I.N.I.: International Neuropsychiatric Interview. Japanese 5.0.0 Ed. Tokyo: Seiwa Shoten Co. Ltd; 2003.
    1. Uki J, Mendoza T, Cleeland CS, Nakamura Y, Takeda F. A brief cancer pain assessment tool in Japanese: the utility of the Japanese Brief Pain Inventory–BPI-J. J Pain Symptom Manage. 1998;16(6):364–373. doi:10.1016/S0885-3924(98)00098-0
    1. Fukuhara S, Bito S, Green J, Hsiao A, Kurokawa K. Translation, adaptation, and validation of the SF-36 Health Survey for use in Japan. J Clin Epidemiol. 1998;51(11):1037–1044. doi:10.1016/S0895-4356(98)00095-X
    1. Hashimoto H, Hanyu T, Sledge CB, Lingard EA. Validation of a Japanese patient-derived outcome scale for assessing total knee arthroplasty: comparison with Western Ontario and McMaster Universities osteoarthritis index (WOMAC). J Orthop Sci. 2003;8(3):288–293. doi:10.1007/s10776-002-0629-0
    1. Scott DJ, Stohler CS, Egnatuk CM, Wang H, Koeppe RA, Zubieta JK. Individual differences in reward responding explain placebo-induced expectations and effects. Neuron. 2007;55(2):325–336. doi:10.1016/j.neuron.2007.06.028
    1. Navratilova E, Porreca F. Reward and motivation in pain and pain relief. Nat Neurosci. 2014;17(10):1304–1312. doi:10.1038/nn.3811
    1. Medoff ZM, Colloca L. Placebo analgesia: understanding the mechanisms. Pain Manag. 2015;5(2):89–96. doi:10.2217/pmt.15.3
    1. Tuominen U, Blom M, Hirvonen J, et al. The effect of co-morbidities on health-related quality of life in patients placed on the waiting list for total joint replacement. Health Qual Life Outcomes. 2007;5:16. doi:10.1186/1477-7525-5-16
    1. van Dijk GM, Veenhof C, Schellevis F, et al. Comorbidity, limitations in activities and pain in patients with osteoarthritis of the hip or knee. BMC Musculoskelet Disord. 2008;9:95. doi:10.1186/1471-2474-9-95
    1. Bellamy N, Buchanan WW, Goldsmith CH, Campbell J, Stitt LW. Validation study of WOMAC: a health status instrument for measuring clinically important patient relevant outcomes to antirheumatic drug therapy in patients with osteoarthritis of the hip or knee. J Rheumatol. 1988;15(12):1833–1840.

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