J Rheum Dis.  2021 Apr;28(2):68-75. 10.4078/jrd.2021.28.2.68.

Health-related Quality of Life Outcomes of Adalimumab for Patients With Rheumatoid Arthritis in Korea

Affiliations
  • 1Department of Internal Medicine, Wonkwang University Hospital, Iksan, Korea
  • 2Department of Internal Medicine, Hanyang University Guri Hospital, Hanyang University School of Medicine, Guri, Korea
  • 3Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Korea
  • 4Department of Internal Medicine, Pohang St. Mary’s Hospital, Pohang, Korea
  • 5Department of Internal Medicine, St. Vincent's Hospital, College of Medicine, The Catholic University of Korea, Suwon, Korea
  • 6Department of Internal Medicine, Eulji University Hospital, Eulji University School of Medicine, Daejeon, Korea
  • 7Department of Internal Medicine, Seoul Medical Center, Seoul, Korea
  • 8Department of Rheumatology, Ajou University School of Medicine, Suwon, Korea
  • 9Department of Internal Medicine, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, Korea
  • 10AbbVie Ltd, Seoul, Korea
  • 11Department of Internal Medicine, Jeonbuk National University Medical School, Research Institute of Clinical Medicine of Jeonbuk National University-Biomedical, Research Institute of Jeonbuk National University Hospital, Jeonju, Korea

Abstract


Objective
Rheumatoid arthritis (RA) is a chronic, progressive, autoimmune disorder that impairs patients’ overall health-related quality of life (HRQOL). In this study, we evaluated the effect of adalimumab in Korean patients with active RA on HRQOL.
Methods
Patients included in the study had moderate to severe active RA that did not respond to conventional drugs with a Disease Activity Score of 28 joints >3.2 and were biologics-naïve. All patients received adalimumab 40 mg subcutaneously every other week and were followed for 24 weeks. The primary endpoint was the change in baseline Health Assessment Questionnaire Disability Index (HAQ-DI) score at week 24. Secondary endpoints were changes in the EuroQol 5-dimension 3-Level (EQ-5D-3L) baseline score and Short Form 36-Item Health Survey (SF-36) domain scores at weeks 12 and 24 and change in baseline HAQ-DI score at week 12.
Results
In total, 91 Korean patients were included. Ninety-three percent of patients were in high disease activity with a baseline mean DAS28 value of 6.1 within all patients. The mean change from baseline in HAQ-DI scores were −0.46 at week 12 and∼0.67 at week 24 (p<0.0001). Additionally, EQ-5D-3L score at weeks 12 and 24 had significantly improved (p<0.0001) compared to baseline. SF-36 at weeks 12 and 24 had significantly improved (p<0.0001, p=0.0001) compared to baseline.
Conclusion
Treatment with adalimumab resulted in significant improvement in HAQ-DI, EQ-5D-3L, and SF-36 scores at 12 and 24 weeks in Korean RA patient.

Keyword

Adalimumab; Patients; Quality of life; Rheumatoid arthritis; Antirheumatic agents

Reference

1. Silman AJ, Pearson JE. 2002; Epidemiology and genetics of rheumatoid arthritis. Arthritis Res. 4 Suppl 3:S265–72. DOI: 10.1186/ar578. PMID: 12110146. PMCID: PMC3240153.
2. Hyrich K, Symmons D, Watson K, Silman A. BSRBR Control Centre Consortium. British Society for Rheumatology Biologics Register. 2006; Baseline comorbidity levels in biologic and standard DMARD treated patients with rheumatoid arthritis: results from a national patient register. Ann Rheum Dis. 65:895–8. DOI: 10.1136/ard.2005.043158. PMID: 16339291. PMCID: PMC1798204.
Article
3. Dougados M, Soubrier M, Antunez A, Balint P, Balsa A, Buch MH, et al. 2014; Prevalence of comorbidities in rheumatoid arthritis and evaluation of their monitoring: results of an international, cross-sectional study (COMORA). Ann Rheum Dis. 73:62–8. DOI: 10.1136/annrheumdis-2013-204223. PMID: 24095940. PMCID: PMC3888623.
Article
4. Choi IA, Lee JS, Song YW, Lee EY. 2019; Mortality, disability, and healthcare expenditure of patients with seropositive rheumatoid arthritis in Korea: a nationwide population-based study. PLoS One. 14:e0210471. DOI: 10.1371/journal.pone.0210471. PMID: 30620765. PMCID: PMC6324802.
Article
5. Uhlig T, Loge JH, Kristiansen IS, Kvien TK. 2007; Quantification of reduced health-related quality of life in patients with rheumatoid arthritis compared to the general population. J Rheumatol. 34:1241–7. PMID: 17516624.
6. Matcham F, Scott IC, Rayner L, Hotopf M, Kingsley GH, Norton S, et al. 2014; The impact of rheumatoid arthritis on quality-of-life assessed using the SF-36: a systematic review and meta-analysis. Semin Arthritis Rheum. 44:123–30. DOI: 10.1016/j.semarthrit.2014.05.001. PMID: 24973898.
Article
7. Bruce B, Fries JF. 2003; The Stanford health assessment questionnaire: a review of its history, issues, progress, and documentation. J Rheumatol. 30:167–78. PMID: 12508408.
8. Ware JE Jr, Sherbourne CD. 1992; The MOS 36-item short-form health survey (SF-36). I. conceptual framework and item selection. Med Care. 30:473–83. DOI: 10.1097/00005650-199206000-00002. PMID: 1593914.
9. Ware JE Jr, Gandek B. 1998; Overview of the SF-36 health survey and the international quality of life assessment (IQOLA) project. J Clin Epidemiol. 51:903–12. DOI: 10.1016/S0895-4356(98)00081-X. PMID: 9817107.
Article
10. EuroQol Group. 1990; EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 16:199–208. DOI: 10.1016/0168-8510(90)90421-9. PMID: 10109801.
11. Atzinger CB, Guo JJ. 2017; Biologic disease-modifying antirheumatic drugs in a national, privately insured population: utilization, expenditures, and price trends. Am Health Drug Benefits. 10:27–36. PMID: 28465766. PMCID: PMC5394542.
12. Bang LM, Keating GM. 2004; Adalimumab: a review of its use in rheumatoid arthritis. BioDrugs. 18:121–39. DOI: 10.2165/00063030-200418020-00005. PMID: 15046527.
13. Center for Drug Evaluation and Research. Center for Biologics Evaluation and Research. c2002. Application number: 125057/0. Approval letter(s) [Internet]. Food and Drug Administration;Rockville (MD): Available from: https://www.accessdata.fda.gov/drugsatfda_docs/nda/2002/BLA_125057_S000_HUMIRA_APPROV.PDF. cited 2019 Jun 25.
14. Fries JF, Spitz P, Kraines RG, Holman HR. 1980; Measurement of patient outcome in arthritis. Arthritis Rheum. 23:137–45. DOI: 10.1002/art.1780230202. PMID: 7362664.
Article
15. Hawker GA, Mian S, Kendzerska T, French M. 2011; Measures of adult pain: visual analog scale for pain (VAS Pain), numeric rating scale for pain (NRS Pain), McGill pain questionnaire (MPQ), short-form McGill pain questionnaire (SF-MPQ), chronic pain grade scale (CPGS), short form-36 bodily pain scale (SF-36 BPS), and measure of intermittent and constant osteoarthritis pain (ICOAP). Arthritis Care Res (Hoboken). 63 Suppl 11:S240–52. DOI: 10.1002/acr.20543. PMID: 22588748.
16. Wells GA, Tugwell P, Kraag GR, Baker PR, Groh J, Redelmeier DA. 1993; Minimum important difference between patients with rheumatoid arthritis: the patient's perspective. J Rheumatol. 20:557–60. PMID: 8478873.
17. Reilly M. c2002. Work productivity and activity impairment questionnaire: low back pain (WPAI-LBP) [Internet]. Reilly Associates;New York (NY): Available from: http://www.reillyassociates.net/English__US__WPAI-LBP__V2.pdf. cited 2019 Jun 25.
18. Kekow J, Moots RJ, Emery P, Durez P, Koenig A, Singh A, et al. 2010; Patient-reported outcomes improve with etanercept plus methotrexate in active early rheumatoid arthritis and the improvement is strongly associated with remission: the COMET trial. Ann Rheum Dis. 69:222–5. DOI: 10.1136/ard.2008.102509. PMID: 19293160.
Article
19. Gossec L, Dougados M, Dixon W. 2015; Patient-reported outcomes as end points in clinical trials in rheumatoid arthritis. RMD Open. 1:e000019. DOI: 10.1136/rmdopen-2014-000019. PMID: 26509052. PMCID: PMC4613162.
Article
20. Kievit W, Adang EM, Fransen J, Kuper HH, van de Laar MA, Jansen TL, et al. 2008; The effectiveness and medication costs of three anti-tumour necrosis factor alpha agents in the treatment of rheumatoid arthritis from prospective clinical practice data. Ann Rheum Dis. 67:1229–34. DOI: 10.1136/ard.2007.083675. PMID: 18174220.
21. Breedveld FC, Weisman MH, Kavanaugh AF, Cohen SB, Pavelka K, van Vollenhoven R, et al. 2006; The PREMIER study: a multicenter, randomized, double-blind clinical trial of combination therapy with adalimumab plus methotrexate versus methotrexate alone or adalimumab alone in patients with early, aggressive rheumatoid arthritis who had not had previous methotrexate treatment. Arthritis Rheum. 54:26–37. DOI: 10.1002/art.21519. PMID: 16385520.
Article
22. Bae SC, Gun SC, Mok CC, Khandker R, Nab HW, Koenig AS, et al. 2013; Improved health outcomes with etanercept versus usual DMARD therapy in an Asian population with established rheumatoid arthritis. BMC Musculoskelet Disord. 14:13. DOI: 10.1186/1471-2474-14-13. PMID: 23294908. PMCID: PMC3606371.
Article
23. Jørgensen TS, Turesson C, Kapetanovic M, Englund M, Turkiewicz A, Christensen R, et al. 2017; EQ-5D utility, response and drug survival in rheumatoid arthritis patients on biologic monotherapy: a prospective observational study of patients registered in the south Swedish SSATG registry. PLoS One. 12:e0169946. DOI: 10.1371/journal.pone.0169946. PMID: 28151971. PMCID: PMC5289416.
Article
24. Han C, Smolen J, Kavanaugh A, St Clair EW, Baker D, Bala M. 2008; Comparison of employability outcomes among patients with early or long-standing rheumatoid arthritis. Arthritis Rheum. 59:510–4. DOI: 10.1002/art.23541. PMID: 18383415.
Article
25. Kim D, Kaneko Y, Takeuchi T. 2017; Importance of obtaining remission for work productivity and activity of patients with rheumatoid arthritis. J Rheumatol. 44:1112–7. DOI: 10.3899/jrheum.161404. PMID: 28507184.
Article
26. Hone D, Cheng A, Watson C, Huang B, Bitman B, Huang XY, et al. 2013; Impact of etanercept on work and activity impairment in employed moderate to severe rheumatoid arthritis patients in the United States. Arthritis Care Res (Hoboken). 65:1564–72. DOI: 10.1002/acr.22022. PMID: 23554320.
Article
27. Hussain W, Janoudi N, Noorwali A, Omran N, Baamer M, Assiry el H, et al. 2015; Effect of adalimumab on work ability assessed in rheumatoid arthritis disease patients in Saudi Arabia (AWARDS). Open Rheumatol J. 9:46–50. DOI: 10.2174/1874312901409010046. PMID: 26312105. PMCID: PMC4541458.
Article
Full Text Links
  • JRD
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2024 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr