Impact of Adalimumab on Work Productivity and Activity Impairment in Japanese Patients with Rheumatoid Arthritis: Large-Scale, Prospective, Single-Cohort ANOUVEAU Study

Overview

Journal Adv Ther

Date 2017 Feb 2

PMID 28144917

Citations 11

Authors

Tsutomu Takeuchi

Ryo Nakajima

Shuichi Komatsu

Kiyotaka Yamazaki

Tomohiro Nakamura

Naoki Agata

Ataru Igarashi

Toshiro Tango

Yoshiya Tanaka

Affiliations

Soon will be listed here.

Abstract

Introduction: The Adalimumab Non-interventional Trial for Up-verified Effects and Utility (ANOUVEAU) was a large-scale, multicenter, prospective, observational, single-cohort study that evaluated the effects of adalimumab (ADA) on rheumatoid arthritis (RA)-related work productivity and activity impairment (RA-related WPAI) and disease activity in routine rheumatology care in Japan.

Methods: Patients with RA were categorized as paid workers (PWs, ≥35 h/week), part-time workers (PTWs, <35 h/week), or homemakers (HMs, unemployed) and were administered the WPAI for RA (WPAI/RA) questionnaire. All patients who received ADA were followed for 48 weeks to evaluate safety and effectiveness.

Results: Of the 1808 patients analyzed, 825, 243, and 740 patients were PWs, PTWs, and HMs, respectively. WPAI/RA domain scores significantly improved at weeks 12, 24, and 48 in all groups, with maximum improvement observed for PWs (p < 0.05). Additionally, remission rates (according to Disease Activity Score 28, erythrocyte sedimentation rate, Simplified Disease Activity Index, or Health Assessment Questionnaire-Disability Index scores) and EuroQol 5-Dimension 3-Level scores significantly increased from baseline to 48 weeks in all groups (p < 0.0001). Analysis of patient subgroups revealed better WPAI/RA outcomes for patients who were biologic-naïve, treated with concomitant methotrexate, or with RA duration of ≤2 years (p < 0.05). The rate of serious adverse events over 48 weeks of ADA treatment was 5.23%.

Conclusions: Treatment with ADA provided sustained improvement in WPAI and had an acceptable safety profile in patients with RA.

Funding: AbbVie GK and Eisai Co., Ltd.

Trial Registration: ClinicalTrials.gov identifier, NCT01346488.

Citing Articles

A Prospective Study to Evaluate the Impact of Golimumab Therapy on Work Productivity and Activity, and Quality of Life in Patients With Rheumatoid Arthritis, Psoriasis Arthritis and Axial Spondyloarthritis in a Real Life Setting in AUSTRIA. The....

Dejaco C, Mueller T, Zamani O, Kurtz U, Egger S, Resch-Passini J Front Med (Lausanne). 2022; 9:881943.

PMID: 35721062 PMC: 9201205. DOI: 10.3389/fmed.2022.881943.

Inflammation and Bone Metabolism in Rheumatoid Arthritis: Molecular Mechanisms of Joint Destruction and Pharmacological Treatments.

Maeda K, Yoshida K, Nishizawa T, Otani K, Yamashita Y, Okabe H Int J Mol Sci. 2022; 23(5).

PMID: 35270012 PMC: 8911191. DOI: 10.3390/ijms23052871.

Patient- and physician-reported outcomes from two phase 3 randomized studies (RAJ3 and RAJ4) of peficitinib (ASP015K) in Asian patients with rheumatoid arthritis.

Tanaka Y, Takeuchi T, Izutsu H, Kaneko Y, Kato D, Fukuda M Arthritis Res Ther. 2021; 23(1):221.

PMID: 34429152 PMC: 8383363. DOI: 10.1186/s13075-021-02590-z.

Methodological aspects of design, analysis and reporting of studies with work participation as an outcome domain in patients with inflammatory arthritis: results of two systematic literature reviews informing EULAR points to consider.

Marques M, Alunno A, Boonen A, Ter Wee M, Falzon L, Ramiro S RMD Open. 2021; 7(1).

PMID: 33542048 PMC: 7868290. DOI: 10.1136/rmdopen-2020-001522.

Real-world evidence of the impact of adalimumab on work productivity and sleep measures in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.

Tektonidou M, Katsifis G, Georgountzos A, Theodoridou A, Koukli E, Kandili A Ther Adv Musculoskelet Dis. 2020; 12:1759720X20949088.

PMID: 33062067 PMC: 7534071. DOI: 10.1177/1759720X20949088.

References

Lazurova I, Tomas L . Cardiac Impairment in Rheumatoid Arthritis and Influence of Anti-TNFα Treatment. Clin Rev Allergy Immunol. 2016; 52(3):323-332. DOI: 10.1007/s12016-016-8566-3. View

Bejarano V, Quinn M, Conaghan P, Reece R, Keenan A, Walker D . Effect of the early use of the anti-tumor necrosis factor adalimumab on the prevention of job loss in patients with early rheumatoid arthritis. Arthritis Rheum. 2008; 59(10):1467-74. DOI: 10.1002/art.24106. View

Raterman H, Hoving J, Nurmohamed M, Herenius M, Sluiter J, Lems W . Work ability: a new outcome measure in rheumatoid arthritis?. Scand J Rheumatol. 2010; 39(2):127-31. DOI: 10.3109/03009740903447044. View

Cross M, Smith E, Hoy D, Carmona L, Wolfe F, Vos T . The global burden of rheumatoid arthritis: estimates from the global burden of disease 2010 study. Ann Rheum Dis. 2014; 73(7):1316-22. DOI: 10.1136/annrheumdis-2013-204627. View

Tanaka E, Hoshi D, Igarashi A, Inoue E, Shidara K, Sugimoto N . Analysis of direct medical and nonmedical costs for care of rheumatoid arthritis patients using the large cohort database, IORRA. Mod Rheumatol. 2012; 23(4):742-51. DOI: 10.1007/s10165-012-0729-3. View

Nakajima A, Inoue E, Shimizu Y, Kobayashi A, Shidara K, Sugimoto N . Presence of comorbidity affects both treatment strategies and outcomes in disease activity, physical function, and quality of life in patients with rheumatoid arthritis. Clin Rheumatol. 2014; 34(3):441-9. DOI: 10.1007/s10067-014-2750-8. View

van Vollenhoven R, Cifaldi M, Ray S, Chen N, Weisman M . Improvement in work place and household productivity for patients with early rheumatoid arthritis treated with adalimumab plus methotrexate: work outcomes and their correlations with clinical and radiographic measures from a randomized controlled.... Arthritis Care Res (Hoboken). 2010; 62(2):226-34. DOI: 10.1002/acr.20072. View

Verstappen S . Rheumatoid arthritis and work: The impact of rheumatoid arthritis on absenteeism and presenteeism. Best Pract Res Clin Rheumatol. 2015; 29(3):495-511. DOI: 10.1016/j.berh.2015.06.001. View

Koike T, Harigai M, Ishiguro N, Inokuma S, Takei S, Takeuchi T . Safety and effectiveness of adalimumab in Japanese rheumatoid arthritis patients: postmarketing surveillance report of the first 3,000 patients. Mod Rheumatol. 2011; 22(4):498-508. DOI: 10.1007/s10165-011-0541-5. View

10.

Zhang W, Bansback N, Guh D, Li X, Nosyk B, Marra C . Short-term influence of adalimumab on work productivity outcomes in patients with rheumatoid arthritis. J Rheumatol. 2008; 35(9):1729-36. View

11.

Kimura N, Suzuki K, Takeuchi T . Time lag between the initiation of adalimumab after methotrexate correlates with the efficacy of adalimumab in rheumatoid arthritis patients. Mod Rheumatol. 2015; 26(5):676-80. DOI: 10.3109/14397595.2015.1132952. View

12.

Kaneko A, Hirano Y, Fujibayashi T, Hattori Y, Terabe K, Kojima T . Twenty-four-week clinical results of adalimumab therapy in Japanese patients with rheumatoid arthritis: retrospective analysis for the best use of adalimumab in daily practice. Mod Rheumatol. 2012; 23(3):466-77. DOI: 10.1007/s10165-012-0705-y. View

13.

Koike R, Takeuchi T, Eguchi K, Miyasaka N . Update on the Japanese guidelines for the use of infliximab and etanercept in rheumatoid arthritis. Mod Rheumatol. 2007; 17(6):451-8. DOI: 10.1007/s10165-007-0626-3. View

14.

Miyasaka N . Adalimumab for the treatment of rheumatoid arthritis. Expert Rev Clin Immunol. 2010; 5(1):19-26. DOI: 10.1586/1744666X.5.1.19. View

15.

Almoallim H, Kamil A . Rheumatoid arthritis: should we shift the focus from "Treat to Target" to "Treat to Work?". Clin Rheumatol. 2013; 32(3):285-7. DOI: 10.1007/s10067-012-2160-8. View

16.

Furuya H, Kasama T, Isozaki T, Umemura M, Otsuka K, Isojima S . Effect of TNF antagonists on the productivity of daily work of patients with rheumatoid arthritis. J Multidiscip Healthc. 2013; 6:25-30. PMC: 3552480. DOI: 10.2147/jmdh.s39158. View

17.

STEINBROCKER O, TRAEGER C, BATTERMAN R . Therapeutic criteria in rheumatoid arthritis. J Am Med Assoc. 1949; 140(8):659-62. DOI: 10.1001/jama.1949.02900430001001. View

18.

Yamanaka H, Ishiguro N, Takeuchi T, Miyasaka N, Mukai M, Matsubara T . Recovery of clinical but not radiographic outcomes by the delayed addition of adalimumab to methotrexate-treated Japanese patients with early rheumatoid arthritis: 52-week results of the HOPEFUL-1 trial. Rheumatology (Oxford). 2014; 53(5):904-13. PMC: 3988871. DOI: 10.1093/rheumatology/ket465. View

19.

Geuskens G, Hazes J, Barendregt P, Burdorf A . Predictors of sick leave and reduced productivity at work among persons with early inflammatory joint conditions. Scand J Work Environ Health. 2009; 34(6):420-9. DOI: 10.5271/sjweh.1298. View

20.

Bertin P, Fagnani F, Duburcq A, Woronoff A, Chauvin P, Cukierman G . Impact of rheumatoid arthritis on career progression, productivity, and employability: The PRET Study. Joint Bone Spine. 2015; 83(1):47-52. DOI: 10.1016/j.jbspin.2015.05.001. View