Top

20-07-2018 | Rheumatoid arthritis | Article

Effect of subcutaneous tocilizumab treatment on work/housework status in biologic-naïve rheumatoid arthritis patients using inverse probability of treatment weighting: FIRST ACT-SC study

Journal: Arthritis Research & Therapy

Authors: Yoshiya Tanaka, Hideto Kameda, Kazuyoshi Saito, Yuko Kaneko, Eiichi Tanaka, Shinsuke Yasuda, Naoto Tamura, Keishi Fujio, Takao Fujii, Toshihisa Kojima, Tatsuhiko Anzai, Chikuma Hamada, Yoshihisa Fujino, Shinya Matsuda, Hitoshi Kohsaka

Publisher: BioMed Central

Abstract

Background

Following the onset of rheumatoid arthritis (RA), patients experience a functional decline caused by various joint symptoms which affects their activities of daily living and can lead to reduced work productivity. We evaluated the effect of a 52-week treatment with tocilizumab by subcutaneous injection (TCZ-SC) among biologic-naive Japanese house workers (HWs) and paid workers (PWs) with RA in a real-world clinical practice.

Methods

This multicenter, observational, prospective study enrolled 377 and 347 RA patients into TCZ-SC and conventional synthetic disease-modifying antirheumatic drugs (csDMARDs)-alone groups, respectively. The primary endpoint was the change in percentage of overall work impairment (OWI) among PWs at week 52 assessed using the Work Productivity and Activity Impairment Questionnaire (WPAI). Inverse probability of treatment weighting analyses were used to compare treatments. The Work Functioning Impairment Scale, disease activity, quality of life (QOL) measures, and safety were also assessed.

Results

The weighted change in OWI from baseline for PWs was −18.9% (TCZ-SC group) and −19.0% (csDMARDs group) at week 52, without a significant between-group difference (adjusted treatment difference 0.1, 95% confidence interval (CI) −6.3 to 6.5; P = 0.978). Changes in WPAI activity impairment in the overall group (between-group difference −6.4, 95% CI −10.7 to −2.2; P = 0.003) and HWs (−9.5, 95% CI − 16.0 to −2.9; P = 0.005) were significantly better with TCZ-SC than with csDMARDs at week 52. TCZ-SC-treated HWs showed significant improvement in all QOL assessments (Frenchay Activities Index, EuroQol 5 Dimension (EQ-5D), Japanese Health Assessment Questionnaire Disability Index (HAQ-DI), and 6-item Kessler scale (K6)) at week 52; PWs did not show any between-group differences for these QOL measures. Disease activity (Disease Activity Score 28-erythrocyte sedimentation rate, Clinical Disease Activity Index, and Simplified Disease Activity Index) and QOL measures (EQ-5D, HAQ-DI, and K6) improved over time in the overall group. No new safety concerns were raised with TCZ-SC.

Conclusions

Despite the lack of differences in OWI between groups at week 52, the overall group (particularly HWs) receiving TCZ-SC in addition to csDMARDs showed significant improvements in activity impairment, disease activity, and QOL versus those receiving csDMARDs alone. This study may promote the evaluation of work productivity improvements in HWs and PWs by RA treatment.

Hone D, Cheng A, Watson C, Huang B, Bitman B, Huang XY, et al. Impact of etanercept on work and activity impairment in employed moderate to severe rheumatoid arthritis patients in the United States. Arthritis Care Res (Hoboken). 2013;65:1564–72.

Furuya H, Kasama T, Isozaki T, Umemura M, Otsuka K, Isojima S, et al. Effect of TNF antagonists on the productivity of daily work of patients with rheumatoid arthritis. J Multidiscip Healthc. 2013;6:25–30.PubMedPubMedCentral

Zhang W, Sun H, Emery P, Sato R, Singh A, Freundlich B, et al. Does achieving clinical response prevent work stoppage or work absence among employed patients with early rheumatoid arthritis? Rheumatology (Oxford). 2012;51:270–4.CrossRef

Smolen JS, Breedveld FC, Burmester GR, Bykerk V, Dougados M, Emery P, et al. Treating rheumatoid arthritis to target: 2014 update of the recommendations of an international task force. Ann Rheum Dis. 2016;75:3–15.CrossRefPubMed

Takeuchi T, Nakajima R, Komatsu S, Yamazaki K, Nakamura T, Agata N, et al. Impact of adalimumab on work productivity and activity impairment in Japanese patients with rheumatoid arthritis: large-scale, prospective, single-cohort ANOUVEAU study. Adv Ther. 2017;34:686–702.CrossRefPubMedPubMedCentral

Verstappen SM. Rheumatoid arthritis and work: the impact of rheumatoid arthritis on absenteeism and presenteeism. Best Pract Res Clin Rheumatol. 2015;29:495–511.CrossRefPubMed

Bertin P, Fagnani F, Duburcq A, Woronoff AS, Chauvin P, Cukierman G, et al. Impact of rheumatoid arthritis on career progression, productivity, and employability: the PRET study. J Bone Spine. 2016;83:47–52.CrossRef

van Vilsteren M, Boot CR, Knol DL, van Schaardenburg D, Voskuyl AE, Steenbeek R, et al. Productivity at work and quality of life in patients with rheumatoid arthritis. BMC Musculoskelet Disord. 2015;16:107.CrossRefPubMedPubMedCentral

Almoallim H, Kamil A. Rheumatoid arthritis: should we shift the focus from “treat to target” to “treat to work?”. Clin Rheumatol. 2013;32:285–7.CrossRefPubMed

10.

Rheumatoid Arthritis (RA) 2017. https://www.cdc.gov/arthritis/basics/rheumatoid-arthritis.html Accessed 2 July 2018.

11.

Tanaka E, Inoue E, Hoshi D, Shidara K, Sugimoto N, Inoue Y, et al. Assessment of work productivity and activity impairment in patients with rheumatoid arthritis based on the Institute of Rheumatology Rheumatoid Arthritis (IORRA) cohort database (FRI0124). Ann Rheum Dis. 2013;72:A412.

12.

Beaton DE, Dyer S, Boonen A, Verstappen SM, Escorpizo R, Lacaille DV, et al. OMERACT filter evidence supporting the measurement of at-work productivity loss as an outcome measure in rheumatology research. J Rheumatol. 2016;43:214–22.CrossRefPubMed

13.

Tang K, Beaton DE, Boonen A, Gignac MA, Bombardier C. Measures of work disability and productivity: rheumatoid arthritis specific work productivity survey (WPS-RA), workplace activity limitations scale (WALS), work instability scale for rheumatoid arthritis (RA-WIS), work limitations questionnaire (WLQ), and work productivity and activity impairment questionnaire (WPAI). Arthritis Care Res (Hoboken). 2011;63(Suppl 11):337–49.CrossRef

14.

Alghasham A, Rasheed Z. Therapeutic targets for rheumatoid arthritis: progress and promises. Autoimmunity. 2014;47:77–94.CrossRefPubMed

15.

Tanaka T, Narazaki M, Ogata A, Kishimoto T. A new era for the treatment of inflammatory autoimmune diseases by interleukin-6 blockade strategy. Semin Immunol. 2014;26:88–96.CrossRefPubMed

16.

Tocilizumab package insert for Japan, https://chugai-pharm.jp/hc/ss/pr/drug/act_via0200/pi/PDF/act_pi.pdf. Accessed 2 July 2018.

17.

Fujino Y, Uehara M, Izumi H, Nagata T, Muramatsu K, Kubo T, et al. Development and validity of a work functioning impairment scale based on the Rasch model among Japanese workers. J Occup Health. 2015;57:521–31.CrossRefPubMed

18.

Shiratsuchi M, Saeki S, Hachisuka K. Japanese version of the self-rating Frenchay activities index and its clinical application and standard values. General Rehabilitation. 1999;27:469–74.

19.

Tsuchiya A, Ikeda S, Ikegami N, Nishimura S, Sakai I, Fukuda T, et al. Estimating an EQ-5D population value set. The case of Japan. Health Econ. 2002;11:341–53.CrossRefPubMed

20.

Matsuda Y, Singh G, Yamanaka H, Tanaka E, Urano W, Taniguchi A, et al. Validation of a Japanese version of the Stanford health assessment questionnaire in 3,763 patients with rheumatoid arthritis. Arthritis Rheum. 2003;49:784–8.CrossRefPubMed

21.

Fries JF, Spitz P, Kraines RG, Holman HR. Measurement of patient outcome in arthritis. Arthritis Rheum. 1980;23:137–45.CrossRefPubMed

22.

Furukawa TA, Kessler R, Slade T, Andrews G. The performance of the K6 and K10 screening scales for psychological distress in the Australian National Survey of mental health and well-being. Psychol Med. 2003;33:357–62.CrossRefPubMed

23.

Smolen JS, Aletaha D, Bijlsma JW, Breedveld FC, Boumpas D, Burmester G, et al. Treating rheumatoid arthritis to target: recommendations of an international task force. Ann Rheum Dis. 2010;69:631–7.CrossRefPubMedPubMedCentral

24.

Kavanaugh A, Smolen JS, Emery P, Purcaru O, Keystone E, Richard L, et al. Effect of certolizumab pegol with methotrexate on home and work place productivity and social activities in patients with active rheumatoid arthritis. Arthritis Rheum. 2009;61:1592–600.CrossRefPubMed

25.

Machado DA, Guzman RM, Xavier RM, Simon JA, Mele L, Pedersen R, et al. Open-label observation of addition of etanercept versus a conventional disease-modifying antirheumatic drug in subjects with active rheumatoid arthritis despite methotrexate therapy in the Latin American region. J Clin Rheumatol. 2014;20:25–33.CrossRefPubMed

26.

Bae SC, Gun SC, Mok CC, Khandker R, Nab HW, Koenig AS, et al. Improved health outcomes with etanercept versus usual DMARD therapy in an Asian population with established rheumatoid arthritis. BMC Musculoskelet Disord. 2013;8(14):13.CrossRef

27.

Keystone EC, Taylor PC, Tanaka Y, Gaich C, DeLozier AM, Dudek A, et al. Patient-reported outcomes from a phase 3 study of baricitinib versus placebo or adalimumab in rheumatoid arthritis: secondary analyses from the RA-BEAM study. Ann Rheum Dis. 2017;76:1853–61.CrossRefPubMedPubMedCentral

28.

Tanaka Y, Yamazaki K, Nakajima R, Komatsu S, Igarashi A, Tango T, et al. Economic impact of adalimumab treatment in Japanese patients with rheumatoid arthritis from the adalimumab non-interventional trial for up-verified effects and utility (ANOUVEAU) study. Mod Rheumatol. 2018;28(1):39–47.

29.

Choy EHS, Calabrese LH. Neuroendocrine and neurophysiological effects of interleukin 6 in rheumatoid arthritis. Rheumatology (Oxford). https://doi.org/10.1093/rheumatology/kex391.

30.

Radner H, Smolen JS, Aletaha D. Remission in rheumatoid arthritis: benefit over low disease activity in patient-reported outcomes and costs. Arthritis Res Ther. 2014;16:R56.CrossRefPubMedPubMedCentral

31.

Koike T, Harigai M, Inokuma S, Ishiguro N, Ryu J, Takeuchi T, et al. Effectiveness and safety of tocilizumab: postmarketing surveillance of 7901 patients with rheumatoid arthritis in Japan. J Rheumatol. 2014;41:15–23.CrossRefPubMed

32.

Yamamoto K, Goto H, Hirao K, Nakajima A, Origasa H, Tanaka K, et al. Longterm safety of tocilizumab: results from 3 years of follow-up postmarketing surveillance of 5573 patients with rheumatoid arthritis in Japan. J Rheumatol. 2015;42:1368–75.CrossRefPubMed