Improvement in Overall Work Productivity Among Biologic-NaïVe Patients with Rheumatoid Arthritis Treated with Tocilizumab Subcutaneous Injection: A Prospective, Real World, Observational Study in Japan

Yoshiya Tanaka¹, Hideto Kameda², Kazuyoshi Saito³, Yuko Kaneko⁴, Eiichi Tanaka⁵, Shinsuke Yasuda⁶, Naoto Tamura⁷, Keishi Fujio⁸, Takao Fujii⁹, Toshihisa Kojima¹⁰, Tatsuhiko Anzai¹¹, Chikuma Hamada¹², Yoshihisa Fujino¹³, Shinya Matsuda¹³ and Hitoshi Kohsaka¹⁴, ¹The First Department of Internal Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan, ²Division of Rheumatology, Department of Internal Medicine, Toho University Ohashi Medical Center, Tokyo, Japan, ³Tobata General Hospital, Fukuoka, Japan, ⁴Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine, Tokyo, Japan, ⁵Institute of Rheumatology, Tokyo Women's Medical University, Tokyo, Japan, ⁶Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine and Graduate School of Medicine, Hokkaido University, Sapporo, Japan, ⁷Department of Internal Medicine and Rheumatology, Juntedo University School of Medicine, Tokyo, Japan, ⁸Department of Allergy and Rheumatology, The University of Tokyo, Tokyo, Japan, ⁹Department of Rheumatism and Collagen Disease, Wakayama Medical University, Wakayama, Japan, ¹⁰Nagoya Univ. Grad. Schl. of Med., Nagoya, Japan, ¹¹Data Science Division, Statistics Analysis Department 1, EPS Corporation, Tokyo, Japan, ¹²Department of Information and Computer Technology, Tokyo University of Science, Tokyo, Japan, ¹³Department of Preventive Medicine and Community Health, University of Occupational and Environmental Health, Japan, Kitakyushu, Japan, ¹⁴Department of Rheumatology, Tokyo Medical and Dental University (TMDU), Tokyo, Japan

Meeting: ACR/ARHP Annual Meeting 2017

Date of first publication: September 18, 2017

Keywords: Disease Activity, quality of life, rheumatoid arthritis, treatment and tocilizumab, Work Disability

Session Information

Date: Sunday, November 5, 2017

Title: Rheumatoid Arthritis – Clinical Aspects Poster I: Treatment Patterns and Response

Session Type: ACR Poster Session A

Session Time: 9:00AM-11:00AM

Background/Purpose: This is the first study assessing the effect of subcutaneous tocilizumab (TCZ-SC) and/or conventional synthetic DMARDs (csDMARDs) on work productivity and activity impairment (WPAI) in paid workers (PWs) and homeworkers (HWs) among Japanese patients with RA.

Methods: FIRST ACT-SC was a real-world, prospective, observational study (Jan 2014 to Sep 2015 at 82 centers). Biologic-naïve patients receiving ≥1 csDMARD, both PWs and HWs, and with moderate/high disease activity were enrolled and treated with TCZ-SC +/− csDMARDs or csDMARDs alone. The primary endpoint was the percentage change in overall work impairment (OWI; assessed using the WPAI questionnaire) from baseline to 52 weeks among PWs. Inverse probability of treatment weighting using propensity score was used to adjust for patient background to compare the 2 groups. Depending on the patientsf symptoms during the observation period, change of dose, change to another csDMARD, or addition of another csDMARD was allowed.

Results: In total, 377 and 347 patients were enrolled in the TCZ-SC +/− csDMARD and csDMARD-alone groups, respectively, of which 321 (mean}SD age, 57.7}14.0 years; female, 81.6%) and 307 (60.1}12.8 years; 85.7%) patients, respectively, were included in the modified intent-to-treat population. Of these, 233 (72.6%) and 224 (73.0%) patients, respectively, completed 52 weeks of follow-up. The primary and secondary endpoint results are summarized in the Table 1. Although disease activity (DAS28, SDAI, CDAI, etc.) and HAQ-DI improvements were better in the TCZ-SC group compared to the csDMARD group, the weighted percentage change in OWI from baseline was only −0.189 in the TCZ-SC group at 52 weeks, and there was no difference between the 2 groups (weighted treatment difference, 0.003; 95% CI, −0.062 to 0.068; P = 0.929). In contrast, the improvement in percentage activity impairment in HWs and the overall group was significantly better in the TCZ-SC group compared to the csDMARD group at week 52 (P = 0.005 and P = 0.003, respectively). TCZ-SC-treated HWs also showed significant improvement in overall quality of life (QOL), including EQ-5D, J-HAQ, and K6.

Conclusion: There was no significant difference in OWI between the 2 treatment groups. However, activity impairment, disease activity, and QOL in HWs and the overall group were significantly improved with TCZ-SC than with csDMARDs alone. Taken together, improvement in work productivity/activity impairment is determined by differences in TCZ-SC +/− csDMARDs and differences in PWs and HWs at baseline.

Role of the Study Sponsor: This study was supported by funding from Chugai Pharmaceutical Co., Ltd.

Acknowledgments: Medical writing assistance was provided by Mami Hirano, M.S., of Cactus Communications. Support for study management was provided by EPS Corporation.

Disclosure: Y. Tanaka, Abbvie, Astellas Pharma, Bristol-Myers Squibb, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Kyowa Hakko Kirin, Mitsubishi-Tanabe Pharma, MSD, Ono Pharmaceutical, Pfizer, and Takeda Pharmaceutical., 2,Asahi Kasei Pharma, Astellas Pharma, Bristol-Myers Squibb, Chugai Pharmaceutical, Daiichi-Sankyo, Eli Lilly, GlaxoSmithKline, Janssen, Mitsubishi-Tanabe Pharma, Teijin Pharma, Pfizer, Sanofi, UCB, and YL Biologics., 8; H. Kameda, AbbVie, Astellas Pharma, Chugai Pharmaceutical, Eisai, Mitsubishi-Tanabe Pharma, Takeda Pharmaceutical, 2,AbbVie, Eli Lilly, Novartis, 5,AbbVie, Astellas Pharma, Bristol-Myers Squibb, Chugai Pharmaceutical, Eisai, Eli Lilly, Janssen, Mitsubishi-Tanabe Pharma, Novartis, Pfizer, Sanofi, Takeda Pharmaceutical, 8; K. Saito, None; Y. Kaneko, AbbVie, Eisai, Daiichi-Sankyo, Sanofi, 2,Bristol-Myers Squibb, Eli Lily, Janssen, 5,AbbVie, Eisai, Astellas Pharma, Chugai Pharmaceutical, UCB, Pfizer, Bristol-Myeres Squibb, Janssen, Mitsubishi-Tanabe Pharma, 8; E. Tanaka, AbbVie, Ayumi Pharmaceutical, Bristol Myers Squibb, Chugai Pharmaceutical, Eisai, Nippon Kayaku, Pfizer, Takeda Pharmaceutical, UCB Pharma., 5; S. Yasuda, Bristol-Myers Squibb, MSD, 2,Chugai Pharmaceutical, Mitsubishi-Tanabe Pharma, Bristol-Myers Squibb, Astellas Pharma, 8; N. Tamura, Astellas Pharma, Asahi Kasei Pharma, AYUMI Pharmaceutical, Chugai Pharmaceutical, Eisai, Takeda Pharmaceutical, 2,Janssen, Bristol-Myers Squibb, Mitsubishi-Tanabe Pharma, 8; K. Fujio, Bristol-Myers Squibb, Chugai Pharmaceutical, 2,Integrated Development Associates, Bristol-Myers Squibb, 5,Chugai Pharmaceutical, 7,Astellas Pharma, Bristol-Myeres Squibb, Chugai Pharmaceutical, Daiichi-Sankyo, Eisai, Janssen, Mitsubishi-Tanabe Pharma, Pfizer, Santen Pharmaceutical, Takeda Pharmaceutical, Taisho Toyama Pharmaceutical, UCB, 8; T. Fujii, Eisai, Mitsubishi-Tanabe Pharma, Ono Pharmaceutical, Daiichi Sankyo, Pfizer, 2,AbbVie, Mitsubishi-Tanabe Pharma, Ono Pharmaceutical, Pfizer, 8; T. Kojima, Chugai Pharmaceutical, Mitsubishi-Tanabe Pharma, Novartis Pharma, Nippon Kayaku, 2,Ayumi Pharmaceutical, Bristol-Myers Squibb, Chugai Pharmaceutical, Eli Lilly, Ono Pharmaceutical, Pfizer, Takeda Pharmaceutical, 8; T. Anzai, EPS Corporation, 3; C. Hamada, Chugai Pharmaceutical, 5; Y. Fujino, None; S. Matsuda, None; H. Kohsaka, AbbVie, Asahi Kasei Pharma, Astellas Pharma, Ayumi Pharmaceutical, Chugai Pharmaceutical, Eisai, Eli Lilly, Japan Blood Products Organization, Mitsubishi-Tanabe Pharma, Novartis, Ono Pharmaceutical, Pfizer, Takeda Pharmaceutical, and Teijin Pharma., 2,Bristol-Myers Squibb, Daiichi Sankyo, and GlaxoSmithKline., 5,AbbVie, Asahi Kasei Pharma, Astellas Pharma, Ayumi Pharmaceutical, Chugai Pharmaceutical, Japan Blood Products Organization, Mitsubishi-Tanabe Pharma, MSD, Nippon Kayaku, Ono Pharmaceutical, and Takeda Pharmaceutical., 8.

To cite this abstract in AMA style:

Tanaka Y, Kameda H, Saito K, Kaneko Y, Tanaka E, Yasuda S, Tamura N, Fujio K, Fujii T, Kojima T, Anzai T, Hamada C, Fujino Y, Matsuda S, Kohsaka H. Improvement in Overall Work Productivity Among Biologic-NaïVe Patients with Rheumatoid Arthritis Treated with Tocilizumab Subcutaneous Injection: A Prospective, Real World, Observational Study in Japan [abstract]. Arthritis Rheumatol. 2017; 69 (suppl 10). https://acrabstracts.org/abstract/improvement-in-overall-work-productivity-among-biologic-naive-patients-with-rheumatoid-arthritis-treated-with-tocilizumab-subcutaneous-injection-a-prospective-real-world-observational-study-in-japa/. Accessed .

ACR Meeting Abstracts - https://acrabstracts.org/abstract/improvement-in-overall-work-productivity-among-biologic-naive-patients-with-rheumatoid-arthritis-treated-with-tocilizumab-subcutaneous-injection-a-prospective-real-world-observational-study-in-japa/