Date: Sunday, November 5, 2017
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.
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 February 26, 2020.
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