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

Abstract

IntroductionThe 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.MethodsPatients 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.ResultsOf 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%.ConclusionsTreatment with ADA provided sustained improvement in WPAI and had an acceptable safety profile in patients with RA.FundingAbbVie GK and Eisai Co., Ltd.Trial RegistrationClinicalTrials.gov identifier, NCT01346488.

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

“…Regarding the main differences in baseline characteristics between groups by type of work performed, HWs had greater disease severity at baseline than PWs. Similar findings were reported previously [ 5 ]. Although a tendency for improvement was observed in terms of other work productivity indices and QOL measures, no differences within the groups were observed for PWs, and a remarkable improvement in QOL measures was observed among HWs.…”

“…However, we did observe an improvement in OWI from baseline in both treatment groups, meaning that RA treatment intervention was effective in decreasing disease activity, improving function, and improving overall QOL. These findings are consistent with a previous, large-scale study that evaluated the effects of adalimumab on WPAI in Japanese RA patients [ 5 ]. Previous studies of etanercept plus methotrexate in Latin America [ 25 ] and Asia [ 26 ] showed similar improvements in patient-reported outcomes, including WPAI.…”

“…Based on previous studies in Japan and the US reporting WPAI of PWs with RA as the main endpoint [ 5 , 24 ], we assumed that the mean percentage of OWI (primary endpoint) was 30% to 40% at baseline. We also assumed that the percent change in OWI from baseline in the TCZ-SC and csDMARDs-alone groups at week 52 would be 40% and 15% (i.e., − 12% and −4.5% change from baseline considering a value of 30% at baseline), respectively.…”

“…It is estimated that, 6 months after the onset of RA, patients experience functional decline secondary to joint symptoms caused by joint inflammation and cartilage destruction. This not only affects activities of daily living, such as home activities, recreation, and social relations, but also results in reduced work productivity among house workers (HWs) and paid workers (PWs) [ 5 – 10 ]. Furthermore, it has been reported that, in Japanese patients with RA, work productivity and activity impairment are strongly correlated with the extent of physical disability and quality of life (QOL) [ 11 ].…”

Improvements in productivity and increased participation in daily activities over 52 weeks of certolizumab pegol treatment of rheumatoid arthritis: results of a Belgian observational study

“…Collectively, these data position CZP alongside a panel of anti-TNF agents that have demonstrated realworld effectiveness in the improvement of clinical outcomes and/or workplace productivity in patients with RA [40,41]. However, the comparative impact of CZP on household productivity cannot be assessed, owing to a lack of real-world data for other anti-TNF agents in this domain.…”