Effectiveness and safety of adalimumab in Japanese patients with rheumatoid arthritis: retrospective analyses of data collected during the first year of adalimumab treatment in routine clinical practice (HARMONY study)

Abstract

We retrospectively investigated the ability of adalimumab (ADA) to reduce disease activity, improve physical function, and retard the progression of structural damage in 167 patients with rheumatoid arthritis. Clinical and functional outcomes were compared between patients with or without prior biologic treatment and those with or without concomitant methotrexate (MTX) treatment. At week 52, 38.3% achieved clinical remission: 42.4 and 28.6% of patients achieved remission in those without and with previous biologics, respectively, while 42.7 and 12.5% of patients achieved remission in those with and without concomitant MTX, respectively. ADA treatment significantly reduced the rate of radiographic progression from 27.1 ± 46.0 (median 13.6; 25th-75th percentiles 8.3 to 28.9) at baseline to 0.8 ± 5.0 (median 0.0; 25th-75th percentiles -0.9 to 2.0) at week 52 (P \ 0.0001). Radiographic progression was absent in 59.8% of patients. Sixty adverse events (34.21/100 patient-years) were reported, 16 of which were serious (9.12/100 patient-years). ADA therapy is highly effective for reducing disease activity, improving physical function, and limiting radiographic progression. It is generally safe and well tolerated by Japanese RA patients in routine clinical practice.

A phase III, randomized, two-armed, double-blind, parallel, active controlled, and non-inferiority clinical trial to compare efficacy and safety of biosimilar adalimumab (CinnoRA®) to the reference product (Humira®) in patients with active rheumatoid arthritis

“…Further, the percentage of patients reaching ACR20, ACR50, and ACR70 increased significantly during the 6-month period. In the retrospective study of Takeuchi et al investigating the ability of adalimumab to reduce disease activity in 167 patients with RA, the mean DAS28-ESR score decreased from 5.3 ± 1.3 at baseline to 3.5 ± 1.5 at week 52 ( p  < 0.0001), which is consistent with our findings [32]. …”

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

“…In the present study, PWs at high risk of work disability showed significantly improved WPAI outcomes after treatment with ADA, as assessed by widely used WPAI/RA domain scores (absenteeism, presenteeism, OWI, and AI) [45, 46]. Significant decreases in DAS28CRP obtained in this real-world setting were consistent with those reported in clinical trials of 24- to 52-week duration, as well as a 24-week post-marketing surveillance study conducted in Japan [27, 39, 47, 48]. Importantly, in the present large-scale study, improvements in WPAI/RA showed a weak to moderately strong positive linear correlation with improvement in disease activity, extending the findings from a previous small-scale study assessing the effects of TNF-α antagonists on DAS28ESR and work productivity in 42 patients [15].…”

“…The differences in baseline HAQ-DI, EQ-5D-3L, and AI scores could be attributed to activity associated with employment status, as the dose of prednisolone, clinical disease activity measured by DAS28ESR, and SDAI were comparable at baseline between groups. Additionally, baseline characteristics of the patient population in this real-world study were heterogeneous in comparison to those of clinical trials in Japan [23, 26, 27, 39, 47, 48, 54]. Moreover, this study did not evaluate patients on the basis of comorbidity [54] and stage of disease, which could potentially impact the effectiveness of ADA.…”

Concomitant methotrexate and tacrolimus augment the clinical response to abatacept in patients with rheumatoid arthritis with a prior history of biological DMARD use

“…This finding is not specific to abatacept; similar data are available for other biological DMARDs [30,31]. Thus, a major challenge in RA management is the treatment of those with a prior history of biological DMARD use.…”