Safety and effectiveness of switching from infliximab to etanercept in patients with rheumatoid arthritis: results from a large Japanese postmarketing surveillance study

Abstract

Finding an effective treatment strategy for rheumatoid arthritis (RA) patients who have not benefited from previous tumor necrosis factor–α antagonist treatment is important for minimizing RA disease activity and improving patient outcomes. The aim of this study was to compare the safety and effectiveness of etanercept in patients with and without infliximab (IFX) treatment experience. Patients (n = 7,099) from a large postmarketing observational study of etanercept use in Japan were divided into 2 cohorts based on previous IFX use (pre-IFX and non-IFX). Baseline characteristics were assessed in each cohort. Adverse events (AEs) and European League Against Rheumatism (EULAR) responses were monitored every 4 weeks for 24 weeks. At baseline, pre-IFX patients were younger and had fewer comorbidities and a shorter RA duration than non-IFX patients. During the study, pre-IFX patients received concomitant methotrexate more often than non-IFX patients. The incidence of AEs and serious AEs were significantly lower in pre-IFX patients, as was the percentage of patients who discontinued treatment. Both cohorts had significant improvement (P < 0.001) in EULAR responses at the end of the treatment period. This study demonstrated that etanercept was effective and well tolerated in active RA patients with and without prior IFX treatment.

Pharmacokinetics, efficacy and safety profiles of etanercept monotherapy in Japanese patients with rheumatoid arthritis: review of seven clinical trials

“…The primary reason for discontinuation in the long-term and self-injections studies also was due to adverse events; relatively few patients discontinued ETN due to lack of efficacy. These data are consistent with previous findings [ 8 , 10 ].…”

“…There were no medically relevant safety differences noted between the two ETN doses or between the QW or BIW dosing regimens. The tolerability of ETN monotherapy in these studies was comparable to post-marketing surveillance analyses that showed overall rates of adverse events of 31–35% [ 8 , 10 ]. Post-marketing surveillance studies have shown that adalimumab [ 22 ] has a similar rate of adverse events (31%).…”

“…The approval of ETN for the treatment of RA in Japan was based on clinical trial data in Japanese patients with the results of pivotal studies from Europe and the United States [ 7 – 10 ]. There has been a large clinical development program to study efficacy, radiographic, and safety outcomes in Japanese patients with RA.…”

The Effectiveness of Intravenous Golimumab Administered Directly After Infliximab in Rheumatoid Arthritis Patients

“…In contrast, our current results show the percentage of patients in remission increased by 22.8% (4.5% pre-golimumab to 27.3% post-golimumab) after transitioning from infliximab to intravenous golimumab (Table 6 ). A similar study found that only 14.4% of patients achieved remission when switched from infliximab to etanercept [ 25 ]. Finally, a study in which patients with RA switched to subcutaneous golimumab from their first TNF (adalimumab, etanercept, or infliximab) found that week 24 American College of Rheumatology improvement by 20% (ACR20) rates were 30.3, 46.8, and 50.9%, for each biologic agent, respectively [ 26 ].…”

Design characteristics of the Corrona Japan rheumatoid arthritis registry

“…As real-world setting of bDMARDs in Japan, various postmarketing surveillance studies (PMS) or smaller registries created by enrolling PMS participants also existed or exist in Japan [18][19][20][21]. As expected, they are heavily focused on safety and most of the time of relatively short duration of follow-up.…”