Clinical effectiveness and safety of additional administration of tacrolimus in rheumatoid arthritis patients with an inadequate response to abatacept: A retrospective cohort study

Abstract

Objective: Abatacept (ABT) demonstrates good clinical efficacy and retention in rheumatoid arthritis (RA) patients. However, no rescue treatment option against inadequate response to ABT exists. Since tacrolimus (TAC) and ABT suppress T lymphocytes via different mechanisms and a combination of these agents could potentially be effective, this study aimed to examine the efficacy and safety of add-on TAC therapy in RA patients with inadequate response to ABT. Methods:Of 550 patients treated with ABT and registered in a Japanese multicenter registry, 25 consecutive patients who underwent add-on TAC therapy and were followed for longer than 24 weeks were included in this study.Results: Mean patient age was 67.0 years, disease duration was 16.2 years, and duration of ABT treatment was 1.2 years at the initiation of add-on TAC therapy. Mean TAC dose was 1.2 mg/d at baseline and 1.6 mg/d at week 24. Mean Disease Activity Score of 28 joints -erythrocyte sedimentation rate was significantly improved at week 24 (3.35) relative to baseline (4.97). The proportion of patients who achieved low disease activity or remission was 40.0%, and the European League Against Rheumatism moderate or good response was 72.0%. ABT retention rate was 92.0% at week 24, as calculated by Kaplan-Meier analysis. Only one patient discontinued add-on TAC therapy due to an adverse event (itching sensation).Conclusion: This is the first report describing the efficacy and safety profile of addon TAC therapy with a focus on RA patients with inadequate response to ABT. Our findings suggest that add-on TAC therapy is a worthwhile complementary treatment option in daily clinical practice. K E Y W O R D Sabatacept, additional administration, inadequate response, rheumatoid arthritis, tacrolimus

Sustained Long-Term Retention Rates of Abatacept in Combination with Conventional Synthetic Disease-Modifying Antirheumatic Drugs in Elderly Patients with Rheumatoid Arthritis

“…[ 22 , 27 ], revealing that TAC was good enough and well-tolerated in Japanese patients who were resistant to biologics. Furthermore, some Japanese authors have described the real-world effect of ABT/TAC combination therapy [ 28 , 29 ]. Fujibayashi et al reported that ABT/TAC, as well as ABT/MTX combination therapy, was effective in Japanese RA patients [ 28 ].…”

“…Fujibayashi et al reported that ABT/TAC, as well as ABT/MTX combination therapy, was effective in Japanese RA patients [ 28 ]. Suzuki et al also reported that additional administration of TAC in RA patients who showed an inadequate response to ABT was effective [ 29 ]. Our study also showed that ABT/TAC combination therapy was effective in elderly as well as younger RA patients, leading to sustained remission rates and implicating a profound combination effect of ABT with TAC.…”

Toward Overcoming Treatment Failure in Rheumatoid Arthritis

“…In a retrospective cohort study involving 550 RA patients treated with abatacept, 25 inadequate responders underwent an add-on macrolide calcineurin inhibitor tacrolimus therapy. At week 24, 40.0% of patients achieved low disease activity or remission, and the EULAR moderate or good response was 72.0% ( 316 ).…”

Difficult-to-treat rheumatoid arthritis treated with Abatacept combined with Baricitinib: A case report

“…Compared to other b/tsDMARDs, Abatacept (ABT), a novel T-cell costimulation modulator, created compelling clinical benefits and security in patients who did not respond to anti-tumor necrosis factor-α or methotrexate treatment[ 7 , 8 ]. However, ABT is not effective in all patients[ 9 ]. The poor response to ABT in D2T RA patients may be linked to inflammatory cytokines; however, the exact pathogenesis remains unknown.…”