Effect of Additional Administration of Tacrolimus in Patients With Rheumatoid Arthritis Treated With Biologics

Abstract

:Objective : To explore the effect of additional administration of tacrolimus to rheumatoid arthritis patients treated with biologics, in whom the effect of biologics is unsatisfactory.Methods : Tacrolimus was administered if the effect of biologics was unsatisfactory for 24 weeks at least in terms of laboratory data or DAS28 level : ESR, CRP level and DAS28 level were not below 15 mm/h, 0.2 mg/dl or 2.6, respectively.Results : Tacrolimus administered in addition to biologics was significantly effective for suppressing the activity of rheumatoid arthritis in our study. The significant effect of tacrolimus appeared at the 4 th week. The effect of tacrolimus achieved quite significant level at the 54 th week (p<0.0001). Conclusion : Tacrolimus may be a promising candidate to suppress the disease activity of rheumatoid arthritis refractory to the conventional treatment with biologics.

Safety and effectiveness of tacrolimus add-on therapy for rheumatoid arthritis patients without an adequate response to biological disease-modifying anti-rheumatic drugs (DMARDs): Post-marketing surveillance in Japan

“…This prospective PMS study undertaken in Japan evaluated the safety and effectiveness of TAC add-on therapy in patients with RA in whom inadequate response to biological DMARDs was noted. Both the number of participating sites (180) and patients (624 in the safety analysis; 566 in the effectiveness analysis) were larger than in similar studies, conducted previously (1-18 sites and 5-28 TAC-treated patients) of TAC add-on therapy in this setting [19][20][21][22][23].…”

“…The safety and efficacy of TAC against RA has already been demonstrated in several clinical trials [13][14][15][16][17] and post-marketing surveillance (PMS) with 3267 Japanese patients with RA [18]. In addition, some reports suggest that TAC add-on therapy with biological DMARDs is a useful therapeutic option for patients without an adequate response to biological DMARDs and who cannot take MTX [19][20][21][22][23]. However, these reports are based on studies with a small number of TAC-treated patients or of retrospective design.…”

Serial measurement of presepsin, procalcitonin, and C‐reactive protein in the early postoperative period and the response to antithymocyte globulin administration after heart transplantation

“…Indeed, similar data can be found in the literature, with the administration of tacrolimus or sirolimus decreasing the concentration of CRP in patients after kidney transplantation or coronary stenting, as well as in patients with rheumatoid arthritis. [24][25][26]…”

Comparison of efficacy and safety of tacrolimus and methotrexate in combination with abatacept in patients with rheumatoid arthritis; a retrospective observational study in the TBC Registry

“…They concluded that the efficacy and safety were generally similar between these two groups. Miyata et al [7] conducted a study of add-on TAC in 16 non-responders to IFX and 12 non-responders to ETN, reporting that the DAS28-CRP significantly decreased at Week 4 in both the combined biologic treatment groups, and with no serious adverse events. Similarly, Mori et al [8] reported that switching to tocilizumab therapy and additional use of TAC in 5 primary non-responders to TFX therapy decreased the disease activity and caused no serious adverse events.…”

“…These patients may be treated with TAC alone, or salazosulfapyridine, leflunomide, or other DMARDs with or without TAC [5]. The biologic drugs: infliximab (IFX), etanercept (ETN) and tocilizumab (TCZ) have also exhibited good efficacy and safety when administered in combination with TAC [6][7][8]. In contrast, the efficacy of combined administration of TAC and ABT has not yet been extensively studied.…”