Efficacy and Safety of Induction Therapy for Rheumatoid Arthritis with Simultaneous Administration of Methotrexate and Low-Dose Tacrolimus: A Retrospective Study

Takashi Nakanishi¹, Hideyuki Horikoshi¹, Reiko Takahashi¹, Kanami Tongu², Junko Nishioka², Fumihiko Kimura³, Yuichi Nishioka² and Kenji Itoh¹, ¹Division of Rheumatology, Department of Internal Medicine, National Defense Medical College, Tokorozawa, Japan, ²Nishioka Clinic for Rheumatic Diseases and Allergic Diseases, Kofu, Japan, ³National Defense Medical College, Tokorozawa, Japan

Meeting: 2014 ACR/ARHP Annual Meeting

Keywords: DMARDs, methotrexate (MTX), rheumatoid arthritis (RA) and tacrolimus

Session Information

Title: Rheumatoid Arthritis - Small Molecules, Biologics and Gene Therapy: Safety of Biologics and Small Molecules in Rheumatoid Arthritis

Session Type: Abstract Submissions (ACR)

Background/Purpose

Additional administration of low-dose tacrolimus (LD-TAC) at 0.5–1.0 mg daily was reported to be quite effective for rheumatoid arthritis (RA) patients with inadequate response to methotrexate (MTX). This study evaluated the efficacy and safety of induction therapy with simultaneous administration of MTX and LD-TAC for RA.

Methods

Clinical records of 147 RA patients initially treated with MTX alone or MTX with LD-TAC were retrospectively analyzed. We classified the patients into the MTX monotherapy group (patients who continued to receive MTX alone during the entire investigation), LD-TAC add-on group (patients with inadequate response to MTX who initially received MTX monotherapy and then an add-on LD-TAC), and simultaneous combination group (patients who initially received concomitant administration of MTX and LD-TAC).Patients who needed to receive other disease-modifying antirheumatic drugs, biological agents, or prednisone > 10 mg daily were excluded from the study.Treatment efficacy was evaluated every 12 weeks for 1 year from the initial treatment, using the Disease Activity Score in 28 joints and erythrocyte sedimentation rate (DAS28-ESR) and Boolean-based remission rate.All adverse events observed in each group were also evaluated.

Results

A total of 26, 18, and 28 patients in the MTX-monotherapy, LD-TAC add-on, and simultaneous combination groups, respectively, were evaluated. The initial DAS28-ESR scores were 4.73, 4.58, and 4.63, respectively. No differences in baseline patient characteristics were found between the groups, except the higher initial prednisone dose in the MTX-monotherapy group.Of the patients in the simultaneous combination group, 92.9% achieved low disease activity at the 48th week, which was a significantly higher rate than that for those in the MTX-monotherapy and LD-TAC add-on groups (65.4% and 66.7%, respectively; p < 0.01). The achievement rates for good response according to the DAS28-based European League of Associations for Rheumatology response and Boolean-based remission criteria were also significantly higher in the simultaneous combination group. In addition, the prednisone dose was lower in the simultaneous combination group than in the MTX monotherapy group at the 48th week.No significant difference in the incidence of adverse events was observed between the groups. No serious adverse event was observed during the study period.

Conclusion

This study demonstrates the efficacy and safety of induction therapy with simultaneous administration of MTX and LD-TAC for RA. Large-scale prospective cohort studies are required for a more precise understanding of the treatment.

Disclosure:

T. Nakanishi,
None;

H. Horikoshi,
None;

R. Takahashi,
None;

K. Tongu,
None;

J. Nishioka,
None;

F. Kimura,
None;

Y. Nishioka,
None;

K. Itoh,
None.

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