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. 2013 Mar;13(1):95-100.
doi: 10.1007/s40268-013-0010-z.

Effectiveness of golimumab in clinical management of patients with rheumatoid arthritis

Eisuke Shono  1
Affiliations

Effectiveness of golimumab in clinical management of patients with rheumatoid arthritis

Eisuke Shono. Drugs R D. 2013 Mar.

Abstract

Background and objectives: Limited data are available regarding the use of golimumab (100 mg) every 4 weeks, with or without methotrexate (MTX). The aim of this retrospective analysis was to evaluate the effectiveness and safety of golimumab following usual clinical practice in Japanese patients with rheumatoid arthritis (RA) according to the recommendations given in the Japanese package insert.

Patients and methods: Japanese RA patients with moderate-to-high disease activity, according to the 28-joint disease activity score based on C-reactive protein (DAS28-CRP) criteria, despite treatment with MTX or another biological agent, were enrolled. Patients were assigned to 50 mg golimumab plus MTX or 100 mg golimumab monotherapy every 4 weeks for 24 weeks. All patients were given MTX if it was not contraindicated. The primary endpoint was the proportion of patients achieving clinical remission (defined as a DAS28-CRP <2.3 or a simplified disease activity index [SDAI] score <3.3) at 24 weeks.

Results: Most patients received combined 50 mg golimumab plus MTX (41/43). In these patients, the primary endpoint, clinical remission, was attained in 83 % of patients according to DAS28-CRP criteria (p < 0.001) and 69 % according to SDAI criteria (p < 0.001) by week 24. Adverse events were reported in 11.6 % of patients receiving golimumab.

Conclusions: Golimumab (50 mg) plus MTX effectively reduced the signs and symptoms of RA and was generally well tolerated in patients with an inadequate response to MTX and other biological agents.

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Conflict of interest statement

The author has no conflicts of interest to declare.

Figures

Fig. 1
Fig. 1
Remission rate in 43 patients with rheumatoid arthritis treated with golimumab alone or in combination with methotrexate. Remission was defined as a 28-joint disease activity score based on C-reactive protein (DAS28-CRP) of <2.3 or a simplified disease activity index (SDAI) score of <3.3. DAS28-CRP remission and DAS28-CRP plus SDAI remission (ALL) are shown. BL baseline, W weeks
Fig. 2
Fig. 2
Changes in mean 28-joint disease activity score based on C-reactive protein (DAS28-CRP) in bio-naïve or previously treated patients with rheumatoid arthritis receiving golimumab alone or in combination with methotrexate. The dashed line represents the defined remission cutoff value of 2.3. BL baseline, W weeks
Fig. 3
Fig. 3
Changes in mean simplified disease activity index (SDAI) score in bio-naïve or previously treated patients with rheumatoid arthritis receiving golimumab alone or in combination with methotrexate. The dashed line represents the defined remission cutoff value of 3.3. BL baseline, W weeks
See this image and copyright information in PMC

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