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Retrospective clinical study on the notable efficacy and related factors of infliximab therapy in a rheumatoid arthritis management group in Japan: one-year clinical outcomes (RECONFIRM-2).

Tanaka Y, Takeuchi T, Inoue E, Saito K, Sekiguchi N, Sato E, Nawata M, Kameda H, Iwata S, Amano K, Yamanaka H - Mod Rheumatol (2008)

Bottom Line: Average DAS28-CRP decreased from 5.5 at week 0 to 3.1 at week 54 after the therapy.Younger age, RF-negativity and low scores of DAS28-CRP showed significant correlations with remission at week 54.In conclusion, we reconfirmed the clinical efficacy of infliximab and demographic factors related to the efficacy over a 54-week study period in 410 Japanese patients with RA using DAS28-CRP and EULAR response criteria.

View Article: PubMed Central - PubMed

Affiliation: The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. tanaka@med.uoeh-u.ac.jp

ABSTRACT
Biologics targeting TNF have brought about a paradigm shift in the treatment of rheumatoid arthritis (RA) and infliximab, anti-TNF-alpha chimeric monoclonal antibody, was marketed in 2003 in Japan. We previously reported on the RECONFIRM study, a retrospective clinical study on the efficacy of infliximab therapy in a RA management group in Japan, where we evaluated the clinical response after 22 weeks of the therapy in 258 patients. The study reported here was aimed at reconfirming the clinical efficacy of the infliximab therapy and demographic factors related to the efficacy over a 54-week study period in 410 RA patients in the same study group. Infliximab was infused according to the domestically approved method, and the clinical response was evaluated following 54 weeks of infliximab therapy using the European League Against Rheumatism (EULAR) response criteria. Disease activity was assessed by DAS28-CRP (Disease Activity Score including a 28-joint count/C-reactive protein). Infliximab was discontinued in 24.4% of the 410 patients at 54 weeks and 9.3% and 8.1% discontinued the therapy due to adverse events and inefficiency, respectively. Average DAS28-CRP decreased from 5.5 at week 0 to 3.1 at week 54 after the therapy. Patients in remission and those showing low-, moderate-, and high-disease activity changed from 0.0, 1.0, 9.0 and 90.0%, respectively, at the start of the study to 27.6, 11.7, 34.4 and 26.3%, respectively, at week 54. Younger age, RF-negativity and low scores of DAS28-CRP showed significant correlations with remission at week 54. EULAR response criteria -- good, moderate, and no response to infliximab -- were 37.0, 41.7 and 21.2%, respectively. In conclusion, we reconfirmed the clinical efficacy of infliximab and demographic factors related to the efficacy over a 54-week study period in 410 Japanese patients with RA using DAS28-CRP and EULAR response criteria.

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Changes in DAS28 values during the 54-week study of patients using infliximab. The ratios of patients who demonstrated high disease activity (defined as DAS28-CRP >4.1), moderate activity (2.7–4.1), low activity (<2.7) and remission (<2.3) at each observation point during the 54-week study are shown
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Fig4: Changes in DAS28 values during the 54-week study of patients using infliximab. The ratios of patients who demonstrated high disease activity (defined as DAS28-CRP >4.1), moderate activity (2.7–4.1), low activity (<2.7) and remission (<2.3) at each observation point during the 54-week study are shown

Mentions: The average DAS28-CRP before starting infliximab was 5.5 ± 1.1, and this decreased to 3.4 ± 1.2, 3.2 ± 1.4, 3.1 ± 1.3 at weeks 2, 22 and 54, respectively, after the infliximab therapy (Fig. 2). Disease characteristics at baseline and after 2, 22 and 54 weeks of the inflilximab therapy were as follows: tender joints count (10.5, 4.2, 3.2 and 2.9), swollen joints count (10.6, 4.2, 2.7 and 2.3), GH (63, 34, 33 and 33 mm), and CRP (3.3, 1.0, 1.5 and 1.1 mg/dl) (Fig. 3). Before starting infliximab, the proportions of patients showing low, moderate, and high disease activity were 1.0, 9.0 and 90.0%, respectively. At week 22, patients in remission (defined as DAS28-CRP <2.3) and those showing low (<2.7), moderate (2.7–4.1), and high disease activity (>4.1) had changed to 27.8, 12.0, 32.4 and 27.8%, respectively, and at week 54 patients in remission and those showing low, moderate, and high disease activity were 27.6, 11.7, 34.4 and 26.3%, respectively (Fig. 4). Thus, approximately 27–28% of the patients satisfied the remission criteria at week 22 and still remained at week 54 after the infliximab therapy. Also, when the responses were evaluated by the EULAR response criteria, the proportions for good, moderate, and no response to infliximab as measured by DAS28-CRP were 37.3, 43.7 and 19.0%, respectively, at week 22 and 37.0, 41.7 and 21.2%, respectively, at week 54 (Fig. 5).Fig. 2


Retrospective clinical study on the notable efficacy and related factors of infliximab therapy in a rheumatoid arthritis management group in Japan: one-year clinical outcomes (RECONFIRM-2).

Tanaka Y, Takeuchi T, Inoue E, Saito K, Sekiguchi N, Sato E, Nawata M, Kameda H, Iwata S, Amano K, Yamanaka H - Mod Rheumatol (2008)

Changes in DAS28 values during the 54-week study of patients using infliximab. The ratios of patients who demonstrated high disease activity (defined as DAS28-CRP >4.1), moderate activity (2.7–4.1), low activity (<2.7) and remission (<2.3) at each observation point during the 54-week study are shown
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Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC2279153&req=5

Fig4: Changes in DAS28 values during the 54-week study of patients using infliximab. The ratios of patients who demonstrated high disease activity (defined as DAS28-CRP >4.1), moderate activity (2.7–4.1), low activity (<2.7) and remission (<2.3) at each observation point during the 54-week study are shown
Mentions: The average DAS28-CRP before starting infliximab was 5.5 ± 1.1, and this decreased to 3.4 ± 1.2, 3.2 ± 1.4, 3.1 ± 1.3 at weeks 2, 22 and 54, respectively, after the infliximab therapy (Fig. 2). Disease characteristics at baseline and after 2, 22 and 54 weeks of the inflilximab therapy were as follows: tender joints count (10.5, 4.2, 3.2 and 2.9), swollen joints count (10.6, 4.2, 2.7 and 2.3), GH (63, 34, 33 and 33 mm), and CRP (3.3, 1.0, 1.5 and 1.1 mg/dl) (Fig. 3). Before starting infliximab, the proportions of patients showing low, moderate, and high disease activity were 1.0, 9.0 and 90.0%, respectively. At week 22, patients in remission (defined as DAS28-CRP <2.3) and those showing low (<2.7), moderate (2.7–4.1), and high disease activity (>4.1) had changed to 27.8, 12.0, 32.4 and 27.8%, respectively, and at week 54 patients in remission and those showing low, moderate, and high disease activity were 27.6, 11.7, 34.4 and 26.3%, respectively (Fig. 4). Thus, approximately 27–28% of the patients satisfied the remission criteria at week 22 and still remained at week 54 after the infliximab therapy. Also, when the responses were evaluated by the EULAR response criteria, the proportions for good, moderate, and no response to infliximab as measured by DAS28-CRP were 37.3, 43.7 and 19.0%, respectively, at week 22 and 37.0, 41.7 and 21.2%, respectively, at week 54 (Fig. 5).Fig. 2

Bottom Line: Average DAS28-CRP decreased from 5.5 at week 0 to 3.1 at week 54 after the therapy.Younger age, RF-negativity and low scores of DAS28-CRP showed significant correlations with remission at week 54.In conclusion, we reconfirmed the clinical efficacy of infliximab and demographic factors related to the efficacy over a 54-week study period in 410 Japanese patients with RA using DAS28-CRP and EULAR response criteria.

View Article: PubMed Central - PubMed

Affiliation: The First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health, Kitakyushu, Japan. tanaka@med.uoeh-u.ac.jp

ABSTRACT
Biologics targeting TNF have brought about a paradigm shift in the treatment of rheumatoid arthritis (RA) and infliximab, anti-TNF-alpha chimeric monoclonal antibody, was marketed in 2003 in Japan. We previously reported on the RECONFIRM study, a retrospective clinical study on the efficacy of infliximab therapy in a RA management group in Japan, where we evaluated the clinical response after 22 weeks of the therapy in 258 patients. The study reported here was aimed at reconfirming the clinical efficacy of the infliximab therapy and demographic factors related to the efficacy over a 54-week study period in 410 RA patients in the same study group. Infliximab was infused according to the domestically approved method, and the clinical response was evaluated following 54 weeks of infliximab therapy using the European League Against Rheumatism (EULAR) response criteria. Disease activity was assessed by DAS28-CRP (Disease Activity Score including a 28-joint count/C-reactive protein). Infliximab was discontinued in 24.4% of the 410 patients at 54 weeks and 9.3% and 8.1% discontinued the therapy due to adverse events and inefficiency, respectively. Average DAS28-CRP decreased from 5.5 at week 0 to 3.1 at week 54 after the therapy. Patients in remission and those showing low-, moderate-, and high-disease activity changed from 0.0, 1.0, 9.0 and 90.0%, respectively, at the start of the study to 27.6, 11.7, 34.4 and 26.3%, respectively, at week 54. Younger age, RF-negativity and low scores of DAS28-CRP showed significant correlations with remission at week 54. EULAR response criteria -- good, moderate, and no response to infliximab -- were 37.0, 41.7 and 21.2%, respectively. In conclusion, we reconfirmed the clinical efficacy of infliximab and demographic factors related to the efficacy over a 54-week study period in 410 Japanese patients with RA using DAS28-CRP and EULAR response criteria.

Show MeSH
Related in: MedlinePlus