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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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Continuation of the infliximab therapy in RA patients for 54 weeks. a Survival rate of RA patients treated with infliximab (n = 410, total and three institutes) during the 54-week therapy. b Cumulative hazards of the discontinuation of infliximab therapy by week 54 of the treatment
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Fig1: Continuation of the infliximab therapy in RA patients for 54 weeks. a Survival rate of RA patients treated with infliximab (n = 410, total and three institutes) during the 54-week therapy. b Cumulative hazards of the discontinuation of infliximab therapy by week 54 of the treatment

Mentions: Infliximab was discontinued in 100 cases (24.4%) among 410 patients during a 54-week period and the survival rate for infliximab use was comparable among three institutes by week 54 after the treatment according to Kaplan–Meier analysis (Fig. 1a). Cumulative hazards of the discontinuation during the 54-week infliximab therapy were different among the causes of discontinuation; discontinuation due to adverse events, inefficiency, remission and other causes (such as change of hospitals/clinics and economic reasons), were 0.093, 0.081, 0.007 and 0.063, respectively (Fig. 1b). Although the cause of the discontinuation was similar among three institutes, adverse events were higher in Center 1 than in the other two institutes, and remission and other causes including economic problems of the patient were greater in Center 3 than in the other two (data not shown). In 100 patients who terminated infliximab treatment, stratified Cox regression was performed to analyze factors associated with the discontinuation of the infusion. Male, older age and RF-negativity were significantly associated with the discontinuation of infliximab due to adverse reactions, whereas there was no significant factor responsible for the discontinuation due to maintained remission or a lack of efficacy (Table 2).Fig. 1


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)

Continuation of the infliximab therapy in RA patients for 54 weeks. a Survival rate of RA patients treated with infliximab (n = 410, total and three institutes) during the 54-week therapy. b Cumulative hazards of the discontinuation of infliximab therapy by week 54 of the treatment
© Copyright Policy
Related In: Results  -  Collection

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

Fig1: Continuation of the infliximab therapy in RA patients for 54 weeks. a Survival rate of RA patients treated with infliximab (n = 410, total and three institutes) during the 54-week therapy. b Cumulative hazards of the discontinuation of infliximab therapy by week 54 of the treatment
Mentions: Infliximab was discontinued in 100 cases (24.4%) among 410 patients during a 54-week period and the survival rate for infliximab use was comparable among three institutes by week 54 after the treatment according to Kaplan–Meier analysis (Fig. 1a). Cumulative hazards of the discontinuation during the 54-week infliximab therapy were different among the causes of discontinuation; discontinuation due to adverse events, inefficiency, remission and other causes (such as change of hospitals/clinics and economic reasons), were 0.093, 0.081, 0.007 and 0.063, respectively (Fig. 1b). Although the cause of the discontinuation was similar among three institutes, adverse events were higher in Center 1 than in the other two institutes, and remission and other causes including economic problems of the patient were greater in Center 3 than in the other two (data not shown). In 100 patients who terminated infliximab treatment, stratified Cox regression was performed to analyze factors associated with the discontinuation of the infusion. Male, older age and RF-negativity were significantly associated with the discontinuation of infliximab due to adverse reactions, whereas there was no significant factor responsible for the discontinuation due to maintained remission or a lack of efficacy (Table 2).Fig. 1

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