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Head-to-head comparison of the safety of tocilizumab and tumor necrosis factor inhibitors in rheumatoid arthritis patients (RA) in clinical practice: results from the registry of Japanese RA patients on biologics for long-term safety (REAL) registry.

Sakai R, Cho SK, Nanki T, Watanabe K, Yamazaki H, Tanaka M, Koike R, Tanaka Y, Saito K, Hirata S, Amano K, Nagasawa H, Sumida T, Hayashi T, Sugihara T, Dobashi H, Yasuda S, Sawada T, Ezawa K, Ueda A, Fujii T, Migita K, Miyasaka N, Harigai M, REAL Study Gro - Arthritis Res. Ther. (2015)

Bottom Line: TNFI 3.03; IR ratio (95% confidence interval [CI]), 3.53 (1.52 to 8.18)], but not SAEs [21.36 vs. 14.72; 1.45 (0.94 to 2.25)], was significantly higher in the TCZ group compared with the TNFI group.However, after adjusting for covariates using the Cox regression hazard analysis, treatment with TCZ was not associated with higher risk for SAEs [hazard ratio (HR) 1.28, 95% CI 0.75 to 2.19] or SIs (HR 2.23, 95% CI 0.93 to 5.37).The adjusted risks for SAEs and SIs were not significantly different between TCZ and TNFIs, indicating an influence of clinical characteristics of the patients on the safety profile of the biologics in clinical practice.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. sakai.phv@tmd.ac.jp.

ABSTRACT

Introduction: The objective of this study was to directly compare the safety of tocilizumab (TCZ) and TNF inhibitors (TNFIs) in rheumatoid arthritis (RA) patients in clinical practice.

Methods: This prospective cohort study included RA patients starting TCZ [TCZ group, n=302, 224.68 patient-years (PY)] or TNFIs [TNFI group, n=304, 231.01 PY] from 2008 to 2011 in the registry of Japanese RA patients on biologics for long-term safety registry. We assessed types and incidence rates (IRs) of serious adverse events (SAEs) and serious infections (SIs) during the first year of treatment. Risks of the biologics for SAEs or SIs were calculated using the Cox regression hazard analysis.

Results: Patients in the TCZ group had longer disease duration (P<0.001), higher disease activity (P=0.019) and more frequently used concomitant corticosteroids (P<0.001) than those in the TNFI group. The crude IR (/100 PY) of SIs [TCZ 10.68 vs. TNFI 3.03; IR ratio (95% confidence interval [CI]), 3.53 (1.52 to 8.18)], but not SAEs [21.36 vs. 14.72; 1.45 (0.94 to 2.25)], was significantly higher in the TCZ group compared with the TNFI group. However, after adjusting for covariates using the Cox regression hazard analysis, treatment with TCZ was not associated with higher risk for SAEs [hazard ratio (HR) 1.28, 95% CI 0.75 to 2.19] or SIs (HR 2.23, 95% CI 0.93 to 5.37).

Conclusions: The adjusted risks for SAEs and SIs were not significantly different between TCZ and TNFIs, indicating an influence of clinical characteristics of the patients on the safety profile of the biologics in clinical practice.

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Related in: MedlinePlus

Kaplan-Meier curves for time to discontinuation for each group. Drug retention rates were compared using the log-rank test between tocilizumab (TCZ) and tumor necrosis factor inhibitors (TNFIs). The y axis shows the cumulative retention rates.
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Fig2: Kaplan-Meier curves for time to discontinuation for each group. Drug retention rates were compared using the log-rank test between tocilizumab (TCZ) and tumor necrosis factor inhibitors (TNFIs). The y axis shows the cumulative retention rates.

Mentions: The median (interquartile (IQR)) treatment period was 1.00 (0.50 to 1.00) year for the TCZ group and 1.00 (0.51 to 1.00) year for the TNFI group. The number of patients who discontinued biologics for any reason during the observation period was 81 (26.8%) in the TCZ group and 62 (20.4%) in the TNFI group, not a significant difference (P = 0.062 by chi-square). The development of AEs was the most frequent reason for discontinuation in both the TCZ group (n = 41, 50.6%) and the TNFI group (n = 24, 38.7%). There was no significant difference in the retention rates of the biologics for one year between the two groups (71.0% in the TCZ group, 76.1% in the TNFI group, P = 0.082 by Kaplan-Meier analysis and log-rank test) (Figure 2).Figure 2


Head-to-head comparison of the safety of tocilizumab and tumor necrosis factor inhibitors in rheumatoid arthritis patients (RA) in clinical practice: results from the registry of Japanese RA patients on biologics for long-term safety (REAL) registry.

Sakai R, Cho SK, Nanki T, Watanabe K, Yamazaki H, Tanaka M, Koike R, Tanaka Y, Saito K, Hirata S, Amano K, Nagasawa H, Sumida T, Hayashi T, Sugihara T, Dobashi H, Yasuda S, Sawada T, Ezawa K, Ueda A, Fujii T, Migita K, Miyasaka N, Harigai M, REAL Study Gro - Arthritis Res. Ther. (2015)

Kaplan-Meier curves for time to discontinuation for each group. Drug retention rates were compared using the log-rank test between tocilizumab (TCZ) and tumor necrosis factor inhibitors (TNFIs). The y axis shows the cumulative retention rates.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4384380&req=5

Fig2: Kaplan-Meier curves for time to discontinuation for each group. Drug retention rates were compared using the log-rank test between tocilizumab (TCZ) and tumor necrosis factor inhibitors (TNFIs). The y axis shows the cumulative retention rates.
Mentions: The median (interquartile (IQR)) treatment period was 1.00 (0.50 to 1.00) year for the TCZ group and 1.00 (0.51 to 1.00) year for the TNFI group. The number of patients who discontinued biologics for any reason during the observation period was 81 (26.8%) in the TCZ group and 62 (20.4%) in the TNFI group, not a significant difference (P = 0.062 by chi-square). The development of AEs was the most frequent reason for discontinuation in both the TCZ group (n = 41, 50.6%) and the TNFI group (n = 24, 38.7%). There was no significant difference in the retention rates of the biologics for one year between the two groups (71.0% in the TCZ group, 76.1% in the TNFI group, P = 0.082 by Kaplan-Meier analysis and log-rank test) (Figure 2).Figure 2

Bottom Line: TNFI 3.03; IR ratio (95% confidence interval [CI]), 3.53 (1.52 to 8.18)], but not SAEs [21.36 vs. 14.72; 1.45 (0.94 to 2.25)], was significantly higher in the TCZ group compared with the TNFI group.However, after adjusting for covariates using the Cox regression hazard analysis, treatment with TCZ was not associated with higher risk for SAEs [hazard ratio (HR) 1.28, 95% CI 0.75 to 2.19] or SIs (HR 2.23, 95% CI 0.93 to 5.37).The adjusted risks for SAEs and SIs were not significantly different between TCZ and TNFIs, indicating an influence of clinical characteristics of the patients on the safety profile of the biologics in clinical practice.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacovigilance, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University, 1-5-45, Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan. sakai.phv@tmd.ac.jp.

ABSTRACT

Introduction: The objective of this study was to directly compare the safety of tocilizumab (TCZ) and TNF inhibitors (TNFIs) in rheumatoid arthritis (RA) patients in clinical practice.

Methods: This prospective cohort study included RA patients starting TCZ [TCZ group, n=302, 224.68 patient-years (PY)] or TNFIs [TNFI group, n=304, 231.01 PY] from 2008 to 2011 in the registry of Japanese RA patients on biologics for long-term safety registry. We assessed types and incidence rates (IRs) of serious adverse events (SAEs) and serious infections (SIs) during the first year of treatment. Risks of the biologics for SAEs or SIs were calculated using the Cox regression hazard analysis.

Results: Patients in the TCZ group had longer disease duration (P<0.001), higher disease activity (P=0.019) and more frequently used concomitant corticosteroids (P<0.001) than those in the TNFI group. The crude IR (/100 PY) of SIs [TCZ 10.68 vs. TNFI 3.03; IR ratio (95% confidence interval [CI]), 3.53 (1.52 to 8.18)], but not SAEs [21.36 vs. 14.72; 1.45 (0.94 to 2.25)], was significantly higher in the TCZ group compared with the TNFI group. However, after adjusting for covariates using the Cox regression hazard analysis, treatment with TCZ was not associated with higher risk for SAEs [hazard ratio (HR) 1.28, 95% CI 0.75 to 2.19] or SIs (HR 2.23, 95% CI 0.93 to 5.37).

Conclusions: The adjusted risks for SAEs and SIs were not significantly different between TCZ and TNFIs, indicating an influence of clinical characteristics of the patients on the safety profile of the biologics in clinical practice.

Show MeSH
Related in: MedlinePlus