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An observational study of tocilizumab and TNF-α inhibitor use in a Japanese community hospital: different remission rates, similar drug survival and safety.

Yoshida K, Tokuda Y, Oshikawa H, Utsunomiya M, Kobayashi T, Kimura M, Deshpande GA, Matsui K, Kishimoto M - Rheumatology (Oxford) (2011)

Bottom Line: First- and second-line tocilizumab users showed similar drug survival and SAE rates compared with TNF inhibitor users.Tocilizumab had drug survival and safety profiles similar to those of TNF inhibitors in this Japanese single-centre registry.Tocilizumab was superior to TNF inhibitors when compared at 6 months by DAS-28-ESR remission.

View Article: PubMed Central - PubMed

Affiliation: Department of Rheumatology, Kameda Medical Center, 929 Higashi-Cho, Kamogawa City, Chiba Prefecture 296-8602, Japan. kazukiyoshid@gmail.com

ABSTRACT

Objective: To assess the effectiveness, drug survival and safety of tocilizumab compared with TNF-α inhibitors in clinical practice.

Methods: Patients in the Cohort of Arthritis Biologic Users at Kameda Institute (CABUKI) registry who were on biologics during July 2003 to October 2010 were included. Remission rates at 6 months, Kaplan-Meier drug survival estimates and serious adverse event (SAE) rates were compared.

Results: A total of 247 RA patients were analysed. For first-line biologic users, the 6-month 28-joint DAS (DAS-28)-ESR remission rates were 66.7% for tocilizumab vs 25.8% for TNF inhibitors (P < 0.001, Fisher's exact test). This advantage disappeared with the application of the newly suggested Boolean remission criterion for clinical trials: 0% for tocilizumab vs 8.2% for TNF inhibitors (P = 0.367, Fisher's exact test). Tocilizumab users in DAS-28-ESR remission had lower mean ESR (3.9  mm/h for tocilizumab vs 7.9  mm/h for TNF inhibitors, P = 0.026, t-test) and higher mean swollen joint count (2.6 for tocilizumab vs 1.3 for TNF inhibitors, P = 0.036, t-test), thus failing to meet the more stringent Boolean criteria. First- and second-line tocilizumab users showed similar drug survival and SAE rates compared with TNF inhibitor users.

Conclusion: Tocilizumab had drug survival and safety profiles similar to those of TNF inhibitors in this Japanese single-centre registry. Tocilizumab was superior to TNF inhibitors when compared at 6 months by DAS-28-ESR remission. However, the newly suggested Boolean criteria are more appropriate measures of effectiveness as DAS-28-ESR remission by tocilizumab was mainly due to very low ESR in our study population.

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Related in: MedlinePlus

Kaplan–Meier drug survival estimates for all biologic users. Number at risk in each group is shown at the bottom. TCZ: tocilizumab; TNFi: TNF inhibitors.
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ker295-F3: Kaplan–Meier drug survival estimates for all biologic users. Number at risk in each group is shown at the bottom. TCZ: tocilizumab; TNFi: TNF inhibitors.

Mentions: No significant difference was found in drug survival time as shown in Fig. 3 (P = 0.879, log-rank test) between the tocilizumab group and TNF inhibitors-combined group (n = 247, tocilizumab 47, infliximab 99, etanercept 96 and adalimumab 5). Between the first-line tocilizumab group and TNF inhibitors-combined group (n = 192, tocilizumab 18, infliximab 95, etanercept 76 and adalimumab 3), there was also no statistically significant difference (Fig. 4, P = 0.860, log-rank test). At 6 and 12 months, respectively, 69.6 and 59.7% remained on first-line tocilizumab, whereas 71.5 and 53.2% remained on TNF inhibitors. Reasons for drug discontinuation in each group were similar. Drug survival was also comparable (P = 0.354, log-rank test) between the second-line tocilizumab group (n = 22; 72.6% at 6 months, 60.5% at 12 months) and TNF inhibitors-combined group (n = 22; 81.8% at 6 months, 76.7% at 12 months), with similar reasons for discontinuation. Baseline factors associated with an increased risk of drug discontinuation were BMI [P = 0.013, hazard ratio (HR) = 1.06 for each 1-point increase in BMI, 95% CI 1.01, 1.11]. In contrast, previous exposure to other biologics (P = 0.016, HR = 0.52, 95% CI 0.31, 0.88), concomitant autoimmune disease (P = 0.042, HR = 0.56, 95% CI 0.32, 0.98) and NSAID use (P = 0.005, HR = 0.57, 95% CI 0.38, 0.84) were associated with decreased risk. Compared with TNF inhibitors-combined, tocilizumab use was not associated with changes in risk (P = 0.357, HR = 1.30, 95% CI 0.74, 2.27).Fig. 3


An observational study of tocilizumab and TNF-α inhibitor use in a Japanese community hospital: different remission rates, similar drug survival and safety.

Yoshida K, Tokuda Y, Oshikawa H, Utsunomiya M, Kobayashi T, Kimura M, Deshpande GA, Matsui K, Kishimoto M - Rheumatology (Oxford) (2011)

Kaplan–Meier drug survival estimates for all biologic users. Number at risk in each group is shown at the bottom. TCZ: tocilizumab; TNFi: TNF inhibitors.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC3198907&req=5

ker295-F3: Kaplan–Meier drug survival estimates for all biologic users. Number at risk in each group is shown at the bottom. TCZ: tocilizumab; TNFi: TNF inhibitors.
Mentions: No significant difference was found in drug survival time as shown in Fig. 3 (P = 0.879, log-rank test) between the tocilizumab group and TNF inhibitors-combined group (n = 247, tocilizumab 47, infliximab 99, etanercept 96 and adalimumab 5). Between the first-line tocilizumab group and TNF inhibitors-combined group (n = 192, tocilizumab 18, infliximab 95, etanercept 76 and adalimumab 3), there was also no statistically significant difference (Fig. 4, P = 0.860, log-rank test). At 6 and 12 months, respectively, 69.6 and 59.7% remained on first-line tocilizumab, whereas 71.5 and 53.2% remained on TNF inhibitors. Reasons for drug discontinuation in each group were similar. Drug survival was also comparable (P = 0.354, log-rank test) between the second-line tocilizumab group (n = 22; 72.6% at 6 months, 60.5% at 12 months) and TNF inhibitors-combined group (n = 22; 81.8% at 6 months, 76.7% at 12 months), with similar reasons for discontinuation. Baseline factors associated with an increased risk of drug discontinuation were BMI [P = 0.013, hazard ratio (HR) = 1.06 for each 1-point increase in BMI, 95% CI 1.01, 1.11]. In contrast, previous exposure to other biologics (P = 0.016, HR = 0.52, 95% CI 0.31, 0.88), concomitant autoimmune disease (P = 0.042, HR = 0.56, 95% CI 0.32, 0.98) and NSAID use (P = 0.005, HR = 0.57, 95% CI 0.38, 0.84) were associated with decreased risk. Compared with TNF inhibitors-combined, tocilizumab use was not associated with changes in risk (P = 0.357, HR = 1.30, 95% CI 0.74, 2.27).Fig. 3

Bottom Line: First- and second-line tocilizumab users showed similar drug survival and SAE rates compared with TNF inhibitor users.Tocilizumab had drug survival and safety profiles similar to those of TNF inhibitors in this Japanese single-centre registry.Tocilizumab was superior to TNF inhibitors when compared at 6 months by DAS-28-ESR remission.

View Article: PubMed Central - PubMed

Affiliation: Department of Rheumatology, Kameda Medical Center, 929 Higashi-Cho, Kamogawa City, Chiba Prefecture 296-8602, Japan. kazukiyoshid@gmail.com

ABSTRACT

Objective: To assess the effectiveness, drug survival and safety of tocilizumab compared with TNF-α inhibitors in clinical practice.

Methods: Patients in the Cohort of Arthritis Biologic Users at Kameda Institute (CABUKI) registry who were on biologics during July 2003 to October 2010 were included. Remission rates at 6 months, Kaplan-Meier drug survival estimates and serious adverse event (SAE) rates were compared.

Results: A total of 247 RA patients were analysed. For first-line biologic users, the 6-month 28-joint DAS (DAS-28)-ESR remission rates were 66.7% for tocilizumab vs 25.8% for TNF inhibitors (P < 0.001, Fisher's exact test). This advantage disappeared with the application of the newly suggested Boolean remission criterion for clinical trials: 0% for tocilizumab vs 8.2% for TNF inhibitors (P = 0.367, Fisher's exact test). Tocilizumab users in DAS-28-ESR remission had lower mean ESR (3.9  mm/h for tocilizumab vs 7.9  mm/h for TNF inhibitors, P = 0.026, t-test) and higher mean swollen joint count (2.6 for tocilizumab vs 1.3 for TNF inhibitors, P = 0.036, t-test), thus failing to meet the more stringent Boolean criteria. First- and second-line tocilizumab users showed similar drug survival and SAE rates compared with TNF inhibitor users.

Conclusion: Tocilizumab had drug survival and safety profiles similar to those of TNF inhibitors in this Japanese single-centre registry. Tocilizumab was superior to TNF inhibitors when compared at 6 months by DAS-28-ESR remission. However, the newly suggested Boolean criteria are more appropriate measures of effectiveness as DAS-28-ESR remission by tocilizumab was mainly due to very low ESR in our study population.

Show MeSH
Related in: MedlinePlus