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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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Remission rates (%) by criteria for toclizumab vs TNF inhibitor groups (first-line users). Pract Boolean: Boolean remission criterion for clinical practice; Trial Boolean: Boolean remission criterion for clinical trials; TCZ: tocilizumab; TNFi: TNF inhibitors.
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ker295-F2: Remission rates (%) by criteria for toclizumab vs TNF inhibitor groups (first-line users). Pract Boolean: Boolean remission criterion for clinical practice; Trial Boolean: Boolean remission criterion for clinical trials; TCZ: tocilizumab; TNFi: TNF inhibitors.

Mentions: Comparisons of remission rates at 6 months are shown in Fig. 1 (n = 230: tocilizumab 46, infliximab 92, etanercept 87 and adalimumab 5), demonstrating a statistically significant difference by DAS-28-ESR remission criteria only. For first-line biologic users (n = 177: tocilizumab 18, infliximab 88, etanercept 68 and adalimumab 3), remission rates are shown in Fig. 2. Statistically significant differences existed in remission rates between the tocilizumab group and TNF inhibitors-combined group with regards to DAS-28-ESR and DAS-28-CRP remission criteria, but not with Boolean criteria. In the additional analysis, tocilizumab users in DAS-28-ESR remission had a significantly higher SJC and lower ESR compared with TNF inhibitor users in DAS-28-ESR remission (Table 2).Fig. 1


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)

Remission rates (%) by criteria for toclizumab vs TNF inhibitor groups (first-line users). Pract Boolean: Boolean remission criterion for clinical practice; Trial Boolean: Boolean remission criterion for clinical trials; TCZ: tocilizumab; TNFi: TNF inhibitors.
© Copyright Policy - creative-commons
Related In: Results  -  Collection

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

ker295-F2: Remission rates (%) by criteria for toclizumab vs TNF inhibitor groups (first-line users). Pract Boolean: Boolean remission criterion for clinical practice; Trial Boolean: Boolean remission criterion for clinical trials; TCZ: tocilizumab; TNFi: TNF inhibitors.
Mentions: Comparisons of remission rates at 6 months are shown in Fig. 1 (n = 230: tocilizumab 46, infliximab 92, etanercept 87 and adalimumab 5), demonstrating a statistically significant difference by DAS-28-ESR remission criteria only. For first-line biologic users (n = 177: tocilizumab 18, infliximab 88, etanercept 68 and adalimumab 3), remission rates are shown in Fig. 2. Statistically significant differences existed in remission rates between the tocilizumab group and TNF inhibitors-combined group with regards to DAS-28-ESR and DAS-28-CRP remission criteria, but not with Boolean criteria. In the additional analysis, tocilizumab users in DAS-28-ESR remission had a significantly higher SJC and lower ESR compared with TNF inhibitor users in DAS-28-ESR remission (Table 2).Fig. 1

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