Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis: Final Results from a Set of Multi-National Non-Interventional Studies

Boulos Haraoui, Gustavo Casado, Laszlo Czirjak, Andrew Taylor, Lingli Dong, Peter Button, Yves Luder, Roberto Caporali

Research output: Contribution to journalArticle

Abstract

IntroductionThe objective of this study was to observe the patterns of usage, efficacy, and safety of tocilizumab (TCZ) in clinical practice in patients with rheumatoid arthritis.MethodsData on the real-world usage, efficacy, and safety of TCZ were collected from patients during routine follow-up visits conducted over a 6-month period. Patients were grouped by previous exposure to biologic therapies (biologic exposed vs. biologic naive).ResultsOf 1912 patients enrolled from 16 countries, 639 (33.4%) received TCZ monotherapy and 1273 (66.6%) received TCZ combination therapy. At baseline, 1073 patients (56.1%) were biologic naive and 839 (43.9%) were biologic exposed. At 6months, 1504 patients (78.7%) continued to receive TCZ treatment, with no descriptive differences in retention rates between biologic-exposed and biologic-naive patients and between patients receiving TCZ monotherapy or combination therapy. Dose and use of methotrexate and prednisone were reduced at 6months. Efficacy at 6months, including patient-reported outcomes, was demonstrated in both biologic-naive and biologic-exposed groups. Adverse events (AEs) occurred in 817 patients [42.7%; incidence rate: 179 events per 100 patient-years (PY)], and serious AEs (SAEs) occurred in 118 patients (6.2%; 17 events per 100 PY), with comparable rates of AEs and SAEs between subgroups.ConclusionIn routine clinical practice, TCZ discontinuation rates were low and unaffected by prior use of biologics. Effectiveness was similar between groups, and no new safety signals were identified.FundingF. Hoffmann-La Roche.

Original languageEnglish
Pages (from-to)231-243
Number of pages13
JournalRheumatology and therapy
Volume6
Issue number2
DOIs
Publication statusPublished - Jun 2019

Cite this

Haraoui, Boulos ; Casado, Gustavo ; Czirjak, Laszlo ; Taylor, Andrew ; Dong, Lingli ; Button, Peter ; Luder, Yves ; Caporali, Roberto. / Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis : Final Results from a Set of Multi-National Non-Interventional Studies. In: Rheumatology and therapy. 2019 ; Vol. 6, No. 2. pp. 231-243.
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abstract = "IntroductionThe objective of this study was to observe the patterns of usage, efficacy, and safety of tocilizumab (TCZ) in clinical practice in patients with rheumatoid arthritis.MethodsData on the real-world usage, efficacy, and safety of TCZ were collected from patients during routine follow-up visits conducted over a 6-month period. Patients were grouped by previous exposure to biologic therapies (biologic exposed vs. biologic naive).ResultsOf 1912 patients enrolled from 16 countries, 639 (33.4{\%}) received TCZ monotherapy and 1273 (66.6{\%}) received TCZ combination therapy. At baseline, 1073 patients (56.1{\%}) were biologic naive and 839 (43.9{\%}) were biologic exposed. At 6months, 1504 patients (78.7{\%}) continued to receive TCZ treatment, with no descriptive differences in retention rates between biologic-exposed and biologic-naive patients and between patients receiving TCZ monotherapy or combination therapy. Dose and use of methotrexate and prednisone were reduced at 6months. Efficacy at 6months, including patient-reported outcomes, was demonstrated in both biologic-naive and biologic-exposed groups. Adverse events (AEs) occurred in 817 patients [42.7{\%}; incidence rate: 179 events per 100 patient-years (PY)], and serious AEs (SAEs) occurred in 118 patients (6.2{\%}; 17 events per 100 PY), with comparable rates of AEs and SAEs between subgroups.ConclusionIn routine clinical practice, TCZ discontinuation rates were low and unaffected by prior use of biologics. Effectiveness was similar between groups, and no new safety signals were identified.FundingF. Hoffmann-La Roche.",
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Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis : Final Results from a Set of Multi-National Non-Interventional Studies. / Haraoui, Boulos; Casado, Gustavo; Czirjak, Laszlo; Taylor, Andrew; Dong, Lingli; Button, Peter; Luder, Yves; Caporali, Roberto.

In: Rheumatology and therapy, Vol. 6, No. 2, 06.2019, p. 231-243.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Tocilizumab Patterns of Use, Effectiveness, and Safety in Patients with Rheumatoid Arthritis

T2 - Final Results from a Set of Multi-National Non-Interventional Studies

AU - Haraoui, Boulos

AU - Casado, Gustavo

AU - Czirjak, Laszlo

AU - Taylor, Andrew

AU - Dong, Lingli

AU - Button, Peter

AU - Luder, Yves

AU - Caporali, Roberto

PY - 2019/6

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N2 - IntroductionThe objective of this study was to observe the patterns of usage, efficacy, and safety of tocilizumab (TCZ) in clinical practice in patients with rheumatoid arthritis.MethodsData on the real-world usage, efficacy, and safety of TCZ were collected from patients during routine follow-up visits conducted over a 6-month period. Patients were grouped by previous exposure to biologic therapies (biologic exposed vs. biologic naive).ResultsOf 1912 patients enrolled from 16 countries, 639 (33.4%) received TCZ monotherapy and 1273 (66.6%) received TCZ combination therapy. At baseline, 1073 patients (56.1%) were biologic naive and 839 (43.9%) were biologic exposed. At 6months, 1504 patients (78.7%) continued to receive TCZ treatment, with no descriptive differences in retention rates between biologic-exposed and biologic-naive patients and between patients receiving TCZ monotherapy or combination therapy. Dose and use of methotrexate and prednisone were reduced at 6months. Efficacy at 6months, including patient-reported outcomes, was demonstrated in both biologic-naive and biologic-exposed groups. Adverse events (AEs) occurred in 817 patients [42.7%; incidence rate: 179 events per 100 patient-years (PY)], and serious AEs (SAEs) occurred in 118 patients (6.2%; 17 events per 100 PY), with comparable rates of AEs and SAEs between subgroups.ConclusionIn routine clinical practice, TCZ discontinuation rates were low and unaffected by prior use of biologics. Effectiveness was similar between groups, and no new safety signals were identified.FundingF. Hoffmann-La Roche.

AB - IntroductionThe objective of this study was to observe the patterns of usage, efficacy, and safety of tocilizumab (TCZ) in clinical practice in patients with rheumatoid arthritis.MethodsData on the real-world usage, efficacy, and safety of TCZ were collected from patients during routine follow-up visits conducted over a 6-month period. Patients were grouped by previous exposure to biologic therapies (biologic exposed vs. biologic naive).ResultsOf 1912 patients enrolled from 16 countries, 639 (33.4%) received TCZ monotherapy and 1273 (66.6%) received TCZ combination therapy. At baseline, 1073 patients (56.1%) were biologic naive and 839 (43.9%) were biologic exposed. At 6months, 1504 patients (78.7%) continued to receive TCZ treatment, with no descriptive differences in retention rates between biologic-exposed and biologic-naive patients and between patients receiving TCZ monotherapy or combination therapy. Dose and use of methotrexate and prednisone were reduced at 6months. Efficacy at 6months, including patient-reported outcomes, was demonstrated in both biologic-naive and biologic-exposed groups. Adverse events (AEs) occurred in 817 patients [42.7%; incidence rate: 179 events per 100 patient-years (PY)], and serious AEs (SAEs) occurred in 118 patients (6.2%; 17 events per 100 PY), with comparable rates of AEs and SAEs between subgroups.ConclusionIn routine clinical practice, TCZ discontinuation rates were low and unaffected by prior use of biologics. Effectiveness was similar between groups, and no new safety signals were identified.FundingF. Hoffmann-La Roche.

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KW - MODIFYING ANTIRHEUMATIC DRUGS

KW - RECEIVING CONCOMITANT METHOTREXATE

KW - QUALITY-OF-LIFE

KW - INADEQUATE RESPONSES

KW - OPEN-LABEL

KW - MONOCLONAL-ANTIBODY

KW - CLINICAL-PRACTICE

KW - BIOLOGIC AGENTS

KW - DOUBLE-BLIND

KW - DISEASE

U2 - 10.1007/s40744-019-0150-x

DO - 10.1007/s40744-019-0150-x

M3 - Article

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SP - 231

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JO - Rheumatology and therapy

JF - Rheumatology and therapy

SN - 2198-6576

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