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Long-term safety and effectiveness of tocilizumab in patients with rheumatoid arthritis and inadequate responses to csDMARDs and/or TNF inhibitors: an open-label study close to clinical practice

Bykerk, Vivian P
Author Bykerk, Vivian P Inflammatory Arthritis Center, Hospital for Special Surgery, 535 East 70th Street, New York, NY, 10021, USA. bykerkv@hss.edu Department of Rheumatology, Mount Sinai Hospital, Toronto, Ontario, Canada. bykerkv@hss.edu
Östör, Andrew J K
Author Östör, Andrew J K Department of Rheumatology, Cabrini Medical Centre, Melbourne, Victoria, Australia
Alvaro-Gracia, José
Author Alvaro-Gracia, José Rheumatology Service, Hospital General Universitario Gregorio Marañon, Universidad Complutense Madrid, Madrid, Spain
Pavelka, Karel
Author Pavelka, Karel Institute of Rheumatology and Clinic of Rheumatology, Charles University, Prague, Czech Republic
Román Ivorra, José Andrés
Author Román Ivorra, José Andrés Rheumatology Service, Division of Rheumatology, Hospital Universitario y Politécnico La Fe, Valencia, Spain
Nurmohamed, Michael T
Author Nurmohamed, Michael T Jan van Breemen Research Institute, VU University Medical Center, Amsterdam, The Netherlands
Luder, Yves
Author Luder, Yves F. Hoffmann-La Roche Ltd, Basel, Switzerland
Sidiropoulos, Paris N M
Author Sidiropoulos, Paris N M Genentech, Inc., South San Francisco, CA, USA
Devenport, Jenny
Author Devenport, Jenny Genentech, Inc., South San Francisco, CA, USA
Sibilia, Jean
Author Sibilia, Jean Department of Rheumatology, CHU Hautepierre, Strasbourg, France

Clinical rheumatology. 2019 Sep ; 38 (9) : 2411-2421. [epub] 20190426

Clin Rheumatol
ISSN 1434-9949 | 0770-3198
Source

Language English Country Germany Media print-electronic

Document type Journal Article

Persistent link https://www.medvik.cz/link/pmid31028551

PubMed 31028551
DOI 10.1007/s10067-019-04535-z
PII: 10.1007/s10067-019-04535-z
Knihovny.cz E-resources

Keywords
Monotherapy, Rheumatoid arthritis, Safety, Tocilizumab,
MeSH
Antirheumatic Agents adverse effects therapeutic use MeSH
Adult MeSH
Glucocorticoids adverse effects therapeutic use MeSH
Antibodies, Monoclonal, Humanized adverse effects therapeutic use MeSH
Tumor Necrosis Factor Inhibitors adverse effects therapeutic use MeSH
Drug Therapy, Combination MeSH
Middle Aged MeSH
Humans MeSH
Young Adult MeSH
Arthritis, Rheumatoid diagnosis drug therapy MeSH
Aged, 80 and over MeSH
Aged MeSH
Severity of Illness Index MeSH
Treatment Outcome MeSH
Check Tag
Adult MeSH
Middle Aged MeSH
Humans MeSH
Young Adult MeSH
Male MeSH
Aged, 80 and over MeSH
Aged MeSH
Female MeSH
Publication type
Journal Article MeSH
Names of Substances
Antirheumatic Agents MeSH
Glucocorticoids MeSH
Antibodies, Monoclonal, Humanized MeSH
Tumor Necrosis Factor Inhibitors MeSH
tocilizumab MeSH Browser

OBJECTIVE: To assess the long-term safety, tolerability, and effectiveness of tocilizumab (TCZ) as monotherapy or in combination with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) in clinical practice in patients with moderate to severe rheumatoid arthritis (RA). METHODS: Patients in the 24-week, open-label ACT-SURE study who had at least a moderate EULAR response by week 24 and were from a participating country were eligible for this long-term extension (LTE); the patients continued to receive TCZ 8 mg/kg intravenously every 4 weeks as monotherapy or in combination with ≥ 1 csDMARD for up to an additional 108 weeks. The primary endpoint was the incidence of adverse events (AEs) and serious AEs (SAEs). Effectiveness endpoints included Disease Activity Score in 28 joints (DAS28) responses, American College of Rheumatology (ACR) responses, and patient-reported outcomes (PROs). RESULTS: Of the 1102 patients who completed the core 24-week study, 934 participated in the LTE; the median exposure to TCZ was 64.3 weeks. From baseline to the end of the LTE, AEs and SAEs occurred in 90% and 9% of patients, respectively. The overall event rates (95% CI) of AEs and SAEs were 406.5 per 100 patient-years (PY) (395.5, 417.8) and 8.8 per 100 PY (7.3, 10.6), respectively. Mean (SD) improvement in DAS28 was 4.12 (1.18), P < 0.0001. The DAS28 remission rates, ACR response rates, and PRO scores were maintained during the LTE study. CONCLUSION: In clinical practice, TCZ as monotherapy or in combination with csDMARDs was safe, well tolerated, and efficacious in patients with moderate to severe RA.

Department of Rheumatology Cabrini Medical Centre Melbourne Victoria Australia

Department of Rheumatology CHU Hautepierre Strasbourg France

Department of Rheumatology Mount Sinai Hospital Toronto Ontario Canada

F Hoffmann La Roche Ltd Basel Switzerland

Genentech Inc South San Francisco CA USA

Inflammatory Arthritis Center Hospital for Special Surgery 535 East 70th Street New York NY 10021 USA

Institute of Rheumatology and Clinic of Rheumatology Charles University Prague Czech Republic

Jan van Breemen Research Institute VU University Medical Center Amsterdam The Netherlands

Rheumatology Service Division of Rheumatology Hospital Universitario y Politécnico La Fe Valencia Spain

Rheumatology Service Hospital General Universitario Gregorio Marañon Universidad Complutense Madrid Madrid Spain

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Lancet. 1999 Dec 4;354(9194):1932-9 PubMed