PMID- 31028551 OWN - NLM STAT- MEDLINE DCOM- 20200211 LR - 20200225 IS - 1434-9949 (Electronic) IS - 0770-3198 (Linking) VI - 38 IP - 9 DP - 2019 Sep TI - 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. PG - 2411-2421 LID - 10.1007/s10067-019-04535-z [doi] AB - 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. FAU - Bykerk, Vivian P AU - Bykerk VP AD - Inflammatory Arthritis Center, Hospital for Special Surgery, 535 East 70th Street, New York, NY, 10021, USA. bykerkv@hss.edu. AD - Department of Rheumatology, Mount Sinai Hospital, Toronto, Ontario, Canada. bykerkv@hss.edu. FAU - Ostor, Andrew J K AU - Ostor AJK AD - Department of Rheumatology, Cabrini Medical Centre, Melbourne, Victoria, Australia. FAU - Alvaro-Gracia, Jose AU - Alvaro-Gracia J AD - Rheumatology Service, Hospital General Universitario Gregorio Maranon, Universidad Complutense Madrid, Madrid, Spain. FAU - Pavelka, Karel AU - Pavelka K AD - Institute of Rheumatology and Clinic of Rheumatology, Charles University, Prague, Czech Republic. FAU - Roman Ivorra, Jose Andres AU - Roman Ivorra JA AD - Rheumatology Service, Division of Rheumatology, Hospital Universitario y Politecnico La Fe, Valencia, Spain. FAU - Nurmohamed, Michael T AU - Nurmohamed MT AD - Jan van Breemen Research Institute, VU University Medical Center, Amsterdam, The Netherlands. FAU - Luder, Yves AU - Luder Y AD - F. Hoffmann-La Roche Ltd, Basel, Switzerland. FAU - Sidiropoulos, Paris N M AU - Sidiropoulos PNM AD - Genentech, Inc., South San Francisco, CA, USA. FAU - Devenport, Jenny AU - Devenport J AD - Genentech, Inc., South San Francisco, CA, USA. FAU - Sibilia, Jean AU - Sibilia J AD - Department of Rheumatology, CHU Hautepierre, Strasbourg, France. LA - eng PT - Journal Article DEP - 20190426 PL - Germany TA - Clin Rheumatol JT - Clinical rheumatology JID - 8211469 RN - 0 (Antibodies, Monoclonal, Humanized) RN - 0 (Antirheumatic Agents) RN - 0 (Glucocorticoids) RN - 0 (Tumor Necrosis Factor Inhibitors) RN - I031V2H011 (tocilizumab) SB - IM MH - Adult MH - Aged MH - Aged, 80 and over MH - Antibodies, Monoclonal, Humanized/adverse effects/*therapeutic use MH - Antirheumatic Agents/adverse effects/*therapeutic use MH - Arthritis, Rheumatoid/diagnosis/*drug therapy MH - Drug Therapy, Combination MH - Female MH - Glucocorticoids/adverse effects/*therapeutic use MH - Humans MH - Male MH - Middle Aged MH - Severity of Illness Index MH - Treatment Outcome MH - Tumor Necrosis Factor Inhibitors/adverse effects/*therapeutic use MH - Young Adult OTO - NOTNLM OT - Monotherapy OT - Rheumatoid arthritis OT - Safety OT - Tocilizumab EDAT- 2019/04/28 06:00 MHDA- 2020/02/12 06:00 CRDT- 2019/04/28 06:00 PHST- 2018/12/21 00:00 [received] PHST- 2019/03/26 00:00 [accepted] PHST- 2019/03/07 00:00 [revised] PHST- 2019/04/28 06:00 [pubmed] PHST- 2020/02/12 06:00 [medline] PHST- 2019/04/28 06:00 [entrez] AID - 10.1007/s10067-019-04535-z [pii] AID - 10.1007/s10067-019-04535-z [doi] PST - ppublish SO - Clin Rheumatol. 2019 Sep;38(9):2411-2421. doi: 10.1007/s10067-019-04535-z. Epub 2019 Apr 26.