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

• DOI: 10.1007/s10067-019-04535-z
• Publication Date: 2019-04-27T06:21:25Z
• Authors: Vivian P. Bykerk; Andrew J. K. Östör; José Alvaro-Gracia; Karel Pavelka; José Andrés Román...; Michael T. Nurmoh...; Yves Luder; Paris N. M. Sidir...; Jenny Devenport; Jean Sibilia
• Keywords: Tocilizumab; Tolerability; Clinical endpoint; Combination therapy

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