Abstract
ObjectiveTo 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).MethodsPatients 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).ResultsOf 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.ConclusionIn clinical practice, TCZ as monotherapy or in combination with csDMARDs was safe, well tolerated, and efficacious in patients with moderate to severe RA.
Highlights
Rheumatoid arthritis (RA) is a chronic, progressive autoimmune disease characterized by inflammation of the synovium, which often results in irreversible joint damage if left untreated
Biologics are recommended in combination with csDMARDs, approximately one-third of patients with RA receive biologics as monotherapy [6]
GC tapering was permitted per the study protocol, no consistent pattern of tapering was observed. This long-term extension (LTE) of the phase IIIb, multinational, open-label ACTSURE study demonstrated that the safety, tolerability, and effectiveness of TCZ administered intravenously in patients with moderate to severe RA were maintained with long-term exposure in patients who had responded to TCZ after the 24-week core study
Summary
Rheumatoid arthritis (RA) is a chronic, progressive autoimmune disease characterized by inflammation of the synovium, which often results in irreversible joint damage if left untreated. Biologics are recommended in combination with csDMARDs, approximately one-third of patients with RA receive biologics as monotherapy [6]. The long-term effectiveness and safety of TCZ have been established in multiple clinical trials [21,22,23,24], informing patient care decisions in clinical practice because patients with RA often receive prolonged treatment. These trials excluded patients with certain prior therapies; patients who have failed multiple therapies may have more severe disease and be at risk for more comorbid conditions.
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