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Key clinical point: The long-term safety profile of sarilumab was consistent with prior clinical studies and postmarketing reports in patients with rheumatoid arthritis (RA) refractory to tumor necrosis factor inhibitors (TNFi).
Major finding: Incidence rates of adverse events (AEs) and serious AEs were 160.4 and 10.2 per 100 patient-years (PY), respectively, with 132 discontinuations (8.1/100 PY). The rate of serious infections was 3.9 per 100 PY. Grade 3/4 neutropenia was observed in 14% of patients and normalized on treatment in 65% of patients. Clinical efficacy was sustained throughout the 5-year follow-up.
Study details: Findings are from the open-label extension (OLE), EXTEND study, which included 454 patients with TNFi-refractory RA who completed the phase 3 TARGET study. In the OLE, patients received sarilumab 200 mg twice per week plus conventional synthetic disease-modifying antirheumatic drugs.
Disclosures: This work was supported by Sanofi (Cambridge, MA, USA) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA). Some of the authors reported receiving research grants and/or consulting fees from various sources. Some authors declared being an employee of and/or holding stocks/stock options at Sanofi or Regeneron Pharmaceuticals, Inc.
Source: Fleischmann R et al. Rheumatology (Oxford). 2021 Jun 24. doi: 10.1093/rheumatology/keab355.
Key clinical point: The long-term safety profile of sarilumab was consistent with prior clinical studies and postmarketing reports in patients with rheumatoid arthritis (RA) refractory to tumor necrosis factor inhibitors (TNFi).
Major finding: Incidence rates of adverse events (AEs) and serious AEs were 160.4 and 10.2 per 100 patient-years (PY), respectively, with 132 discontinuations (8.1/100 PY). The rate of serious infections was 3.9 per 100 PY. Grade 3/4 neutropenia was observed in 14% of patients and normalized on treatment in 65% of patients. Clinical efficacy was sustained throughout the 5-year follow-up.
Study details: Findings are from the open-label extension (OLE), EXTEND study, which included 454 patients with TNFi-refractory RA who completed the phase 3 TARGET study. In the OLE, patients received sarilumab 200 mg twice per week plus conventional synthetic disease-modifying antirheumatic drugs.
Disclosures: This work was supported by Sanofi (Cambridge, MA, USA) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA). Some of the authors reported receiving research grants and/or consulting fees from various sources. Some authors declared being an employee of and/or holding stocks/stock options at Sanofi or Regeneron Pharmaceuticals, Inc.
Source: Fleischmann R et al. Rheumatology (Oxford). 2021 Jun 24. doi: 10.1093/rheumatology/keab355.
Key clinical point: The long-term safety profile of sarilumab was consistent with prior clinical studies and postmarketing reports in patients with rheumatoid arthritis (RA) refractory to tumor necrosis factor inhibitors (TNFi).
Major finding: Incidence rates of adverse events (AEs) and serious AEs were 160.4 and 10.2 per 100 patient-years (PY), respectively, with 132 discontinuations (8.1/100 PY). The rate of serious infections was 3.9 per 100 PY. Grade 3/4 neutropenia was observed in 14% of patients and normalized on treatment in 65% of patients. Clinical efficacy was sustained throughout the 5-year follow-up.
Study details: Findings are from the open-label extension (OLE), EXTEND study, which included 454 patients with TNFi-refractory RA who completed the phase 3 TARGET study. In the OLE, patients received sarilumab 200 mg twice per week plus conventional synthetic disease-modifying antirheumatic drugs.
Disclosures: This work was supported by Sanofi (Cambridge, MA, USA) and Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, USA). Some of the authors reported receiving research grants and/or consulting fees from various sources. Some authors declared being an employee of and/or holding stocks/stock options at Sanofi or Regeneron Pharmaceuticals, Inc.
Source: Fleischmann R et al. Rheumatology (Oxford). 2021 Jun 24. doi: 10.1093/rheumatology/keab355.