Effectiveness and safety of certolizumab pegol in rheumatoid arthritis patients in Canadian practice: 2-year results from the observational FαsT-CAN study

Abstract

Background: The aim of this study was to assess the real-world effectiveness and safety of certolizumab pegol (CZP) in rheumatoid arthritis (RA) patients, and the impact on patients’ productivity, pain, and fatigue, in Canadian practice. Methods: FαsT-CAN, a 2-year prospective, observational study, evaluated CZP use in Canadian adults with moderate to severe, active RA. The primary objective was to assess the proportion of patients achieving 28-joint Disease Activity Scores (DAS28) <2.6 at Week 104. Secondary and additional endpoints assessed the improvements in Patients’ Assessment of Arthritis Pain (PtAAP), fatigue, Health Assessment Questionnaire-Disability Index (HAQ-DI), and the proportion of patients achieving minimal clinically important differences (MCID) in HAQ-DI. Validated arthritis-specific Work Productivity Surveys (WPS-RA) assessed the RA-associated impact on productivity. Incidence of CZP-related treatment-emergent adverse events (TEAEs) was reported for patients receiving ⩾1 dose of CZP (safety set). Results: The full analysis set (baseline DAS28 ⩾ 2.6, ⩾1 dose of CZP and ⩾1 valid post-baseline DAS28 measurement) included 451 of the 546 patients recruited into the study; a total of 229/451 (50.8%) patients completed Week 104. At Week 104, 90/451 (20.0%) patients achieved DAS28 < 2.6. Rapid improvements in disease activity, pain, and fatigue were observed. At Week 104, 66.2% of patients achieved HAQ-DI MCID. Patients employed at Week 104, reported reduced absenteeism, and improved productivity. CZP-related TEAEs were consistent with the known CZP safety profile. Conclusions: CZP was an effective RA treatment in Canadian practice, and no new CZP-related safety signals were identified. The improvements in household and workplace productivity are the first observations in a real-world Canadian setting.

Three-year clinical outcomes in patients with rheumatoid arthritis treated with certolizumab pegol: results from the observational ECLAIR study

“…The majority of patients achieved a EULAR response within 12 months (75.3%), which was sustained to 36 months among patients still in the study. Similar improvements in disease activity have been observed in previous observational studies into the long-term effec-tiveness of CZP (11)(12)(13). However, the EULAR response rate in ECLAIR was lower compared to the RAPID 1 study (96.2% at 12 months), which is likely due to higher baseline disease activity in the latter.…”

“…Long-term observational data in more representative populations are therefore necessary, and are frequently considered or requested by health authorities. Several observational studies have previously reported on the effectiveness and safety of CZP in real-world settings in Canada, Germany and the UK, but an observational study of an anti-TNF has yet to be conducted in France (11)(12)(13). To this end, the French National Authority for Health requested an observational study to assess the effectiveness and safety of CZP up to 36 months in patients with moderate-to-severe RA in a real-world setting in France.…”

Monoclonal Antibodies for Chronic Pain Treatment: Present and Future

“…Respiratory tract infections. [ 178 , 179 ] Infliximab Pain relief and inhibition of cartilage destruction. Decrease in the expression of inflammatory cytokines in the synovial fluid and cartilage.…”

Effectiveness and Safety of Tofacitinib in Canadian Patients With Rheumatoid Arthritis: Primary Results From a Prospective Observational Study

“…CANTORAL is the first study reporting the real‐world effectiveness and safety of a JAK inhibitor for moderate to severe RA in Canada and complements previous Canadian observational studies of patients with RA receiving bDMARDs (26–29). The proportion of patients with CDAI‐defined LDA and remission at month 6 was 52.9% and 15.4%, respectively, demonstrating the effectiveness of tofacitinib for moderate to severe RA.…”