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

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.

Déclaration de conflit d'intérêts

Conflict of interest statement: The author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: LB: Advisory boards/consulting, and/or received research grants: Amgen, BMS, Janssen, Roche, UCB Pharma, AbbVie, Pfizer, Merck, Celgene, Sanofi, Eli Lilly and Novartis; BH: Advisory boards/consulting, and/or received research grants: AbbVie, Amgen, BMS, Celgene, Janssen, Eli Lilly, Merck, Novartis, UCB Pharma and Pfizer; AC: Advisory boards/consulting, and/or received research grants: AbbVie, Amgen, AstraZeneca, BMS, Celgene, Eli Lilly, Genzyme, GSK, Janssen, Merck, Novartis, Pfizer, Roche, Sanofi Aventis, UCB Pharma; IF, SD: None declared; MK: Received research grants: Abbott, Amgen and Pfizer; DH: Advisory boards/consulting, conducted research, and/or received grants: AbbVie, Amgen, AstraZeneca, Adiga Life Sciences, Abbott, BMS, Celgene, Circassia, GSK, Janssen, Eli Lilly, Novartis, Pfizer, Roche, Sanofi Genzyme, Takeda, and UCB Pharma; SE, JS: Employees of UCB Pharma; SS: Consulting: Roche, Eli Lilly, Sanofi, and Amgen.