Session Type: Abstract Submissions (ACR)
Efficacy and safety of anti-TNF in rheumatoid arthritis (RA) management has been demonstrated in numerous controlled clinical trials. Longitudinal observational studies assessing the real-world effectiveness and safety of anti-TNF agents are essential to demonstrate the true population-based benefit-risk ratio. The purpose of this study was to assess in Canadian routine clinical practice the long-term effectiveness and safety profile of infliximab (INF) in RA patients.
Biologic Treatment Registry Across Canada (BioTRAC) is an ongoing, prospective registry of rheumatology patients initiating INF or golimumab treatment as first biologics or after having been treated with a biologic < 6 mos. RA patients treated with INF who enrolled between 2002 and 2011 and had at least one follow-up assessment were included in the effectiveness analysis (N=628), while the safety population comprised all patients treated with INF during that period (N=838). Adverse events (AEs) were classified as per the Medical Dictionary for Regulatory Activities and were counted once per System Organ Class and Preferred Term.
Mean (SD) age and disease duration among the effectiveness population were 55.8 (13.6) yrs and 10.2 (10.0) yrs, respectively. At the time of the analysis, 96 (15.3%) had completed 5 yrs of followup. At treatment initiation, 90.9% were treated with DMARDs, 56.1% with NSAIDs, and 40.0% with steroids. Mean (SD) patient parameters at baseline: C-reactive protein (CRP) = 19.5 (24.9) mg/L, erythrocyte sedimentation rate (ESR) = 32.2 (24.0) mm/hr, morning stiffness = 70.4 (43.6) min, tender joint count (TJC28) = 12.5 (7.9), swollen joint count (SJC28) = 10.6 (7.1), health assessment questionnaire (HAQ) = 1.7 (0.7), patient global assessment of disease activity (PtGA) = 6.0 (2.4) cm, physician global assessment of disease activity (MDGA) = 6.6 (2.1) cm, and DAS28-CRP = 5.4 (1.3). Upon 6 mos of treatment, statistically significant (P<0.05) and clinical meaningful improvements were observed in all parameters analyzed, which were sustained over 60 mos of treatment.
A total of 1,740 AEs were reported for 43.3% patients in the safety population (110.24 events / 100 patient yrs (PYs)), the majority of which (92.3%) were non-serious as per the judgment of the treating physician. Most frequently reported AEs included arthralgia (5.3% of patients), headache (3.8%), and upper respiratory tract infections (3.8%). There were 134 serious AEs reported for 84 (10.0%) patients (8.49 events/100 PYs). The incidence of serious infections and neoplasms was 1.96 and 0.70 events per 100 PYs, respectively. Five deaths (pulmonary fibrosis, miliary tuberculosis, severe arteriosclerotic heart disease, intestinal gangrene, and atrial fibrillation with hypotension and interstitial lung disease) were reported during the study, of which three (pulmonary fibrosis, intestinal gangrene, atrial fibrillation with hypotension and interstitial lung disease) were judged by the treating physician as unlikely related to INF.
The results of this Canadian longitudinal observational study have shown that INF is well tolerated and effective in reducing symptom severity and improving outcomes in RA patients over a 5-yr period.
JNJ, Amgen, Pfizer, Abbvie, UCB, Eli Lilly, Celgene, Takeda, Astra Zeneca, BMS, Roche,
J. T. Kelsall,
M. K. Sheriff,
J. F. Rodrigues,
J. S. Sampalis,
S. M. Otawa,
A. J. Lehman,
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ACR Meeting Abstracts - https://acrabstracts.org/abstract/real-world-effectiveness-and-safety-of-infliximab-in-the-treatment-of-rheumatoid-arthritis-over-5-years-the-canadian-experience/