RESUMEN
Introduction: This multicenter, real-world, retrospective cohort study aimed to assess the effectiveness and safety of tofacitinib (TOFA) in rheumatoid arthritis (RA). Material and methods: Two hundred nine patients with active RA treated with TOFA, unresponsive to at least 2 conventional synthetic disease-modifying drugs, were recruited. Clinical characteristics were extracted from an electronic registry and supplemented with manual chart review and data linkage with ambulatory care. Drug retention and reasons for discontinuation were evaluated. Results: Median (interquartile range) follow-up in the whole sample was 16.9 (5.93-31.7) months. Mean (standard deviation) age was 51.44 (±11.84) years, with female predominance (n = 168, 80.4%). Only 30 patients (14.4%) had no pre-existing traditional cardiovascular (CV) risk factor at TOFA initiation. Tofacitinib retention rates were high, with median survival estimated at 89.3% at 6 months, 82.4% at 12 months, and 60.4% at 24 months. Ineffectiveness was the primary cause of discontinuation (n = 50). The rate of adverse events (AEs) was relatively low, with lipid abnormalities, blood count alterations, and infectious events among the most common. No major adverse CV event was reported. The incidence rate of AEs necessitating treatment switch was 60.34 (95% CI: 37-92) per 1,000 person-years of follow-up. Presence of multiple (> 3) CV risk factors was associated with lower odds of TOFA retention and treatment effectiveness. Conclusions: Tofacitinib demonstrated high retention rates and a favorable safety profile in RA patients, including those with traditional CV risk factors. Tofacitinib may be a valuable treatment option for RA patients when combined with individualized CV risk management. Further studies are warranted to explore the long-term effects of TOFA and its CV impact in larger populations.
RESUMEN
Real-life data that support effectiveness of secukinumab (SEC), an interleukin 17A inhibitor, in Poland are few. We aimed to evaluate SEC effectiveness based on drug retention and safety measures reported in electronic medical records (EMRs) of patients with psoriatic arthritis (PsA) and ankylosing spondylitis (AS) from two tertiary-care centers in the region of Lesser Poland. A total one-hundred eighty seven (127 PsA and 60 AS) first (n = 112), second (n = 59) and third-line SEC users were enrolled. The mean (SD) age of the sample was 45.7 (12.9), and 48% were male. All patients were classified with active and severe disease prior to initiation. Administrative delays for SEC users last a median 2 weeks. Median delay from symptom onset to diagnosis was 4 years (IQR 8), and differed by predominant disease subtype. The inefficacy rate was 10.7% and 18.6% for first and second-line users with median (IQR) drug maintenance estimated at 1.22 years (1.46) and 1.51 (1.38), respectively. First-year drug loss defined as drug switch due to inefficacy or adverse event was rare, with median estimates of 0.91 (95% CI; 0.85, 0.97) and 0.86 (95% CI; 0.77, 0.95) for first and second-line, respectively.
