Real-world evidence of biologic treatments in psoriatic arthritis in Italy: results of the CHRONOS (EffeCtiveness of biologic treatments for psoriatic artHRitis in Italy: an ObservatioNal lOngitudinal Study of real-life clinical practice) observational longitudinal study

Abstract

Background Biologics have demonstrated efficacy in PsA in randomized clinical trials. More evidence is needed on their effectiveness under real clinical practice conditions. The aim of the present work is to provide real-world evidence of the effectiveness of biologics for PsA in the daily clinical practice. Methods CHRONOS was a multicenter, non-interventional, cohort study conducted in 20 Italian hospital rheumatology clinics. Results 399 patients were eligible (56.9% females, mean (SD) age: 52.4 (11.6) years). The mean (SD) duration of PsA and psoriasis was 7.2 (6.9) and 15.3 (12.2) years, respectively. The mean (SD) duration of the biologic treatment under analysis was 18.6 (6.5) months. The most frequently prescribed biologic was secukinumab (40.4%), followed by adalimumab (17.8%) and etanercept (16.5%). The proportion of overall responders according to EULAR DAS28 criteria was 71.8% (95% CI: 66.7–76.8%) out of 308 patients at 6 months and 68.0% (95% CI: 62.7–73.3%) out of 297 patients at 1 year. Overall, ACR20/50/70 responses at 6 months were 41.2% (80/194), 29.4% (57/194), 17.1% (34/199) and at 1-year were 34.9% (66/189), 26.7% (51/191), 18.4% (36/196), respectively. Secondary outcome measures improved rapidly already at 6 months: mean (SD) PASI, available for 87 patients, decreased from 3.2 (5.1) to 0.6 (1.3), the proportion of patients with dactylitis from 23.6% (35/148) to 3.5% (5/142) and those with enthesitis from 33.3% (49/147) to 9.0% (12/133). Conclusions The CHRONOS study provides real-world evidence of the effectiveness of biologics in PsA in the Italian rheumatological practice, confirming the efficacy reported in RCTs across various outcome measures.

A real-world economic analysis of biologic therapies for psoriatic arthritis in Italy: results of the CHRONOS observational longitudinal study

“…The study was conducted in 20 Italian rheumatology hospitals, which enrolled N = 409 patients; of these, N = 10 patients did not meet the CHRONOS study inclusion criteria [ 17 ]. Therefore, N = 399 patients were evaluated in terms of clinical assessment and healthcare resource use.…”

“…Patients who had interrupted treatment before enrolment could also be included. Detailed description of eligibility and evaluability criteria are reported elsewhere [ 17 ].…”

“…Two types of analyses were conducted: i) overall analysis, on the entire cohort of PsA patients treated with biologic therapies; ii) a post-hoc analysis stratified by secukinumab or TNFis subgroups (TNFi comprising adalimumab (originator and biosimilar), certolizumab, etanercept (originator and biosimilar), golimumab, and infliximab (originator and biosimilar)) given that most patients were treated with these two major treatment groups [ 17 ]. All other treatments were not analysed as subgroups in the post-hoc analyses, as their sample size was small, with findings being potentially affected by precision and accuracy issues.…”

“…The use of observational research for economic purposes can inform on critical aspects of decision-making, such as budget impact/allocation, cost-effectiveness and cost-utility analysis of new technologies [ 12 ]. Given the chronic nature of PsA and the considerable amount of direct costs (drugs costs, inpatient costs for acute care, outpatient costs for regular monitoring) and indirect costs (caregivers, loss of working days) spent in the treatment of PsA [ 13 – 16 ], the analysis of real-world data is important to assess the economic burden of the disease [ 17 ].…”

“…The CHRONOS (Effe C tiveness of biologic treatments for psoriatic art HR itis in Italy: an O bservatio N al l O ngitudinal S tudy of real-life clinical practice) study was designed to provide real-world evidence (RWE) of the effectiveness of biologic treatments for PsA in the Italian real-life clinical practice; main results of the study are presented elsewhere [ 17 ].…”