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.

Keywords: ACR; Biologics; DAS28; Psoriatic arthritis; Real world evidence; Secukinumab; TNF-inhibitors.

Fig. 1

Patient’s scheme. Each letter represents one patient, and each blue line represents a biologic therapy line; if the line ends with a circle, then the treatment line was interrupted, while if the line ends with an arrow, then the treatment line was not interrupted. All patients from “A” to “E” were eligible for the study because in all these cases at least one line of biological therapy for psoriatic arthritis was initiated at least 6 months before enrolment visit but no more than 24 months before enrolment visit; also patient “B” was eligible, even though he/she has interrupted the treatment line before enrollment. Regarding patients “A” and “C”, only the biologic therapy lines initiated within the retrospective period were considered (e.g. for patient “C”, only 2nd and 3rd line was evaluated). Patients with a red cross (i.e. “F”, “G” and “H”) were not eligible for the study because in all these cases every line of biological therapy for psoriatic arthritis was initiated less than 6 months before enrolment visit (patient “F”) or more than 24 months before enrolment visit (patients “G” and “H”). Patient “I” was eligible for the study because in this case at least one line of biological therapy for psoriatic arthritis was initiated at least 6 months but no more than 24 months before enrolment visit. Patient “J” was eligible too, but only the 2nd therapy line was considered (because the first therapy line did not start within the retrospective period)

Fig. 2

Patient disposition

Fig. 3

Distribution of patients by DAS28 ESR and DAS28 CRP classes at start of biologic treatment under analysis, and after 6 months and 1 year after treatment start

Fig. 4

Persistence of the biologic treatment under analysis: Kaplan–Meier survival curve