Skip to main content
2024 ISPE Annual Meeting Main banner
Icon Legend
This session is not in your schedule.
This session is in your schedule. Click again to remove it.
Back
Evaluation

Oral Presentation

Session: Lightning Session 1

Switching pattern of biological drugs in patients with psoriasis and psoriatic arthritis: insight from the Italian multi-regional VALORE distributed database network

Monday, August 26, 2024
5:30 PM – 5:35 PM CEST
Location: Room III
Background: Biological drugs changed dramatically the management of immune-mediated inflammatory diseases like psoriasis (PsO) and psoriatic arthritis (PsA). Patients may switch among biologics for medical reasons and between originators/biosimilars for economic (non-medical) reasons.

Objectives: To explore switching patterns of biological drugs in PsO/PsA patients and determinants of multiple switches and switch back.

Methods: A retrospective cohort study was conducted using the multiregional distributed database network of the VALORE project. Incident users (no biological drugs before first biological dispensing, i.e. index date) of biological drugs with at least two dispensing and treated because of PsO/PsA during years 2010-2022 were included. Patients with at least 1 year of look back and 6 months of follow up were selected. Time to switch and swap (among biologics belonging to different drug classes) was analyzed employing Kaplan Meier analysis. Multivariate COX proportional hazards model was used to identify predictors of multiple switches (≥2) and switch back (i.e. from biologic A to B and then back to A).

Results: Overall, 30,700 incident users of biologics drugs with PsO/PsA were included in the study: 22,796 with TNF-α inhibitors, 7,583 with anti-interleukin (IL) drugs and 321 with selective immunosuppressant (SI). Cumulative frequency of patients with at least one switch/swap was equal to 8.5%, 17.9% and 37.1% and 47.8% at 6 months, 1, 3, and 5 years of follow-up, respectively. For patients with psoriasis switching from originator to corresponding biosimilar, switch back to originator occurred in 4%, 10.5% and 2% of patients with adalimumab, etanercept and infliximab, respectively. The median time to first medical switch/swap was significantly shorter (p-value: < 0.001) for TNF-α inhibitors (2,068 days) versus anti-IL (2,780 days). Patients with anti-IL reported a significant lower risk of multiple switches and switch back than those starting with TNF-α inhibitors (0.80, 95%CI: 0.73-0.87; 0.71, 95%CI:0.58-0.86, respectively). Moreover, older age was associated with a lower risk of multiple switches (65-79 years old vs < 65: 0.69, 95%CI:0.62-0.76; 80+ years old vs < 65: 0.64, 95%CI: 0.52-0.78) and switch back (65-79 years old vs < 65: 0.73, 95%CI:0.58-0.92), while women were associated with higher risk of switch back (1.25, 95%CI:1.09-1.43) than men.

Conclusions: This Italian, large-scale, study found out that up to 1 out of 3 of incident biological users with PsO/PsA at three years switched or swapped to other biologics. TNF-α inhibitor starters switched/swapped more rapidly than anti-IL starters, who also showed lower risk of multiple switches and switching back.