Real-World Data Support ITABIO Guidelines for Second-Line Biologic Use in Inflammatory Arthritis

A cross-sectional analysis of 616 patients with rheumatoid arthritis (RA), spondyloarthritis (SpA), and psoriatic arthritis (PsA) confirms that the Italian Committee for Tailored BIOlogic Therapy (ITABIO) recommendations are being applied in clinical practice and can guide appropriate second-line biologic prescriptions. The study evaluated treatment patterns and patient characteristics to assess the impact of these guidelines in real-world care.

The majority of patients analyzed were treated for RA (46.7%), followed by PsA (34.3%) and SpA (19%). Treatment appropriateness was evaluated using a centralized database developed by
the pharmaceutical governance and appropriateness of prescription unit at the Hospital S. Stefano in Prato, Italy.

Anti-tumor necrosis factor biosimilars were commonly prescribed, with the highest use in SpA (65.1%), followed by PsA (52.4%) and RA (24.3%). Monotherapy accounted for 68% of all treatments, particularly in RA, where biologics such as tocilizumab, sarilumab, upadacitinib, and filgotinib were frequently used without methotrexate.

Among patients with RA, 34.2% were classified as difficult-to-treat (D2T), highlighting the continued therapeutic challenges in this subgroup. “RA and especially D2T-RA remains the disease with the greatest therapeutic failures,” the authors noted, citing high rates of monotherapy and methotrexate discontinuation.

Treatment selection also reflected patient comorbidities and biomarkers. Abatacept was the most prescribed in rheumatoid factor and anti-citrullinated peptide antibodies-positive patients with RA and in those with interstitial lung disease. In SpA, secukinumab was used in 12% of patients, with 71% presenting with enthesitis and dactylitis. For patients with PsA, prior cardiovascular events. and aged over 65 years, ixekizumab was prescribed in 10.4%, and apremilast was chosen in 71% of those with a history of cancer.

The findings confirm that ITABIO guidance supports personalized prescribing based on clinical features and comorbidities. As the authors concluded, “The cross-sectional analysis of prescriptions… demonstrates how the ITABIO recommendations can guide towards the correct appropriateness of prescription.”

This study underscores the importance of structured decision-making tools in optimizing biologic therapy across inflammatory arthritis subtypes.

Reference
Benucci M, Gobbi FL, Cassarà EAM, Marigliano AL, Mannoni A, Benvenuti E. Single-center cross-sectional analysis of patients with RA, SPA, and PSA: data from the prescription database. J Pers Med. 2025;15(8):366. doi:10.3390/jpm15080366