In this scenario, the arrival of biosimilars could represent a step toward overcoming certain prescribed limits, improving treatment standards and controlling costs. However, the high costs associated with the use of these innovative drugs have sometimes limited their use, also causing consequent problems of therapy adherence and persistence. The introduction of biotechnological drugs in the 1990s has resulted in a real revolution for patients with chronic arthritis, particularly for cases that are nonresponsive or intolerant to conventional Disease Modifying Anti-Rheumatic Drugs (DMARDs), allowing a clear improvement in prognosis and a consistent reduction in mortality rates. The current recommendations for the management of patients with chronic arthritis, taking into account the greater therapeutic possibilities available, aim to help the clinician personalize the therapy, based on both the disease characteristics and any comorbidities or needs of the patient. In recent decades, the therapeutic approach to chronic inflammatory joint diseases has progressively changed and has switched from symptomatic therapy, aimed at improving quality of life, to drugs that can change the course of the disease and stop radiographic progression. Most of the patients transitioned to the same dose regimen of biosimilar as that received for the originator, and the regimen remained unchanged at 6 months, supporting the effectiveness of the transition. Both the cohorts are representative of typical patients with long-standing established diagnoses. Italian patients with stable RA or axSpA who transitioned from originator Etanercept to SB4 maintained clinical response at 6 months post-transition. Of note, 100.0% (95% CI 89.1, 100.0) in the axSpA and 90.8% (95% CI 81.5, 95.5) in the RA cohort of patients continued to receive SB4 at month 6 (binary variable with 95% Clopper-Pearson CI). In both cohorts, the efficacy was maintained at 3 months and 6 months from the transition to the biosimilar with no significant change in mean DAS28 and BASDAI scores: at the end of the 6 months of observation the mean DAS28 and BASDAI was similar to baseline (confidence interval −0.22, 0.22), while the mean variation of the BASDAI was −0.14.

One-hundred and eleven subjects (out of the 557 in total enrolled in the study) were derived from 8 Italian sites, including 79 with RA and 32 with axSpA. Outcome measures of interest include clinical characteristics at time of transition and disease activity scores (Disease Activity Score-28 for RA, Bath Ankylosing Spondylitis Disease Activity Index for axSpA) over time and safety.

MethodsĪ prospective study for up to 6 months following transition was conducted. The analysis aims to illustrate the peculiarities of the Italian cohort of patients compared with the whole population to provide a more real-life approach to the data for the Italian rheumatologists, ruling out possible local confounding factors.

The pan-European BENEFIT study of patients with stable rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) who transitioned from reference etanercept to SB4 found no clinically meaningful changes in disease control after transition.

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