Real-World Data Show 12-Month Drug Survival Rates Among Anti-TNF Biosimilars in Psoriasis, PsA

A retrospective, long-term real-world study of 93 patients with psoriasis and psoriatic arthritis (PsA) treated with anti-tumor necrosis factor (TNF)-α biosimilars showed an overall drug survival rate of 91% at 12 months and reported drug survival rates for 72 to 102 months for different molecules. There were no significant differences in drug survival between infliximab, etanercept, and adalimumab biosimilars.

Monoclonal antibodies targeting TNF are used to treat chronic inflammatory conditions, such as psoriasis and psoriatic arthritis (PsA). The authors noted that “highly targeted” molecules, such as anti-interleukin biologics have recently been introduced, however, anti-TNF biologics still play a role in treatment of psoriasis and PsA, because of their efficacy and safety profiles and the availability of lower-cost biosimilars. According to the authors, there is a lack of high-quality, long-term studies evaluating treatment persistence ofadalimumab, etanercept, and infliximab biosimilars specifically in psoriasis and PsA.

The retrospective study at a single center in Florence, Italy, included 93 patients with a median treatment duration of 86 months and a mean disease duration of 20 years. Patients treated with etanercept were prescribed SB4 (Benepali). Adalimumab biosimilars included SB5 (Imraldi), GP2017 (Hyrimoz), ABP 501 (Amgevita) and MSB11022 (Idacio), and infliximab biosimilars included CT-P13 (Inflectra) and SB2 (Flixaby) based on pharmacy availability.

Of the 93 patients, 36 were biologic-naive, and 57 were switched from an originator biologic. Three (8%) biologic-naive patients received infliximab, 12 (33%) received adalimumab, and 21 (58%) received etanercept. Sixteen switched patients (17%) were treated with infliximab, 27 (29%) with adalimumab, and 50 (54%) with etanercept.

The overall drug survival at 12 months for all anti-TNF biosimilars was 91%, with no significant differences between molecules: 94% for etanercept, 82% for adalimumab, and 94% for infliximab. Among naive patients, drug survival at 12 months was 83%, compared to 97% for switched patients, with no significant difference between groups. At the last available follow-up, drug survival was 39% among biologic-naive patients (92 months) and 46% for switched patients (102 months). By molecule, drug survival rates at the last available follow-up were 78% for adalimumab (72 months), 51% for etanercept (79 months), and 44% for infliximab (102 months).

Age, sex, body mass index, disease duration, smoking status, cardiovascular comorbidities, previous treatment with disease-modifying anti-rheumatic drugs, and previous originator treatment did not show significant associations with drug survival.

Among switched patients, there was no significant difference in therapy discontinuation between patients who were previously treated with the reference product for more than 5 years and those treated for 5 years or less. Interestingly, the authors commented, the presence of PsA was associated with a lower risk of drug discontinuation.

Adverse drug reactions (ADRs) were reported in 57 (61%) patients, and infections were the most common (42%). Hematological alterations occurred in 4 patients (9% of ADRs). Severe adverse events occurred in 4 patients (4%), including new diagnosis of polycythemia vera, a severe lower respiratory tract infection, a transient ischemic attack, and a hypertensive crisis.

The most common reason for treatment discontinuation was loss of efficacy. About one-third (36%) of patients discontinued treatment, including 10 (28%) biologic-naive patients and 23 (40%) switched patients. Of patients treated with etanercept, 19 (38%) discontinued treatment, five (19%) treated with adalimumab, and 9 (56%) with infliximab. Three patients (9%) discontinued treatment due to adverse events (a severe cutaneous infection, a lower respiratory tract infection, and a diagnosis of polycythemia vera), and 2 patients (6%) due to remission of the disease. Seven patients (21%) were lost to follow-up.

The authors said their findings “underscore the long-term effectiveness and safety of anti-TNF-α biosimilars in psoriasis and PsA management,” and emphasize the importance of considering disease characteristics when making treatment decisions.

Reference

Nunziati G, Di Cesare A, Rosi E, Scandagli I, Silvi G, Guerra P, et al. Drug survival, long-term safety and efficacy of anti-TNF-alpha biosimilars: a monocentric retrospective study. Ital J Dermatol Venereol 2025;160:204-11. DOI: 10.23736/S2784-8671.25.08060-0