In a sample of children and the elderly with psoriasis, biosimilar biosimilar treatment of adalimumab and etanercept showed comparable efficacy results and a good safety profile. according to an Italian real-life study lasting 72 weeks, published in the journal Psoriasis: Targets and Therapy.
In a sample of children and the elderly with psoriasis, biosimilar biosimilar treatment of adalimumab and etanercept showed comparable efficacy results and a good safety profile. This is what appears from an Italian real-life study lasting 72 weeks, published in the journal Psoriasis: Targets and Therapy.
Biologic agents represent a valuable therapeutic option for patients with moderate to severe psoriasis, especially if they respond poorly to conventional systemic therapies or if these are contraindicated by the presence of comorbidities. These drugs exhibit an optimal safety and efficacy profile as well as rapid and long-lasting effects, but have enormous manufacturing costs that limit their prescription to health care cost containment policies, leading to unequal access to care for patients, the study authors said.
To date, the FDA has approved 12 biologics for the treatment of psoriasis and/or psoriatic arthritis, classified into four classes based on the target molecule: anti-tumor necrosis factor (TNF), anti-interleukin (IL)-12/23, anti-IL17 and anti-IL23 . TNF blockers were the first to be developed and marketed: adalimumab, etanercept and infliximab were approved more than 20 years ago (in 2002, 1998 and 1998 respectively), so their biosimilars.
This entails significant cost savings as well as easier access for patients to treatment options around the world. Several studies have already shown the effectiveness and safety of biosimilars in the treatment of psoriasis and their comparability with the originals.
“However, as real-world data are scarce, especially with regard to special populations underrepresented in clinical trials, i.e. children and the elderly, we have decided to conduct a retrospective study to evaluate the efficacy and safety of anti-biosimilars.” TNF in these categories of patients» wrote the authors.
An Italian retrospective study of children and the elderly
From January 2018 to January 2022, a real-life retrospective observational study was conducted in 11 children with psoriasis (<18 years) and 23 elderly patients with psoriasis (≥ 65 years) treated with agents anti-TNF biosimilars of adalimumab and etanercept who belonged to the Psoriasis Unit at the University of Naples Federico I.
At baseline, demographic characteristics (age and gender), data on disease duration and severity as measured by the Psoriasis Area Severity Index (PASI), body surface area involved by the disease (BSA), the presence of psoriatic arthritis and comorbidities, and previous treatments for psoriasis have been registered.
Patients were monitored through regular follow-ups (weeks 12, 24, 48 and 72) through clinical and hematological evaluations (complete blood count, blood sugar, transaminase, gamma-glutamyl transpeptidase, erythrocyte sedimentation rate, C-reactive protein, urea, creatinine, cholesterol and triglycerides, protein electrophoresis ) and adverse events were recorded.
Overlapping results between biosimilars
As for the children, 6 (54.5%) were being treated with an adalimumab biosimilar and 5 (45.5%) with an etanercept biosimilar. The two drugs were equally effective (p <0.001) and safe for up to 72 weeks of treatment (mean PASI and BSA <3). No significant side effects were reported and no patients discontinued treatment.
In the elderly, 15 (65.2%) were treated with a biosimilar adalimumab and 8 (34.8%) with a biosimilar etanercept. Also in this case, the two biosimilars were equally effective (p <0.001) for up to 72 weeks (mean PASI <4 and mean BSA <5%). Side effects, mostly minor, were recorded in 9 subjects (39.1%). In addition, 4 patients (17.4%) discontinued biologic therapy due to lack of secondary effect (3.75%) or side effects (1 25%).
“Our study showed that adalimumab and etanercept biosimilars are effective and safe for the treatment of moderate to severe psoriasis in children and the elderly. There were no statistically significant differences in efficacy and safety between the drugs in the two patient groups,” the researchers concluded. “The geriatric subjects showed a higher discontinuation rate and adverse events than their pediatric counterpart, but they did not approach statistical significance.”
Megana M et al. Efficacy and safety of anti-TNF biosimilars for psoriasis in pediatric and geriatric populations: A 72-week real-world study. Psoriasis (Auckl). 9 July 2022, 12 July: 199-204.