Tolerability and Safety of Biological Therapies for Psoriasis in Daily Clinical Practice: A Study of 103 Italian Patients

Abstract

Studies comparing the safety and tolerability of biological therapies for psoriasis in the long-term and in daily clinical practice are lacking. Most published studies are of selected patients with short-term (3-6 months) follow-up. We performed a retrospective cohort study of 103 patients in order to describe the frequency and the clinical features of adverse events, and to evaluate and compare the tolerability and safety of efalizumab, etanercept, infliximab, and adalimumab in clinical practice. A total of 136 courses of biological therapies were administered, with a mean duration of 16 months/patient; 55 patients received efalizumab, 45 etanercept, 33 infliximab, and 3 adalimumab. Infliximab had an incidence rate ratio of suspension due to severe adverse events 5.9 times (95% confidence interval (95% CI) 1.9-18, p < 0.001) higher than etanercept and 9.8 times (95% CI 3.2-30.1, p < 0.001) higher than efalizumab. Safety profiles for efalizumab and etanercept were more favourable than for infliximab. Concerning tolerability, we found that more patients responded to infliximab, but long-term tolerability was higher for both efalizumab and etanercept due to the better safety profile and a higher compliance to therapy.

Efficacy and cost of etanercept in long-term psoriasis: Rational use in clinical practice

“…Mention must also be made of our sustained efficacy results, with 13 patients with PASI90 after 4 years of treatment, 11 patients with PASI 90 after 5 years, and three patients with PASI90 after 6 years, respectively, as well as the absence of important side effects. These data are even discreetly better than those published by other authors (20,(22)(23)(24). By way of conclusion, we would like to emphasize that they demonstrate a greater efficacy of etanercept in regular clinical practice versus outcomes published on pivotal studies on the drug (25)(26)(27).…”

Adherence, satisfaction and preferences for treatment in patients with psoriasis in the European Union: a systematic review of the literature

“…The majority of psoriasis patients suffer from mild disease (PASI ≤10), which can often be managed with topical agents, while phototherapy or systemic therapies are usually used for patients with moderate-to-severe psoriasis (PASI >10). In the last decade, significant advances in the management and treatment of psoriasis have been made with the introduction of biologic agents,14,15 which have shown greater clinical benefit than traditional systemic therapies 16–22…”

Patient-reported reasons for the discontinuation of commonly used treatments for moderate to severe psoriasis

“…19–21 Nevertheless, studies have demonstrated annual treatment discontinuation rates of 15–25% among traditional systemic therapies and phototherapy. 18 Studies on biologics also showed a progressive loss of treatment persistence, with first-year attrition rate of 10–15%.…”

“…18 Studies on biologics also showed a progressive loss of treatment persistence, with first-year attrition rate of 10–15%. 19, 20 As a composite surrogate marker of treatment efficacy, safety, tolerability, and overall satisfaction, treatment persistence in moderate-to-severe psoriasis is low and may contribute to suboptimal treatment response and increased healthcare utilization. 17–20 …”