Background Multiple trials have been conducted in which the safety and efficacy of different biological therapies for psoriasis have been studied. However, the treatment course in clinical practice is different from the setting in which trials are conducted.
Objectives The evaluation of the efficacy, safety and adverse events of etanercept and efalizumab treatment in daily practice and the investigation of interfering clinical strategies that could be of influence on treatment outcome.
Methods A prospective cohort consisting of 101 patients with high-need psoriasis was followed for 2 years and analysed. Patients were treated with etanercept or efalizumab between February 2005 and May 2007. Efficacy, safety and adverse events were investigated. Furthermore, all accompanying factors of which an influence on treatment efficacy outcome was suspected were registered, including treatment interruptions, dosage adjustments and combinations of therapies.
Results Etanercept and efalizumab treatment was effective and safe in most patients. However, in many cases the treatment course was characterized by unsatisfactory efficacy (83%), necessitating combination therapies or dosage adjustments. Treatment interruptions occurred in 56% (etanercept 2 × 50 mg group), 84% (etanercept 2 × 25 mg group) and 10% (efalizumab-treated patients).
Conclusions Treatment of high-need psoriasis patients in daily practice is highly different from treatment courses in clinical trials. Frequently applied clinical strategies such as treatment interruptions, dosage adjustments and combinations of treatments influence treatment outcome in routine treatment in comparison with randomized controlled trials. Information about treatment with these new drugs in daily clinical practice is important for adjusting treatment schedules and guidelines.