Treatment of Psoriasis with Different Dosage Regimens of Etanercept: Preliminary Results from the TαRanta Plastic Study Group

Abstract

This pilot open-label study is aimed to assess clinical response in psoriasis patients receiving diverse dose regimens of etanercept, consisting of the same global cumulative dose of etanercept administered over different treatment periods. Eligible patients were assigned sequentially in a 1:1 ratio to receive: etanercept 50 mg once weekly (QW) or 50 mg twice weekly (BIW) for 12 weeks. The final analysis included a total of 72 patients. At week 12 the Psoriasis Area and Severity Index (PASI) and Skindex-29 scores notably improved in both treatment arms, without significant differences between the two groups. The rate of patients attaining a PASI improvement >or= 50% (PASI 50) at week 12 was 92% in the high-dose group. In these patients, etanercept dosage was decreased to 50 mg QW from week 13, with persistence of the PASI 50 response at week 24 in all cases. Thereafter, treatment was discontinued up to week 36 and almost 30 % of patients experienced a gradual relapse of their psoriasis within this period. In the low-dose group, the PASI 50 response was observed in 75% of patients. These responders continued to be treated with etanercept 50 mg QW up to week 36 with persistence of the PASI 50 in 100% of cases at week 24 and 93% at week 36. In the low-dose regimen, 8 patients who did not respond at week 12 underwent dose escalation to 50 mg BIW for a further 12 weeks. At week 24, six of these patients gained the PASI 50 response, 4 of whom maintained the response up to week 36, after treatment discontinuation from week 24. Our results confirm that etanercept is very effective and well-tolerated in psoriasis and that the drug dosages and treatment duration may be modulated and adapted to clinical needs in a flexible way.

Efficacy and safety of systemic treatments for moderate‐to‐severe psoriasis: meta‐analysis of randomized controlled trials

“…All large trials with > 500 patients investigated biological interventions. The primary outcome was PASI 75 response in 30 studies (62%), mean PASI change in 11 studies (23%), Investigator Global Assessment of clear or almost clear in four studies, [41][42][43]46 American College of Rheumatology-20 response in two studies, 52,58 PASI 50 response in two studies 33,44 and mean change in Psoriasis Scalp Severity Index in one study. 40 The primary end point was assessed between week 8 and week 24 in all trials included.…”

“…Reporting of adverse events was heterogeneous across trials (Table S2; 28,44 did not report total adverse events or patients with adverse events during active treatment by intervention (Table S2). Due to these differences in reporting of safety, these outcomes were not pooled in a meta-analysis.…”

Efficacy of etanercept for the treatment of psoriasis: an overview of the Italian clinical experience from the real-life setting and independent studies

“…(11) Moreover, 12 weeks after the interruption of etanercept treatment, nearly 70% of patients were reported to maintain a PASI 50 response. (17) A preliminary pilot experience supports the usefulness of an initial treatment using the 50 mg weekly dose with subsequent dose escalation in nonresponders. (17) In particular, this dose escalation in patients who initially did not attain the PASI 50 at week 12 led to the achievement of PASI 50 in 75% of them at week 24.…”

“…(10)(11)(12)(13)(14)(15)(16)(17) These studies included a total of 810 patients, and most of them were observational, open label or retrospective, thus depicting the effectiveness in a real-life setting, where therapeutic management is usually more complex than that apparently shown in clinical trials. Real-life setting in fact often involves very high-need patients, who have failed multiple therapeutic approaches, or problematic patients who have comorbidities and comedications that sometimes are considered exclusion criteria for the enrolment in clinical trials and that may also negatively affect the efficacy and tolerability profile of psoriasis treatment in clinical practice.…”

“…(11,17) After discontinuation of etanercept, patients treated sequentially with other, mostly topical, therapies appeared to relapse later than those who did not receive any treatments (mean time to relapse 174 days versus 117 days, respectively). (11) Moreover, 12 weeks after the interruption of etanercept treatment, nearly 70% of patients were reported to maintain a PASI 50 response.…”