Efficacy and Safety of Clinical Use of Etanercept for the Treatment of Moderate-to-Severe Psoriasis in Spain: Results of a Multicentric Prospective Study at 12 Months Follow-Up

Abstract

Background: The efficacy of etanercept in the treatment of psoriasis has been demonstrated in several clinical trials, but information regarding results derived from prospective observational studies in clinical practice is scarce. Objectives: To evaluate the efficacy and safety of etanercept administration according to routine clinical use in moderate-to-severe plaque psoriasis. Materials and Methods: Postauthorization, prospective study, carried out at 59 dermatology units in Spain. Patients diagnosed with moderate-to-severe plaque psoriasis received etanercept during a 12-month period. Results: Altogether, 444 patients were enrolled. Overall, 325 patients (73.2%) initiated etanercept treatment at a dose of 50 mg twice weekly; 96 patients (21.6%) received etanercept as a continuous regimen for the entire study period, and 348 patients (79.4%) an intermittent regimen. Among these, 185 patients (41.6% overall) received one course of treatment, stopped at various study points and did not restart etanercept treatment, whereas the remaining 163 patients (36.7% overall) stopped etanercept treatment, lost response, relapsed and were retreated. Most patients who interrupted etanercept treatment did so at month 6. Altogether, 79.7% of patients completed the study period. Etanercept treatment resulted in significant improvement in disease activity. A Psoriasis Area and Severity Index (PASI) 75 response was achieved by 76.1% of patients at month 6. Out of 252 adverse events reported, 31 were considered severe. Three possibly treatment-related malignancies were detected during the study. No opportunistic infections, tuberculosis or demyelinating events were reported. Conclusion: The PASI 75 response rate at month 6 in this observational, naturalistic study is similar to those observed in recent published trials with etanercept, and within the range of those reported for other marketed biologicals.

An observational study to evaluate the long‐term outcomes of treatment with etanercept in patients with plaque‐type psoriasis

“…Other results were comparable for this German observational study vs. a recent Spanish observational study: (1) the majority of patients in both studies initiated etanercept treatment at a dose of 50 mg twice weekly (73.3% vs. 73.2% respectively); (2) etanercept treatment resulted in significant improvement in disease activity (61.1% vs. 76.1% PASI75 response at month 6 respectively). However, although only 21.6% of patients received etanercept as a continuous regimen in the Spanish study, sustained improvement in PASI scores was achieved throughout 1 year…”

Effectiveness of Biologic and Conventional Systemic Therapies in Adults with Chronic Plaque Psoriasis in Daily Practice: A Systematic Review

“…Overall, PASI75 was attained by 27-68% with short-term, 31-82% with intermediate-term and 44-89% with long-term (1 and 2 year) adalimumab treatment ( (Table SIII 1 ). Nine studies (13,18,20,22,24,26,32,33,35) were prospective and 11 retrospective (19, 21, 23, 25, 27-31, 34, 40), including a total of 2,079 patients. Five of 20 articles (21,25,29,31,40) reported results on etanercept monotherapy.…”

“…Five of 20 articles (21,25,29,31,40) reported results on etanercept monotherapy. In 7 studies (13,21,25,27,30,33,40) all patients were naïve for biologics, in 12 articles a proportion of patients was non-naïve for biologic therapy. In one article (28) a highly selected group of patients was treated with etanercept, since all patients switched from efalizumab therapy.…”

How should a patient with rheumatoid arthritis behave after achievement of remission?

“…В многоцентровом открытом исследовании, прове-денном в Испании [30] среди 444 больных псориазом, по-лучавших ЭТЦ, у 348 (79,4%) наблюдались отмены лече-ния по разным причинам, как правило, в течение первых 6 мес. У 163 больных, которым препарат назначали по-вторно, хороший ответ на терапию PASI75 через 6 мес на-блюдения достигнут в 76,1% случаев.…”