Clinical and economic impact of etanercept in real-life: a prospective, non-interventional study of etanercept in the treatment of patients with moderate to severe plaque psoriasis in private dermatologist settings (ESTHER).

BACKGROUND: Real-life data on the therapeutic effectiveness and costs of etanercept are scarce. OBJECTIVES: To assess the clinical and economic impact of etanercept in patients with psoriasis in Denmark and Norway. MATERIAL & METHODS: This prospective, non-interventional study in a private dermatologist care setting in Denmark and Norway included patients ≥18 years with moderate to severe plaque psoriasis, selected for treatment with etanercept. Assessments during 1 year from etanercept initiation included Dermatology Life Quality Index (DLQI), Self-Administered Psoriasis Area and Severity Index (SAPASI) and adverse events. Direct and indirect costs were calculated. RESULTS: 163 subjects were enrolled. Baseline mean SAPASI was 19.1 . Proportion of patients with ≥50% decrease in SAPASI from baseline was 85% and 81% at weeks 24 and 52. DLQI decreased significantly from 11.4 (7.0) to 3.2 (4.3) and 3.7 (4.6) at weeks 24 and 52. Total annual costs increased from 78,000 to 286,000 DKK (p<0.0001), mainly due to the cost of etanercept. Outpatient-care costs and loss-of-productivity costs decreased from 9,500 to 5,000 (p = 0.0002), and from 33,000 to 18,000 DKK (p = 0.0105), respectively. The decrease in costs was more pronounced in patients who also had psoriatic arthritis. Cost increase was greatest during the first 6 months. CONCLUSION: Etanercept treatment was associated with decreased psoriasis severity and improved quality of life. Cost increase was driven by medication, while costs of outpatient care and loss-of-productivity decreased. Maintained improved quality of life was accompanied by decreasing cost during the second 6 month period of etanercept treatment. There were no new safety signals reported.

A higher score on the dermatology life quality index, being on systemic treatment and having a diagnosis of psoriatic arthritis is associated with increased costs in patients with plaque psoriasis.

The aim of this study was to examine the relationship between measures of disease severity and costs from a societal perspective in patients with plaque psoriasis. Dermatologists in Sweden recruited 443 consecutive patients who had had no biological treatment during the past 12 months. Following a Psoriasis Area and Severity Index (PASI) assessment, subjects completed self-assessments on health status/quality of life and a healthcare resource utilization/work status questionnaire. The costs of healthcare resources and sick-leave due to plaque psoriasis were estimated and related to the subject's health status. A patient's Dermatology Life Quality Index (DLQI) and being on systemic therapy, or having diagnosis of psoriatic arthritis, appeared to be more strongly associated with direct and indirect costs than did their PASI. The cost of biological therapy should be considered from the perspective of the already high costs of patients with high DLQI undergoing traditional systemic treatment.

Reduction of direct and indirect costs in patients with AS receiving etanercept: results from an open-label 36-week extension of the ASCEND study in four European countries.

OBJECTIVE: To characterize the impact of etanercept (ETN) in AS on cost, work productivity and quality of life (QoL). METHODS: A Phase 4, open-label, multi-centre (UK, Scandinavia) extension study in AS. Eligible subjects (n = 84) were treated for 36-52 weeks with ETN 50 mg s.c. once weekly. Analysis included direct costs (transformed out-patient and in-patient care elements), indirect costs (sick leave and lost working days), efficacy and QoL. RESULTS: Annualized direct and indirect costs decreased (55.5%, P ≤ 0.008) during ETN treatment, as did out-patient and in-patient episodes (physiotherapist/physician visits, P = 0.012). Work productivity and QoL increased. CONCLUSION: ETN therapy significantly reduces direct and indirect health-care costs and increases work ability and QoL in AS. Trial Registration. EUDRACT, https://eudract.ema.europa.eu/, 2006-001061-42.

The combination of etanercept and methotrexate increases the effectiveness of treatment in active psoriasis despite inadequate effect of methotrexate therapy.

Many patients with moderate-to-severe plaque psoriasis do not respond adequately to methotrexate monotherapy. This pilot study, with a small patient population, was performed to evaluate the effectiveness and safety of etanercept and methotrexate combination in patients with plaque psoriasis and inadequate response to methotrexate. Outpatients with plaque psoriasis (Psoriasis Area and Severity Index > or = 8 and/or body surface area > 10%), despite methotrexate treatment (> or = 3 months; > or = 7.5 mg/week) were randomized to either etanercept with metho nottrexate tapered and discontinued (n = 28) or etanercept with continuous methotrexate (n = 31). Significantly more patients had a Physicians' Global Assessment of "clear"/"almost clear" in the combination group compared with etanercept/methotrexate taper (66.7 vs. 37.0%, respectively; p = 0.025). Adverse events were similar for both groups, with no cases of tuberculosis, malignancies or opportunistic infections reported. Addition of etanercept to methotrexate achieved significant improvement in psoriasis after 24 weeks.

A double-blind, placebo-controlled study of sertraline in the prevention of depression in stroke patients.

The authors tested the effect of sertraline in the prevention of poststroke depression. After experiencing an acute ischemic stroke, nondepressed patients (N=137) were randomly assigned to 12 months of double-blind treatment with either sertraline (N=70) or placebo (N=67). Kaplan-Meier analysis showed sertraline to have significantly superior prophylactic efficacy compared with placebo. Two definitions of clinical depression were used: total score >18 on the HAM-D(17) and score >or=9 on the HAM-D(6). Approximately 10% of the sertraline-treated group developed depression according to either definition, whereas 30% developed depression in the placebo group. On the HAM-D(6) the superiority of sertraline to placebo was demonstrated already after 6 weeks of therapy. Treatment was well tolerated; patients treated with sertraline experienced significantly fewer adverse events.

Treatment strategies in patients with major depression not responding to first-line sertraline treatment. A randomised study of extended duration of treatment, dose increase or mianserin augmentation.

RATIONALE: A large proportion of patients with major depression do not respond sufficiently to any first-line treatment. OBJECTIVES: The aim of this study was to compare a strategy of sertraline dose increase with a strategy of adding mianserin in patients with major depression insufficiently responding to 6 weeks of open treatment with sertraline, controlling for the effect of an extended duration of treatment. METHODS: One thousand six hundred and twenty-nine patients, 18-65 years of age, with major depression scoring at least 18 on the 17-item Hamilton depression scale (HDS) were treated openly with 50 mg/day sertraline, and patients who after 4 weeks had not responded (achieving at least a 50% reduction in score on the HDS) were treated with 100 mg/day sertraline for an additional 2-week period. The patients who had still not responded were then randomised to double-blind treatment for an additional 5 weeks with either 100 mg/day sertraline plus placebo, 200 mg/day sertraline plus placebo or 100 mg/day sertraline plus 30 mg/day mianserin. RESULTS: After 6 weeks of open treatment, 60% had responded and 22% had dropped out, leaving 295 non-responding patients (18%) for randomisation. In the intention-to-treat-analysis, continuing the treatment with 100 mg/day sertraline resulted in response in 70% of the non-responders, similar to the response rate (67%) obtained in the patients who had mianserin added. However, increasing the sertraline dose to 200 mg/day resulted in a lower response rate at 56% ( P<0.05). Similar results were seen in the completers. A substantial increase in the accumulated response rate from week 6 to week 8 was seen. There was no influence of baseline variables, including the presence of melancholic features on the overall post-randomisation response rate. CONCLUSION: After 6 weeks of insufficient antidepressant treatment with 50-100 mg/day sertraline, a continued treatment with 100 mg/day sertraline can be considered until at least week 8 before considering changing strategy, unless the condition deteriorates.