Time, Psoriasis Area and Severity Index and Dermatology Life Quality Index of patients with psoriasis who drop out of clinical trials on etanercept because of lack of efficacy: a pooled analysis from 10 clinical trials.

BACKGROUND: Patient-reported outcomes in psoriasis studies are assessed at specific study time points. If a treatment has not become effective by a certain time point, it may increase the likelihood of patients being dissatisfied and leaving a clinical study. OBJECTIVES: To generate evidence concerning the number of patients dropping out of etanercept trials over time including Psoriasis Area and Severity Index (PASI) and Dermatology Life Quality Index (DLQI) data. METHODS: Data from patients with psoriasis in 10 trials with etanercept were pooled. Analyses were performed for (i) patients who dropped out because of 'lack of efficacy' and (ii) patients who continued the trial. The PASI and DLQI data were summarized for different time points. The distribution of dropout over time, PASI, DLQI and the proportion of patients dropping out with given treatment responses were calculated. RESULTS: Of 6119 patients, 128 dropped out because of lack of efficacy (or synonym). The highest increase of patients dropping out happened between day 75 and 85 (cumulative percentage rise from 46% to 73%). The lowest PASI of patients dropping out was 6·3 within 120 days. Individuals who dropped out who achieved ≥ PASI 75 (at least a 75% improvement from baseline PASI) were rare. CONCLUSIONS: A critical time when many patients might have lost their willingness to wait for their treatment with etanercept to show a better effect appeared to be at around day 80. Most of the patients dropping out showed little improvement, stable disease or worsening of their psoriasis.

Pattern of response in patients with moderate-to-severe psoriasis treated with etanercept.

BACKGROUND: Etanercept (ETN) 50 mg once weekly (QW) or 50 mg twice weekly (BIW) for 12 weeks, followed by 50 mg QW in all subjects to Week 24 improved psoriasis in patients with concomitant psoriatic arthritis in the PRESTA trial. OBJECTIVES: To use data from PRESTA to evaluate the effect of ETN in the treatment of psoriasis by Psoriasis Area Severity Index (PASI) body-region and component, and determine if PASI responses correlate with the Dermatology Life Quality Index (DLQI). METHODS: Median time to 75% improvement in PASI (PASI75), body- and component-specific subscales over 24 weeks were estimated. Pearson correlation coefficients determined the association between DLQI score and PASI total score, body- and component-specific subscales with ETN treatment at baseline and up to Week 24. RESULTS: In total, 748 patients from PRESTA were included (ETN 50 mg QW/QW, n = 371; BIW/QW, n = 377). Patients achieved PASI75 total score and 75% improvements in all body regions and components faster on ETN 50 mg BIW/QW than QW/QW (all P < 0·05). Median time to 75% improvement was faster for the head and trunk followed by upper and lower extremities, and for induration and desquamation followed by erythema and total area. Weak to moderately positive correlations between improvements in DLQI and PASI total score (r = 0·223-0·463), all PASI body-specific (r = 0·114-0·432) and component-specific (r = 0·178-0·478) subscales were observed over 24 weeks. CONCLUSIONS: Etanercept treatment-response appears to occur in a body- and component-specific manner. Changes in quality of life are not captured by PASI or its subscales.