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

Summary 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. What's already known about this topic? Widely accepted maximum times to attain a response are 16 weeks for fast‐acting or 24 weeks for slow‐acting psoriasis drugs. What does this study add? The median time until patients dropped out of etanercept trials was 80 days, suggesting this may be the length of time that patients are willing to wait to attain a response. The dropout rate and response to etanercept treatment appear to correspond with one another. However, responses in the dropout group ranged widely. Linked Comment: Schmitt‐Egenolf. Br J Dermatol 2018; 178:318–319. Plain language summary available online