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

Psoriasis is a common skin disease, and clinical trials are a way of measuring how effective different treatments for psoriasis are. During such trials, researchers generally use specific methods for measuring improvements in patients’ symptoms and quality of life. These include the Psoriasis Area Severity Index (PASI, for which the lower the score, the worse the severity of the disease), the Physician Global Assessment (PGA) and the Dermatology Life Quality Index (DLQI). 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. In this study, the researchers looked at clinical trials involving a drug for psoriasis called etanercept, to learn more about the number of patients who drop out due to ‘lack of efficacy’, when they most commonly do so, and how this relates to their PASI and DLQI. Of 6119 patients taking part in the studies looked at, 128 dropped out due to ‘lack of efficacy’. The highest increase of patients dropping out happened between Day 75 and 85. The lowest PASI score of patients dropping out was 6.3 within 120 days. Dropouts who achieved ≥ PASI 75 were rare. The authors conclude that around Day 80 is the critical time when many patients might have lost their willingness to wait for their treatment with etanercept to show a better effect. Most of the patients dropping out had experienced little or no improvement, or worsening of their psoriasis.