Time, PASI and DLQI of psoriasis patients who “drop out” of clinical trials on etanercept due to “lack of efficacy” - a pooled analysis from ten 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

Generate evidence concerning the number of patients dropping out of etanercept trials over time including PASI and DLQI data.

Methods

Data from psoriasis patients in ten trials with etanercept were pooled. Analyses were performed for a) patients who dropped out due to 'lack of efficacy' b) patients who continued the trial. Psoriasis Area Severity Index (PASI) and Dermatology Life Quality Index (DLQI) data were summarized for different time points. Distribution of dropouts over time, PASI and DLQI and the proportion of patients dropping out with given treatment responses, were calculated.

Results

Of 6119 patients 128 dropped out due to 'lack of efficacy'(or synonym). The highest increase of patients dropping out happened between Day 75 and 85 (46% to 73%). The lowest PASI of patients dropping out was 6.3 within 120 days. Dropouts who achieved ≥ PASI 75 were rare.

Conclusion

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.

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