Impact of efalizumab on psoriasis-specific patient-reported outcomes: results from three randomized, placebo-controlled clinical trials of moderate to severe plaque psoriasis

Journal of Drugs in Dermatology, Jan-Feb, 2004 by Alan Menter, Mark Kosinski, Brian W. Bresnahan, Kim A. Papp, John E. Ware

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Disease Burden

Baseline data on disease burden of moderate-to-severe psoriasis presented in Figure 1 (black bar = baseline) indicate a substantial burden across all items of the DLQI. Prior to study treatment, the degree of burden was similar in the two groups, thus the baseline bar in Figure 1 represents both efalizumab and placebo treatment groups combined. More than 60% of patients reported that they were bothered "a lot" or "very much" by "itchy, sore, painful skin," "being embarrassed or self-conscious," and "influencing clothes worn." Problems with prior treatment were reported by 41% of patients, more than one third of patients reported problems with social and leisure activities, and nearly one fourth reported problems participating in sports. To a lesser extent, psoriasis produced problems with basic activities of daily living such as "interfering with shopping or looking after the home and garden" (19%), "prevented from work or studying" (19%), with interpersonal relationships such as "problems with a partner, close friends, or relatives" (19%), and "sexual difficulties" (18%).

Baseline data on the extent to which specific psoriasis symptoms were troublesome or bothersome to patients are presented in Figure 2. "Itching" and "scaling" skin were most bothersome to more than 80% of patients. More than one half of the patients reported being significantly bothered by "irritated," "sensitive," "hurting," and "burning or stinging" skin. Water sensitivity (36%) and bleeding skin (40%) were the least bothersome symptoms. Similar results were observed for PSA-F item responses (not reported).

Impact of Efalizumab on DRQL and Psoriasis Symptoms

Changes in DLQI, PSA, and Itch scale scores from baseline to 12 weeks differed significantly between the efalizumab and placebo groups, with efalizumab-treated patients showing greater improvement in all measures (p<0.001) (Table 2). The mean improvements in scores on the DLQI (5.6 points), the PSA-S (6.7 points), the PSA-F (6.4 points), and the Itch scale (2.8 points) among patients in the efalizumab group were as large as one standard deviation, which is considered a large effect size improvement (37). By comparison, mean changes in DLQI (1.9 points), the PSA-S (2.0 points), the PSA-F (2.0 points), and the Itch scale (0.6 points) among patients in the placebo group were roughly one third of a standard deviation, which is considered a small effect size improvement (37). These results, which are the aggregate across the three trials, were in fact replicated in each one of the three trials. The consistency observed across three large well-controlled studies provides robust evidence for the benefits reported by efalizumab patients in DRQL and psoriasis-specific symptom measures.

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Table 2 also presents the changes in DLQI, PSA, and Itch scale scores from baseline to 12 weeks that were categorized as "better," "same," or "worse." Across all scales, twofold differences in favor of efalizumab were observed for the percentage of patients who improved (% better). Among patients randomized to efalizumab, 51.1% to 61.3% were categorized at "better" on each scale, whereas 22.5% to 29.0% of patients in the placebo group improved on each scale. Furthermore, the percentage of patients in the placebo group who got worse (% worse) was double the percentage of patients in the efalizumab group categorized as "worse," consistent across all scales.