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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Figure 2 presents the percentage of patients in the efalizumab and placebo groups that reported being bothered by psoriasis symptoms as assessed by the PSA-S at baseline and at 12 weeks. Efalizumab significantly reduced the proportion of patients who reported being bothered by psoriasis symptoms after 12 weeks of treatment. On average, the proportion was reduced by 61.6% (range: 55%-66%) across the 8 PSA-S items. The largest reduction was observed with "bleeding skin," where 43.0% reported being significantly bothered at baseline and 14.4% after 12 weeks of treatment--a 66.5% improvement from baseline. By comparison, the proportion of the placebo group reporting bothersome psoriasis symptoms was reduced on average by only 20.0% (range, 3%-26%) across the 8 PSA-S items.

Discussion

In this analysis of pooled data from three phase III randomized, placebo-controlled, double-blinded studies in patients with moderate to severe psoriasis, patient-reported outcome measures were informative for quantifying the burden of moderate to severe psoriasis on the patient's dermatology-related quality of life, determining the extent to which itch and other psoriasis symptoms were bothersome to patients, and understanding the benefits of efalizumab treatment from the patients' experience of their disease. Overall, at baseline, patients reported substantial deficits in DRQL while experiencing significant problems with psoriasis symptoms. Efalizumab treatment was observed to significantly improve DRQL and to significantly reduce the extent to which itching and other psoriasis symptoms bothered the patient. These analyses are unique in that no other publication to date has demonstrated consistent improvements in such a large set of patient-reported outcomes from multiple, large Phase III treatment effect studies for moderate to severe plaque psoriasis.

The DRQL and symptom reduction benefits of efalizumab shown in this study in the aggregate were replicated independently in each of the three clinical trials. The consistency of efalizumab-related improvement in patient-reported outcomes provides strong evidence supporting the benefits patients experience in functional status and psoriasis-related well-being. For example, the improvement in DLQI scores among patients treated with efalizumab was 5.5, 5.6, and 5.6 points across the three trials. Likewise, the improvement in PSA-S scores among patients treated with efalizumab was 6.4, 6.5, and 7.0 across the three trials. Lastly, the improvement in Itch scores among patients treated with efalizumab was 2.8, 2.7, and 2.9 across the three trials. More importantly, the magnitude of the improvement in each of these patient reported outcomes observed in all three trials was larger than one-half a standard deviation, which has been shown to be the threshold of discrimination for changes in most generic and disease-specific health-related quality of life measures (39).

Consistent with previous studies (10,14) the psychosocial burden of moderate-to-severe psoriasis was substantial in this study, as two thirds of all patients reported at baseline that they were embarrassed or self conscious because of their skin, one third reported that their skin greatly affected social and leisure activities, and nearly one fifth reported substantial problems with their partner and/or close friends and relatives. Moderate to severe psoriasis was also shown to have an important impact on functional status: approximately 20% to 25% of all patients reported substantial problems with working and studying, shopping and taking care of the home and garden, and participating in recreational activities, such as sports. These results corroborate those observed in previous studies showing the functional impairment associated with moderate to severe psoriasis (12,15,40). Lastly, at baseline, more than one half of the patients in both groups were greatly bothered by itch and 6 of 8 other psoriasis symptoms, indicating a potentially large unmet need for more effective longer term treatment.