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

Table 3 summarizes the results of the responder analyses. A significantly higher proportion of patients in the efalizumab group than in the placebo group met each of the response criteria used for each scale. Using the statistically based response criteria, approximately one half of the efalizumab group (range, 46.3% to 56.4%) showed a significant response, compared with less than one fourth of the placebo group (range, 21.5% to 23.6%). Using the clinically derived response criterion based on a PASI percentage improvement in the range 50%-74.9%, more than 40% of the efalizumab group showed a significant response, compared with less than 17% of the placebo group. Using the clinically derived response criterion based on a PASI improvement of greater than or equal to 75%, roughly 30% of the efalizumab group showed a significant response, compared with roughly 10% of patients in the placebo group. The oddsratio statistics indicate that patients in the efalizumab group were 3 to 4 times more likely than patients in the placebo group to meet the statistically based and both clinically based response criteria on each patient-reported outcome scale.

Figures 3-5 present the trends in DLQI, PSA-S, and Itch scales observed across the first and extended treatment periods of the trials. As shown, patients who were randomized to placebo during the first treatment period and then received efalizumab during the extended treatment period showed significant improvement in all three patient reported outcome measures from the end of the first treatment period (week 12) to the end of the extended treatment period (week 24). Patients who were randomized to receive efalizumab in the first treatment period and who remained on treatment during the extended treatment period showed significant improvement on all three patient reported outcome measures during the first treatment period which was maintained during the extended treatment period, a total of 24 weeks.

Interpreting Changes in DQOL and Symptom Severity Scores

As a basis for interpreting the changes in DLQI and PSA scale scores from baseline to 12 weeks, the content of questionnaire items was examined. The results of these analyses are presented in Figures 1 and 2.

Figure 1 presents the percentage of patients in the efalizumab and placebo groups reporting significant DRQL impact associated with their psoriasis condition (DLQI questionnaire item responses) at baseline and at 12 weeks. Efalizumab significantly reduced the proportion of patients reporting DRQL impact associated with their psoriasis. On average, the proportion of the efalizumab-treated patients reporting skin-related limitations was reduced by 60.2% (range: 51%-65%) across the 10 DLQI items. The largest reduction was observed with "embarrassment and self-consciousness": 64.5% reported limitations at baseline, compared with 22.3% after 12 weeks of treatment--a 65% decrease in limitations. In contrast, the proportion of the placebo group with skin-related limitations was reduced on average by only 19.6% (range: 2%-25%) across the 10 DLQI items.