The published results are from an analysis of prespecified quality of life measures from one of the large, pivotal phase III trials for Stelara, Phoenix 2.
Data from the 1,230 patients included in the Phoenix 2 study show comparable levels of depression and anxiety to previous studies in psoriasis patients, as analysed using the Hospital Anxiety and Depression Scale (HADS).
At baseline, over a quarter of patients reported symptoms of depression (27%; HADS-D greater than or equal to 8, mild to severe symptoms) and more than a third reported symptoms of anxiety (40%; HADS-A greater than or equal to 8).
The mean baseline scores of depression and anxiety reported by patients (HADS-D, 5.1; HADS-A, 6.9) are comparable to, or worse than patients diagnosed with breast cancer (2.8; 6.8) and chronic obstructive pulmonary disease (7.6; 7.0), further demonstrating the overall impact of psoriasis on patients’ health-related quality of life (HRQoL).
At week 12, 63.5% of patients (141 out of 222 patients) treated with Stelara reported improvements in symptoms of depression, defined as a change in HADS-D score from greater than or equal to 8, at baseline (mild to severe depression) to a HADS-D score of < 8 (normal).
This was compared with 29.9% of patients receiving placebo (29 out of 97 patients, P < 0.001). Similarly, 47.9% of Stelara-treated patients (152 out of 317 patients) with symptoms of anxiety reported improvements at week 12, defined as a change in HADS-A score of greater than or equal to 8 at baseline (mild to severe anxiety) to < 8 (normal) compared to 22.2% of placebo-treated patients (37 out of 167 patients, P < 0.001). This response was maintained up to week 24 in the Stelara-treated group.