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Published on 19 May 2010

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Stelara improves symptoms of depression

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New research published online in the Journal of the American Academy of Dermatology (JAAD) shows that treatment with Stelara significantly improves symptoms of depression, anxiety and quality of life in patients with moderate to severe psoriasis compared to placebo.

These results are from an analysis of prespecified quality of life measures from one of the large, pivotal phase III trials for STELARA, PHOENIX 2.

Psoriasis affects approximately 1.5 million people in the UK,with 20-30% of those considered to have severe disease. It is a chronic skin condition that can be painful and potentially debilitating, and is associated with much higher rates of clinically significant psychiatric symptoms, including depression and anxiety, compared with the general population (25-43% vs 1.6-10%).

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.

HRQoL was also assessed in the study using the Dermatology
Life Quality Index (DLQI), a clinically recognised measure of the impact of skin disease on quality of life. Improvements in HRQoL were observed at week 12 of treatment, with 55.9% of STELARA-treated patients achieving a normal DLQI score (0 or 1) compared with only 3.2% of patients receiving placebo (P < 0.001).

Improvements in HRQoL were maintained through to week 24 for those patients receiving treatment with STELARA.

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