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

Measuring the efficacy of psoriasis treatment can be complex. The objective clinical measures used to gauge treatment efficacy may not always correlate well with the disability and psychosocial consequences of psoriasis (22,23). Therefore, improvement in clinical measures do not necessarily mean that the patient feels better. In addition to meeting clinically defined standards of improvement, a primary goal of treatment is to improve the patient's experience related to their disease and treatment. Accordingly, a more comprehensive assessment of treatment benefits should include the voice of the patient and be defined in terms that matter the most to them. Patient-reported outcome measures are informative in assessing the impact of disease and treatment on functional status and well-being for psoriasis patients. Psoriasis can impact physical, mental, and social aspects of patients' lives.

Pooled results are reported for three well-controlled, similarly designed studies of treatment of moderate to severe psoriasis in which patient-reported outcome measures were used to assess the benefits of efalizumab, a humanized monoclonal IgG1 antibody that targets T-cell interactions central to the pathophysiology of psoriasis (24-29). Disease burden, as indicated by patient-reported DRQL and psoriasis symptom burden, was documented using validated, self-administered, skin-specific quality-of-life and psoriasis symptom questionnaires: the Dermatology Life Quality Index (DLQI), the Psoriasis Symptom Assessment (PSA), and an Itch scale (32).

Methods

Study Design

The pooled study population consisted of 1,242 patients with moderate to severe psoriasis who participated in three phase III, randomized, double-blinded, parallel-group, placebo-controlled, multicenter clinical trials of the efficacy and safety of efalizumab. Eligible patients were between the ages of 18 and 75 years; diagnosed with plaque psoriasis for at least 6 months with [greater than or equal to]10% of total body surface area (BSA) affected; had a minimum Psoriasis Area and Severity Index (PASI) score of 12 at screening: and were candidates for systemic therapy. All patients provided signed informed consent, and all sites received Institutional Review Board approval prior to study initiation.

Following a 28-day screening phase during which patients were washed out of their pre-study psoriasis medications, eligible patients entered the first treatment phase (Days 0 through 84). On Day 0, patients were randomized to receive 12 weekly doses of subcutaneous (SC) efalizumab or placebo (in two of the trials additional patients were randomized to receive a 2 mg/kg dose of efalizumab; these patients were excluded from the present analysis, since preliminary analyses showed that the two efalizumab dose groups did not differ in clinical and patient-based outcomes). Patients randomized to efalizumab received an initial conditioning dose of 0.7 mg/kg followed by II weekly doses of 1 mg/kg. A subset of patients who completed the 12-week initial treatment period were eligible for a second, extended treatment period of an additional 12 weeks.