In people with moderate to severe psoriasis, treatment with Raptiva (efalizumab) reduces the frequency and severity of symptoms and improves quality of life, according to the latest study from The Efalizumab Study Group published in this week’s issue of the Journal of the American Medical Association.

The US Food and Drug Administration (FDA) approved Raptiva for moderate-to-severe psoriasis earlier in 2003, but the primary focus of the current study was how patients perceived the improvements.

Psoriasis and Psoriatic Arthritis
Psoriasis, a disease affecting millions of persons worldwide, is a chronic inflammatory disease that has a profound adverse effect on patients' physical, social, and mental well being.

This study did not evaluate Raptiva’s effect on people with psoriatic arthritis, but it is important to note that psoriasis can coexist with arthritis in some people. Psoriatic arthritis belongs to a group of diseases, which are referred to collectively as spondyloarthritis. Psoriatic arthritis itself can be broken down into five sub-categories, each of which share two main symptoms: psoriasis, which is a scaly rash that occurs most frequently on the elbows, knees and scalp; and joint pain in the form of arthritis. About one-fifth of those with psoriatic arthritis will develop involvement of the spine, called psoriatic spondylitis.

Study Set-Up
556 adults with psoriasis were randomly assigned to 12 weekly injections of Raptiva or placebo (an inactive substance or preparation used as a control in an experiment or test to determine the effectiveness of a medicinal drug). Researchers evaluated a broad set of outcome measures, including physicians’ assessments and patients' perceptions.

Results
Mirroring results of previous studies, Raptiva improved psoriasis severity as determined by a doctor and was safe and generally well tolerated. Treatment with the medication also seemed to improve quality of life, according to the authors.

Those receiving Raptiva felt better about their disease, their ability to participate in daily activities, and their personal relationships. Interestingly, these patient-reported improvements appeared to occur faster than those observed by the doctor.

Raptiva treatment reduced the frequency and severity of psoriasis symptoms, particularly in the severity of itching and scaling, the two most frequently reported subjective symptoms. The severity and frequency of other symptoms, including bleeding and burning or stinging, also improved, along with improvement across measures of social and mental assessment. Raptiva-treated patients reported greater improvement in their attitudes about their disease, their ability to participate in daily activities (including leisure and work), and their personal relationships, and they reported fewer treatment-related problems compared with placebo.

The most commonly occurring adverse events during the initiation of Raptiva treatment were mild to moderate flu-like symptoms following the first one to two injections. Serious adverse events were infrequent and occurred at only a slightly greater frequency in the Raptiva group (2%) than in the placebo group (1%).

Dr. Robert S. Stern of Beth Israel Deaconess Medical Center in Boston discussed the findings in a related editorial piece. He wrote that new drugs like Raptiva represent a promising step in developing safe and effective treatments for psoriasis. However, “Given the lower clinical response rates, higher cost, and unknown long-term risks relative to established therapies, these new agents are best reserved for patients with severe disease unresponsive to, intolerant of, or lacking access to” the older, better studied drugs.

Study Limitations
The authors point out a few limitations to be considered in evaluating this study’s results. Since psoriasis is a chronic disease, outcomes with longer-term use of Raptiva are important. An ongoing open-label study evaluating the efficacy and safety of up to three years of continuous Raptiva therapy is currently being conducted. Additional randomized studies would be needed to compare this medication with other currently available therapies.

There was no evidence to suggest clinically relevant increases in either infection or malignancy, including lymphoma, among Raptiva-treated patients; however, longer follow-up will be needed to accurately characterize the risk of infection and malignancy.