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Efalizumab Safe for Treatment of Chronic Plaque Psoriasis: Presented at EADV

By Jill Stein

RHODES, GREECE -- October 5, 2006 -- The recombinant, humanised, monoclonal antibody efalizumab does not increase the risk of arthropathy adverse events in patients with chronic plaque psoriasis, investigators reported here at the 15^th Congress of the European Academy of Dermatology and Venereology (EADV).

Carlo Pincelli, MD, associate professor, dermatology division, University of Modena, Modena, Italy, and colleagues conducted a pooled safety analysis of data in more than 3,000 patients with moderate-to-severe chronic plaque psoriasis enrolled in 7 phase 2/3/4 clinical trials.

"Chronic plaque psoriasis is an immune-mediated disease that frequently requires long-term therapy to manage symptoms effectively," Dr. Pincelli observed in his presentation on October 4^th. "However, traditional systemic therapies such as methotrexate and cyclosporine have treatment-limiting side effects that may prevent continuous use over the long term."

New targeted biologic therapies such as efalizumab show a better risk-benefit profile for patients with chronic plaque psoriasis, he said.

"Psoriatic arthritis constitutes a major consideration in patients who are receiving long-term treatment for their psoriasis, and the prevalence of arthritis in such patients has been reported to be as high as 30%," he continued. "Despite the observation that symptoms of arthropathy adverse events can be managed successfully with nonsteroidal anti-inflammatory drugs, it is very important to assess the potential role of efalizumab with respect to the incidence of arthropathy adverse events."

Arthropathy adverse events were defined either by Coding Symbols for Thesaurus of Adverse Reaction Terms (CO-START)-preferred terms -- 'arthritis' and 'arthrosis' -- or the Medical Dictionary for Regulatory Activities (MedDRA) terminology-preferred terms -- 'arthritis not otherwise specified (NOS),' 'psoriatic arthropathy,' 'arthropathy NOS,' 'monoarthritis,' 'polyarthritis,' and 'osteoarthritis NOS.'

Each period of efalizumab exposure was analysed. The first treatment period referred to the period during which patients received 12 weeks of weekly subcutaneous efalizumab dose of 1 mg/kg or placebo in a randomised, blinded manner. The extended treatment or retreatment periods were open-label periods where patients received 1 or 2 mg/kg of subcutaneous efalizumab for an additional 12 weeks of therapy. The long-term periods included 12- week treatment segments from 2 open-label, long-term studies for up to 3 years.

The incidence of arthropathy adverse events per patient/year was similar for placebo- and efalizumab-treated patients during the first treatment period (0.16 and 0.15, respectively).

During the extended treatment and retreatment periods, an incidence of 0.17 and 0.12 patient/year was seen, respectively.

Three-month segment analysis from long-term periods showed a similar and stable incidence of arthropathy adverse events during lengthy treatment exposure (range 0.06-0.19 patient/year).

Dr. Pincelli said the study is 1 of the largest safety analyses conducted with patients treated for chronic plaque psoriasis.

The trial was sponsored by Serono.


[Presentation title: Efalizumab Therapy and Incidence of Arthropathy Adverse Events: A Pooled Safety Analysis From 7 Clinical Trials. Abstract PO35.115]

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