Long-term efalizumab therapy for patients with moderate-to-severe, chronic plaque psoriasis: results from an Australian expanded access program

Authors: Foley, Peter; Freeman, Michael; Gebauer, Kurt; Murrell, Dedee; Shumack, Stephen; Tyson, Christopher; Varigos, George

Source: International Journal of Dermatology, Volume 48, Number 12, December 2009 , pp. 1376-1384(9)

Publisher: Wiley-Blackwell

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Abstract:

Background

Psoriasis is a chronic skin disease that can impact heavily on a patient's well-being. Efalizumab, a unique, targeted, biological therapy, has demonstrated efficacy in treating moderate-to-severe, chronic plaque psoriasis with ≤36 months of continuous therapy. The objective of this Extended Access Program (EAP) was to evaluate further the benefit of efalizumab as long-term therapy in a real-world clinical setting. Methods

After an initial conditioning dose of efalizumab (0.7 mg/kg subcutaneously), a weekly dose of efalizumab (1.0 mg/kg) was administered for ≤21 months. Patients with reduced Psoriasis Area and Severity Index (PASI) scores (≥50%, or a score ≤8) at month 3 entered the long-term maintenance treatment period. Results

In total, 101 patients (>18 years) with severe plaque psoriasis enrolled on the EAP, of these 93 (92.1%) met all the inclusion criteria. After 3 months of treatment, 84/101 (83.2%) patients had evaluable data and entered the maintenance period. After 3 months, 57/84 (67.9%) patients had achieved PASI-50. Using an intent-to-treat analysis, after 21 months of treatment, PASI-75 and PASI-50 were achieved by 43/101 (42.6%) and 69/101 (68.3%) of patients, respectively. Efalizumab was generally well tolerated during the 21 months of continuous therapy. Conclusion

Efalizumab, 1.0 mg/kg/week, is effective and well tolerated in a `real world' clinical setting, providing enduring reduction of psoriasis symptoms for up to 21 months.

Document Type: Research article

DOI: http://dx.doi.org/10.1111/j.1365-4632.2009.04217.x

Publication date: 2009-12-01

Long-term efalizumab therapy for patients with moderate-to-severe, chronic plaque psoriasis: results from an Australian expanded access program

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