Evaluation of efalizumab using safe psoriasis control
- Equal contributors
1 Probity Medical Research, 135 Union Street East, Waterloo, Ontario, Canada, N2J 1C4, USA
2 Serono International S.A., 15bis, chemin des Mines, Case postale 54, CH-1211 Geneva 20, Switzerland
BMC Dermatology 2006, 6:8 doi:10.1186/1471-5945-6-8Published: 19 September 2006
Safe Psoriasis Control (SPC) is an important comprehensive measure that is validated for the assessment of benefit:risk of psoriasis treatments, combining efficacy, quality of life, and safety measures. The objective of this analysis was to assess the benefit:risk of efalizumab, a novel biologic agent indicated for the treatment of moderate-to-severe plaque psoriasis, by applying the SPC to data from randomized, placebo-controlled clinical studies of efalizumab.
SPC was applied to week 12 data from four placebo-controlled, Phase III studies: three retrospective and one prospective, the latter including a cohort of "high-need" patients for whom existing therapies were inadequate or unsuitable.
In the retrospective analysis, 39.4% of patients achieved SPC after 12 weeks of treatment with efalizumab, compared with 10.4% for placebo. In the prospective analysis, 34.3% of patients achieved SPC after 12 weeks of treatment with efalizumab, compared with 7.3% on placebo. Among high-need patients, 33.0% achieved SPC, compared with 3.4% on placebo.
Efalizumab has a favorable benefit:risk profile using the comprehensive outcome measure SPC.