The safety and efficacy of alefacept in the treatment of chronic plaque psoriasis

Figures & data

Figure 1 Overview of the structure of the human fusion protein alefacept.

Abbreviations: IgG, immunoglobulin G; LFA, leukocyte function antigen.

Figure 2 Schematic summary of studies on the reduction of the psoriasis area severity index (PASI) induced by alefacept treatment (from data of Ellis CN, Krueger GG. 2001) (A) PASI ≥75 and (B) PASI ≥50.

Figure 3 Schematic summary of the study data on different courses of Alefacept treatment (from data of Krueger et al 2002) (A), and results achieved with intramuscular application of different doses of alefacept versus placebo (from data of Lebwohl et al 2003) (B).

Table 1 Summary of studies on alefacept

Study type	Phase of the studey	Alefacept dose and way of administration	Duration of one course	Total number Patient	Patient subgroups	Single or multiple course	Percentage of PASI 75 reduction reduction (overall response*)	Percentage of PASI 50 reduction (overall responsea)	Reference
MC, R, DB, PC, dose-response	II	0.025, 0.075 or 0.15 mg/kg i.v.	12 week	229	0.025 mg active group (n = 57) 0.075 mg active group (n = 55) 0.15 mg active group (n = 44) placebo group(n = 42)	Single	33% of the 0.025 mg group; 31% of the 0.075 mg group; 19% of the 0.15 mg group; 11% of the placebo group	47% of the 0.025 group; 63% of the 0.075 group; 42% of the 0.15 group; 32% of the placebo group	Ellis and Krueger 2001
MC, open-labelled, re-treatment study	II	7.5 mg i.v.	12 week	174	Re-treatment course I (n = 174) Re-treatment couse 2 (n = 50)	Multiple	32% after one re-treatment couse; 32% after 2 re-treatment courses	64% after one re-treatment course; 68% after 2 re-treatment courses	Lowe et al 2003
MC, R, DB, PC	III	7.5 mg i.v.	12 week	553	alefacept (n = 367) placebo (n = 186)	Double	28% of patients with one course; 40% of patients with 2 courses	56% of patients with one course; 71% of patients with 2 courses	Krueger et al 2002
MC, R, DB, PC	III	10 or 15 mg i.m.	12 week	507	10 mg alefacept (n = 173)15 mg alefacept (n = 166) placebo (n = 168)	Single	33% of the 15 mg group; 28% of the 10 mg group; 8% of the placebo group	57% of the 15 mg group; 53% of the 10 mg group; 35% of the placebo group	Lebwohl et al 2003
MC, R, DB, re-treatment study to Lebwohl 2003	III	15 mg i.m.	12 week	375		Single, extension course	43% of patients with one additional course alefacept	69% of patients with one additional course alefacept	Gordon and Langley 2003

* Overall response is defined as the response at any time after the first dose of alefacept during the first 24 weeks.

Abbreviations: DB, double blind; MC, multi-center study; PC, placebo controlled; R, randomized; SC, single-center study; i.v., intravenous, i.m., intramuscular; s.c., subcutaneous.

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