Table 1 Studies used for retrospective and prospective application of SPC

ACD 2058[14]

"A Phase III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter, Multidose Study to Evaluate the Efficacy and Safety of Subcutaneously Administered Anti-CD11a in Adults with Moderate to Severe Plaque Psoriasis"

498 subjects

•efalizumab 1 mg/kg – 162

•efalizumab 2 mg/kg – 166

•placebo – 170

Retrospective

ACD 2059[13]

"A Phase III, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter, Multidose Study to Evaluate the Efficacy and Safety of Subcutaneously Administered Anti-CD11a in Adults with Moderate to Severe Plaque Psoriasis Who Are Candidates for Systemic Therapy"

597 subjects

•efalizumab 1 mg/kg – 232

•efalizumab 2 mg/kg – 243

•placebo – 122

Retrospective

ACD 2390[12]

"A Phase IIIb, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of 1.0 mg/kg Subcutaneously Administered Efalizumab in Adults with Moderate to Severe Plaque Psoriasis"

556 subjects

•efalizumab 1 mg/kg – 369

•placebo – 187

Retrospective

IMP 24011[15]

"A multicentre, randomised, double blind, placebo controlled phase III study of subcutaneously administered Raptiva in the treatment of patients with moderate to severe psoriasis"

793 subjects

•efalizumab 1 mg/kg – 529

•placebo – 264

•(526 high-need)

Prospective