Effects Criteria Definitions and Effects of Placebo and Efalizumab 1mg/kg/wk from the Wave 1 Case Study Report Efalizumab. Name Description Source Patient population Fixed Lower† Fixed Upper† Units Placebo (pts number) Efalizumab 1mg/kg/wk (pts number) Favourable effects PASI75* Percentage of patients achieving 75% reduction in baseline PASI at week 12 The PASI is a measure of the average redness, thickness, and scaliness of the lesions (each graded on a 0–4 scale), weighted by the area of involvement ACD2390g Moderate to severe plaque psoriasis candidate for systemic treatment 0 100 % 4.3 (175) 26.6 (345) ACD2058g “ 0 100 % 2.4 (151) 38.9a (149) ACD2059g “ 0 100 % 4.9 (111) 22.4 a (211) ACD2600g “ 0 100 % 3.0 (236) 23.5 a (450) IMP24011 Moderate to severe plaque psoriasis candidate for systemic treatment + “high need” subgroup 0 100 % 4.2 (264) 2.7(184) 31.4 a (529) 29.5(342)
ACD2390g GNE SC “ 0 100 % 3.2 25.7 IMP24011 Moderate to severe plaque psoriasis candidate for systemic treatment + “high need” subgroup 0 100 % 5 2.7 34.8 21.3 DLQI (Dermatology Life Quality ACD 2058g Moderate to severe plaque psoriasis candidate for systemic treatment 0 100 % 2.1 5.3 ACD 2059g Moderate to severe plaque psoriasis candidate for systemic treatment 0 100 % 1.7 5.5 ACD Moderate to severe plaque psoriasis candidate for 0 100 % 1.6 5.6
systemic treatment IMP 24011 Moderate to severe plaque psoriasis candidate for systemic treatment + “high need” subgroup 0 100 % 2.5 2.3 6.2 5.4 PASI 50 Percentage of patients achieving 50% reduction in baseline PASI at week 12 IMP24011 Moderate to severe plaque psoriasis candidate for systemic treatment + “high need” subgroup 0 100 % 20 12 56.7 52 effects ADRs Mild to moderate dose related acute flu-like symptoms ISS (all RCTs + open trials) 3291 pts EU SPC 4.8 Moderate to severe plaque psoriasis candidate for % 24 41
systemic treatment + “high need” subgroup ADRs Hypersensitivity reactions, psoriasis, Arthralgia, psoriatic arthritis, (exacerb./flare) Back pain, asthenia ALT and Ph. Alk increase ISS (RCTs and all open label trials 3,291 pts EU SPC 4.8 Moderate to severe plaque psoriasis candidate for systemic treatment + “high need” subgroup % >1/100 <1/10 Meningitis aseptic Number of cases PSUR 10 Cumulative data 47,000 pt/yrs No 29 Serious infections including pneumonia, sepsis, cellulitis Proportion of patients experiencing severe infections ISS (RCTs and all open label trials 3,291 pts Moderate to severe plaque psoriasis candidate for systemic treatment + “high need” subgroup %/100 pt-yrs 1.4 2.8 Opportunistic infections including fungal infections, tuberculosis, herpes Number of PSUR 10 Cumulative data 47,000 pt/yrs No 111
virus infections, EBV, CMV Serious thrombo cytopenia Number of cases PSUR 10 Cumulative data 47,000 pt/yrs No 70 Immune haemolytic anemia Number of cases PSUR 10 Cumulative data 47,000 pt/yrs No 24 Psoriasis severe forms (erythrodermic, pustular) Number of cases ISS (RCTs and all open label trials 3,291 pts Moderate to severe plaque psoriasis candidate for systemic treatment + “high need” subgroup % 1.4 3.2 Nervous System disorders including Inflammatory polyradiculopathy, Facial Palsy, GBS, Fisher Miller Syndrome Number of cases PSUR 10 Cumulative data 47,000 pt/yrs No NA Intersticial lung diseases including lung infiltration, pulmonary fibrosis Number of cases PSUR 10 Cumulative data 47,000 pt/yrs No 18