systemic treatment + need” “high subgroup Hypersensitivity ISS (RCTs and Moderate to reactions, psoriasis, all open label severe plaque Arthralgia, psoriatic trials psoriasis arthritis, 3,291 pts candidate for % >1/100 <1/10 ADRs (exacerb./flare) EU SPC 4.8 systemic Back pain, asthenia treatment ALT and Ph. Alk + need” “high increase subgroup PSUR 10 Cumulative Meningitis aseptic Number of cases data No 29 47,000 pt/yrs ISS (RCTs and Moderate to all open label severe plaque trials psoriasis Serious infections Proportion of 3,291 pts candidate for %/100 including pneumonia, patients experiencing 1.4 2.8 systemic pt-yrs sepsis, cellulitis severe infections treatment + need” “high subgroup Opportunistic PSUR 10 Cumulative infections including data Number of No 111 fungal infections, 47,000 pt/yrs tuberculosis, herpes
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
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