TEAEs suspected to be related to study drug during TP1, by preferred term (1% or greater total incidence of either system organ class (SOC) or preferred term (PT), study GP15-302 Preferred term ERELZI Enbrel N=264 N=267 n (%) n (%) Number of patients with at least 35 (13.3) 37 (13.9) one TEAE Nasopharyngitis 2 (0.8) 4 (1.5) Upper respiratory tract infection 3 (1.1) 3 (1.1) Weight increased 3 (1.1) 3 (1.1) n (%)=number of subjects (percentage) with adverse events; N=number of subjects studied; PT=preferred term; SOC=system organ class; TEAE=treatment-emergent adverse event; TP1=Treatment Period 1 The overall incidence of SAEs was low and comparable, with no SAE occurring in more than one patient. Similar safety profiles and comparisons were observed in TP2 and Extension Period. The table below provides a list of the TEAEs with a suspected causal relationship to study treatment from baseline to week 52, in those patients who continuously received either ERELZI or the reference medicine. TEAEs suspected to be related to study drug (baseline to week 52), by preferred term (1% or greater total incidence) ERELZI Enbrel Preferred term N=164 N=171 n (%) n (%) Number of patients with at least 34 (20.7) 33 (19.3) one TEAE Nasopharyngitis 4 (2.4) 2 (1.2) Viral upper respiratory tract 2(1.2) 4 (2.3) infection Upper respiratory tract infection 2 (1.2) 3 (1.8) Pharyngitis bacterial 2 (1.2) 0 Rhinitis 0 2 (1.2) Upper respiratory tract infection 2 (1.2) 0 bacterial Weight increased 2 (1.2) 3 (1.8) Gamm-glutamyltransferase 2 (1.2) 0 increased Psoriasis 0 3 (1.8)
TEAEs suspected to be related to study drug during TP1, by preferred term (1% or greater total incidence of either system organ class (SOC) or preferred term (PT), study GP15-302 Preferred term ERELZI N=264 n (%) Enbrel N=267 n (%) Number of patients with at least one TEAE 35 (13.3) 37 (13.9) Nasopharyngitis 2 (0.8) 4 (1.5) Upper respiratory tract infection 3 (1.1) 3 (1.1) Weight increased 3 (1.1) 3 (1.1) n (%)=number of subjects (percentage) with adverse events; N=number of subjects studied; PT=preferred term; SOC=system organ class; TEAE=treatment-emergent adverse event; TP1=Treatment Period 1 The overall incidence of SAEs was low and comparable, with no SAE occurring in more than one patient. Similar safety profiles and comparisons were observed in TP2 and Extension Period. The table below provides a list of the TEAEs with a suspected causal relationship to study treatment from baseline to week 52, in those patients who continuously received either ERELZI or the reference medicine. TEAEs suspected to be related to study drug (baseline to week 52), by preferred term (1% or greater total incidence) Preferred term ERELZI N=164 n (%) Enbrel N=171 n (%) Number of patients with at least one TEAE 34 (20.7) 33 (19.3) Nasopharyngitis 4 (2.4) 2 (1.2) Viral upper respiratory tract infection 2(1.2) 4 (2.3) Upper respiratory tract infection 2 (1.2) 3 (1.8) Pharyngitis bacterial 2 (1.2) 0 Rhinitis 0 2 (1.2) Upper respiratory tract infection bacterial 2 (1.2) 0 Weight increased 2 (1.2) 3 (1.8) Gamm-glutamyltransferase increased 2 (1.2) 0 Psoriasis 0 3 (1.8)
auspar-etanercept-180907-pi.docx