120 Safety of Guselkumab in Patients With Moderate to Severe Psoriasis: Pooled Analyses Across Clinical Studies

Guselkumab (GUS) studies in plaque psoriasis (PsO) have established a favorable safety profile for the drug. To evaluate cumulative experience PsO, we pooled placebo-controlled (wk 0-16 CNTO1959PSO2001, CNTO1959PSO3001/3002, and CNTO1959PSO3006) end-of-reporting 0-40 CNTO1959PSO3006; wk16-44 CNTO1959PSO3003; wk0-52 CNTO1959PSO2001 CNTO1959PSO3004; wk0-56 CNTO1959PSO3009; through wk264 CNTO1959PSO3001/3002) periods from phase2/3 of GUS. Pooled data were adjusted by exposure /100 patient (pts)-years follow-up (100PY). During placebo (PBO)-controlled period, 544 pts received PBO (165PY) 1220 GUS (378PY). Adverse event (AE) rates similar (341.12/100PY) (345.63/100PY); corresponding serious AE (SAE) 6.66/100PY 6.34/100PY. Infection were: PBO, 83.61/100PY; GUS, 95.92/100PY. Serious infections (SIs) occurrence 1.21/100PY; 1.06/100PY. The rate was 0.26/100PY both nonmelanoma skin cancer (NMSC) malignancies other than NMSC group; none PBO. Through period (n=2891 pts; 8662PY), remained low -treated pts: AE, 169.02/100PY; SAE, 5.26/100PY; infections, 65.92/100PY; SIs, 0.88/100PY. Other AEs interest malignancies, 0.43/100PY; NMSC, 0.35/100PY; major adverse cardiovascular events, 0.33/100PY. In GUS-treated pts, there no reported active tuberculosis or opportunistic infections; serum sickness-like/anaphylactic reactions related to reported. This analyses confirm treated up 5 years.