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

ESDR120 - Safety of Guselkumab in Patients With Moderate to Severe Psoriasis: Pooled Analyses Across Clinical Studies

The scientific meeting of the European Society for Dermatological Research (ESDR) is held yearly, usually in September. With an international attendance of more than 1000 skin scientists from around the globe, the four-day event includes short oral presentations from peer-reviewed abstracts, keynote lectures from international experts, sponsored symposia, satellite programs, educational events as well as an important focus on posters, networking and building collaborations amongst scientists. For more information about this year’s meeting visit our website.