34346 Pooled safety analysis of respiratory tract infections, including COVID-19, in psoriasis patients treated with secukinumab

Objective: To assess risk of respiratory tract infections (RTIs) in secukinumab treated psoriasis patients, evaluate potential association of COVID-19 risk factors [age >65, diabetes, obesity (BMI >40), heart and respiratory disease] with RTI incidences and report COVID-19 cases from Periodic Safety Update Report (PSUR: 26-Dec-2019–25-Dec-2020). Methods: Pooled data from clinical trials and postmarketing safety surveillance, including patients who received ≥1 secukinumab dose, were analyzed. RTIs were reported as exposure-adjusted incidence rates (EAIRs) per 100 patient-years. Results: EAIR (95% CI; n) for ‘any RTI’ with secukinumab 150 mg/300 mg/150 mg+300 mg, was 42.1 (39.6–44.8; n = 2117)/47.5 (46.1–48.9; n = 9704)/46.6 (45.3–48.0; n = 11232). EAIR for ‘viral RTI’ at same doses was 7.1 (6.2–8.0)/7.4 (6.9–7.9)/7.3 (6.9–7.7), and for ‘other RTI’ was 34.3 (32.1–36.6)/38.8 (37.5–40.1)/ 37.7 (36.6–38.9). EAIR ratios in obese versus nonobese patients for viral pharyngitis/streptococcal pharyngitis/bacterial sinusitis with secukinumab 150 mg+300 mg were 4.2 (1.2–15.1)/3.4 (1.7–7.0)/6.9 (2.1–22.3), respectively. Strong associations with other COVID-19 risk factors were not observed. Of 952 COVID-19 cases retrieved, outcome was reported in 416 cases: completely recovered (n = 101), recovered with sequelae (n = 7), condition improving (n = 68), unchanged (n = 165), deteriorated (n = 54) and fatal (n = 21). Overall, 221 cases were confounded by risk factors (age >65, comorbidities, or concomitant use of immunosuppressant). Of 21 COVID-19 fatal cases, 14 had risk factors (age >65, comorbidities and smoking) whereas 7 had limited information. Conclusion: RTIs in secukinumab treated psoriasis patients from pooled clinical trials and postmarketing surveillance data were consistent with previous publications. In this analysis, obesity increased the risk for RTIs. COVID-19 cases in the PSUR revealed no new safety signals regarding known risk of ‘infections and infestations.’