1459: Fungal Infections, Including Candida, in Patients With Active Psoriatic Arthritis (PsA) Treated With Secukinumab: A Pooled Analysis of 9 Phase 3 Trials

Background/Purpose: PsA is a chronic inflammatory disease characterized by joint pain, swelling and stiffness, and is often accompanied by cutaneous changes linked to psoriasis. Patients receiving treatment with an IL-17 inhibitor, such as secukinumab (SEC), reported higher incidence of Candida and other fungal infections. The objective of this post hoc analysis is to describe the incidence, severity, seriousness, and type of fungal infections, including Candida, among patients with PsA treated with SEC.

Methods: This post hoc analysis included patients with active PsA from a pooled population of 9 phase 3 clinical trials who received SEC 150 mg, SEC 300 mg, or placebo (PBO). Following the PBO-controlled period, patients randomized to PBO were switched to SEC 150 mg or SEC 300 mg while patients randomized at baseline to receive either dose of SEC continued the same dose. Baseline demographic and clinical characteristics are reported in patients with or without ≥1 fungal infection adverse event during the entire treatment period. Incidence of fungal infections, including Candida, are reported for the PBO-controlled period and through the entire treatment period. Characteristics of infections including the specific types (defined by MedDRA preferred term), severity grades, and infections resulting in treatment discontinuation are reported through the entire treatment period.

Results: Overall, 2416 and 932 patients with active PsA receiving SEC or PBO, respectively, were included. A total of 167 (6.9%) patients receiving SEC reported ≥1 fungal infection through the entire treatment period, and most (62.3%) were female. Female patients comprised 51.8% of the entire study population and the mean age was 48.6 years. During the PBO-controlled period, rates of total fungal infections were infrequent in each treatment group (exposure adjusted incidence rate [EAIR] per 100 patient years [95% CI], SEC 150 mg: 3.97 [2.17-6.66], SEC 300 mg: 10.04 [6.04-15.67], PBO: 4.45 [2.37-7.61]). EAIRs of Candida infections were also infrequent in patients receiving either SEC 150 mg (2.54 [1.16-4.83]), SEC 300 mg (5.78 [2.89-10.34]), or PBO (2.04 [0.75-4.45], Table 1). Through the entire treatment period, the rates of total fungal infections (SEC 150 mg: 3.86 [3.05-4.81], SEC 300 mg: 4.68 [3.75-5.77) and Candida infections (SEC 150 mg: 1.86 [1.33-2.55], SEC 300 mg: 2.18 [1.57-2.95]) did not increase. The majority of fungal infections, including Candida, in patients receiving any SEC in the entire treatment period were mild or moderate (99.6%). One severe fungal infection (0.04%) was reported in the SEC 150 mg group (Figure 1). The vast majority (83.1% of total fungal infections and 89.7% of Candida infections) were fully resolved before the end of the treatment period (Figure 2), and 2 (0.8%) infections resulted in treatment discontinuation.

Conclusion: Fungal infections, including Candida, were infrequent with incidence rates not increasing throughout the entire treatment period. Fungal infections during treatment with SEC were mild or moderate in most instances and most infections were fully resolved before the end of treatment, allowing almost all patients to continue treatment.