Infection Risk and Biologics: Current Update
The risk of infection in spondyloarthritis appears to be lower than that in RA, although long-term data on this topic are limited. A systematic review and meta-analysis of clinical trial experience comparing the risk of infection between TNFi and placebo in ankylosing spondylitis (AS) found the risk of serious infections in 2202 patients with AS not exposed to immunosuppressive drugs was very low (0.4/100 patient years). In the meta-analysis of nine RCTs of TNFi, wherein the trial duration ranged from 12 to 30 weeks, the risk of serious infection was 1.9 per 100 patient years in the treatment group versus 1.0 per 100 patient years in the control group. The difference was not statistically significant, although this may be explained by a lack of power. In addition, the period of observation was short. Burmester et al. evaluated 71 global clinical trials of adalimumab across six diseases for safety and mortality rates. Four clinical trials (comprising 1684 patients) in AS were included. The rate of serious infection was 1.4 per 100 patient years compared with 4.6 per 100 patient years in RA and 2.8 per 100 patient years in psoriatic arthritis. This analysis did not include control patients who were not treated with TNFi. A retrospective cohort study from four large US databases investigated the risk of hospitalization for infection in patients treated with TNFi. The investigators combined patients with psoriasis, psoriatic arthritis or AS and found the serious infection hospitalization rates to be 5.41 per 100 patient years in the TNFi versus 5.37 per 100 patient years in the comparator group with no significant difference between the groups. The databases used in this study comprised predominantly low-income patients from medically underserviced areas, which may contribute to the higher absolute rates of infection compared with previously published cohort studies.
Infection in Spondyloarthritis
The risk of infection in spondyloarthritis appears to be lower than that in RA, although long-term data on this topic are limited. A systematic review and meta-analysis of clinical trial experience comparing the risk of infection between TNFi and placebo in ankylosing spondylitis (AS) found the risk of serious infections in 2202 patients with AS not exposed to immunosuppressive drugs was very low (0.4/100 patient years). In the meta-analysis of nine RCTs of TNFi, wherein the trial duration ranged from 12 to 30 weeks, the risk of serious infection was 1.9 per 100 patient years in the treatment group versus 1.0 per 100 patient years in the control group. The difference was not statistically significant, although this may be explained by a lack of power. In addition, the period of observation was short. Burmester et al. evaluated 71 global clinical trials of adalimumab across six diseases for safety and mortality rates. Four clinical trials (comprising 1684 patients) in AS were included. The rate of serious infection was 1.4 per 100 patient years compared with 4.6 per 100 patient years in RA and 2.8 per 100 patient years in psoriatic arthritis. This analysis did not include control patients who were not treated with TNFi. A retrospective cohort study from four large US databases investigated the risk of hospitalization for infection in patients treated with TNFi. The investigators combined patients with psoriasis, psoriatic arthritis or AS and found the serious infection hospitalization rates to be 5.41 per 100 patient years in the TNFi versus 5.37 per 100 patient years in the comparator group with no significant difference between the groups. The databases used in this study comprised predominantly low-income patients from medically underserviced areas, which may contribute to the higher absolute rates of infection compared with previously published cohort studies.