Risk of Reactivation of Hepatitis B Virus Infection in Psoriasis Patients Treated With Biologics: A Retrospective Analysis of 20 Cases From the BIOBADADERM Database

Safety of biologics in psoriasis

“…A recent systematic review reported that a reactivation rate in 712 rheumatic patients with resolved HBV infection who were treated with biologics was 1.7% . The lower risk of HBV reactivation in psoriatic patients may reflect the less frequent use of concomitant immunosuppressants than in rheumatic patients . Patients with chronic HBV infection, characterized by antigen positivity regardless of the status of other serological markers, are at greatest risk for HBV reactivation .…”

“…81 The lower risk of HBV reactivation in psoriatic patients may reflect the less frequent use of concomitant immunosuppressants than in rheumatic patients. 82 Patients with chronic HBV infection, characterized by antigen positivity regardless of the status of other serological markers, are at greatest risk for HBV reactivation. 80,83 In immunosuppressed patients with chronic HBV infection, oral anti-HBV agents have proven to be effective in reducing acute exacerbation and preventing fatal complications.…”

Rate of serious infection in patients who are prescribed systemic biologic or nonbiologic agents for psoriasis: A large, single center, retrospective, observational cohort study

“…Patients on either adalimumab or infliximab in RA populations also have been reported to have increased rates of Legionella pneumonia (Bodro, Carratala, & Paterson, 2014). Reactivation of latent tuberculosis (TB), as well as increased susceptibility to systemic deep fungal infection (Jourabchi, Adelzadeh, & Wu, 2014) (Bongartz et al, 2006;Leombruno et al, 2009 Bodro et al, 2014;Kalb et al, 2015;Kim et al, 2015;Reich et al, 2015;Sanz-Bueno et al, 2015;Yun et al, 2015).…”

“…al., 2012;Kalb et al, 2015;Leombruno et al, 2009;Peyrin- Biroulet et al, 2008;Rustin, 2012;Sanz-Bueno et al, 2015;Tan et al, 2013). The Psoriasis Longitudinal Assessment and Registry (PSOLAR) project revealed that psoriatic patients on systemic agents with (a) chronic conditions such as diabetes mellitus, (b) a history of significant…”

Optimizing case reports and case series: guidance on how to improve quality

“…Absence of adverse events is frequently seen when discussing safety in a case series. As an example, 20 patients with previous hepatitis B infection were treated with biologics, and none showed a reactivation of infection . While common sense suggests that 20 is a small number, the rule of three indicates that the upper 95% confidence interval in the sample is three cases out of 20 (3/ n ), or 15%.…”