PSS5 - Systematic Review And Meta-Analysis Of Briakinumab, A Fully Human Interleukin 12/23 Monoclonal Antibody, For The Treatment Of Moderate To Severe Chronic Plaque Psoriasis

Abstract

To evaluate the efficacy and safety of briakinumab, a fully human interleukin 12/23 monoclonal antibody, for the treatment of moderate to severe chronic plaque psoriasis (CPP). Literature searches were conducted in MEDLINE, EMBASE and the Cochrane Library. In addition, references of included studies and clinicaltrials.gov were searched for relevant studies. No language or date restrictions were imposed. Study quality of included trials were assessed using the Cochrane Risk of Bias Tool. All randomized controlled trials (RCTs) examining the efficacy and safety of briakinumab in adult patients with moderate to severe CPP were searched. Primary outcome was improvement in symptom severity assessed by Psoriasis Area Severity Index (PASI) score and Dynamic Global Physician Assessment (DGPA) score at 12 weeks. Secondary outcomes were quality of life assessed using Dermatology Life Quality Index (DLQI) and adverse events reported. A total of 8 RCTs with 2659 CPP patients were included in the synthesis. At week 12, 80.4% versus 23% who received briakinumab or control arm, respectively, achieved the PASI 75 [risk ratio (RR) 3.21, 95% confidence interval (CI) 1.09 to 9.45; P=0.03, four RCTs]. The improvement in symptom severity at 12 week assessed using DGPA, was 3.89 times better in briakinumab compared to control arm (95% CI 1.36 to 11.1, P=0.01, four RCTs). The percentage improvement of the DLQI scores at week 12 was higher in the briakinumab group than comparator arm [36.1% versus 7.9%, respectively (RR 3.99, 95% CI 0.78 to 20.36; P=0.01, three RCTs)]. No significant difference was observed in adverse events between briakinumab (49.9%) and control arms (51.8%). Briakinumab is associated with significant improvement in symptom severity compared to other treatments among patients with moderate to severe CPP. As the reported outcomes show wide confidence intervals, results should be interpreted with some caution.