PSY14 - Multi-Criteria Benefit-Risk Assessment of Biological Agents in the Treatment of Moderate to Severe Psoriais: A Stochastical Approach

Abstract

To evaluate the benefit-risk of biological agents (BA) in the treatment of moderate to severe psoriasis. It was performed a mixed treatment comparison (MTC) based on all available clinical trials of psoriasis treated with BA. The common agent comparator was placebo and the time-horizon was up to 24 weeks of treatment. This indirect meta-analysis was followed by a stochastic multicriteria acceptability analysis (SMAA) to compare adalimumab, etanercept, infliximab and ustekinumab on two benefit and two risk criterias. Efficacy was evaluated by means of Psoriasis Area Severity Index 90 and 75 response (rPASI90 and rPASI75, respectively) and the risks corresponded to any adverse event (AAE) and serious adverse event (SAE). MTC/SMAA analysis was performed for two scenarios: one with missing outcome preference and the other with ordinal preference information established by experts in psoriasis (SAE > rPASI90 > rPASI75 > AAE). Results show the same tendency for both created scenarios. Infliximab 5 mg/kg had the highest probability of being the 1st-place in MTC/SMAA ranking (84% to 67%). It was followed by ustekinumab 90 mg for the 2nd-place (54% to 50%), ustekinumab 45 mg for the 3rd-place (51% - 50%), adalimumab 80 mg followed by 40 mg (51% - 47%), etanercept 50 mg TW (74% to 62%) and placebo in the 6th-place(97% - 94%). From all available evidence on treatment with BA for psoriasis, the designed method was enabled to point that infliximab 5 mg/kg is the BA with the highest probability of having the best benefit-risk ratio in the short-term follow up. It is followed by ustekinumab 90mg, ustekinumab 45 mg, adalimumab 80-->40 mg, etanercept 50 mg TW and placebo, respectively. Our findings can be useful to help on deciding which sequence of BA must be defined by guidelines and health services when therapy failure happens.