Presented at the 47th Annual ESDR 2017 meeting in Salzburg, Austria. 27-30 September 2017
Biologic therapies are very effective treatments for psoriasis however because of how they work patients and clinicians are concerned about the risk of serious infections associated with biologic treatments however randomized controlled trials are not powered to look at rare adverse events and they have a poor external validity and therefore we set out to determine
Whether a tennis at adalimumab or auster kinema were associated with a higher risk of serious infection as compared to non biologic systemic therapies we use the british association of dermatologists biologic interventionist register or bad bear this is a large national prospective safety registry established in 2007 with the primary aim to investigate the safety
Of biologic therapies in psoriasis and the structure of the registry compares a cohort of patients on biologic therapies against a cohort of patients on non biological systemic therapies but crucially their entry criteria in terms of disease severity is the same so puzzy above or equal to 10 and a dl qi above 10 we define our outcome of serious infection as those
Infections associated with hospitalization iv antimicrobial therapy or death we identified some potential confounders a priori this included demographic factors lifestyle factors and comorbidities and also disease severity and treatments we calculated crude incidence rates for each biologic and a non balaji cohort we then adjusted for those covariates and potential
Confounding using propensity score methods and inverse probability treatment weighting we then also looked at how well our adjustment worked so in other words the balance between our cohorts after adjustment we then calculated proportional hazards models for hazard ratios to the first serious infection moving on to our results we had over 9,000 patients in total
With our largest biologic cohort of adalimumab over 3,000 patients our median follow-up duration was around one and a half years for the non balaji cohort and around two years for the biologic cohorts table one shows the crude incidence rates you can see on the right hand column we show the incidence rates per thousand person years and they are very similar between
The cohorts figure two is a first plot it shows the reduction in expected bias we were able to achieve and this is an example using a dilemma map the light purple dots are the values before adjustment and the dark purple dots are after adjustment and the closer the dots are to the line the less bias there is and you can see that we will be able to achieve a nice
Reduction of the bias after adjustment table 2 shows our main results both the crude hazard ratios and adjusted hazard ratios in our comparison of at nsf adalimumab and istic in the map with non biologics islamic ferries were all non significant so our crude incidence rates were of serious infections for a 10 acept and a dilemma were very similar to the reported
Figures but for us to kingdom up they were higher our just the results are very similar to shown that this is a european collaboration of psoriasis registries they had compared a cohort on tnf inhibitors against the cohort on as a tretton and methotrexate and cyclosporine and they didn’t find an increased risk however our results are very different from sola this
Is a single company sponsored us-based psoriasis registry and they showed their high risk with adalimumab compared with asset repton and all phototherapy do the strengths of that this study is that we used real-world data we had a large sample and we had detailed data capture allowing us to adjust for confounders we involve many centers in the uk resulting in
The high external validity and we were fully in the independent of industry for our analysis however this is an observational study and therefore there is the risk of residual confounding so in conclusion we found that a 10 acept adalimumab and mr. kiner map were not associated with a high risk of serious infection as compared to non biologic systemic therapies
In patients with psoriasis so what does this mean for patients and clinicians well the risk of serious infections shouldn’t be the discriminator when a patient is deciding on embarking on a certain biologic therapy on the flip side healthcare professionals should be equally vigilant for serious infections when looking after patients with psoriasis on any of the systemic therapies
Transcribed from video
Poster #001 Zenas ZN Yiu By ESDR Association