Psoriasis biologic clinical trial findings confirmed by study of real-world data


A study of real-world data has shown that the relative difference in efficacy of secukinumab compared to ustekinumab used for psoriasis treatment in an everyday clinical setting is comparable to that seen in controlled clinical trials. The authors of the study say this shows that emulating trials using real-world datasets can produce robust estimates that can inform clinicians and regulatory bodies.


These findings come from a paper published online ahead of print in JAMA Dermatology (Dec. 2, 2020). In the study, investigators set out to see if the relative effectiveness estimate of the earlier CLEAR randomized clinical trial could be replicated using a target trial emulation approach based on real-world data.


In a press release, lead author Dr. Zenas Yiu said: “We know that randomized clinical trials can over-estimate the effect of medicines when compared with what happens to the population of patients suffering from the condition outside of trials.”


“However, it is not yet clear whether observational studies can robustly test the relative effectiveness between two different psoriasis treatments.”


Dr. Yiu is a National Institutes of Health Research (NIHR) Clinical Lecturer in Dermatology at The University of Manchester, in the U.K. He is also the Specialty Registrar in Dermatology at Salford Royal NHS Foundation Trust.


“We wanted to see how effective secukinumab and ustekinumab were for the treatment of psoriasis in a large population of patients with psoriasis outside the trial setting in the U.K.”


“We also wanted to see if we can reach the same conclusions as the equivalent published clinical trial as to which treatment was more effective.”


Data on 1,231 patients from the British Association of Dermatologists Biologics and Immunomodulators Register (BADBIR), collected between Nov. 2007 and Aug. 2019 was used.


As the research team expected, they found that the treatment effect for both secukinumab and ustekinumab were approximately 15% lower in BADBIR compared with the CLEAR trial.


However, the relative effect in BADBIR between the two treatments was similar to CLEAR, with a relative risk of achieving the studies’ primary outcomes for secukinumab compared with ustekinumab of 1.28 in BADBIR compared to 1.24 in CLEAR.


“We feel these results are important as they confirm that less patients respond to secukinumab and ustekinumab in the real-world compared with the strictly selected and monitored clinical trial environment,” said Dr. Yiu.


“Despite these differences we replicated the relative treatment effect between secukinumab and ustekinumab found in the CLEAR trial reliably in BADBIR.”


“Although data from randomized controlled trials remain the gold-standard evidence for evaluation of treatment efficacy, our study suggests that, with the right analytical approach, observational data can also be used to inform clinical treatment decision making.”


“We feel that in the future, data from BADBIR may reliably tell us about the relative effect of other treatments for psoriasis that are currently not informed by trial evidence.”