UK: A recent study revealed that there is a gap between the efficacy of biologic therapies in an idealized trial setting and effectiveness of biologic therapies in the real-world clinical setting in the treatment of psoriasis. Further, it found that secukinumab resulted in more patients achieving a lower psoriasis severity as measured by PASI versus ustekinumterab after 12 months of therapy.
The results of the study, published in the journal JAMA Dermatology, were reported by Zenas Z. N. Yiu, National Institute for Health Research (NIHR) Manchester Biomedical Research Centre, Manchester, United Kingdom, and colleagues.
In the comparative effectiveness research study, the researchers assessed the comparative effectiveness of ustekinumab and secukinumab in psoriasis patients. Also, they tested whether relative effectiveness estimate of the CLEAR trial, a randomized clinical trial that compared secukinumab with ustekinumab for psoriasis, can be replicated.
The study used a target trial emulation approach and was performed between November 2007 and August 2019. The data was obtained from BADBIR -- a multicenter longitudinal pharmacovigilance register of patients with moderate to severe psoriasis in the United Kingdom and Republic of Ireland. The analysis included 1231 patients -- 917 receiving ustekinumab and 314 receiving secukinumab. Included patients were 18 years or older, and had at least 1 record of a Psoriasis Area and Severity Index (PASI) of 12 or higher before their initiation to secukinumab or ustekinumab.
Propensity score (PS) 1:1 matched analysis and inverse probability treatment weighted analysis were performed.
The primary outcomes were the risk ratio (RR) and the risk difference (RD) for achieving PASI of 2 or lower after 12 months of therapy for secukinumab compared with ustekinumab.
Key findings of the study include:
Secukinumab was superior to ustekinumab in all analyses, except under the nonresponder imputation method, in the proportion of participants achieving a PASI of 2 or lower (PS-weighted complete case analysis: RR, 1.28; RD, 11.9%).
All analyses, except for nonresponder imputation, reached regulatory agreement in both PS-matching and PS-weighted analyses.
"Our study found that secukinumab resulted in more patients achieving a PASI of 2 or lower after 12 months of therapy compared with ustekinumab in patients with psoriasis," wrote the authors. "Target trial emulation in this study resulted in regulatory and estimate agreement with the CLEAR randomized clinical trial; further such studies may help fill the evidence gap when comparing other systemic therapies for psoriasis."
"Randomized Trial Replication Using Observational Data for Comparative Effectiveness of Secukinumab and Ustekinumab in Psoriasis: A Study From the British Association of Dermatologists Biologics and Immunomodulators Register," is published in the journal JAMA Dermatology.
DOI: https://jamanetwork.com/journals/jamadermatology/fullarticle/2773729