Safety, efficacy, and drug survival of biologics and biosimilars for moderate-to-severe plaque psoriasis

Abstract

Background

Real-life data on newer biologic and biosimilar agents for moderate-to-severe psoriasis are lacking.

Objectives

To examine safety, efficacy, and time to discontinuation (drug survival) of biologics (adalimumab, etanercept, infliximab, secukinumab, and ustekinumab) and compare originators with biosimilars (i.e. Enbrel with Benepali, and Remicade with Remsima).

Methods

The DERMBIO registry contains data on all Danish patients with moderate-to-severe plaque psoriasis treated with biologics. We examined patients treated between January 1^st, 2007 and March 31^st, 2017. We used Kaplan-Meier survival curves and Cox-regression to examine drug survival patterns.

Results

A total of 3495 treatment series (2161 patients) were included (adalimumab n=1332, etanercept n=579, infliximab n=333, ustekinumab n=1055, and secukinumab n=196). Secukinumab had the highest number of PASI100 respondants, but also the lowest drug survival among all biologics. Ustekinumab had the highest drug survival overall. There were no significant differences in discontinuation risk between originator and biosimilar versions of infliximab or etanercept. Treatment with higher-than-approved dosages was frequent for all drugs except for adalimumab and secukinumab. Adverse events (predominantly infections) were most frequent for secukinumab and showed an increased (albeit low) incidence of cardiovascular events compared with the other agents.

Conclusions

Ustekinumab was associated with the highest drug survival, and secukinumab with the lowest, albeit that most patients on secukinumab were non-naïve. Switching from originator to biosimilar had no significant impact on drug survival, and the safety profiles were comparable. Adverse events occurred most frequently with secukinumab. Future studies are warranted to assess the long-term safety of novel biologics for psoriasis.

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