Real-world outcomes and drug survival of brodalumab: results from the German Psoriasis Registry PsoBest

Abstract

Brodalumab, a human monoclonal antibody that targets interleukin-17 receptor A (IL-17RA), is approved in the US and EU for treatment of adults with moderate-to-severe plaque psoriasis. Although brodalumab has demonstrated efficacy and safety vs placebo in clinical trials of patients with psoriasis and psoriatic arthritis (PsA), real-world evidence is needed to evaluate long-term effectiveness and safety of brodalumab in routine care. This interim analysis of the German Psoriasis Registry PsoBest examined patient profiles, treatment outcomes, and drug survival of first-time use of brodalumab for 12 months in adult patients with moderate-to-severe plaque-type psoriasis (with and without PsA) (data cutoff: June 30, 2021). Clinician and patient-reported outcomes of the total cohort (n = 227; PsA, n = 38) indicated a rapid response to brodalumab treatment within the first 3 months, which was maintained up to 12 months. The overall one-year drug survival rate was 76.2%, the mean time to discontinuation was 8.3 months. Reasons for discontinuation were mainly loss/lack of effectiveness, followed by adverse events, contraindication and skin clearance. In sum, brodalumab demonstrated rapid and sustained effectiveness and was well-tolerated over 12 months in German patients with moderate-to-severe psoriasis and PsA in a real-world setting.

Keywords:

• Psoriasis
• psoriatic arthritis
• brodalumab
• PsoBest
• real-world

Acknowledgements

The authors thank the Scientific Communication Team of the IVDP, in particular, Amber Hönning and Sara Tiedemann for copy editing.

Ethical approval

Patients gave written informed consent on registry participation and approval from the local ethics committee was obtained to conduct the PsoBest registry.

Disclosure statement

Lisa Schaeffer, Christina Sorbe, and Stephan Jeff Rustenbach are employees at the University Medical Center Hamburg-Eppendorf (UKE) and report no conflicts of interest.

Nesrine Ben-Anaya has served as consultant and/or paid speaker of the following companies: AbbVie, Almirall, Incyte, Novartis, UCB, Pfizer.

Ulrich Mrowietz has been an advisor and/or received speakers’ honoraria and/or received grants and/or participated in clinical trials of the following companies: AbbVie, Aditxt, Almirall, Amgen, Aristea, Biogen, Boehringer-Ingelheim, Bristol-Myers Squibb, Celgene, Dr. Reddy’s, Eli Lilly, Formycon, Immunic, Janssen-Cilag, LEO Pharma, Merck, Sharp & Dohme, MetrioPharm, Novartis, Phi-Stone, Sanofi-Aventis, UCB Pharma, UNION therapeutics.

Matthias Augustin has served as consultant and/or paid speaker for and/or has received research grants and/or honoraries for consulting and/or scientific lectures for and/or got travel expenses reimbursed and/or participated in clinical trials sponsored by companies that manufacture drugs including Abbott/AbbVie, ALK Scherax, Almirall, Amgen, Beiersdorf, Biogen Idec, BMS, Boehringer Ingelheim, Celgene, Centocor, Dermira, Eli Lilly, Forward Pharma, Fresenius, Galderma, GSK, Hexal, Incyte, Janssen-Cilag, LEO Pharma, Lilly, Medac, Menlo, Merck, MSD, Mylon, Novartis, Pfizer, Regeneron, Sandoz, Sanofi-Aventis, Stallergenes, Stiefel, Teva, TK, Trevi, UCB and Xenoport outside the submitted work.

Data availability statement

The data that support the findings of this study are available from the corresponding author, Nesrine Ben-Anaya upon reasonable request.

Additional information

Funding

The PsoBest registry is/was supported by AbbVie, Almirall, Amgen, Biogen, BMS, Celgene, Hexal, Janssen-Cilag, LEO Pharma A/S, Eli Lilly, Medac, Novartis, Pfizer, UCB and Viatris. These companies do not have influence on the design of the registry, data collection, analyses, the publication decisions or development. LEO Pharma supported this analysis via an additional educational grant. Medical writing support, including assisting authors with the development of the manuscript drafts and incorporation of comments, was provided by Matthew Hartmann, PhD of Alphabet Health (New York, NY), supported by LEO Pharma A/S (Ballerup, Denmark), according to Good Publication Practice guidelines (https://www.ismpp.org/gpp-2022). The authors received no honoraria related to the development of this publication.