Real World Data on Clinical Characteristics of Psoriasis Patients Treated with Tapinarof Cream

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This research provides an early analysis of plaque psoriasis patients within routine clinical practice settings and outside of a clinical trial setting.

Individuals initiating treatment with tapinarof cream have comorbidity profiles consistent with those of the US general population diagnosed with plaque psoriasis, according to recent findings, and providers also find benefit in combining tapinarof with other treatments such as topical agents and systemic agents.1

These findings resulted from an initial examination of individuals diagnosed with plaque psoriasis who begin using tapinarof cream 1% once-per-day in real-world scenarios, specifically in routine clinical practice beyond the context of clinical trials. The research was authored by Janine Fournier from Dermavant Sciences, Inc.

The drug is known for being a groundbreaking non-steroidal topical aryl hydrocarbon receptor (AhR) agonist that was approved by the US Food and Drug Administration (FDA) to address psoriasis in adult patients. Tapinarof’s efficacy is being looked at for psoriasis treatment among children as young as 2 years old, as well as for eczema in adults as well as children in this same age range.

In the parallel, 12-week pivotal phase 3 studies known as PSOARING 1 and PSOARING 2, the efficacy of tapinarof cream 1% given to patients once-per-day was shown to be statistically significant compared to control. The long-term extension study known as PSOARING 3 showed continued improvement, with a substantial rate of complete disease clearance, sustained remission for around 4 months following cessation, and a lasting positive response for up to 52 weeks.

Since the drug’s approval, there has been an opportunity to analyze real-world data regarding the patient demographics and characteristics of those undergoing this treatment in routine clinical practice. This analysis aims to provide a deeper understanding of how this pioneering AhR agonist is utilized outside the controlled environment of clinical trials.

The investigators were seeking to look at the clinical, demographic, and treatment-related qualities of those diagnosed with plaque psoriasis and treated with tapinarof cream in routine clinical practice.

To achieve this, the research team used a retrospective analysis focusing on adult individuals diagnosed with plaque psoriasis between January 2016 - June 2023. The database the team implemented for their data collection process was Anlitiks' All-Payor Claims (AAPC) database, an open-source, fully adjudicated pharmacy and medical claims database.

This database used by the investigators had de-identified, tokenized, encrypted patient-level information that was found to have represented about 80% of the insured population in the US.

The research team determined that their study population would involve all of those featured in the database who also had a confirmed diagnosis of plaque psoriasis who satisfied the specified criteria for inclusion and exclusion.

The team included patients if their index date for tapinarof cream occurred on or between May 2022 - December 2022, which the team established through claims data. The subjects also had to be ≥18 years of age at the point of tapinarof initiation and have a ≥12-month baseline period beforehand along with ≥6 months of follow-up following initiation.

As far as criteria for subject exclusion, they investigators noted that pregnancy before or after initiation of tapinarof would be considered excluded from their research.

Overall, the research team’s findings revealed that the comorbidity profiles of subjects beginning tapinarof therapy aligned with the profiles of the broader population dealing with plaque psoriasis in the US.

The investigators reported that about 24% of the study subjects had undergone prior treatments before commencing their treatment with tapinarof cream. Additionally, the team noted that while 65% of participants included in their real-world analysis used the drug as a standalone treatment, healthcare providers were shown to have pointed to its efficacy when combined with several different treatment approaches, such as systemic agents, other topical agents, and/or phototherapy.

References

  1. Fournier, J., Bin Sawad, A., Zwick, E., Vazquez, M., Fredericks, D., Tallman, A. ., & Rajagopalan, K. (2023). Early Real-World Description of Baseline Demographics and Clinical Characteristics of Patients with Plaque Psoriasis on Tapinarof Cream 1%. SKIN The Journal of Cutaneous Medicine, 7(6), s234. https://doi.org/10.25251/skin.7.supp.234.
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