Study Highlights Real-World Characteristics of Providers Treating Psoriasis in US

Lana D. Schmidt, MD

Credit: Springfield Clinic

Health care providers report frequent complaints of nausea, diarrhea, and headaches following initiation of apremilast (Otezla) therapy for psoriasis, according to recent findings, resulting in additional time and further resources applied to management of adverse events (AEs).¹

This analysis was authored in part by Lana D. Schmidt, MD, of Springfield Clinic Effingham Dermatology in Illinois. Schmidt and her team’s data were presented at the 44th Annual Fall Clinical Dermatology Conference in Las Vegas.

The investigators highlighted the over 7.5 million adults aged 20 years or older who are known to be impacted by psoriasis in the US. The US Food and Drug Administration (FDA) approved apremilast in 2021 for adults with psoriasis who are candidates for phototherapy or for systemic drugs.²

The treatment is an oral small-molecule inhibitor of phosphodiesterase 4 (PDE4) which is specifically designed for cyclic adenosine monophosphate (cAMP). Despite clinical trials data having previously established apremilast therapy’s safety and efficacy, the drug is also shown to be associated with various AEs.¹

Trial Design Details

“Management of AEs may increase healthcare provider (HCP) burden, which has been linked to provider burnout and concerns for patient safety,” Schmidt and colleagues wrote. “To date, there remains limited real-world data regarding the use of apremilast, the influence of AEs, and the burden of AEs on HCPs in the US.”¹

In this study, the research team sought to address such gaps by evaluating the real-world characteristics of providers based in the US who were also treating psoriasis. They also looked at the healthcare resource utilization linked to management of AEs in individuals on apremilast.

Those deemed as eligible for inclusion in the analysis included care providers who showed interest, routinely treated and managed psoriasis, and were able to engage in research that had been approved by a central Institutional Review Board. A multicenter survey design was implemented by the team, targeting clinicians who had been recruited from the Dermatology Provider Extended Network.

Clinicians provided data on patients in the age range of 18 years or older with a plaque psoriasis diagnosis who began apremilast treatment on or following January 1, 2018. These patients would also have had at least 3 months of clinical follow-up following the initiation of their psoriasis treatment regimen.
The outcomes of their analysis included assessment of the characteristics of both healthcare providers and their practices. Specifically, the investigative team looked at resource use related to apremilast and any AEs associated with treatment, keeping notes on messages, calls, and additional visits.

Additionally, the team evaluated the severity and timing of treatment-related AEs through the use of physician ratings as well as the Common Terminology Criteria for Adverse Events (CTCAE) grading system. There were 47 healthcare professionals, all dermatologists, who were recruited from across the US.

Notable Findings

The included dermatologists had been practicing for an average of 12.1 years (standard deviation [SD] 9.3). The investigators reported that, on average, each clinician identified approximately 48.6 patients (SD 61.4) who met their criteria for eligibility in the study.

Among the patients identified by the providers, it was reported that 29.2% experienced an AE related to apremilast therapy. The research team added that the most frequently reported AEs had been nausea, diarrhea, and headache, with such effects typically arising within the first 30 days following the start of treatment.

Reports suggested that 78.7% of health care providers reported nausea instances, 91.5% of providers observed cases of diarrhea, and 55.3% (n = 26) noted complaints among patients of headaches. Based on the Common Terminology Criteria for Adverse Events (CTCAE), these AEs were most often classified as grade 2 in their level of severity.

As a result of the aforementioned AEs following treatment with apremilast, high numbers of calls and related management strategies were conducted by providers.

“This cross-sectional survey study provides insight into clinical practice patterns and treatment outcomes in US dermatology practices,” they wrote. “...More research is needed to further confirm and quantify the economic impact of apremilast-related AE burden on patients and HCPs.”¹

References

1. ^{Schmidt L, Wu Y, Feinberg B, et al. Provider burden associated with apremilast adverse events. Presented at the 2024 Fall Clinical Dermatology Conference. Las Vegas, Nevada. 24-27 October.}
2. ^{Butera A. FDA Approves Apremilast for Adult Patients with Plaque Psoriasis Across All Severities. HCPLive. December 20, 2021. https://www.hcplive.com/view/fda-approves-apremilast-adult-psoriasis-all-severities. Date accessed: November 15, 2024.}