Adverse Events from Apremilast Contribute to Provider Burden, New Survey Reveals

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A recent poster, presented at Fall Clinical 2024 in Las Vegas, Nevada, from October 24 to 27, reported that clinicians treating plaque psoriasis experienced high provider burden due to the adverse events (AEs) associated with apremilast treatment.¹ The study aimed to provide real-world characteristics using information reported directly from providers regarding the healthcare resource use burden from AEs such as headache, nausea, and diarrhea.

Background

Previous clinical trials have confirmed the safety and efficacy of apremilast. However, these studies also reported several adverse effects including diarrhea, nausea, and headache. Managing these AEs may increase healthcare provider (HCP) burden, thus linking to provider burnout and concerns for patient safety.² Prior to this study, there was limited real-world data regarding the burden of AEs on HCPs in conjunction with apremilast treatment.

Methods and Materials

Results were conducted through a multicenter, cross-sectional, physician survey in which 47 HCPs, who routinely treated patients with psoriasis, were recruited from the Dermatology Provider Extended Network. All dermatologists had been in practice for a mean of 12.1 years.

Eligible patients (n = 48) were 18 and older with a clinical diagnosis of plaque psoriasis. Each was treated with apremilast on or after January 1, 2018, and had 3 or more months of clinical treatment after initiating the treatment.

Measured outcomes included the characteristics of each HCP and their practice, and the resources used to manage apremilast treatment, such as follow-up messages and additional in-office or virtual visits. Treatment-related AEs were measured based on the date of onset, the physician severity rating, and a Common Terminology Criteria for Adverse Events (CTCAE) grade.

Results

About 29.2% of patients reported a treatment-related AE, with the most common being diarrhea in 91.5%, nausea in 78.7%, and headache in 55.3%. These most often occurred within 30 days of apremilast initiation and were grade 2 in severity, according to CTCAE guidelines. Other reported AEs included fatigue, depression, insomnia, weight loss, and stomach upset.

In terms of HCP burden for diarrhea management, 34.9% of HCPs managed about 3 calls per patient and 18.6% managed about 3 messages per patient. Nearly all of these phone calls lasted 10 minutes or less. Almost 40% of HCPs reported 1 or more additional visits, of which approximately half lasted between 11 and 20 minutes.

Clinicians treating nausea as an AE saw similar results as 35.1% of HCPs managed approximately 1 call per patient and 16.2% received approximately 2 messages per patient. Most of these calls (81.1%) lasted 10 minutes or less. Moreover, 29.7% of HCPS reported 1 or more supplemental visits, in which nearly half of these lasted 10 minutes or less.

Finally, in patients experiencing headaches, 26.9% of HCPs managed about 1 call per patient and 23.1% managed about 3 messages per patient. Over 75% of these calls lasted 10 minutes or less. One or more supplemental visits were reported by 42.3% of HCPs and nearly half of these visits lasted 10 minutes or less.

Conclusion

Overall, this cross-sectional study provides insight into clinical practice and treatment outcomes for HCPs in the US. The frequent complaints of diarrhea, nausea, and headache following apremilast initiation resulted in additional time and resources dedicated to AE management. According to investigators, “more research is needed to further confirm and quantify the economic impact of apremilast-related AE burden on patients and HCPs.”

References

1. Schmidt L, Wu Y, Patel V, et al. Provider burden associated with apremilast adverse events. Poster presented at the 44th Annual Fall Clinical Dermatology Conference. Las Vegas, Nevada. October 24 to 27, 2024.

2. Gupta K, et al. J Patient Saf. 2022;18(6):531-538.