Effects of Body Mass Index on Hypertriglyceridemia Associated with Oral Bexarotene Therapy: A Post Hoc Analysis of an Open-Label Comparative Clinical Study of Combined Bexarotene and Phototherapy Versus Bexarotene Monotherapy for Japanese Patients with Cutaneous T-Cell Lymphoma

Drugs R D. 2024 Jun;24(2):227-238. doi: 10.1007/s40268-024-00465-7. Epub 2024 Jun 13.

Abstract

Background: Bexarotene, which has been approved for use in Japan since 2016, is an effective drug for cutaneous T-cell lymphoma; however, careful management is imperative because of its adverse events. We previously demonstrated the severity of bexarotene-associated hypertriglyceridemia and the need for bexarotene dose reduction for patients with cutaneous T-cell lymphoma and high body mass index (BMI); however, high BMI does not affect the efficacy of combined bexarotene and phototherapy treatment.

Objective: This study aimed to verify the effects of BMI on hypertriglyceridemia associated with oral bexarotene therapy.

Methods: We conducted a post hoc analysis of data from a previous randomized, open-label clinical study that compared combined bexarotene-phototherapy treatment with bexarotene monotherapy for cutaneous T-cell lymphoma by dividing patients into two groups based on BMI (<23 kg/m2 and ≥23 kg/m2).

Results: No statistically significant association was observed between patients with BMI ≥23 kg/m2 and severe hypertriglyceridemia; however, there was a significant association between BMI ≥23 kg/m2 and severe hypertriglyceridemia for patients who received bexarotene monotherapy, but not for those who received combined bexarotene-phototherapy treatment. The exact reasons for the discrepancies between the results of this thorough analysis and those of our past research are unclear. However, high BMI may be a risk factor for hypertriglyceridemia. Additional unidentified risk factors could also affect treatment outcomes.

Conclusion: High BMI is the primary reason for hypertriglyceridemia-associated bexarotene dose reduction; however, unexplored risk factors other than high BMI could exist.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Oral
  • Adult
  • Aged
  • Bexarotene* / administration & dosage
  • Bexarotene* / adverse effects
  • Bexarotene* / therapeutic use
  • Body Mass Index*
  • Combined Modality Therapy
  • East Asian People
  • Female
  • Humans
  • Hypertriglyceridemia* / chemically induced
  • Japan
  • Lymphoma, T-Cell, Cutaneous* / drug therapy
  • Male
  • Middle Aged
  • Phototherapy / adverse effects

Substances

  • Bexarotene