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Clinical Trial
. 2021 Jan;48(1):80-84.
doi: 10.1111/1346-8138.15596. Epub 2020 Sep 10.

Pharmacodynamic analysis of apremilast in Japanese patients with moderate to severe psoriasis: Results from a phase 2b randomized trial

Shinichi Imafuku  1 , Osamu Nemoto  2 , Yukari Okubo  3 , Mayumi Komine  4 , Peter Schafer  5 , Rosemary Petric  5 , Mamitaro Ohtsuki  4
Affiliations
Clinical Trial

Pharmacodynamic analysis of apremilast in Japanese patients with moderate to severe psoriasis: Results from a phase 2b randomized trial

Shinichi Imafuku et al. J Dermatol. 2021 Jan.

Abstract

We evaluated the pharmacodynamic effects of apremilast in 69 patients who were included in biomarker subanalyses of a phase 2b study that demonstrated the long-term safety and efficacy of apremilast in Japanese adults with moderate to severe psoriasis. The association between cytokine levels and Psoriasis Area and Severity Index (PASI) improvement was evaluated using linear regression and Spearman's rank correlation coefficient analysis. At baseline, median plasma levels of interleukin (IL)-17A, IL-17F and IL-22 were elevated versus reference values for healthy individuals, whereas tumor necrosis factor-α levels were close to normal. With apremilast 30 mg b.i.d., there were significant associations between percentage change in PASI score and percentage change in IL-17A, IL-17F and IL-22 levels at week 16. Findings demonstrate that the efficacy of apremilast in psoriasis is associated with inhibition of key cytokines involved in the pathology of psoriasis.

Keywords: apremilast; biomarker analysis; cytokines; pharmacodynamics; psoriasis.

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Conflict of interest statement

S. I. received research funds, consultancy fees and speaker fees from Celgene, Kyowa Hakko Kirin, LEO Pharma, Maruho and Novartis. Y. O. received grants from Eisai, Kyowa Hakko Kirin, Maruho and Mitsubishi‐Tanabe. P. S. and R. P. were employed by Bristol‐Myers Squibb, and Celgene at the time of study conduct. M. O. received grants and personal fees from AbbVie, Eisai, Mitsubishi‐Tanabe and Novartis. The remaining authors have nothing to disclose.

Figures

Figure 1
Figure 1
Correlation between Psoriasis Area and Severity Index (PASI) score and (a) interleukin (IL)‐17A, (b) IL‐17F, (c) IL‐22 and (d) tumor necrosis factor (TNF)‐α levels at baseline.
Figure 2
Figure 2
Correlations between percentage change from baseline at week 16 (last observation carried forward, LOCF) in Psoriasis Area and Severity Index (PASI) score with interleukin (IL)‐17A, IL‐17F, IL‐22 and tumor necrosis factor (TNF)‐α at week 16 in patients receiving (a–d) placebo b.i.d., (e–h) apremilast 20 mg b.i.d. and (i–l) apremilast 30 mg b.i.d.
See this image and copyright information in PMC

References

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