Disparate effects of adalimumab and fumaric acid esters on cardiovascular risk factors in psoriasis patients: results from a prospective, randomized, observer‐blinded head‐to‐head trial
Background The effect of adalimumab and fumaric acid esters (FAE) on the cardiovascular risk associated with psoriasis has only been investigated scarcely in randomized controlled studies. Objective The aim of this prospective, randomized controlled head‐to‐head trial was to compare the influence of...
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| Published in: | Journal of the European Academy of Dermatology and Venereology Vol. 35; no. 2; pp. 441 - 449 |
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| Main Authors: | , , , , , , , |
| Format: | Journal Article |
| Language: | English |
| Published: |
England
01-02-2021
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| Subjects: | |
| Online Access: | Get full text |
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| Summary: | Background
The effect of adalimumab and fumaric acid esters (FAE) on the cardiovascular risk associated with psoriasis has only been investigated scarcely in randomized controlled studies.
Objective
The aim of this prospective, randomized controlled head‐to‐head trial was to compare the influence of adalimumab and FAE on cardiovascular disease markers in psoriasis patients.
Methods
Sixty‐five patients with moderate to severe plaque psoriasis were randomly assigned to adalimumab or FAE treatment for 6 months. Cardiovascular haemodynamic parameters [flow‐mediated dilation (FMD), nitro‐glycerine mediated dilation (NMD) and carotid intima–media thickness (CIMT), blood pressure] were assessed at baseline (v0) and after 6 months (v6). Cutaneous disease severity, inflammatory and lipid cardiovascular risk markers were analysed at baseline(v0), after 3 (v3) and 6 months (v6).
Results
After 6 months of treatment FMD in the adalimumab group increased significantly [v0 5.9% (6.4% SD), v6 8.0% (4.8% SD), P = 0.048) but not in the FAE group. (v0 7.0% (4.1% SD), v6 8.4% (6.1% SD), P = 0.753]. This was paralleled by a significant decrease of high sensitive C‐reactive protein (hsCRP) in the adalimumab group in comparison to the FAE group (v0: 0.39 mg/dL (0.38 SD), v6: 0.39 mg/dL (0.48 SD), P = 0.043). No significant changes were observed in any other haemodynamic parameters. FAE, however, additionally decreased total cholesterol (P = 0.046) and apolipoprotein B (P = 0.041) levels compared to adalimumab. Mean Psoriasis Area and Severity Index (psoriasis area severity score) reduction was greater but not significant (P = 0.116) under adalimumab treatment compared to FAE treatment [−71.1% (29.9 SD) vs. −54.6% (45.7%)].
Conclusion
In our study, both treatments were documented to exert effects on the cardiovascular system. While adalimumab showed anti‐inflammatory effects and improved FMD, FAE interacted favourably with the cholesterol metabolism. |
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| Bibliography: | Conflicts of interest Funding sources G.H. has served as a consultant and/or paid speaker for and/or participated in clinical trials sponsored by companies that manufacture drugs used for the treatment of psoriasis, including AbbVie, Celgene, Janssen, Leo Pharma, Novartis, Pfizer and Eli Lilly; A. T. has served as a speaker and on advisory boards for Abbvie, Almirall, Celgene, Janssen, LEO, Novartis and Pfizer; M.H., S.S, T.P., A.R., B.S. and S.R. have nothing to disclose Laboratory assays were funded by an unrestricted research grant from Pfizer. ObjectType-Article-2 SourceType-Scholarly Journals-1 ObjectType-News-1 ObjectType-Feature-3 content type line 23 |
| ISSN: | 0926-9959 1468-3083 |
| DOI: | 10.1111/jdv.16635 |