Table 2. Randomized placebo controlled clinical trials assessing the impact of biologics on vascular health in psoriasis.
In all listed studies, a crossover to active treatment occurred at the end of the randomized portion.
| Clinical Trial | Year | N | Inclusion Criteria | Treatment (N) | Duration | Primary Outcome | Main Findings | Misc |
|---|---|---|---|---|---|---|---|---|
| Adalimumab | ||||||||
| NCT01722214 TNF-α Antagonist and Vascular Inflammation in Psoriasis Vulgaris | 2017 | 107 | -≥ 5% BSA - Elevated TBR |
Adalimumab (54) Placebo (53) |
16 weeks | Change from baseline in TBR of ascending aorta | −0.002 (−0.048 to 0.053) −0.002 (−0.053 to 0.049d) |
−30% hs-CRP reduction in adalimumab group |
| NCT01553058 Vascular Inflammation in Psoriasis (VIP) | 2018 | 97 | -≥ 10% BSA | Adalimumab (33) Placebo (31) UVB (33) |
12 weeks | Percent change from baseline in maximum aortic TBR | −1.84% (−7.17% to 3.47%) −2.49% (−6.29% to 1.31%) −4.09% (−7.78 to −0.39%) |
-GlycA reduced in adalimumab group -HDL-p increased in phototherapy group |
| Ustekinumab | ||||||||
| NCT02187172 Vascular Inflammation in Psoriasis (VIP-U) | 2020 | 43 | - ≥ 10% BSA | Ustekinumab (22) Placebo (21) |
12 weeks | Change from baseline of TBR in 5 aortic segments | −6.58% (−13.64% to 0.47%) 12.07% (3.26% to 20.88%) |
-Difference between groups significant at 12 weeks (p<0.01) -TBR reductions not maintain at 52 weeks |
| Secukinumab | ||||||||
| NCT02690701 Vascular Inflammation in Psoriasis (VIP-S) | 2020 | 91 | -≥ 10% BSA | Secukinumab (46) Placebo (45) |
12 weeks | Change from baseline in maximum aortic TBR | 2.6% (−2.5% to 7.6%) 3.3% (−0.8 to 7.5) |
|
|
NCT02559622 Evaluation of Cardiovascular Risk Markers in Psoriasis Patients treated with Secukinumab (CARIMA) |
2020 | 151 | - ≥ 10 Psoriasis area and severity index score | Secukinumab 300mg (48) Secukinumab 150mg (54) Placebo (26)* Placebo (23)* |
12 weeks | Change in brachial artery flow mediated dilatation | 4.6% ± 3.5% → 5.1% ± 5.2% 4.6% ± 4.6% → 4.8% ± 3.9% 3.9% ± 3.9% → 3.6% ± 3.7% 3.7% ± 3.6%→ 3.6% ± 4.6% |
- No difference between groups at 12 weeks. |
*
Crossover to Secukinumab 300mg and 150mg doses at week 12 through 52.
BSA; body surface area (of active psoriasis). CAD; Coronary artery disease. HDL-p; high-density lipoprotein particle number. Hs-CRP; high sensitivity C-reactive protein. TBR; Target:background ratio (of 18F-fludeoxyglucose [FDG] uptake assessed by positron emission tomography/computed tomography [PET/CT]). UVB; Ultraviolet B (phototherapy).