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Taking biologics to heart

DII small banner By Warren R. Heymann, MD
Oct. 16, 2016

Comorbidities related to psoriasis have dominated the dermatologic literature for more than a decade since Joel Gelfand published his seminal paper (1). In my 2008 commentary for Dialogues in Dermatology, I stated that “It remains to be determined if treating psoriasis has any influence on decreasing the risk of developing atherosclerosis.” (2). Should further studies confirm the data from the following article, we now have an answer — yes it does.

Hjuler et al investigated the association of biological therapy (with either adalimumab, etanercept, infliximab, or ustekinumab) with changes in coronary artery disease progression, measured by repeated coronary computed tomography (CT) in a single-center prospective, controlled, observer-blinded clinical study in patients with severe psoriasis initiating biological therapy and matched controls not receiving systemic therapy. Patients underwent noncontrast coronary artery calcium (CAC) CT and contrast-enhanced coronary CT angiography at baseline and after 13 months of follow-up. Changes in CAC score, number of coronary plaques, severity of narrowing, composition, and vessel wall volume were measured. There were 28 treated patients (mean [SD] age, 49.2 [10.2] years; 71% men; mean [SD] Psoriasis Area Severity Index [PASI], 15.4 [4.3]) and 28 controls (mean [SD] age, 52.8 [10.6] years; 71% men; mean [SD] PASI, 12.4 [3.9]). The CAC scores remained stable in the intervention group (mean [SD] yearly CAC change, -16 [56]; P = .15) and progressed in the control group (14 [29]; P = .02) (intervention vs controls: P = .02). The number of segments with luminal abnormalities remained unchanged in both groups. The severity of luminal narrowing in the diseased segments was unchanged in the intervention group (Wilcoxon W = 76, n = 483, P = .39) but increased at follow-up in the control group (Wilcoxon W = 281, n = 414, P = .02). Automated vessel wall volume index remained unchanged from baseline to follow-up in the intervention group (mean [SD] baseline, 7.1 [1.5], follow-up, 7.1 [1.7]; P = .91), while controls demonstrated statistically nonsignificant progression (baseline, 8.3 [1.6], follow-up, 8.9 [2.2]; P = .06). The authors concluded that clinically effective treatment with biologic agents was associated with reduced coronary artery disease progression in patients with severe psoriasis (3).

One of the major challenges in using biologic agents is in overcoming patients’ fear of potential adverse reactions. Yesterday I had a patient with rapidly progressing pyoderma gangrenosum – she was adamant that she did not want to use adalimumab because of a family history of cancer. She was more comfortable with the potential nephrotoxicity of cyclosporine, despite my explanation that cyclosporine, as an immunosuppressant, also increases her malignancy risk. She is not alone. According to Patel, “Although recent studies do not show an increased risk of new or recurrent malignancy in patients with psoriasis treated with biologic agents, there is still hesitancy in the widespread use of biologic agents in these patients. Considering all of the current data and opinions, the benefits of biologic therapy to improve quality of life often outweigh the negligible risk of solid organ malignancy associated with biologics in patients with existing or previous malignancies” (4). Schaarschmidt et al have demonstrated that patients with cardiovascular disease are particularly concerned about safety, even if TNF antagonists favorably influence cardiovascular risk (5). Perception is reality — patient fear must be addressed, even if their anxiety is unfounded.

In conclusion, we are on the cusp of changing the dynamic from just informing our moderate-to-severe psoriatic patients about their cardiovascular disease risk to addressing the fact that biologic intervention may obviate that risk. Patients and dermatologists need to take this new data to heart.

1. Gelfand JM, et al. Prevalence and treatment of psoriasis in the United Kingdom. Arch Dermatol 2005; 141: 1537-41.
2. Heymann WR. Psoriasis: The heart of the matter. J Am Acad Dermatol 2008; 58: 477-8.
3. Hjuler K, et al. Association between changes in coronary artery disease progression and treatment with biologic agents for severe psoriasis. JAMA Dermatology 2016; 152; 1114-21.
4. Patel S, et al. The risk of malignancy or progression of existing malignancy in patients with psoriasis treated with biologics: case report and review of the literature. Int J Dermatol 2016; 55: 487-93.
5. Schaarschmidt ML, et al. Patient preferences for biological in psoriasis: Top priority of safety for cardiovascular patients. PLoS One 2015; 10: e0144335.

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