Formulary Review of 2 New Biologic Agents: Tocilizumab for Rheumatoid Arthritis and Ustekinumab for Plaque Psoriasis

Schafer, Jeremy A.; Kjesbo, Nicole K.; Gleason, Patrick P.

doi:10.18553/jmcp.2010.16.6.402

Cited by 18 publications

(14 citation statements)

References 30 publications

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“…ind/+ mice and we had already been able to show an improvement of skin pathology with reduced skin thickness and less infiltrating CD11b + cells under anti-IL6 treatment ( Figure ID in the online-only Data Supplement), 22 we also used anti-IL-6 in another approach, which is approved for the treatment of refractory rheumatoid arthritis, 35 for further analysis. Both treatment regimen led to a significant improvement in skin pathology shown by reduced psoriasis area and severity index score ( Figure 7A Figure 7E), and under IL-6 also a slight improvement was noticed.…”

Section: Blockade Of Cytokines Downstream Of Il-17a Attenuates Both Smentioning

confidence: 99%

Interleukin 17 Drives Vascular Inflammation, Endothelial Dysfunction, and Arterial Hypertension in Psoriasis-Like Skin Disease

Karbach

Croxford

Oelze

et al. 2014

ATVB

223

187

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Objective— Interleukin (IL)-17A is regarded as an important cytokine to drive psoriasis, an inflammatory skin disease marked by increased cardiovascular mortality. We aimed to test the hypothesis that overproduction of IL-17A in the skin leading to dermal inflammation may systemically cause vascular dysfunction in psoriasis-like skin disease. Approach and Results— Conditional overexpression of IL-17A in keratinocytes caused severe psoriasis-like skin inflammation in mice (K14-IL-17A ind/+ mice), associated with increased reactive oxygen species formation and circulating CD11b + inflammatory leukocytes in blood, with endothelial dysfunction, increased systolic blood pressure, left ventricular hypertrophy, and reduced survival compared with controls. In K14-IL-17A ind/+ mice, immunohistochemistry and flow cytometry revealed increased vascular production of the nitric oxide/superoxide reaction product peroxynitrite and infiltration of the vasculature with myeloperoxidase + CD11b + GR1 + F4/80 − cells accompanied by increased expression of the inducible nitric oxide synthase and the nicotinamide dinucleotide phosphate (NADPH) oxidase, nox2. Neutrophil depletion by anti-GR-1 antibody injections reduced oxidative stress in blood and vessels. Neutralization of tumor necrosis factor-α and IL-6 (both downstream of IL-17A) reduced skin lesions, attenuated oxidative stress in heart and blood, and partially improved endothelial dysfunction in K14-IL-17A ind/+ mice. Conclusions— Dermal overexpression of IL-17A induces systemic endothelial dysfunction, vascular oxidative stress, arterial hypertension, and increases mortality mainly driven by myeloperoxidase + CD11b + GR1 + F4/80 − inflammatory cells. Depletion of the GR-1 + immune cells or neutralization of IL-17A downstream cytokines by biologicals attenuates the vascular phenotype in K14-IL-17A ind/+ mice.

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Section: Blockade Of Cytokines Downstream Of Il-17a Attenuates Both Smentioning

confidence: 99%

Interleukin 17 Drives Vascular Inflammation, Endothelial Dysfunction, and Arterial Hypertension in Psoriasis-Like Skin Disease

Karbach

Croxford

Oelze

et al. 2014

ATVB

223

187

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“…Two doses are administered in the first 30 days at weeks 0 and 4, with an average wholesale price of US$11,192, and US$5596 every 12 weeks thereafter, yielding an annual drug cost of approximately US$27,980 in the first year for five doses and US$22,384 annually thereafter for four doses per year. This can be compared with the US$1995 monthly cost of etanercept, giving an annual cost of US$23,940 58. Additionally, a recent cost analysis was performed, showing that the cost per responder was around US$17,842 for ustekinumab vs US$20,007 for etanercept 59.…”

Section: Resultsmentioning

confidence: 99%

Ustekinumab: differential use in psoriasis

Uhlenhake¹,

Mehregan²

2011

CCID

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Chronic plaque psoriasis is a systemic disease affecting over 3% of the population, and many patients are unsatisfied with their current treatment regimen. With advances in understanding of the pathophysiology of psoriasis, new therapeutic options are being developed. The newest of these agents, ustekinumab, offers patients rapid results and the convenience of four annual subcutaneous doses, with efficacy and safety profiles comparable with those of other biologics. However, ustekinumab has been on the market in the US for less than 2 years and will require years of extensive use before the full adverse event profile is fully understood. The purpose of this paper is to summarize the treatment options currently available for psoriasis, with an emphasis on ustekinumab in order to give prescribers an overview of the available data and allow them to make educated and informed prescribing decisions.

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“…For cost-efficacy analysis, we considered the direct drug costs of the approved regimen based on the US drug price in April 2010 [6]. The direct costs are Cost b and Cost c in the biologics and placebo groups, respectively.…”

Section: Methodsmentioning

confidence: 99%

“…Based on the US drug price in April 2010 [6], the 6 month drug costs are $17,954, $13,429, $19,725, $16,787, and $33,574 for the etanercept, adalimumab, infliximab (for a person weighing 81–100 kg), ustekinumab 45 mg, and ustekinumab 90 mg regimens approved by the Food and Drug Administration (FDA) (see below), respectively. Healthcare payers therefore often have an eligibility criterion for the reimbursement of biologics therapies.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and Cost-Efficacy of Biologic Therapies for Moderate to Severe Psoriasis: A Meta-Analysis and Cost-Efficacy Analysis Using the Intention-to-Treat Principle

Chi

Wang

2014

BioMed Research International

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Background. Compared to conventional therapies, biologics are more effective but expensive in treating psoriasis. Objective. To evaluate the efficacy and cost-efficacy of biologic therapies for psoriasis. Methods. We conducted a meta-analysis to calculate the efficacy of etanercept, adalimumab, infliximab, and ustekinumab for at least 75% reduction in the Psoriasis Area and Severity Index score (PASI 75) and Physician's Global Assessment clear/minimal (PGA 0/1). The cost-efficacy was assessed by calculating the incremental cost-effectiveness ratio (ICER) per subject achieving PASI 75 and PGA 0/1. Results. The incremental efficacy regarding PASI 75 was 55% (95% confidence interval (95% CI) 38%–72%), 63% (95% CI 59%–67%), 71% (95% CI 67%–76%), 67% (95% CI 62%–73%), and 72% (95% CI 68%–75%) for etanercept, adalimumab, infliximab, and ustekinumab 45 mg and 90 mg, respectively. The corresponding 6-month ICER regarding PASI 75 was $32,643 (best case $24,936; worst case $47,246), $21,315 (best case $20,043; worst case $22,760), $27,782 (best case $25,954; worst case $29,440), $25,055 (best case $22,996; worst case $27,075), and $46,630 (best case $44,765; worst case $49,373), respectively. The results regarding PGA 0/1 were similar. Conclusions. Infliximab and ustekinumab 90 mg had the highest efficacy. Meanwhile, adalimumab had the best cost-efficacy, followed by ustekinumab 45 mg and infliximab.

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Formulary Review of 2 New Biologic Agents: Tocilizumab for Rheumatoid Arthritis and Ustekinumab for Plaque Psoriasis

Cited by 18 publications

References 30 publications

Interleukin 17 Drives Vascular Inflammation, Endothelial Dysfunction, and Arterial Hypertension in Psoriasis-Like Skin Disease

Interleukin 17 Drives Vascular Inflammation, Endothelial Dysfunction, and Arterial Hypertension in Psoriasis-Like Skin Disease

Ustekinumab: differential use in psoriasis

Efficacy and Cost-Efficacy of Biologic Therapies for Moderate to Severe Psoriasis: A Meta-Analysis and Cost-Efficacy Analysis Using the Intention-to-Treat Principle

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