Ustekinumab vs Etanercept for Psoriasis: Trial Results

Author: Ian C. Langtree - View Credentials
Published: 13 Jan 2010 - Updated: 13 Oct 2026
Publication Type: Findings

Table of Contents:
Synopsis - Definition - Overview - FAQs - Insights, Updates - Related Content

Synopsis

This research reviews the ACCEPT trial, a peer-reviewed head-to-head study published in the New England Journal of Medicine that compared two biologic drugs, ustekinumab and etanercept, in 903 people with moderate to severe plaque psoriasis. After 12 weeks, at least a 75% improvement in skin symptoms was seen in 67.5% of patients on the 45 mg dose of ustekinumab and 73.8% on the 90 mg dose, compared with 56.8% on high-dose etanercept, even though ustekinumab needed only two injections versus twice-weekly dosing. The findings matter to anyone living with psoriasis and to the clinicians choosing between treatments, and the article sets the results alongside current treatment guidelines and newer drug options, making it useful for seniors, people with disabilities and caregivers who have to weigh effectiveness against how often injections are needed.

At a Glance

1 - About 3.0% of U.S. adults have psoriasis, an estimated 7.55 million people, with rates similar in women and men.
2 - Among patients who did not respond to etanercept, 48.9% reached a 75% improvement within 12 weeks of switching to ustekinumab.
3 - Dermatology guidelines call for a test for latent tuberculosis before starting a biologic, along with blood work and hepatitis screening.
4 - In 2023 the FDA approved Wezlana, the first interchangeable biosimilar to ustekinumab, for adults and children 6 and older with plaque psoriasis.

Topic Definition

Biologic Therapy for Psoriasis: Biologic therapy for psoriasis is a type of treatment that uses lab-made proteins, usually monoclonal antibodies or receptor-based drugs, to block specific immune system signals that drive the skin inflammation seen in psoriasis. Unlike older systemic drugs such as methotrexate and cyclosporine, which broadly suppress the immune system, biologics target a single pathway, such as tumor necrosis factor alpha, interleukin 17 or interleukin 23. They are given by injection or infusion and are generally used for moderate to severe plaque psoriasis or psoriatic arthritis, especially when creams, light therapy or oral medicines have not worked well enough. Because they lower parts of the immune response, patients are screened for infections such as tuberculosis before treatment and monitored during it.

Overview

Ustekinumab Versus Etanercept: The ACCEPT Trial

A head-to-head clinical trial led by Professor Christopher Griffiths, a dermatologist at The University of Manchester and Salford Royal Hospital, compared two biologic drugs for moderate to severe plaque psoriasis: etanercept (Enbrel) and ustekinumab (Stelara). At the time, biologics were a newer group of treatments, and little was known about how their benefits and risks compared with each other. The international study, known as ACCEPT, was published in the New England Journal of Medicine on January 14, 2010 [Griffiths et al., 2010].

Researchers randomly assigned 903 patients with moderate to severe psoriasis to one of three groups. Two groups received ustekinumab at either 45 mg or 90 mg, given as subcutaneous (under the skin) injections at week 0 and week 4 only. The third group received high-dose etanercept, 50 mg injected twice a week for 12 weeks. The doctors who assessed the results did not know which treatment each patient had received [Griffiths et al., 2010].

Key Results After 12 Weeks

The main measure was PASI 75, meaning at least a 75% improvement in the Psoriasis Area and Severity Index, a standard tool that scores how much skin is affected and how severe the plaques are. A second measure was the share of patients whose skin was rated clear or almost clear by a physician [Griffiths et al., 2010].

PASI 75 was reached by 67.5% of patients on 45 mg of ustekinumab and 73.8% on 90 mg, compared with 56.8% on etanercept.
Clear or minimal disease was reported in 65.1% of patients on 45 mg of ustekinumab and 70.6% on 90 mg, compared with 49.0% on etanercept.
Among patients who did not respond to etanercept and were then switched to ustekinumab, 48.9% reached PASI 75 within 12 weeks of the switch.

"Our findings show that the efficacy of ustekinumab at either dosage was superior to that of high-dose etanercept using the 75% improvement measure over a 12-week period," said Professor Griffiths.

Safety Findings

Side effects were reported at similar rates across the groups. Through week 12, one or more adverse events occurred in 66.0% of patients on 45 mg of ustekinumab, 69.2% on 90 mg and 70.0% on etanercept. Serious adverse events were uncommon, at 1.9%, 1.2% and 1.2% respectively, and safety patterns did not change after patients switched from etanercept to ustekinumab [Griffiths et al., 2010].

"There were, however, more injection-site reactions with etanercept but this may be accounted for by the fact patients received more injections of this drug than ustekinumab," Professor Griffiths noted. Because the trial lasted only 12 weeks, it could not show how the two drugs compare over years of use.

How Common Is Psoriasis?

Psoriasis is a chronic inflammatory disease of the immune system that affects much more than the skin. An analysis of national health survey data found that 3.0% of U.S. adults aged 20 and older have psoriasis, an estimated 7.55 million people, with similar rates in women (3.2%) and men (2.8%) [Armstrong et al., 2021].

Plaque psoriasis, which causes raised, red patches covered with silvery-white scales, is the most common type. Other types include guttate, pustular, inverse and erythrodermic psoriasis, a rare but severe form. People with psoriasis have a higher risk of psoriatic arthritis, which causes joint pain, swelling and stiffness, as well as heart attack, stroke, anxiety and depression [National Institute of Arthritis and Musculoskeletal and Skin Diseases, n.d.].

How These Drugs Work

Older systemic treatments such as methotrexate and cyclosporine work by broadly suppressing the immune system. Biologics are more targeted. Etanercept blocks tumor necrosis factor alpha (TNF-alpha), a chemical signal that drives inflammation, while ustekinumab blocks two other immune signaling proteins, interleukin 12 (IL-12) and interleukin 23 (IL-23) [Griffiths et al., 2010].

Biologic Treatment Options Today

The range of biologics has grown considerably since this trial. Guidelines from the American Academy of Dermatology and the National Psoriasis Foundation cover four main groups [Menter et al., 2019]:

TNF-alpha inhibitors: etanercept, infliximab, adalimumab and certolizumab.
IL-12/IL-23 inhibitor: ustekinumab, approved by the FDA for psoriasis in 2009.
IL-17 inhibitors: secukinumab (2015), ixekizumab (2016) and brodalumab (2017).
IL-23 inhibitors: guselkumab (2017) and tildrakizumab (2018), with more approved since.

Because biologics affect the immune system, the same guidelines recommend a test for latent tuberculosis before treatment begins, along with blood work and hepatitis B and C screening, and yearly tuberculosis testing during treatment [Menter et al., 2019].

Lower-cost versions are also becoming available. In October 2023, the U.S. Food and Drug Administration approved Wezlana (ustekinumab-auub) as the first biosimilar that is interchangeable with Stelara. It is approved for adults with moderate to severe plaque psoriasis and active psoriatic arthritis, as well as for children aged 6 and older with these conditions. Depending on state pharmacy laws, an interchangeable biosimilar may be substituted at the pharmacy without the prescriber's involvement [U.S. Food and Drug Administration, 2023].

What This Means for Patients and Caregivers

No single biologic suits everyone. The choice usually depends on how severe the psoriasis is, whether joints are affected, other health conditions, infection risk, cost and insurance coverage, and how often injections are needed. A schedule of a few injections a year can make a real difference for seniors, people with limited hand strength or dexterity, and caregivers who give the injections. Anyone considering a biologic should discuss the benefits, risks and monitoring needs with a dermatologist or other qualified health professional.

Frequently Asked Questions

Can psoriasis spread from one person to another?

No. Psoriasis is an immune-mediated condition, not an infection, so it cannot be caught by touching someone, sharing towels or swimming in the same pool.

How long does a biologic usually take to work for psoriasis?

Many people see improvement within the first few months, and clinical trials often measure results at around 12 to 16 weeks. A dermatologist will usually review progress after several months before deciding whether to continue or switch treatments.

Can people with limited hand strength use injectable psoriasis drugs?

Yes. Many biologics come in prefilled pens or autoinjectors that are easier to grip, and a caregiver, family member or nurse can be trained to give the injection. Some biologics are also given as infusions in a clinic.

Should vaccinations be reviewed before starting a biologic?

Yes. Live vaccines are generally avoided during biologic treatment, so doctors often recommend bringing routine vaccinations up to date before the first dose. A doctor or pharmacist can advise on which vaccines are appropriate.

Are biologics safe to use during pregnancy?

This depends on the specific drug and the person's health. Anyone who is pregnant, planning a pregnancy or breastfeeding should talk with their dermatologist and obstetrician before starting or stopping a biologic.

What can trigger a psoriasis flare?

Common triggers include stress, skin injuries such as cuts or scrapes, infections, cold and dry weather, and some medications. Keeping track of flares can help identify personal triggers to discuss with a doctor.

Why do some insurers require other treatments before a biologic?

Many insurance plans use step therapy or prior authorization, which means a patient may need to try lower-cost treatments first. A dermatologist can submit records showing why a biologic is needed, and biosimilars or manufacturer assistance programs may help reduce costs.

Can a biologic stop working over time?

Yes. Some people find that a biologic becomes less effective after months or years. When that happens, doctors may adjust the dose or switch to a drug that targets a different part of the immune system.

References:

Armstrong, A. W., Mehta, M. D., Schupp, C. W., Gondo, G. C., Bell, S. J., and Griffiths, C. E. M. (2021). Psoriasis prevalence in adults in the United States. JAMA Dermatology, 157(8), 940 - 946.
Griffiths, C. E. M., Strober, B. E., van de Kerkhof, P., Ho, V., Fidelus-Gort, R., Yeilding, N., Guzzo, C., Xia, Y., Zhou, B., Li, S., Dooley, L. T., Goldstein, N. H., and Menter, A. (2010). Comparison of ustekinumab and etanercept for moderate-to-severe psoriasis. New England Journal of Medicine, 362(2), 118 - 128.
Menter, A., Strober, B. E., Kaplan, D. H., Kivelevitch, D., Prater, E. F., Stoff, B., Armstrong, A. W., Connor, C., Cordoro, K. M., Davis, D. M. R., Elewski, B. E., Gelfand, J. M., Gordon, K. B., Gottlieb, A. B., Kavanaugh, A., Kiselica, M., Korman, N. J., Kroshinsky, D., Lebwohl, M., ... Elmets, C. A. (2019). Joint AAD-NPF guidelines of care for the management and treatment of psoriasis with biologics. Journal of the American Academy of Dermatology, 80(4), 1029 - 1072.
National Institute of Arthritis and Musculoskeletal and Skin Diseases. (n.d.). Psoriasis. National Institutes of Health.
U.S. Food and Drug Administration. (2023). FDA approves interchangeable biosimilar for multiple inflammatory diseases.

Insights, Analysis, and Developments

Editorial Note: The ACCEPT trial was one of the first studies to put two psoriasis biologics side by side, and its message still holds: targeting specific immune signals such as IL-12 and IL-23 can clear skin more effectively than blocking TNF-alpha alone, with short-term safety that looked similar between the two drugs. Since 2010 the choice has widened to include IL-17 and IL-23 inhibitors, which gives patients more options if a first drug stops working. That matters because psoriasis is tied to psoriatic arthritis, heart disease, anxiety and depression, so good control affects far more than appearance. For older adults and people with limited dexterity, a treatment needing only a few injections a year can also be easier to manage, whether they inject themselves or rely on a caregiver.

Author Credentials: Ian C. Langtree is a writer, editor, and the founder and Editor-in-Chief of Disabled World, which he established in 2004 as one of the longest-running independent resources for disability news and information. Over more than two decades, he has written and edited thousands of articles on disability rights, health, accessibility, and assistive technology. Drawing on a global perspective shaped by extensive travel and lived experience, Ian is a committed advocate of the Social Model of Disability, the framework developed by disabled activists in the 1970s that focuses on removing societal barriers rather than on individual impairments. His writing is grounded in that framework and in a lasting commitment to disability rights, accessibility, and social inclusion. To learn more about Ian's background, expertise, and accomplishments, visit his full biography.