Patients with PsA treated with ustekinumab are twice as likely to achieve acr20 vs. placebo

June 8, 2012

A new Phase III study presented today at EULAR 2012, the Annual Congress of the European League Against Rheumatism, shows that patients with active psoriatic arthritis (PsA) treated with Ustekinumab (UST) 90mg were more than twice as likely to achieve the study's primary endpoint, ACR20* at 24 weeks, than those treated with placebo (49.5% vs 22.8%). 42.4% of patients treated with UST 45mg were also more likely to achieve ACR20 at 24 weeks compared to placebo.

Significant improvements were also seen with UST 45mg and 90mg in ACR50* (24.9% and 27.9% respectively vs 8.7%), in ACR70* (12.2% and 14.2% respectively vs 2.4%) and in DAS28-CRP** responses at week 24 vs placebo (65.9% and 67.6% for UST 45mg and 90mg respectively vs 34.5%). Changes from baseline in HAQ-DI*** at week 24 were also significantly greater in treated with UST versus placebo and for a greater proportion of patients these changes were clinically meaningful (≥0.3).

In addition, patients in the UST groups who were affected with enthesitis (n=425) or dactylitis (n=286) at baseline, showed greater improvements at week 24 than those in the placebo groups.

"There are a number of patients with who do not respond to currently available treatment options, including biologic medicines targeting TNF. As physicians, we struggle to manage such people as well as we would like," commented Professor Iain McInnes, lead study author from University of Glasgow, Scotland. "The development of this new medicine is a welcome step forward. These results highlight not only Ustekinumab's efficacy but also its promising safety profile. We look forward now to seeing how it compares in trials with standard treatments."

Safety profiles were similar between the two groups. The proportion of patients suffering from one or more adverse events was 41.8% in the UST group compared to 42% in the placebo group. Infections were the most common adverse event; serious adverse events (>1) were reported in 1.7% UST and 2% placebo of patients.

This double-bind placebo controlled trial followed 615 patients with active (≥5 swollen joint counts and ≥5 tender joint counts; c-reactive protein ≥0.3mg/dL) despite treatment with disease modifying anti-rheumatic drugs (DMARDs) and/or non-steroidal anti inflammatory drugs (NSAIDs). Patients were randomised to UST 45mg, 90mg or at weeks zero, four and 12 weeks thereafter. At week 16, patients with <5% improvement in tender joint counts and swollen joint counts entered blinded early escape (PBO to UST 45mg, UST 45mg to UST 90mg, UST 90mg to UST 90mg). Stable concomitant methotrexate (MTX) use was permitted but not mandated. Nearly half of the patients studied used concomitant MTX at baseline but this did not alter the likelihood of benefit of UST.

Explore further: Patients taking certolizumab pegol are twice as likely to achieve ACR20 compared to placebo

More information: Abstract Number: OP0158

*ACR (American College of Rheumatology) criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate), patient assessment, physician assessment, pain scale and disability/functional questionnaire. ACR20 refers to a 20% improvement in tender/swollen joint counts, as well as three of the five other criteria. ACR50 refers to a 50% improvement and ACR70 refers to a 70% improvement.

**DAS28 (Disease Activity Score) is an index used by physicians to measure how active an individual's RA is. It assesses number of tender and swollen joints (out of a total of 28), levels of C-reactive protein (CRP, a protein found in the blood, the levels of which rise in response to inflammation), and the patient's 'global assessment of global health'. A higher score indicates more active disease. A score of <2.6 indicates that the patient is in remission.

***HAQ DI (Health Assessment Questionnaire – Disease Index) is a patient questionnaire that measures function and health-related quality of life through measuring a patient's ability to perform everyday tasks.

Related Stories

Patients taking certolizumab pegol are twice as likely to achieve ACR20 compared to placebo

June 7, 2012
A new Phase III study presented today at EULAR 2012, the Annual Congress of the European League Against Rheumatism, shows that patients treated with certolizumab pegol (CZP) were twice as likely to meet the primary endpoint ...

US study shows that tofacitinib is an efficacious treatment for active RA

May 25, 2011
Results of a Phase III study presented today at the EULAR 2011 Annual Congress show that at 6 months, 58.3 percent of patients who had previously not responded to treatment with DMARDs, achieved ACR20 response (a 20 percent ...

Head-to-head study in RA shows that abatacept has comparable efficacy to adalimumab

June 7, 2012
Data from one of the few head-to-head trials in rheumatoid arthritis (RA) presented today at EULAR 2012, the Annual Congress of the European League Against Rheumatism, demonstrates that at one year, 64.8% of patients receiving ...

The use of placebo in rheumatoid arthritis clinical trials may negatively impact patients

May 27, 2011
The results of this study, conducted in Germany, re-open the debate on whether it is ethical to conduct placebo-controlled studies where patients in the placebo-group are at a serious disadvantage compared to patients taking ...

Recommended for you

Maintaining sufficient vitamin D levels may help to prevent rheumatoid arthritis

November 20, 2017
Maintaining sufficient vitamin D levels may help to prevent the onset of inflammatory diseases like rheumatoid arthritis, research led by the University of Birmingham has discovered.

Old World monkeys could be key to a new, powerful rheumatoid arthritis therapy

November 16, 2017
In the quest for a new and more effective treatment for rheumatoid arthritis, researchers from the Keck School of Medicine of USC looked to a primate that mostly roams the land in Asia, the Middle East and Africa. It was ...

Study lists foods for fighting rheumatoid arthritis symptoms and progression

November 8, 2017
A list of food items with proven beneficial effects on the progression and symptoms of rheumatoid arthritis is provided in a new study published today in Frontiers in Nutrition. The authors suggest incorporating these foods ...

Prototype equipment can detect rheumatoid arthritis

September 28, 2017
According to a first clinical study published in the scientific journal Photoacoustics, the University of Twente and various European partners have designed a device that shows the difference between healthy fingers and arthritic ...

Improving the recognition of anxiety and depression in rheumatoid arthritis

August 28, 2017
A study conducted by Keele University shows that patients with rheumatoid arthritis who are also suffering with anxiety or depression may avoid talking to their GP about their mental health symptoms.

How you think about your arthritis makes a difference

August 24, 2017
(HealthDay)—How well you cope with knee arthritis depends a lot on your mental outlook, a new study suggests.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.