Patients taking certolizumab pegol are twice as likely to achieve ACR20 compared to placebo
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 of ACR20* response at week 12 than those on placebo: 58% on CZP200mg Q2W; and 51.9% on CZP 400 mg Q4W compared to 24.3% on placebo.
This randomised, placebo controlled, 24 week period of an ongoing Phase III study of 409 patients indicated that more patients treated with both doses of CZP achieved ACR50* and ACR70* response compared to placebo (CZP 200mg Q2W: 36.2%, CZP 400mg Q4W: 32.6%, PBO: 11% for ACR50, CZP 200mg Q2W: 24.6%, CZP 400mg Q4W: 12.6%, PBO: 2.9% for ACR70). HAQ-DI** scores were also higher in the combined CZP groups at week 24. In addition patients treated with both doses of CZP also showed greater improvements in PASI 75*** than placebo (62.2% and 60.5% respectively vs 15.1%).
"We know that certolizumab is effective in rheumatoid arthritis but this is the first study to review its efficacy and safety in psoriatic arthritis," commented Dr. Mease, University of Washington, USA and lead author of the study. "Not only were the signs and symptoms of arthritis improved, but so too were patients' physical function and skin manifestations, which is a great breakthrough for us and our patients."
The study followed 409 patients with active psoriatic arthritis who had failed one or more disease modifying anti-rheumatic drugs (DMARDs) including a maximum of one anti-TNF. Patients were randomised 1:1:1 to placebo, or started on a loading dose of 400mg CZP every two weeks for the first four weeks then continued either on 200mg CZP Q2W or 400mg CZP Q4W. Patients receiving placebo who failed to achieve a ≥10% improvement in tender joint count (TJC) and swollen joint count (SJC) at both weeks 14 and 16 were rescued and randomized to one of the CZP arms following loading dose.
CZP use in psoriatic arthritis was associated with a similar safety profile to what has been observed in rheumatoid arthritis. Adverse events occurred at the rates of 68% for the placebo group versus 62% for the combined CZP group, and serious adverse events at 4% for the placebo group versus 7% for the combined CZP group. Two deaths occurred during this 24 wk double-blind phase of the study, one sudden death of unknown cause (CZP 400mg Q4W) and one myocardial infarction (CZP 200mg Q2W).
More information: Abstract Number: LB0001
*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.
**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
***PASI (Psoriasis Area and Severity Index) is an index used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area. PASI 75 is equal to a 75% reduction in the PASI score and is the current benchmark of primary endpoints for most clinical trials of psoriasis.
Provided by European League Against Rheumatism
- New drug shows promising results for psoriatic arthritis Apr 07, 2009 | not rated yet | 0
- Head-to-head study in RA shows that abatacept has comparable efficacy to adalimumab Jun 07, 2012 | not rated yet | 0
- US study shows that tofacitinib is an efficacious treatment for active RA May 25, 2011 | not rated yet | 0
- Rituximab combined with a TNF inhibitor and methotrexate shows no safety signal in RA treatment Mar 08, 2011 | not rated yet | 0
- Antibody injection lowers LDL, adding to effectiveness of statin therapy Mar 26, 2012 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
Question of reflection and transmission of TEM wave in normal incidenc
6 hours ago Suppose TEM wave in +z normal to a boundary on xy plane at z=0. We know *E* & *H* are tangential to the boundary. Let ##\vec E_i=\hat x E##, be the...
the rudyak-krasnolutski effective potencial
6 hours ago Hi ... anyone now how to calculate or the formula of the rudyak-krasnolutski EFFECTIVE potencial ? the effective potencial includes the angular...
Normal force for a lever model
8 hours ago My model is a lever on a table top. One arm is horizontal on the table, while the other arm is raised at an angle alpha. I'm assuming the weight of...
gravity is std. therefore can we rate a 'mass at height' by watts?
13 hours ago For example.... wind turbines are primarily listed by their wattage (1.5MW etc.) Presumably their output is varied according to rotational speed, so...
Calculating on-axis elements of a solenoid
May 22, 2013 I wanted to mention that this solenoid has many winds over many layers. The thickness of the windings is 2.4 inches coming off of the engineering...
latitude & longitude & air pressure
May 22, 2013 Hi there, I have a peculiar question. Imagine that you are in a earth position, obtained by google, that gives you the latitude and longitude....
- More from Physics Forums - Classical Physics
More news stories
In a series of lab experiments designed to unravel the workings of a key enzyme widely considered a possible trigger of rheumatoid arthritis, researchers at Johns Hopkins have found that in the most severe ...
Arthritis & Rheumatism May 22, 2013 | 5 / 5 (2) | 0 |
(HealthDay)—Injections of a sugar solution appear to help relieve knee pain and stiffness related to osteoarthritis, a new study suggests.
Arthritis & Rheumatism May 21, 2013 | 4.5 / 5 (2) | 0 |
A novel study reports that white men and women of European descent inherit common foot disorders, such as bunions (hallux valgus) and lesser toe deformities, including hammer or claw toe. Findings from the Framingham Foot ...
Arthritis & Rheumatism May 20, 2013 | not rated yet | 0 |
Scientists at Johns Hopkins have turned their view of osteoarthritis (OA) inside out. Literally. Instead of seeing the painful degenerative disease as a problem primarily of the cartilage that cushions joints, ...
Arthritis & Rheumatism May 19, 2013 | 4.9 / 5 (8) | 0 |
(HealthDay)—Compared to clinical diagnosis of synovitis, ultrasound-detected synovitis provides either improved sensitivity or specificity when used with the American College of Rheumatology/European League ...
Arthritis & Rheumatism May 15, 2013 | not rated yet | 0
(Medical Xpress)—Regulating the distribution of power in neurons is done by a system that makes the national electric grid look simple by comparison. Each neuron has several thousand mitochondria confined ...
5 hours ago | 4.8 / 5 (5) | 0 |
Teams of highly respected Alzheimer's researchers failed to replicate what appeared to be breakthrough results for the treatment of this brain disease when they were published last year in the journal Science.
8 hours ago | 5 / 5 (1) | 2 |
Scientists at the National Institutes of Health report they have discovered in mouse studies that a small molecule released in the spinal cord triggers a process that is later experienced in the brain as ...
8 hours ago | 5 / 5 (2) | 0 |
A brief visual task can predict IQ, according to a new study. This surprisingly simple exercise measures the brain's unconscious ability to filter out visual movement. The study shows that individuals whose ...
10 hours ago | 4.9 / 5 (7) | 0 |
Little is known about why asthma develops, how it constricts the airway or why response to treatments varies between patients. Now, a team of researchers at Weill Cornell Medical College, Columbia University Medical Center ...
9 hours ago | not rated yet | 0 |
Ethnic background plays a surprisingly large role in how diabetes develops on a cellular level, according to two new studies led by researchers at the Stanford University School of Medicine.
6 hours ago | not rated yet | 0 |