Navigation Links
Long-term apremilast demonstrates continued efficacy in patients with psoriatic arthritis

Madrid, Spain, 12 June 2013: New data presented today at EULAR 2013, the Annual Congress of the European League Against Rheumatism show that apremilast administered to patients with psoriatic arthritis continues to demonstrate meaningful clinical responses beyond 24 weeks. For patients who completed 52 weeks of the study, up to 65% achieved ACR20* response rates. Also, apremilast continued to be well tolerated with an acceptable longer-term safety profile.

Apremilast is a novel, oral small-molecule inhibitor of phosphodiesterase 4 (PDE4). It works as an anti-inflammatory drug by modulating a network of pro- and anti-inflammatory mediators inside cells.

PsA is a chronic inflammatory arthritis associated with psoriasis which significantly impacts health-related quality of life in patients, and increases risk of co-morbid cardiovascular and gastrointestinal disease.2 Psoriasis occurs in 2-3% of the population, with PsA occurring in up to 30% of those of cases.3

"Over the course of their disease patients with psoriatic arthritis may take a variety of treatment regimens over extended periods of time. Durability of response is therefore important. This relatively large study suggests that apremilast has sustained efficacy and tolerability over a year among patients previously treated with DMARDs and/or biologic agents" said Dr Arthur Kavanaugh, Professor of Medicine at the University of California, San Diego. "These results show that apremilast may become a potential therapy for psoriatic arthritis patients," he added.

PALACE-1 is a phase III multi-centre, double-blind, placebo-controlled, parallel-group study with two active-treatment groups. 504 patients with active psoriatic arthritis, despite prior disease-modifying anti-rheumatic drugs (DMARDs) and/or biologicals over the previous 24 weeks were randomised 1:1:1 to receive either apremilast 20 mg twice daily, 30 mg twice daily or identically-appearing placebo for 24 weeks.

The primary endpoint of the study was the proportion of patients in each treatment group who achieved ACR20 compared to baseline at week 16. Secondary endpoints included other measures of symptoms and signs, physical function and patient-reported outcomes.

At week 16, significantly more apremilast 20mg (31.3%; P=0.0140) and apremilast 30mg patients (40.0%; P<0.0001) achieved an ACR20 vs. placebo (19.4%). At week 52, by which time all patients had received a minimum of 28 weeks treatment with apremilast, response was generally maintained over the treatment period. At week 52, ACR20 was achieved by 63.0% (apremilast 20mg) and 54.6% (apremilast 30mg) of patients.

At week 16, patients in the placebo group with <20% reduction in swollen/tender joints were re-randomised to apremilast 20mg or apremilast 30mg; placebo patients with ≥20% reduction in swollen/tender joints at week 16 were re-randomised to apremilast 20mg or apremilast 30mg at week 24; patients receiving apremilast remained on their initial dose. At week 24, all remaining placebo patients were re-randomised to apremilast 20mg or apremilast 30mg through to week 52.

Exposure-adjusted incidence rates for adverse events (AEs), severe AEs, and serious AEs were comparable between 0-24 and 0-52 wks. The proportion of patients remaining on apremilast to week 52 who first reported the most common GI disturbances (e.g., diarrhoea, nausea, and vomiting) after week 24 was low (ranging from 0.6-3% for apremilast 20mg and 0-1.8% for apremilast 30mg). There were no clinically meaningful laboratory findings with exposure up to 52 weeks.

No safety signals with respect to major cardiac events, malignancies, and opportunistic infections were observed, consistent with the 0-24 week period. No cases of lymphoma, tuberculosis, or tuberculosis reactivations were reported for the 52-week period.


Contact: EULAR Press Office
European League Against Rheumatism

Related medicine news :

1. No increased risk of infection for long-term sex partners of people with HPV-related oral cancers
2. Integrated stroke care system results in fewer deaths, discharges to long-term care facilities
3. Sun Damage - The Long-Term Benefits of Sunscreen
4. Long-Term Use of Antibiotic May Help Those With COPD
5. Long-term outcomes in patients with advanced coronary artery disease are better than expected
6. Erectile Dysfunction Tied to Long-Term Narcotic Use in Men
7. Long-term use of prescription painkillers for back pain linked to erectile dysfunction in men
8. BMA Affordable Assisted Living Community to Host Informational Program on Long-Term Care Insurance
9. hCGTreatments / Diet Doc hCG Diets & Weight Loss Plans Offers New Unlimited Support To Dieters, Making the Transfer to Long-term Improved Health Easier
10. A "FAST" Response to Stroke Can Reduce Long-Term Damage
11. Chickenpox Shot Provides Long-Term Protection, Study Finds
Post Your Comments:
(Date:11/30/2015)... , ... November 30, 2015 , ... ... Beard and Brooke Bennett are collaborating with brands across various categories through traditional ... influential figures make up an elite group of Gold Medal Moms who can ...
(Date:11/30/2015)... ... December 01, 2015 , ... The National ... 2015-2016 inductee into its VIP Woman of the Year Circle. She is recognized ... networking organization exclusively for professional women, boasting 850,000 members and over 200 operating ...
(Date:11/30/2015)... ... 30, 2015 , ... During the National Family Caregivers Month, ... two webinars on topics of ‘Medical and Palliative Care Decisions,’ and ‘Self-Care for ... . , With a loved one's diagnosis of mesothelioma, the closest family member ...
(Date:11/30/2015)... ... November 30, 2015 , ... MOSI recently added two state-of-the-art augmented reality ... to the Jurassic to their collection of interactive exhibits within the Kids In Charge! ... will allow guests to get closer than ever to a range of animals as ...
(Date:11/30/2015)... ... November 30, 2015 , ... ... across the United States to access life-saving information provided directly from top ... will consist of three individual conferences in three major cities: Houston, San Francisco, ...
Breaking Medicine News(10 mins):
(Date:11/30/2015)... 2015  Kevin Smith has been appointed Chief ... pioneer in wireless monitoring of vital signs.  As ... , Mr. Smith will be responsible for the ... He will also directly oversee partnering with US ... for SensiumVitals, the first early warning detection device ...
(Date:11/30/2015)... LAKE, N.J. and SAN DIEGO ... and Arena Pharmaceuticals, Inc. (NASDAQ: ARNA ) today ... has accepted for filing the New Drug Application (NDA) ... the extended release formulation will offer patients a chronic ... ® ) is currently approved as an ...
(Date:11/30/2015)... iCAD, Inc. (Nasdaq: ICAD ) ... solutions for advanced image analysis and workflow tools ... Radiological Society of North American (RSNA) 2015 Annual ... November 29 to December 4, 2015. The company ... automated breast density assessment solution, PowerLook® Advanced Mammography ...
Breaking Medicine Technology: