Featured Research

from universities, journals, and other organizations

New oral treatment shows significant promise in the treatment of mouth and genital ulcers in people with Behcet's syndrome

Date:
October 27, 2013
Source:
American College of Rheumatology (ACR)
Summary:
Apremilast, an orally available small molecule modulating several inflammatory pathways, which is pending approval by the United States Food and Drug Administration, is showing promise in the treatment of mouth and genital ulcers in people with Behcet’s syndrome, according to new research.

Apremilast, an orally available small molecule modulating several inflammatory pathways, which is pending approval by the United States Food and Drug Administration, is showing promise in the treatment of mouth and genital ulcers in people with Behcet's syndrome, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in San Diego.

Behcet's syndrome is a type of vasculitis that causes inflammation in the blood vessels throughout the body. Among other symptoms, the main symptom of Behcet's is painful ulcers in the mouth and genital areas, and researchers recently discovered Apremilast is both safe and effective in treating these ulcers -- a promising finding for the 5,000 to 15,000 Americans who suffer from the disease.

"Mucocutaneous lesions in Behçet's syndrome can be painful and occasionally disabling, impairing the quality of life of patients," explains Gulen Hatemi, MD, the lead investigator in the study. "Currently available drugs may not control mouth or genital ulcers in some patients, or have potential adverse events that may limit their use. There is an unmet need for effective and safe treatment modalities that are easy to tolerate for these lesions.

In this phase-two study, which took place across multiple sites, 111 people with Behcet's (who did not have any organs affected by disease and had at least two ulcers at the beginning of the study) were randomly assigned to either take 30mg of Apremilast or placebo twice a day for 12 weeks. After the first 12 weeks, all participants were treated with Apremilast for an additional 12 weeks, and all patients were observed at a follow up appointment 28 days after the last dose of the drug.

Dr. Hatemi's team was primarily interested in noting the number of mouth ulcers and amount of pain each participant had at 12 weeks into the study, but they also noted the number of genital ulcers at the same point in time, pain of oral ulcers, the effectiveness of the treatment over time, each participant's disease activity, changes in health as reported by participants and any negative reactions patients had to the treatment.

Ninety-five of the 111 participants (who were, on average 34.5 years old and predominately female) completed the study. At 12 weeks, the average number of mouth ulcers among 50 participants on Apremilast was 0.5, compared to 2.1 in the 45 participants taking placebo. Notably, the beneficial effect of Apremilast began within two weeks of starting the treatment, and these benefits continued as long as the participants were receiving Apremilast. But, the beneficial effect disappeared shortly after Apemilast was stopped at 24 weeks.

Pain was also noted as being significantly lower in those on Apremilast; and at 12 weeks, significantly more participants on the treatment were completely free of mouth ulcers (71 percent on the treatment versus 29 percent on placebo).

Among the 16 participants who began the study with genital ulcers, 10 received Apremilast and six received placebo. The 10 on Apremilast were completely genital ulcer free at 12 weeks, compared to three of the six in the placebo group. Additionally, the average disease activity scores were found to have greater improvement among those who were given Apremilast versus those who received placebo. Finally, the researchers noted two serious medical events among those taking Apremilast: one participant experienced diplegia -- a type of paralysis -- which the researchers deemed unrelated to the treatment, and one patient worsened anal fissure and hemorrhoids while having diarrhea. Among the participants taking placebo, two had flares of their Behcet's and one experienced fever.

"In this study Apremilast decreased the number of oral ulcers and the associated pain, starting from two weeks of treatment onset. The drug was generally well tolerated with few adverse events. An improvement in quality of life and decrease in disease activity, as reported by the patient, was observed," says Dr. Hatemi. "These results warrant further work on the possible efficacy of Apremilast on other manifestations of Behçet's syndrome, including genital ulcers. Considering the important down regulating effect of Apremilast on the inflammatory cascade, such work also can also help us to better explain the disease mechanism(s) in Behçet's syndrome."


Story Source:

The above story is based on materials provided by American College of Rheumatology (ACR). Note: Materials may be edited for content and length.


Cite This Page:

American College of Rheumatology (ACR). "New oral treatment shows significant promise in the treatment of mouth and genital ulcers in people with Behcet's syndrome." ScienceDaily. ScienceDaily, 27 October 2013. <www.sciencedaily.com/releases/2013/10/131027123151.htm>.
American College of Rheumatology (ACR). (2013, October 27). New oral treatment shows significant promise in the treatment of mouth and genital ulcers in people with Behcet's syndrome. ScienceDaily. Retrieved September 20, 2014 from www.sciencedaily.com/releases/2013/10/131027123151.htm
American College of Rheumatology (ACR). "New oral treatment shows significant promise in the treatment of mouth and genital ulcers in people with Behcet's syndrome." ScienceDaily. www.sciencedaily.com/releases/2013/10/131027123151.htm (accessed September 20, 2014).

Share This



More Health & Medicine News

Saturday, September 20, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

Sierra Leone's Nationwide Ebola Curfew Underway

Sierra Leone's Nationwide Ebola Curfew Underway

Newsy (Sep. 20, 2014) — Sierra Leone is locked down as aid workers and volunteers look for new cases of Ebola. Video provided by Newsy
Powered by NewsLook.com
Changes Found In Brain After One Dose Of Antidepressants

Changes Found In Brain After One Dose Of Antidepressants

Newsy (Sep. 19, 2014) — A study suggest antidepressants can kick in much sooner than previously thought. Video provided by Newsy
Powered by NewsLook.com
Could Grief Affect The Immune Systems Of Senior Citizens?

Could Grief Affect The Immune Systems Of Senior Citizens?

Newsy (Sep. 19, 2014) — The study found elderly people are much more likely to become susceptible to infection than younger adults going though a similar situation. Video provided by Newsy
Powered by NewsLook.com
Jury Delivers Verdict in Salmonella Trial

Jury Delivers Verdict in Salmonella Trial

AP (Sep. 19, 2014) — A federal jury has convicted three people in connection with an outbreak of salmonella poisoning five years ago that sickened hundreds of people and was linked to a number of deaths. (Sept. 19) Video provided by AP
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:
from the past week

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins