Treatment for Painful Curved Penis Shows Promise

Xiaflex up for FDA approval later this year, but some experts think injections required would be a tough sell

By Barbara Bronson Gray

HealthDay Reporter

WEDNESDAY, May 8 (HealthDay News) -- Some diseases are especially tough to discuss.

When Tony Lee realized that his penis was curving whenever he had an erection -- making it painful and difficult for him to have sex -- he had no idea what was wrong. He became depressed and very worried, and his relationship with his wife started to change.

"For a man to dread sex, it's just not natural," he said. "There were times when I would stay up late on purpose, just to make sure my wife was sleeping before I got into bed. I was just totally embarrassed."

His wife finally convinced him to see his primary care physician, who referred him to a urologist. The specialist told him he had Peyronie's disease, a connective tissue disorder involving the growth of fibrous collagen plaques in the soft tissue of the penis. The condition can cause pain, erectile dysfunction and shortening of the penis.

The diagnosis was difficult to face.

"You do freak out. It's such a personal area. It's like, 'Noooooo! Why couldn't I just lose a finger? Anything but this,'" said Lee, who is 46. Lee asked that his full name not be used.

Experts estimate Peyronie's disease, a connective tissue disorder, affects at least 5 percent of men. Although the cause of the disorder is not known, physicians think genetic predisposition and repetitive minor trauma to the penis during sexual activity may play a role. People with diabetes, and those who have had prostate cancer surgery or erectile dysfunction, are also susceptible to the disease, according to Dr. Larry Lipshultz, a professor of urology at Baylor College of Medicine.

The treatment options are very limited, and there is no cure. "There is no oral or topical medication," said Dr. Elizabeth Kavaler, a urologist at Lenox Hill Hospital, in New York City. "You can excise the plaque and tighten up the other side, but that reduces the length, or you can use a penile prosthesis."

Lipshultz said he's had some luck with about half of his patients when he gives them a drug called verapamil, a calcium channel blocker, which is injected into the shaft of the penis. The use of the drug is based on its ability to degrade collagen, slowing, preventing or even reversing plaque formation and the progression of Peyronie's disease, according to a 2002 study published in the International Journal of Impotence Research. A verapamil gel that is applied to the skin is also sometimes used, according to Kavaler.

Lee, who has been dealing with Peyronie's for about two years, has used a "straightening machine" that stretches the penis, and he participated in one of two clinical trials for a new drug that is up for review by the U.S. Food and Drug Administration: Xiaflex, produced by Auxilium Pharmaceuticals Inc. He said his penis is now 70 percent of its pre-disease length as a result of the interventions.

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Treatment for Painful Curved Penis Shows Promise

By Barbara Bronson Gray
HealthDay Reporter

WEDNESDAY, May 8 (HealthDay News) -- Some diseases are especially tough to discuss.

When Tony Lee realized that his penis was curving whenever he had an erection -- making it painful and difficult for him to have sex -- he had no idea what was wrong. He became depressed and very worried, and his relationship with his wife started to change.

"For a man to dread sex, it's just not natural," he said. "There were times when I would stay up late on purpose, just to make sure my wife was sleeping before I got into bed. I was just totally embarrassed."

His wife finally convinced him to see his primary care physician, who referred him to an urologist. The specialist told him he had Peyronie's disease, a connective tissue disorder involving the growth of fibrous collagen plaques in the soft tissue of the penis. The condition can cause pain, erectile dysfunction and shortening of the penis.

The diagnosis was difficult to face.

"You do freak out. It's such a personal area. It's like, 'Noooooo! Why couldn't I just lose a finger? Anything but this,'" said Lee, who is 46. Lee asked that his full name not be used.

Experts estimate Peyronie's disease, a connective tissue disorder, affects at least 5 percent of men. Although the cause of the disorder is not known, physicians think genetic predisposition and repetitive minor trauma to the penis during sexual activity may play a role. People with diabetes, and those who have had prostate cancer surgery or erectile dysfunction, are also susceptible to the disease, according to Dr. Larry Lipshultz, a professor of urology at Baylor College of Medicine.

The treatment options are very limited, and there is no cure. "There is no oral or topical medication," said Dr. Elizabeth Kavaler, an urologist at Lenox Hill Hospital, in New York City. "You can excise the plaque and tighten up the other side, but that reduces the length, or you can use a penile prosthesis."

Lipshultz said he's had some luck with about half of his patients when he gives them a drug called verapamil, a calcium channel blocker, which is injected into the shaft of the penis. The use of the drug is based on its ability to degrade collagen, slowing, preventing or even reversing plaque formation and the progression of Peyronie's disease, according to a 2002 study published in the International Journal of Impotence Research. A verapamil gel that is applied to the skin is also sometimes used, according to Kavaler.

Lee, who has been dealing with Peyronie's for about two years, has used a "straightening machine" that stretches the penis, and he participated in one of two clinical trials for a new drug that is up for review by the U.S. Food and Drug Administration: Xiaflex, produced by Auxilium Pharmaceuticals Inc. He said his penis is now 70 percent of its pre-disease length as a result of the interventions.

Xiaflex, which breaks down the scar tissue that is a component of penile plaque, was approved by the FDA in 2010 to treat Dupuytren's contracture, an inherited connective tissue disorder that causes the fingers to bend toward the palm. The concept of using Xiaflex with Peyronie's is based on some common features of both diseases. The hand condition is caused by an abnormal buildup of a substance called collagen. Fingers begin to bend toward the palm and the patient cannot straighten them.

The two clinical trials designed to test how Xiaflex worked in people with Peyronie's disease -- done in 2011 and 2012 -- together involved a total of 551 patients who received Xiaflex and 281 who were given a placebo. Each participant received four to six injections with a small needle into the penis every 25 to 72 hours over a period of several weeks. "The results showed people got a 30 percent improvement in curvature, which is clinically significant in terms of function," Lipshultz said

Recent data on the treatment appeared online in February and will be published in the July print issue of the Journal of Urology.

Lipshultz, who was involved in the clinical trials and is paid by Auxilium to speak to physicians about the treatment, said the company thinks Xiaflex will be approved by the FDA by mid-September.

Yet, Kavaler expressed concerns about whether Xiaflex will be helpful.

"The data show it looks like the drug made people feel better about their condition, maybe because they were getting treatment in the clinical trial, but I'm not sure if functionally it made a big difference," she said. "I don't think I could convince somebody to let me inject their penis four to six times with the hope of getting some small improvement."

Side effects from the injection of the drug included: bruising, swelling and pain. There were also three serious adverse events involving penile fracture and three hematomas, according to Auxilium Pharmaceuticals.

But Lee is hopeful.

"I was so far gone with this, the curvature was so bad, and so I feel a whole lot better about myself now," he said. "It's kind of like if a person was paralyzed, and then all of a sudden you can walk, even though you might need assistance, it's a wonderful thing. That's how I'm looking at it."

Lee encouraged people to involve their partners to help them deal with the disease. "If there is a significant other in your life, you guys need to come together with this. For me, that made all the difference."

Copyright © 2013 HealthDay. All rights reserved. SOURCES: Larry Lipshultz, M.D., professor, urology, and chief, division of male reproductive medicine and surgery, Baylor College of Medicine, Waco, Texas; Elizabeth Kavaler, M.D., urologist, Lenox Hill Hospital, New York City; Tony Lee, Georgia; April 23, 2013, press release, Auxilium Pharamacuticals

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Gene-Based Blood Test for Colon Cancer Shows Promise

Early trial supports accuracy of the screening, which could be a boon in preventing the disease

By Robert Preidt

HealthDay Reporter

WEDNESDAY, June 19 (HealthDay News) -- Could screening for colon cancer someday be as easy as having a blood test? Researchers say just such a test is showing early promise in trials.

The screening checks for levels of miR-21 -- a piece of DNA known as microRNA. Researchers in the gastrointestinal cancer research lab at the Baylor Research Institute in Dallas studied several hundred patients with either colorectal polyps (noncancerous growths that often precede cancer) or full-blown cancer.

They found that measuring levels of miR-21 in the blood accurately spotted up to 92 percent of patients with colorectal cancer.

The test also accurately identified up to 82 percent of patients with advanced colorectal polyps -- growths that put people at high risk of developing colorectal cancer.

The study was published June 19 in the Journal of the National Cancer Institute.

"This blood-based test could be transformative in how we screen patients for colorectal cancer; it would save lives and could result in major savings of health care dollars," Dr. Michael Ramsay, president of Baylor Research Institute, said in an institute news release.

Other experts were cautiously optimistic.

"These results are very promising for the future of cancer screening and treatment," said Dr. Jerald Wishner, director of colorectal surgery at Northern Westchester Hospital in Mount Kisco, N.Y.

"Colonoscopy screening is the current gold standard to detect colon cancer. However, less than 50 percent of Americans who should be screened get screened," Wishner said. "The blood test is a less invasive screening method that will eliminate barriers to colonoscopies, including embarrassment and possible discomfort in preparation for the test."

Dr. David Robbins, associate chief of endoscopy at Lenox Hill Hospital in New York City, agreed that it is "only a matter of time before we can screen for the most common, and most lethal, cancers using a simple blood test."

"This well-designed study brings us one step closer to the holy grail of colon cancer eradication by identifying those at high risk for developing colon cancer by measuring a pretty straightforward genetic signature," Robbins said.

According to the American Cancer Society, colon cancer is the second leading cancer killer, after lung cancer. More than 102,000 new cases of the disease will be diagnosed among Americans this year, and almost 51,000 people will die from the disease in 2013.

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Treatment for New, Deadly Coronavirus Shows Promise

THURSDAY, April 18 (HealthDay News) -- A treatment for a new coronavirus that has caused 11 deaths, mostly in the Middle East, shows promise in early tests, U.S. government researchers report.

The investigators discovered that a combination of two antiviral drugs -- ribavirin and interferon-alpha 2b -- can stop the so-called nCoV coronavirus from multiplying in laboratory-grown cells. While the results suggest that this drug combination could be used to treat patients infected with nCoV, more research is needed to confirm these early findings.

Both drugs are approved in the United States for treating people with hepatitis C.

The nCoV coronavirus was first identified in Saudi Arabia in September 2012. As of April 16, 2013, there had been 17 reported cases, including 11 deaths. Most cases have occurred in the Middle East.

While the number of cases is small, there has been person-to-person transmission of the nCoV coronavirus in situations where people -- mainly family members -- have had close contact with infected people, the researchers noted in a news release from the U.S. National Institute of Allergy and Infectious Diseases (NIAID).

That, along with the high death rate, led the NIAID researchers to look for treatments. In laboratory tests using cells from two monkey species, the research team found that either ribavirin or interferon-alpha 2b alone could stop nCoV from replicating in the cells.

However, the drug concentrations needed to do this were higher than what is recommended for people. The researchers then combined the two drugs, and found that they were effective at a dose that can be used in people, according to the study in the April 18 issue of the journal Scientific Reports.

-- Robert Preidt
Copyright © 2013 HealthDay. All rights reserved. SOURCE: U.S. National Institute of Allergy and Infectious Diseases, news release, April 18, 2013

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New Kind of Therapy Shows Early Promise in MS Patients

Approach may shield patients' immune systems to allow safer treatment, study suggests

By Brenda Goodman

HealthDay Reporter

WEDNESDAY, June 5 (HealthDay News) -- A new therapy for multiple sclerosis that teaches the body to recognize and then ignore its own nerve tissue appears to be safe and well-tolerated in humans, a small new study shows.

If larger studies prove the technique can slow or stop the disease, the therapy would be a completely new way to treat autoimmune diseases such as multiple sclerosis (MS) and type 1 diabetes.

Most treatments for MS and other autoimmune diseases work by broadly suppressing immune function, leaving patients vulnerable to infections and cancers.

The new treatment targets only the proteins that come under attack when the immune system fails to recognize them as a normal part of the body. By creating tolerance to only a select few proteins, researchers hope they will be able to cure the disease but leave the rest of the body's defenses on guard.

"This is important work," said Dr. Lawrence Steinman, a professor of neurology at Stanford University who was not involved with the study.

"Very few investigators are trying therapies in humans aimed at simply turning off unwanted immune responses and leaving the rest of the immune system intact to fight infections -- to do surveillance against cancer," Steinman said. "The early results show encouragement."

For the study, published in the June 5 issue of the journal Science Translational Medicine, researchers in the United States and Germany recruited nine patients with MS. Seven had the relapsing-remitting form of the disease, while two others had secondary progressive MS (a more advanced phase). All were between the ages of 18 and 55, and were in good health except for their MS.

Blood tests conducted before the treatments showed that each patient had an immune reaction against at least one of seven myelin proteins.

Myelin is a white tissue made of fats and proteins that wraps nerve fibers, allowing them to conduct electrical signals through the body. In MS, the body attacks and gradually destroys these myelin sheaths. The damage disrupts nerve signals and leads to myriad symptoms, including numbness, tingling, weakness, loss of balance and disrupted muscle coordination.

Six patients in the study had low disease activity, while three others had a history of more active disease. Most were not experiencing symptoms at the time of their treatment.

On the day of the treatments, patients spent about two hours hooked up to a machine that filtered their blood, harvesting white cells while returning red cells and plasma to the body.

After the white cells were collected, they were washed and then combined with seven proteins that make up myelin tissue. A chemical was used to link the proteins to the white blood cells, which were dying.

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'Sensory-Focused' Autism Therapy Shows Early Promise

In small study, parents used variety of methods to stimulate boys' senses

By Mary Brophy Marcus

HealthDay Reporter

WEDNESDAY, June 5 (HealthDay News) -- Smelling essential oils, walking across textured surfaces, immersing hands in warm water -- these are just some of the therapeutic experiences that boys with autism had while participating in a small new study.

The scientists wanted to learn how "sensory-motor" therapy compared to traditional behavioral therapy methods in boys with autism.

Twenty-eight boys aged 3 to 12 and their parents participated in the six-month-long study, published online May 20 in Behavioral Neuroscience. The boys were split into two groups. Both groups of children participated in daily behavioral therapy, but 13 of the boys also received environmental enrichment, another term for sensory-motor therapy.

The environmental enrichment therapy had a significant positive effect on these children with autism, the study authors said.

"What we've done here for the first time is give humans a sensory-enriched environment and found out that a neurological disorder -- autism -- responds favorably. We saw a 600 percent greater likelihood of having a positive clinical outcome in individuals that had enriched environments compared to those receiving the standard care that children have been receiving for autism up to this point," said study author Michael Leon, a professor of neurobiology and behavior at Center for Autism Research and Treatment at the University of California, Irvine.

However, an autism expert who wasn't part of the study cautioned that other sensory-based therapies showing early promise haven't proven effective so far.

For the new study, parents of the children in the sensory enrichment group were given a kit that contained a broad range of materials aimed at stimulating their child's senses of smell, temperature, texture, sight and movement. Vials of essential oils scented of apple, lavender, sweet orange and vanilla, were among the items. Squares of different textured materials included smooth foam, hardwood flooring, sponges, felt and sandpaper.

The children were also given the opportunity to play with objects: beads, a small piggy bank with plastic coins, pictures of famous art, a can of Play-Doh, a bowl to hold warm or cool water and more.

The researchers asked parents to conduct two therapy sessions a day with their child, and to run four to seven different exercises during each session that involved different combinations of the items in the kit. Sessions ranged from 15 to 30 minutes. The children also listened to classical music once a day.

As the six-month period progressed, parents were encouraged to offer more complex enrichment exercises. For example, a child would be given the chance to select a textured square and in addition to feeling it would be encouraged to match it to another square of the same material.

By the end of the six months, Leon said the enrichment group children had significantly improved compared to the children who received standard therapy alone. He said 42 percent of the boys in the enrichment group improved in their ability to relate to other people and in their ability to respond to sights and sounds, compared with 7 percent of the standard care group.

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Drug Shows Promise Against Advanced Melanoma

In preliminary trial, nivolumab shrank tumors in 30 percent of tough-to-treat patients

By Alan Mozes

HealthDay Reporter

SATURDAY, June 1 (HealthDay News) -- Nearly one-third of patients with advanced melanomas who received nivolumab, a new immune-based drug, experienced reductions in the size of their tumors, a preliminary study reveals.

Since these types of drugs have typically shrunk tumors in only 5 percent to 10 percent of patients in prior studies, the new results are a boost for immunotherapy generally, the researchers noted.

"I think nivolumab is a real breakthrough drug for patients with metastatic melanoma, and probably for other diseases, too," study author Dr. Mario Sznol, a professor of medical oncology at the Yale Cancer Center in New Haven, Conn., said in a news release.

"The high level of activity observed with this drug opens up a number of avenues for future research to understand and challenge the ways tumors evade the immune system. We're very excited that there is potential for even more activity in combination with other drugs," Sznol added.

One expert not connected to the study was also optimistic about the results.

"Nivolumab shows exciting promise for patients suffering from an otherwise fatal disease -- metastatic melanoma," said Dr. Michele Green, a dermatologist at Lenox Hill Hospital in New York City. "The fact that 30 percent of patients showed improvement from this immunotherapy drug is remarkable since these patients had some of the worse disease."

The study was funded by drugmaker Bristol-Myers Squibb and is scheduled for presentation Saturday at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Findings presented at medical meetings are typically considered preliminary until published in a peer-reviewed journal.

According to the researchers, nivolumab works by honing in on PD-1 cellular receptors located on immune system T-cells. These receptors are known to function as immune system "gatekeepers," and by working to open such gates the patient's immune system is triggered into cancer-fighting action.

The new study involved 107 patients, all of whom had been previously treated with multiple forms of standard therapies that failed to halt their disease.

Following treatment with one of five different doses of nivolumab, the team found that 31 percent of the patients went on to experience a minimum tumor shrinkage of 30 percent across the various doses.

Forty-three percent of the patients are estimated to have survived two years after treatment, the researchers said, and average survival for patients across all treatment doses is now projected to be nearly 17 months.

In an ASCO news release, melanoma expert Dr. Lynn Schuchter called the results "truly remarkable."

The findings "confirm that 'revving' up the immune system is a powerful approach in shrinking melanoma," said Schuchter, who is also a spokeswoman for ASCO. "Melanoma patients are living longer and better with these new treatments."

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Experimental Drugs Show Promise Against Prostate Cancer

Tumor growth suppressed in lab tests; human trials still needed, study authors say

By Mary Elizabeth Dallas

HealthDay Reporter

FRIDAY, May 31 (HealthDay News) -- Researchers have identified a new class of drugs that show promise for treating advanced prostate cancer. The drugs, known as peptidomimetics, interfere with the signaling necessary for prostate cancer cells to grow, according to a new study.

Prostate cancer depends upon the actions of androgens, such as the hormone testosterone. Androgens activate androgen receptors, resulting in a signal that causes prostate cancer cells to grow.

To stop tumor growth, men with prostate cancer have been treated with drugs to block the production of androgens or block the receptor where androgens bind. However, tumors can grow despite this treatment because of mutations in androgens or receptors.

In the latest study, published online May 28 in Nature Communications, a team of researchers led by Dr. Ganesh Raj, associate professor of urology at UT Southwestern Medical Center at Dallas, found the nontoxic peptidomimetic agents could disrupt androgen-receptor signaling and prevent tumor growth.

When tested in mouse and human tissue models, the drugs blocked the activity of androgens by attacking the protein in a different spot from where the androgen binds, the researchers explained. As a result, prostate cancer cells do not receive the signal to grow -- even when the androgen receptor is activated.

"We are hopeful that this novel class of drugs will shut down androgen-receptor signaling and lead to added options and increased longevity for men with advanced prostate cancer," Raj, the study's senior author, noted in a university news release.

One expert was optimistic about the new findings.

"The study represents a significant step forward in the development of a new molecular targeted therapy for advanced prostate cancer," said Dr. Manish Vira, director of the Fellowship Program in Urologic Oncology at North Shore-LIJ's Arthur Smith Institute for Urology in Lake Success, N.Y.

He said the new drug works at "preventing the [cell] receptor from promoting cancer cell growth signaling," and added that "the study is proof in principle that rationale design of peptidomimetics can lead to the development of a new class of anti-cancer therapy."

The researchers noted more testing is needed before the drugs could progress to clinical trials involving humans. Results obtained in laboratory experiments are not always replicated in humans.

"Most drugs now available to treat advanced prostate cancer improve survival rates by three or four months," Raj added. "Our new agents may offer hope for men who fail with the current drugs."

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Immune Therapy Shows Early Promise for Advanced Leukemia

Title: Immune Therapy Shows Early Promise for Advanced Leukemia
Category: Health News
Created: 3/20/2013 4:35:00 PM
Last Editorial Review: 3/21/2013 12:00:00 AM

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DNA Test Shows Promise in Guiding Advanced Breast Cancer Care

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Gene Therapy Shows Early Promise for Heart Failure

By Amy Norton

HealthDay Reporter

THURSDAY, Feb. 21 (HealthDay News) -- When it comes to treating heart failure, the ultimate hope is to develop a therapy that repairs the damaged heart muscle.

Now, an early study hints at a way to do that by harnessing the body's natural capacity for repair.

Heart failure is a chronic, progressive condition where the heart cannot pump blood efficiently enough to meet the body's needs, which leads to problems like fatigue, breathlessness and swelling in the legs and feet. Most often, it arises after a heart attack leaves heart muscle damaged and scarred.

In the new study, researchers were able to use gene therapy to modestly improve symptoms in 17 patients with stage III heart failure -- where the disease is advanced enough that even routine daily tasks become difficult.

What is novel about the tactic, the researchers said, is that the gene therapy is designed to attract the body's own stem cells to the part of the heart muscle that's damaged. The hope is that the stem cells will then get some repair work done.

The findings, published Feb. 21 in the journal Circulation Research, are preliminary, and much more research needs to be done.

"This is a proof-of-concept study," explained lead researcher Dr. Marc Penn, a professor at Northeast Ohio Medical University in Rootstown, and director of research at Summa Cardiovascular Institute in Akron. But Penn and other heart failure experts said they were cautiously optimistic about the therapy's potential for at least some patients.

Stem cells are primitive cells that can develop into different types of body tissue. Adults have the cells in their bone marrow, and they give rise to blood cells. Researchers have also found that individual organs in the body, including the heart, have their own pools of stem cells.

Those stem cells may try to repair damaged tissue, but they are not all that successful, Penn said. So his team sought to give the stem cells a helping hand. They infused patients' heart muscle with three different doses of a drug that carried a gene for SDF-1, a natural protein in the body believed to recruit stem cells to sites of tissue damage.

Lab research has suggested that after a heart attack, SDF-1 activity in the heart goes up -- but only for a short time, Penn said. The goal of the experimental therapy is to enhance SDF-1 and draw more stem cells to where they are needed.

The initial results are promising, Penn said. The approach seemed safe, with no major side effects linked to the treatment. Two of the study patients died within a year, but the deaths were deemed not to be connected to the treatment.

Among the 15 patients who were alive one year later, there were improvements in their symptoms and walking ability.

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Surgical Delivery of Drug Shows Promise Against 'Bleeding' Stroke

Title: Surgical Delivery of Drug Shows Promise Against 'Bleeding' Stroke
Category: Health News
Created: 2/7/2013 2:36:00 PM
Last Editorial Review: 2/8/2013 12:00:00 AM

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Drug Shows Promise for Lupus Skin Conditions

BySalynn Boyles
WebMD Health News Reviewed byLouise Chang, MD

Dec. 7, 2012 -- A drug related to thalidomide may be more potent and less toxic than thalidomide, which is often used to treat lupus skin conditions.

In a small study from Spain, lupus patients showed dramatic improvements in skin lesions while taking the drug, lenalidomide (Revlimid), and most relapsed soon after they stopped taking it.

Thalidomide’s Infamous Past

Thalidomide is best known as the drug that caused thousands of children to be born with missing limbs and other birth defects in the late 1950s and early 1960s.

In more recent years it has been brought back to the market to treat a number of serious conditions, but its use is monitored closely to ensure that it is not taken by women who are pregnant or who might become pregnant.

Dermatology professor Andrew G. Franks Jr., MD, of the NYU Langone Medical Center, says thalidomide is very effective for treating people with lupus skin conditions who do not respond to standard treatments such as steroids and antimalarial drugs.

He says about 75% of patients with affected skin will go into remission with these standard treatments.

“The question has been, ‘What do you do with the rest?’” he says.

Franks says thalidomide can help an additional 75% of patients achieve remission. But side effects are common and some, including nerve damage in the hands and feet, can be permanent.

Lenalidomide Highly Effective in Small Study

The lenalidomide study included 15 women with lupus skin conditions; six had lupus in other areas of the body, too. They all were followed for seven to 30 months.

All had received standard treatments, and 14 had been treated with thalidomide previously.

The majority of the patients (60%) had the most common subtype of lupus-related skin disease, known as discoid lupus erythematosus, which is characterized by red, scaly patches that can scar.

One patient withdrew from the study after one week due to digestive system side effects. All the other patients showed improvement, and the rash cleared up in 86%.

The researchers note that the study dose was “generally well-tolerated.” No new nerve symptoms were reported.

Similar to treatment with thalidomide, most of the patients had a relapse of their skin problems within weeks of stopping the drug.

No Progression to Full Disease

Several earlier small studies raised concerns that treatment with lenalidomide may be linked to an increased risk of progression to full-blown lupus, not just lupus limited to the skin.

Josep Ordi-Ros, who led the Spanish study, says this was not seen in the latest study, which was published Dec. 6 in the journal Arthritis Research & Therapy.

But Cynthia Aranow, MD, of the Feinstein Institute for Medical Research in Manhasset, N.Y., says larger studies will be needed to determine if the drug is truly safe and effective for patients who do not respond to other treatments.

She adds that the drug appears to have a similar risk for birth defects as thalidomide, so it will need to be monitored just as carefully.

“There are many questions that remain,” she says.

Lenalidomide is available as Revlimid to treat people with multiple myeloma and myelodysplastic syndromes. According to the manufacturer’s site, the cost of Revlimid at the doses used in this study would be about $440 a pill.

View Article Sources

SOURCES:

Cortes-Hernandez, J. Arthritis Research & Therapy, Dec. 6, 2012.

Andrew G. Franks, Jr., MD, director, Skin, Lupus & Autoimmune Connective Tissue Disease Center; clinical professor of dermatology and medicine (rhematology), NYU Langone Medical Center, New York.

Cynthia Aranow, MD, researcher, Feinstein Institute for Medical Research, Manhasset, N.Y.

News release, BioMed Central.

Revlimid web site: "Information for Prescribers of Prescription Drugs."

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