Some Dermatology Program Directors Continue to Violate Match Program Rules

In 2009, a joint study from researchers in Florida and California demonstrated that some program directors violated policy requirements of the National Resident Matching Program (NRMP). A follow-up study published online ahead of print in the Journal of the American Academy of Dermatology (JAAD) reveals that, despite knowledge of these violations, some dermatology match program personnel continue to violate NRMP policy.

The researchers from Stanford University School of Medicine in California and the University of Florida College of Medicine re-distributed the 2009 study to 2011 applicants to the department of dermatology at Stanford’s medical school. The survey found that among the applicants, 14% were asked to reveal how they intended to rank a program before Match Day and 32% felt pressure to disclose how they intended to rank programs. An overwhelming majority (90%) were asked about interviews with other programs. Slightly fewer than half of applicants (44%) were asked about their marital status and 19% were asked if they had children or intended to have children.

While the researchers acknowledge a poor response rate (53%), the study reveals that some dermatology program personnel continue to violate NRMP policy, despite awareness of the issue raised by the first study. The authors “continue to recommend that programs avoid post-interview contact and recommend that the NRMP create training videos for applicants and interviewers.”

Sbicca JA, Gorell ES, Peng DH, Lane AT. A follow-up survey of the integrity of the dermatology National Resident Matching Program. J Amer Acad Derm, 2011, doi:10.1016/j.jaad.2011.09.035

iPledge Program is Effective, Though Inevitable Problems Remain

The iPLEDGE program is effectively monitoring isotretinoin use in women of childbearing potential, according to the results of a meeting of the Drug Safety and Risk Management Advisory Committee and the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) held in December 2011.

More than 5 years after iPLEDGE was implemented, the program’s primary goal — to prevent patients from starting isotretinoin therapy if pregnant or from becoming pregnant during therapy and for 30 days post-therapy — is being met, according to researchers.

The FDA concludes: “iPLEDGE is necessary to ensure that the benefits of isotretinoin for nodular acne outweigh the risk of a potent human teratogen and that it is ensuring delivery of needed knowledge and clinical practices for the majority of patients.”

Despite this success, the committee did highlight some problems with iPLEDGE that are essentially unavoidable. “The number of fetal exposures to isotretinoin is an obvious direct metric for determining iPLEDGE effectiveness,” the committee writes. “This metric, however, presents two problems that FDA finds challenging.”

The first of these concerns is the inability to determine “how many pregnancies are too many.” While the goal of iPLEDGE is to prevent all fetal exposure to isotretinoin, the DODAC acknowledges that this is impossible because “no risk management program can eliminate all the complex factors that contribute to unplanned pregnancy.”

Second, the committee believes it is “unlikely” that the total number of isotretinoin-exposed pregnancies is actually known.

“Since acne is not a life-threatening condition, women who stop taking the drug when discovering they are pregnant have no medical need to return to the iPLEDGE prescriber (usually a dermatologist),” according to the DODAC. “In fact, women who view iPLEDGE’s pregnancy reporting requirements as an invasion of their privacy have considerable disincentive to continue enrollment in iPLEDGE.”

Despite these concerns, DODAC concludes: “iPLEDGE gives prescribers and pharmacists a powerful web-based tool to optimize the probability that patients served under any healthcare delivery system benefit from systematized execution of best practices codified in the approved package insert for isotretinoin. While we work to develop a more technologically advanced, feasible strategy for systematically managing the use of potential teratogens, programs such as iPLEDGE are required to ensure continued availability of the drug product for eligible patients while minimizing the risk of fetal harm.”

To see the complete report, please visit http://bit.ly/uGPiFn.

FDA APPROVALS AND NEWS

Epiduo Pump Dispenser Receives FDA Approval

The FDA has approved a new pump dispenser for Epiduo Gel 0.1%/2.5%, the first dispenser of its kind for Epiduo, a once-daily topical acne treatment that combines adapalene, a retinoid, and benzoyl peroxide, an antimicrobial.

A recent study reveals the new pump is the preferred format for Epiduo. The randomized study of 291 acne patients between 12 and 35 years of age showed that nearly 80% of patients intended to request the pump rather than the tube at their next office visit, 88% reported that the pump made it easier to follow a physician’s instructions and more than 90% noted that the pump delivered a consistent amount of gel and saved time.

Epiduo is indicated for the treatment of acne in patients 12 years of age and older. The pump will be available by prescription in pharmacies nationwide the first quarter of 2012.

OTHER DRUG NEWS

Drug In Development For Psoriasis Also Effective For Atopic Dermatitis

In August, Anacor Pharmaceuticals reported positive results for AN2728, a drug in development for psoriasis. Now, Anacor reports, the same drug and another boron-based phosphodiesterase-4 (PDE-4) inhibitor, AN2898, have shown positive results in a Phase IIa trial for mild-to-moderate atopic dermatitis (AD).

The 6-week, double blind, bilateral trial included 46 patients randomized 1:1 to treat AD lesions with either 2% AN2728 ointment and vehicle or 1% AN2898 ointment and vehicle; 25 patients were treated with AN2728 and 21 with AN2898. Both drugs met their respective primary endpoints; 64% of patients treated with AN2728 had improvement in Atopic Dermatitis Severity Index (ADSI) scores from baseline compared to 24% of lesions treated with vehicle (P = 0.05). Nearly three-quarters of patients treated with AN2898 (71%) showed improvement in ADSI scores from baseline compared to 14% treated with vehicle (P = 0.01).

A full review of the trial is expected in early 2012, Anacor reports.

LEO Pharma Initiates Quality Care Program For Taclonex Patients

Leo Pharma Inc., a wholly-owned subsidiary of U.S.-based Leo Pharma A/S, has launched the Leo Quality Care Program, designed to provide patient education and support. Leo Pharma makes Taclonex, a group of prescription products for psoriasis.

The starter kit includes a sample of Taclonex Ointment or Taclonex Scalp Topical Suspension, a reduced copay card, patient education materials on the Taclonex website, access to a registered nurse support network and prescribing information.

Interested physicians should contact their Leo Pharmaceuticals representative. More information can also be found at www.taclonex.com.

Astellas Pharma US Discontinues Amevive

Astellas Pharma US has announced that it will no longer be manufacturing the plaque psoriasis drug alefacept (Amevive), citing “business needs” as the reason for the discontinuation.

The company stopped distribution of Amevive in November 2011. Physicians have until November 16, 2012 to return Amevive inventory for either the full contract price if the drug was purchased under an Astellas pricing agreement or 100% of current WAC if the purchase was not made under a pricing agreement.

Astellas recommends that physicians do not start any new patients on Amevive and begin to transition current patients to a different therapy. Current patients will have access to support programs (eg, reimbursement services and the Patient Assistance Program) through March 16th, 2012.

For more information, please visit www.amevive.com.

Intendis Changes Name to Bayer HealthCare

Intendis Inc., makers of dermatology brands azelaic acid (Finacea Gel 15%) and desonide (Desonate Gel 0.05%) will change its name to Bayer HealthCare. Under this new name, the unit will continue to build on Intendis’ long-standing dedication to dermatologists, patients and passion for skin health.

According to the company, while all Intendis Inc., branding will be changed to reflect the Bayer brand, there will be no changes in the well-established organization, structure or product quality of the company. The points of contact assisting physicians, pharmacists and partner companies remain the same. Intendis has been an integrated part of the Bayer organization’s Consumer Care division since 2006, when Bayer acquired Schering AG.

ONLINE EXTRA

Stanford Researchers Identify Enzyme That May Play A Significant Role In The Development Of Scar Tissue

Focal adhesion kinase (FAK), an enzyme that is activated by physical force in the body, may play a significant role in the development of scar tissue, researchers from Stanford University School of Medicine report.

Working under the direction of senior author Geoffrey Gurtner, MD, professor and associate chair of surgery, researchers genetically engineered mice to lack the FAK enzyme. These mice had less inflammation and fibrosis in their incisions compared to control mice. Mice injected with the organic compound small molecule PF-573228, which blocks FAK, also had reduced inflammation and scar formation.

According to the researchers, who published the results of the study in Nature Medicine, the FAK enzyme has been implicated in cellular responses to force, but it was unclear whether FAK was related to scarring and inflammation. In the present study, mice genetically engineered to lack the FAK enzyme had incisions that healed normally, but the scars that formed were markedly diminished. Ten days after the incision, the FAK-lacking mice had 48% fewer scar tissue cells around the incision than mice in a control group.

“We just haven’t taken the physical environment — the environment of mechanical forces that hold all our cells together — seriously enough as a source of inflammation and fibrosis,” Dr. Gurtner explains.

While tests in human skin are needed before this could be considered a viable therapeutic approach, the researchers believe this discovery has significant potential.

“These results suggest that targeted strategies to uncouple mechanical force from inflammation and fibrosis may prove clinically successful across diverse organ systems,” the researchers write.

Wong VW, Rustad KC, Akaishi S, Sorkin M, Glotzbach JP, Januszyk M, et al. Focal adhesion kinase links mechanical force to skin fibrosis via inflammatory signaling. Nature Med, 2011, doi: 10.1038/nm.2574

Psoriasis Patients With Inadequate Response To Etanercept may Benefit from Infliximab

Psoriasis patients who do not respond to etanercept, a tumor necrosis factor-alpha (TNF-a) inhibitor, may benefit from a switch to infliximab, another TNF-a inhibitor, according to a new study in JAAD.

Adults with moderate-to-severe plaque psoriasis and an inadequate response (IR) to etanercept were eligible to participate; 215 patients enrolled. At week 10, 65.4% (95% confidence interval [CI]: 58.6%-71.8%) of participants achieved a Physician’s Global Assessment (PGA) score of clear (0) or minimal (1), the primary endpoint. This response was durable through week 26, when 61.3% (95% CI: 54.2%-68.1%) of patients achieved a PGA score of 0 or 1. No unexpected side effects or safety issues were noted.

Writing in JAAD, the researchers conclude: “After switching to infliximab, a substantial portion of patients with psoriasis and IR to etanercept experienced rapid and durable improvement.”

Gottlieb AB, Kalb RE, Blauvelt A, Heffernan MP, Sofen HL, Ferris LK, et al. The efficacy and safety of infliximab in patients with plaque psoriasis who had an inadequate response to etanercept: Results of a prospective, multicenter, open-label study. Jour Amer Acad Derm, 2011, published online 12 December.