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Following Suit

Centocor's new anti-TNF agent, Simponi (golimumab) is soon coming to market for the treatment of chronic immune types of arthritis. FDA approved the agent in April. It is the first self-administered, monthly, injected drug for moderate to severe rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. At 50mg, it is indicated:

  • In combination with methotrexate for the treatment of adult patients with moderately to severely active rheumatoid arthritis
  • Alone or in combination with methotrexate for the treatment of adult patients with active psoriatic arthritis
  • For the treatment of adult patients with active ankylosing spondylitis.

In a Phase 3 trial evaluating golimumab in the treatment of psoriatic arthritis, 50mg monthly significantly improved signs and symptoms of active psoriatic arthritis.

Similar to other TNF-alpha blockers, the FDA required a REMS for the agent, which includes a medication guide for patients and a communication plan to help prescribers understand the drug's risks. The most common adverse events are upper respiratory tract infections, sore throat, and nasal congestion.

Just days after the approval, Abbott filed a lawsuit against Centocor, contending that Simponi infringes on a patent owned by Abbott and issued in 2007. The patent covers certain methods for treating rheumatoid arthritis by using an antibody that neutralizes TNF together with methotrexate. Abbott is seeking a court declaration that Simponi infringes Abbott's patent, as well as damages. However, Abbott is not seeking a preliminary injunction, which would halt sales before a trial is held. Centocor has said it will fight the suit.

Phototherapy Comes Home
For years, phototherapy has been cited as an effective psoriasis treatment though hindered by impracticality. Recently, patients and physicians have taken interest in exploring more options, including home phototherapy. A new study found that ultraviolet B phototherapy administered at home is equally safe and effective as if it were administered in an outpatient setting (BMJ 2009; 338: b1542).

In two groups of patients-one treated at home and one in-office-researchers observed similar, significant reductions in PASI and SAPASI scores. Additionally, researchers found that patients treated at home had a significantly lower burden of undergoing UVB phototherapy. Although both groups had equal increases in quality of life, patients treated at home more often rated their experience with treatment as "excellent" (42 percent vs. 23 percent).

Seeking to expand the use and indication of Levulan photodynamic therapy, DUSA Pharmaceuticals recently announced the initiation of a company-sponsored study to evaluate the safety and efficacy of multiple broad area PDT for the treatment of AKs and reduction of new non-melanoma skin cancer in chronically immunosuppressed solid organ transplant recipients. The study will examine the effect of multiple courses of Levulan plus BLU-U on the treatment of AKs, as well as the reduction of the incidence of new non-melanoma skin cancers on the scalp or forearms of this patient group over the course of one year.

Pain-Free Foam
Results from an open label study assessing the reduction in Procedure-Associated Pain with the use of Anestafoam (lidocaine 4% foam, Onset Therapeutics) suggest that it may be acceptable to patients and clinicians for the safe and effective reduction of pain associated with cosmetic dermatologic laser procedures (J Clin Aest Dermatol, April). Primary endpoints were clinician and patient assessments of procedural pain intensity, recorded on a visual analog scale (VAS) for both treated and untreated areas. Secondary objectives included clinician indication of overall satisfaction and ease of foam application on a five point Likert scale and the patients' subjective assessment of increased comfort associated with Anestafoam during the procedures. Importantly, both clinician and patient VAS ratings of treated sites demonstrated significantly reduced pain compared to sites receiving no topical anesthesia. Seventy percent of patients indicated that the treated areas were more comfortable than the non-treated areas during the procedure. Clinician satisfaction reports for ease of application and overall product satisfaction were favorable.

Promising Kit
Sol-Gel Technologies has reported encouraging results from a comparative clinical study for the company's two strength anti-acne kits, containing a cleanser, toner and lotion. The Sol-Gel products feature timed-release benzoyl peroxide. Participants in the four-week, four-arm parallel group study were randomized to receive one of Sol-Gel's kits or a comparable leading commercial product. The principal investigator dermatologist assessed safety and tolerability, while also evaluating the rates and grades of erythema, edema, dryness, scaling/peeling, stinging/burning, itching and skin tightness. According to the company, results demonstrates that the company's two strength anti-acne kits achieved pronounced efficacy and markedly improved tolerability versus other products.

Sweating Infections
According to a new report, those who are more prone to excessive sweating are more likely to develop skin infections (JAAD, May). Researchers collected data for 387 patients who were diagnosed with primary hyperhidrosis, as well as for 410 age- and gender-matched patients who were diagnosed with an unrelated condition. They found that the overall risk of developing a skin infection caused by bacteria, fungi, or viruses was significantly higher for the patients with primary hyperhidrosis than those without (30 percent vs. 12 percent). Additionally, researchers observed an increased association with atopic or eczematous dermatitis in patients with primary hyperhidrosis (9.3 percent) versus those without (3.4 percent).

Finding Meaning
If you're as confused as most other medical professionals about the concept of "meaningful use" as it relates to Electronic Health Records and government incentives, consider logging onto That's where the Association of Medical Directors of Information Systems is hosting a dialogue about "meaningful use" in efforts to shape the definition of the term. The site also features news updates, links to resources, and more.

Melanoma Update
Recent studies may provide new insights on detection of melanoma and support the need for regular dermatologic skin exams. Results of one investigation indicated that physician-detected melanoma in older men is more likely to be thinner, more treatable, located on the back, and associated with a history of atypical nevi (Arch Dermatol. 145: 397). Given that nearly 80 percent of all melanoma deaths in the US are white men 50 years or older, researchers set out to identify factors associated with detection of melanoma overall and to compare factors associated with detection of thinner vs. thicker tumors in middle aged and older men. Of the men who completed the study, 25 percent had thicker tumors, which were associated with nodular histologic features (in 44 percent of patients), a lack of atypical nevi, educational status less than high school and detection by the patient instead of a physician. By contrast, factors associated with thinner tumors were knowledge of melanoma, awareness of information regarding detection of skin cancer, an interest in health topics, and knowledge of the importance of skin examinations.

Another new study found that health system factors, such as insurance and facility type, influence the rate of sentinel lymph node biopsy (SLNB) in patients with clinically staged node-negative melanoma (J Clin Oncol; 27: 1857-1863). Researchers examined data from the National Cancer Database and found that among patients with clinical stage IB/II disease, SLNB was significantly less likely to be done if patients were older than 75 years of age, were nonwhite, were covered by Medicaid or Medicare, were treated at other academic centers, VA facilities, or community hospitals, or lived in the Northeast, South and West census regions. Importantly, patients with clinical stage IA disease were significantly more likely to undergo SLNB if they were younger than 56 years of age, if they underwent surgery at community hospitals, or if they received treatment at hospitals in the Mountain or Pacific regions.

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