August 21
IN THIS ISSUE / August 21, 2019
- FDA grants breakthrough therapy designation to advanced melanoma treatment
- DW Insights and Inquiries: Rejecting preconceived notions of squamous cell carcinomas in patients experiencing transplant rejections
- Quality Payment Program hardship exemption applications now available
- New hidradenitis suppurativa guidelines highlight disease complexity
- Submit an abstract for the Gross and Microscopic Symposium
FDA grants breakthrough therapy designation to advanced melanoma treatment
The U.S. Food and Drug Administration (FDA) has granted breakthrough therapy designation to bempegaldesleukin (NKTR-214) in combination with nivolumab (Opdivo®) for the treatment of unresectable or metastatic melanoma. Nivolumab is approved in the U.S. for the treatment of several cancers, including certain patients with melanoma. Bempegaldesleukin is an investigational CD122-preferential IL-2 pathway agonist.
The breakthrough designation was based on results of patients with metastatic melanoma who received the combination therapy in phase 1/phase 2 trials. Enrollment is underway for a phase 3 trial to evaluate the combination therapy versus nivolumab alone as first-line treatment of advanced melanoma. Learn more about the latest guidelines of care for the management of primary cutaneous melanoma in Dermatology World.
Related Content:
- What is the USPSTF and what do its skin cancer counseling recommendations mean for the specialty and patients? – Dermatology World (April 2019)
- On target: New approaches to skin cancer treatment and prevention – Dermatology World (August 2016)
- AAD product: Melanoma patient pamphlet
Dermatologists are keenly aware of immunosuppression’s profound biologic effects. Whether by disease or iatrogenic means, clinical vigilance is mandated because of an elevated risk of malignancy, infection, or inflammatory dermatoses.
In a study of 177 organ transplant recipients (OTR) in Brazil, the mean age of the study participants was 52 years, while the mean age of those with transplantation was 42.7 years. The kidney was the most common organ transplanted (72%). Skin lesions were found in 147 patients (83%). Cutaneous infections were seen in 106 patients (60%). Warts (30%) had the highest incidence. Superficial mycoses occurred in 16% of OTR, mostly onychomycosis. Actinic keratosis (AK) occurred in 31% of patients and cutaneous tumors in 56%. Squamous cell carcinoma (SCC) was the most common tumor type affecting 36% of OTR (n = 64), with invasive SCC predominating over in situ SCC, whereas basal cell carcinoma (BCC) accounted for 17% of the tumors. Inflammatory complications predominantly due to transplantation medications (acne, alopecia, hypertrichosis, and gingival overgrowth) were observed in 17.5% of patients.
This commentary focuses on solid organ transplantation (SOT) patients, with an emphasis on squamous cell carcinomas in the context of organ transplant rejection. As the number of transplant recipients escalates, dermatologists will increasingly confront this problem.
Quality Payment Program hardship exemption applications now available
MIPS-eligible clinicians who are impacted by extreme and uncontrollable circumstances may submit a request for reweighting the Quality, Cost, and Improvement Activities performance categories. “Extreme and uncontrollable circumstances” are defined as rare events entirely outside of your control and the control of the facility in which you practice.
These extreme and uncontrollable circumstances would cause you to either be:
- Unable to collect information necessary to submit for a performance category OR
- Unable to submit information that would be used to score a performance category for an extended period (e.g., if you were unable to collect data for the Quality performance category for three months).
To learn more about applying for a hardship exemption, view the QPP exceptions before Dec. 31, 2019, for the 2019 MIPS performance year. You will be notified by email regarding the approval or denial of your request. Approval will be added to your eligibility profile in the QPP Participation Status Tool. For more information and resources about 2019 MIPS reporting visit the Academy's MIPS Reporting Resource Center.
Related content:
- Get ready for MIPS in 2019 – Dermatology World (February 2019)
- Earning a high performance bonus for MIPS: Using DataDerm to report – Dermatology World (November 2018)
- Academy's DataDerm™
- AAD product: 2019 MIPS Reporting Module
New hidradenitis suppurativa guidelines highlight disease complexity
New guidelines for the diagnosis, evaluation, and management of hidradenitis suppurativa (HS) have been published by experts from the United States and Canadian Hidradenitis Suppurativa Foundations in JAAD. According to the guidelines, the latest HS research suggest genetic susceptibility and dysregulation in the innate and adaptive immune pathways. Treatment can combine both medical and surgical approaches.
The guidelines recommend Hurley staging in the clinical setting, which is categorized in stages of severity from I to III. The Hidradenitis Suppurativa Clinical Response is the most validated dynamic physical measure to assess treatment response. Regular screening for smoking, diabetes, metabolic syndrome, depression/anxiety, and squamous cell carcinoma is recommended.
While there was little high-quality research on the surgical management of HS lesions, “In a series of 590 patients with excision, deroofing or drainage, drainage was associated with the highest recurrence, whereas deroofing and wide excision were about equal in effectiveness,” wrote the study authors. Typically, surgical intervention is reserved for disease unresponsive to pharmacologic care.
Related Content:
- Hidradenitis suppurativa and socioeconomic status: Food for thought (and benefit) – DW Insights and Inquiries (October 2016)
- Do HS patients have a greater comorbidity burden than psoriasis patients? – DW Weekly (June 2019)
- Hidradenitis suppurativa linked to cardiovascular disease – DW Weekly (March 2019)
- AAD product: Dialogues in Dermatology podcast subscription
Submit an abstract for the Gross and Microscopic Symposium
The Gross and Microscopic Dermatology Symposium provides an opportunity for a five-minute presentation of clinical and investigative studies of patients and their disease. Studies for consideration should focus on common diseases with unusual facets or unusual diseases with attendant teaching value. Selected applicants will present at the symposium during the Academy’s 2020 Annual Meeting in Denver.
A panel of judges will select a grand prize winner, who will receive complimentary registration for the 2021 Annual Meeting. Abstracts must be submitted by 5 p.m. (CST) Aug. 28, 2019.
