March 13
IN THIS ISSUE / March 13, 2019
- Is routine laboratory monitoring for isotretinoin patients necessary?
- Welcome to Dermatology World Insights and Inquiries
- Innovative learning experiences equip members to provide compassionate patient care
- Scientists report curing HIV-positive patient for a second time
- Hidradenitis suppurativa linked to cardiovascular disease
- FDA statement discusses plan for naming biological medicines
Is routine laboratory monitoring for isotretinoin patients necessary?
Based on a recent study accepted for publication in JAAD, researchers suggest that monthly lab monitoring may be unnecessary for and burdensome to patients taking isotretinoin. The retrospective analysis included 903 patients taking isotretinoin for acne. Patients took twice-daily isotretinoin, starting at 10 to 20 mg and increasing to a maximum dose of 40 to 80 mg for a duration of four to nine months. There was no clinically significant anemia, thrombocytopenia, or leukopenia observed. Any elevations in triglycerides, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) resolved at follow-up upon completion of isotretinoin treatment.
Since alterations of lipid and liver aminotransferases levels tended to be clinically insignificant, the authors recommend reducing laboratory tests to baseline, at two to three months, and upon completion of the treatment course, with more frequent monitoring as needed. Routine baseline plus monthly laboratory monitoring in patients who complete a six-month course of isotretinoin would cost approximately $525, compared to $225 for patients who are assessed at baseline, two to three months, and six months.
Keep reading about acne updates as experts discuss isotretinoin, pregnancy, and other hot topics in Dermatology World.
Related Content:
- Overusing acne antibiotics? – Dermatology World (August 2015)
- Comparing therapies for pre-adolescent acne – Dermatology World (March 2014)
- Dissecting the FDA’s Risk Evaluation and Mitigation Strategies safety program – Dermatology World (July 2017)
- For your patients: Isotretinoin – Treatment for severe acne
- AAD product: Simulated Patient Encounter – Medication Management
Welcome to Dermatology World Insights and Inquiries
Keeping up with clinically relevant dermatologic literature has become an increasingly daunting task. The time constraints facing dermatologists (and all physicians) have multiplied, as have administrative demands, burdens of electronic records, etc., challenging even the most time-efficient, organized practitioner.
Dermatology World Insights and Inquiries (DWI&I) is the culmination of a process that began years ago. When I had the honor of editing Dialogues in Dermatology, I needed to read widely, writing three commentaries per month. Although demanding, I truly felt “at the top of my game.”
There was a void once my editorship ended. Although I continued to read broadly, it was not with the same urgency, purpose, or alacrity. A sense of mastery is vital in battling burnout. Mukherjee observed that when she and her colleagues survived burnout by committing themselves to research. “We didn’t burn out, perhaps, by burning a little more.”
Innovative learning experiences equip members to provide compassionate patient care
Excellence in dermatology through education and advocacy. One of five strategic goals under the Academy’s new Strategic Plan, this reflects the Academy’s commitment to providing dermatologists with the education and environment that equip them to deliver quality and compassionate patient care. Dermatology World Weekly asked AAD Board member Robert Kirsner, MD, PhD, what this goal means for Academy members.
Scientists report curing HIV-positive patient for a second time
Scientists believe a patient has been cured of HIV for only the second time ever, reported The Hill. The patient, who has chosen to remain anonymous, quit taking the HIV drugs in September 2017 and has remained virus-free for more than a year since stopping the medication. The New York Times reported that scientists are publicly calling this case a long-term “remission,” but others are calling it a cure. The researchers are expected to publish a report in the journal Nature.
Both HIV cures resulted from bone-marrow transplants intended to treat cancer. However, some experts indicate that bone marrow transplantation is unlikely to be a realistic option in the near future because of the procedure’s high risk and harsh side effects, although rearming the body with immune cells similarly modified to resist HIV may prove to be a practical and successful treatment.
Read about how dermatologists continue to build upon decades-long involvement with the global treatment of HIV in Dermatology World.
Related Content:
- Exploring dermatology’s role in identifying and treating public health trends – Dermatology World (July 2018)
- Experts discuss cultural and medical competencies of caring for lesbian, gay, and bisexual patients –Dermatology World (November 2017)
- AAD product: Digital patient pamphlets
Hidradenitis suppurativa linked to cardiovascular disease
Hidradenitis suppurativa (HS) is associated with an elevated risk for stroke, coronary artery disease, heart failure, and peripheral artery disease, according to a new study presented at the AAD’s 2019 Annual Meeting in Washington, D.C. The risk persists even after controlling for comorbidities such as hyperlipidemia, smoking, and diabetes, said lead investigator Rachel Ward, MPH, from Duke University School of Medicine.
The researchers performed a retrospective cohort study of patients from Duke University Medical Center: 4,914 patients with HS; 4,641 patients with psoriasis; and a random selection of 23,000 healthy control subjects. Patients with HS were at a significantly higher risk than control subjects for stroke, peripheral artery disease, coronary artery disease, and heart failure. They were also at higher risk for these events than patients with psoriasis, although not significantly so. The researchers recommend screening all HS patients, including children, more vigilantly so that cardiovascular disease risk can be assessed and treated if necessary.
Related Content:
- Are HS patients at increased risk for CV events? – Dermatology World (February 2017)
- Use of laser and light-based treatments and anti-TNFα therapy for hidradenitis supurativa – Dermatology World (December 2015)
- Connecting the dots: Experts profile the link between metabolic syndrome and dermatologic disease –Dermatology World (June 2016)
- For your patients: All about HS
FDA statement discusses plan for naming biological medicines
On March 7, FDA Commissioner Scott Gottlieb, MD, announced an important update on naming conventions for biological medicines to balance market competition and patient safety. “In January 2017, the FDA published a guidance document in which we sought to balance these concerns by using a distinguishing suffix to the proper names of biological products, including not just biosimilars, but originator products as well,” said Dr. Gottlieb. Additionally, the FDA had said it was considering retrospectively changing the names of biological products already on the market by adding distinguishable suffixes.
In this recent statement, Dr. Gottlieb announced the following three decisions:
- The FDA no longer intends to modify proper names of biological products that have already been licensed or approved without an FDA-designated suffix in their proper names.
- The FDA does not intend to apply the naming convention to the proper names of transition biological products.
- Going forward, for interchangeable biosimilars, the FDA intends to designate a proper name that is a combination of the core name and a distinguishing suffix composed of four meaningless lowercase letters.
The goal of the FDA’s naming policy is to provide consistency among biologics and help ensure health care providers and patients feel confident and safe using any biological product on the market. “To achieve these goals, the unique four-letter suffix that’s incorporated as part of a biological product’s nonproprietary name is being applied to originator products going forward, as well as to any biosimilar and interchangeable products, so they can be appropriately distinguished from one another at the pharmacy level.” The unique suffixes will also allow the FDA to track adverse events to a specific biological product and manufacturer. The FDA is aiming to mitigate the risk of false perceptions from health care providers and patients that there’s a difference in the relative safety and effectiveness of these biological products based on their name.
Want a refresher on biosimilars versus interchangeable biosimilars, or why it’s taking so long for biosimilars to reach the market? Catch up in Dermatology World.
Related Content:
- Will the biosimilars pathway lead to savings? – Dermatology World (November 2016)
- Battling for biologics – Dermatology World (September 2015)
- The promise and pitfalls of biosimilars – Dermatology World (June 2013)
- AAD product: 2019 Annual Meeting On-Demand Recordings
