What treatment is most effective for refractory spontaneous urticaria?
According to a study published in JAMA Dermatology, ligelizumab and omalizumab were found to be the most effective treatments for adolescent and adult patients with chronic spontaneous urticaria who had did not respond to H1 antihistamines.
In a meta-analysis of 23 randomized clinical trials, which included 2,480 participants, 18 different interventions and dosages were studied, in addition to placebo groups. Ligelizumab, 72 or 240 mg, was found to have a large beneficial effect, and 300 or 600 mg of omalizumab was found to have a moderately beneficially effect. The standardized mean differences for change in urticaria symptoms was 1.05 for 72 mg of ligelizumab (1.07 for 240 mg) while the SMD for 300 mg of omalizumab was 0.77 (0.59 for 600 mg).
Read about how collaboration and diverse expertise strengthen clinical practice guidelines inDermWorld.
DermWorld Insights and Inquiries: Following up on “A Trend I Cannot Endorse”
After finishing an excellent article about public perceptions of sunscreen labeling, I wanted to see if the medical use of the word “endorse” is now in the dictionary. In the manuscript itself there were two sentences utilizing the word: 1) “More than half endorsed at least one previous dermatology visit (54.2%) and having received prior sunscreen counseling by a health care provider (51.9%).” 2) “Approximately half (46.1%) assumed ‘dermatologist recommended’ or ‘clinically proven’ sunscreens were endorsed by the AAD.”
I am 100% comfortable with the second sentence. The first I find irksome. Would patients have endorsed the visit if perchance they were dissatisfied with the encounter?Keep reading!
DermWorld Young Physician Focus: Serendipity
If you were offered a chance to see into the future, would you take it? I often think about how blatantly wrong I would have been if I were asked to predict my career path after residency. During my training, one of the things I enjoyed most was working with so many unique mentors, whose imparted wisdom I have tried to incorporate into my treatment of patients. I recall admiring the widely variable interest areas of my attendings, and the mental picture I attempted to form of my own future practice. Throughout my training, the search for a niche or area of interest eluded me, but as with so many important questions in life, looking back I realize that all my worry was for nothing. Read more from DermWorld Young Physician Advisor Jenna O’Neill, MD, FAAD.
Lawsuit filed against FDA alleged inaction on hair loss drug potential side effects
The consumer advocacy group Public Citizen filed a lawsuit on behalf of the Post-Finasteride Syndrome Foundation against the U.S. Food and Drug Administration (FDA), alleging that the agency failed to act on a petition submitted by the foundation four years ago, according to a report from Medscape.
The petition requested that the FDA remove finasteride, 1 mg, from the market due to evidence of serious risk of patient injury, including depression and suicidal ideation. As an alternative ask, the foundation requested that the FDA ensure the revision of safety information, including a boxed warning to disclose the potential for side effects.
The foundation also noted that Canadian and European regulators do require a warning about suicide, and advise that treatment be discontinued if a patient becomes depressed.
To those outside the world of dermatology, hair is sometimes perceived to be a cosmetic concern. Dermatologists know better. With a high psychosocial burden and limited or no treatments approved by the FDA, patients with a variety of life-altering hair loss conditions must often wade through a multitude of treatments — and even still — may only have partial or no response. Read more about managing hair loss in DermWorld.
Dermatologist Seemal R. Desai, MD, FAAD, reappointed to FDA Pharmacy Compounding Advisory Committee
Seemal R. Desai, MD, FAAD, has been reappointed for a four-year term as a full voting member of the U.S. Food and Drug Administration’s Pharmacy Compounding Advisory Committee (PCAC). Dr. Desai is the sole dermatologist on this national FDA committee, and was originally appointed in 2017. With this reappointment he will serve a second term through Sept. 30, 2025.
The committee provides advice on scientific, technical, and medical issues concerning drug compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act, and, as required, any other product for which the Food and Drug Administration has regulatory responsibility, and makes appropriate recommendations to the Commissioner of Food and Drugs. Dr. Desai’s presence on the committee ensures representation for dermatology on an important body for regulatory policy.
Hurricane Ida triggers MIPS extreme and uncontrollable circumstances policy
The Centers for Medicare & Medicaid Services (CMS) has determined that the automatic extreme and uncontrollable circumstances (EUC) policy will apply to Merit-based Incentive Payment System (MIPS)-eligible clinicians in FEMA-designated disaster areas of Louisiana, Mississippi, New York, New Jersey, and Missouri. MIPS eligible clinicians in these areas will be automatically identified and receive a neutral payment adjustment for the 2023 MIPS payment year. The automatic EUC policy won’t apply to MIPS eligible clinicians participating in MIPS as a group, virtual group, or Alternative Payment Model (APM) entity.
During the data submission period for the 2021 performance period (Jan. 3, 2022, to March 31, 2022), all four performance categories for these clinicians will be weighted at 0%, resulting in a score equal to the performance threshold. However, if MIPS-eligible clinicians in these areas choose to submit data on two or more performance categories, they will be scored on those categories and receive a 2023 MIPS payment adjustment based on their 2021 MIPS final score. View the CMS fact sheet for more information.
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