Dermatology Month in Review | November 2024

This installment of the Month in Review series features a set of highlights of the HCPLive editorial team’s dermatology news coverage. A wide variety of developments in the field of dermatology are covered in this review, including US Food and Drug Administration (FDA) news.

Some of the most significant events taking place in November in dermatology included a new approval of bimekizumab, several accepted resubmissions to the FDA, and several stories related to psoriasis and hidradenitis suppurativa (HS).

Here, the editorial team present this series of major developments from November in the field of dermatology:

FDA News in Dermatology:

FDA Approves Bimekizumab for Adults with Hidradenitis Suppurativa

UCB made an announcement that FDA officials had given their approval to bimekizumab-bkzx (Bimzelx), a humanized IgG1 monoclonal antibody, for the treatment of adults with moderate-to-severe HS. The therapy option is the first and only treatment specifically design with the goal of targeting and inhibiting both interleukin (IL)-17A and IL-17F cytokines.

“The approval of (bimekizumab) in moderate-to-severe hidradenitis suppurativa is welcome given the substantial unmet clinical needs and limited number of treatment options available today,” Alexa B. Kimball, MD, MPH, investigator and professor of dermatology at Harvard Medical School, said in a statement. “In the Phase 3 clinical studies, patients treated with bimekizumab-bkzx achieved deep and sustained clinical responses up to 48 weeks.”

FDA Accepts Resubmitted sBLA for Dupilumab Treatment of Chronic Spontaneous Urticaria

In another FDA-related announcement, Regeneron Pharmaceuticals, Inc. and Sanofi expressed that their resubmitted supplemental Biologics License Application (sBLA) for dupilumab (Dupixent) had been accepted by FDA officials for chronic spontaneous urticaria (CSU) treatment among adults and adolescents aged 12 and older with CSU that has been inadequately managed using H1 antihistamines.

The sBLA’s resubmission was supported by findings resulting from the LIBERTY-CUPID phase 3 clinical program. This program included 3 studies that evaluated the use of dupilumab in individuals with CSU.

FDA Accepts Resubmission of Pz-cel Gene Therapy BLA for Epidermolysis Bullosa

Abeona Therapeutics Inc. also announced in November that that their Biologics License Application (BLA) was resubmitted for the investigational gene therapy known as prademagene zamikeracel (pz-cel), a therapy designed for patients with recessive dystrophic epidermolysis bullosa (RDEB).

The FDA, as part of the process of reviewing this treatment, assigned pz-cel a target action date under the Prescription Drug User Fee Act (PDUFA) for April 29, 2025. Abeona’s resubmission of the treatment’s BLA resulted from recent clinical findings that highlighted the safety and efficacy of pz-cel following a single administration for both the pivotal phase 3 VIITAL study as well as a phase 1/2a study.

Psoriasis Developments:

Link Identified Between Obesity, Inflammatory Skin Diseases Such as Psoriasis

In another story covered in November, a new study suggested that 1 of the highest associations between obesity and inflammatory skin conditions was the diagnosis of rosacea. However, these data also indicated that morbid obesity had the strongest link with plaque psoriasis and lichen simplex chronicus.

“Obesity as a risk factor has been predominantly associated with psoriasis and hidradenitis suppurativa in cutaneous pathology, but limited studies have explored the connection to other diseases within the inflammatory skin domain,” the investigators wrote.

Positive Phase 3 Results Announced for JNJ-2113 Treatment of Psoriasis

Another story covered in November was the announcement by Protagonist Therapeutics, Inc. that, positive findings from their collaboration with Johnson & Johnson on the ICONIC-LEAD and ICONIC-TOTAL studies in phase 3 research were identified for individuals with psoriasis treated with the oral peptide JNJ-2113 (icotrokinra).

“These positive Phase 3 results confirm the compelling efficacy and safety trends that were observed with the previous Phase 2b FRONTIER-1 and -2 studies, highlighting (JNJ-2113’s) potential as a best-in-class oral agent providing an ideal combination of significant skin clearance with demonstrated tolerability in a once-daily pill for treating plaque psoriasis,” Dinesh V. Patel, PhD, president and CEO of Protagonist, said in a statement.

Other Dermatology News:

Study Finds Chronic Psychological Stress Triggers Skin Aging

In another study covered in November, investigators found that chronic psychological stress significantly affects skin homeostasis and can lead to the aging of one’s skin. The research team noted that while data exists regarding biological markers of psychological stress and their effect on immune function and inflammatory markers, their had been very little data on precise causes of visible skin aging’s connection to stress.

“The present investigations confirm that chronic (psychological stress) impacts skin appearance through stress hormones such as cortisol and epinephrine, and these studies have provided the first supporting elements,” the investigators wrote. "Further research and clinical studies need to be conducted to confirm these findings.”

Study Highlights Factors Associated with Diagnostic Wandering Among Patients with HS

Another study highlighted from November showed that diagnostic wandering among individuals with HS is associated with several factors such as being female, being over the age of 40, having an income below minimum wage, and having a lower level of educational attainment. ‘Diagnostic wandering’ refers to the process in which multiple tests, consultations, or referrals are provided to patients without a definitive diagnosis.

“This term often describes situations where healthcare providers are unable to pinpoint the exact cause of a patient's symptoms, leading to a prolonged search for a diagnosis,” the investigators wrote. “This study aimed to assess diagnostic wandering in HS patients and identify associated factors in France.”