Dermatology Month in Review: April 2025

Every month, the HCPLive editorial team publishes a Month in Review series highlighting some of the most notable news coverage from the month in each medical subfield. Here, we highlight some of our biggest stories in the field of dermatology.

The dermatology space in the month of April saw a variety of notable developments, including a variety of significant therapeutic pipeline data and 2 notable approvals by the US Food and Drug Administration (FDA) for chronic spontaneous urticaria (CSU) and recessive dystrophic epidermolysis bullosa (RDEB). In the following review, these stories represent some of April’s most significant coverage of such developments in the field of dermatology:

FDA Approvals:

FDA Approves Pz-cel (Zevaskyn) Gene Therapy for RDEB

In 1 notable April approval, the FDA made prademagene zamikeracel (Zevaskyn) the first autologous cell-based gene therapy to be approved for individuals living with the rare genetic disease RDEB, a subtype of episodermolysis bullosa. The therapy itself uses genetically modified patient cells to deliver the COL7A1 gene.

Clinical research prior to the approval demonstrated the treatment’s efficacy in wound healing and reduction of RDEB-related pain, with effects lasting years following a single application. The approval by the agency addresses unmet needs for reliable RDEB wound treatment, especially for those showing chronic and infection-prone wounds.

FDA Approves Dupilumab (Dupixent) for Chronic Spontaneous Urticaria

In another significant move by the FDA from April, dupilumab was approved by the agency for CSU in individuals aged 12 and older who report uncontrolled by H1-antihistamines, making the drug the first new targeted treatment approved for the condition in over a decade. In phase 3 results released prior to the approval, dupilumab was shown to significantly improve pruritus severity and urticaria activity versus those given a placebo at 24 weeks.

“[Duilumab] is the first new targeted treatment for chronic spontaneous urticaria, or CSU, in over ten years, with pivotal trials demonstrating its ability to help patients significantly reduce the hallmark symptoms of intense itch and unpredictable hives associated with this disease,” George D. Yancopoulos, MD, PhD, board cochair, president, and chief scientific officer at Regeneron, and a principal inventor, said in a statement.

Treatment Pipeline News:

Baricitinib Confirmed Safe and Efficacious for Treating Alopecia Areata

Results from the BRAVE-AA1 and BRAVE-AA2 trials were also highlighted in April, the study of which had the following primary outcome: a Severity of Alopecia Tool (SALT) score of 20 or less at the 36-week mark. These clinical trials were ongoing randomized, double-blind, parallel-group, placebo-controlled analyses that included 654 and 546 participants, respectively.

“The long-term data from the integrated safety analysis of patients with severe [alopecia areata] in the BRAVE-AA1 and BRAVE-AA2 clinical trials, spanning up to 4 years, reinforce the established safety profile of baricitinib over an extended period,” the investigators wrote. “Importantly, the rates of [adverse events of special interest] AESIs have remained stable, falling within the expected background rates for the general [alopecia areata] population.”1

Topline Results Released on IMG-007 Monoclonal Antibody for Alopecia Areata

IMG-007, a treatment targeting OX40, was shown to result in dose-related hair regrowth and SALT score improvements among individuals living with severe alopecia areata in another study covered in April. The anti-OX40 humanized IgG1 monoclonal antibody was assessed in the phase 2a study, during which investigators used a multiple ascending dose trial design at 11 sites in both Canada and the US.

The investigative team found that those in the higher-dose cohort exhibited significant SALT score reductions, as well as a durable response and no plateau by the 36-week mark. IMG-007 was found by the team to be well-tolerated, with the study demonstrating a lack of serious adverse events as well as only mild to moderate treatment-emergent adverse events among those treated.

Icotrokinra Clears Skin Among 75% of Adolescents with Plaque Psoriasis

New phase 3 findings from the ICONIC-LEAD trial were also highlighted in April, with findings demonstrating icotrokinra's efficacy and safety among both adolescents and adults with moderate-to-severe plaque psoriasis. Adolescents given icotrokinra were shown to have significantly higher skin clearance rates than those in the placebo group at 16 weeks, with 84.1% achieving Investigator's Global Assessment (IGA 0/1 and 70.5% attaining Psoriasis Area and Severity Index (PASI) 90.

“Data from the Phase 3 ICONIC LEAD subgroup analysis demonstrate impressive efficacy rates, showing the promise of this novel therapeutic option in the treatment of adolescents with moderate-to-severe plaque psoriasis who've often not yet received an advanced therapy," Lawrence Eichenfield, MD, investigator and Chief of Pediatric and Adolescent Dermatology at Rady Children's Hospital-San Diego, said in a statement.

Subcutaneous Methotrexate Superior to Oral Version in Key Areas for Psoriasis

Other data released in April demonstrated that subcutaneous methotrexate (MTX) may provide greater efficacy with increased response time versus oral treatment among patients with psoriasis, a recent literature review’s findings suggest.

The subcutaneous version overcame certain limitations observed in the oral version in terms of intestinal absorption, bioavailability, and safety results. These findings were the result of a literature review that evaluated studies from the timeframe between 2015 - 2023, with the investigators focusing on safety, treatment efficacy, and adherence, despite the limited and heterogeneous data available on the subject.

Upadacitinib Effective for Atopic Dermatitis, Maintaining High Retention Rate

Upadacitinib was shown in another study highlighted in April to provide patients with atopic dermatitis with a longer-lasting therapeutic option. This real-world study demonstrated strong overall retention rates among individuals with this inflammatory skin disease.

“The results of this study have broad implications for clinical practice and healthcare policy," the investigators wrote. "By providing real-world evidence on drug survival rates and the factors influencing treatment discontinuation, this research informs clinicians on the relative merits of each biologic in the management of [atopic dermatitis].”